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REAGENTS
Version : CAN-011 March 2005
SEPPIM S.A
ZONE INDUSTRIELLE
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CLINICAL
CHEMISTRY
REAGENTS
Pages
A Pages GLUCOSE PAP SL . . . . . . . . . . . . . . . . . GPSL-4 . . . . . 57-58
Update ACID PHOSPHATASE . . . . . . . . . . . . . . . PACI-4 . . . . . 11-12 GLUCOSE PAP . . . . . . . . . . . . . . . . . . . . GLUP-3 . . . . . . . 59
AMYLASE . . . . . . . . . . . . . . . . . . . . . . . AMYL-4 . . . . . . . . 19 I
Update AST/GOT 4+1 SL. . . . . . . . . . . . . . . . ASSL 4/1-3 . . . . . 20-21 IRON CHROMAZUROL . . . . . . . . . . . . . FECA-3 . . . . . . . 62
AST/GOT . . . . . . . . . . . . . . . . . . . . . . . . . ASAT-3 . . . . . . . . 22 IRON FERROZINE® . . . . . . . . . . . . . . . . FEFR-3 . . . . . 63-64
IRON TIBC . . . . . . . . . . . . . . . . . . . . . . . . TIBC-3 . . . . . . . 65
B L
LACTATE . . . . . . . . . . . . . . . . . . . . . . . . . LACT-2 . . . . . 66-67
BILIRUBIN TOTAL & DIRECT . . . . . . . . . BILI-2 . . . . . 23-24 Update LDH-P 4+1 SL . . . . . . . . . . . . . . . . . . . LDSL 4/1-3 . . . . . 68-69
LDH-P . . . . . . . . . . . . . . . . . . . . . . . . . . . LDHP-3 . . . . . . . 70
C
CALCIUM ARSENAZO . . . . . . . . . . . . . . CALA-3 . . . . . . . . 25 M
CALCIUM OCPC . . . . . . . . . . . . . . . . . . CALO-2 . . . . . 26-27 MAGNESIUM CALMAGITE . . . . . . . . . MAGN-3 . . . . . . . 71
CHLORIDE . . . . . . . . . . . . . . . . . . . . . . CHLO-2 . . . . . . . . 28 MAGNESIUM RBCs . . . . . . . . . . . . . . . . MGER-2 . . . . . . . 72
MICROPROTEIN . . . . . . . . . . . . . . . . . . . PRTP-4 . . . . . 73-74
Update CHOLESTEROL SL . . . . . . . . . . . . . . . . CHSL-6 . . . . . 29-30
CHOLESTEROL . . . . . . . . . . . . . . . . . . CHOL-2 . . . . . . . . 31
Update CHOLESTEROL LDL DIRECT SL . . . . . LDLD-3 . . . . . 32-33
P
PAL (DEA) SL . . . . . . . . . . . . . . . . . . . . . . PASL-3 . . . . . 75-76
Update CHOLESTEROL HDL DIRECT SL . . . . . HDLD-3 . . . . . 34-35 PAL (DEA) . . . . . . . . . . . . . . . . . . . . . . . . PALC-3 . . . . . . . 77
HDL CHOLESTEROL . . . . . . . . . . . . . . . HDLC-3 . . . . . . . . 36 PHOSPHORUS . . . . . . . . . . . . . . . . . . . PHOS-6 . . . . . 78-79
CHOLINESTERASE . . . . . . . . . . . . . . . CHES-3 . . . . . 37-38
CK NAC SL . . . . . . . . . . . . . . . . . . . . . . CKSL-3 . . . . . 39-40
T
TOTAL PROTEIN . . . . . . . . . . . . . . . . . . PRTB-3 . . . . . 80-81
CK NAC . . . . . . . . . . . . . . . . . . . . . . . . . CKNA-3 . . . . . . . . 41 Update TRIGLYCERIDES MONO SL NEW . . . . TGMLN-8 . . . . . 82-83
CK-MB SL. . . . . . . . . . . . . . . . . . . . . . . . CMSL-2 . . . . . 42-43 TRIGLYCERIDES . . . . . . . . . . . . . . . . . . TRIG-2 . . . . . 84-85
IMMUNOLOGY
AGGLUTINATION REAGENTS
Update ASO LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXAS-4 . . . . . . . . . . 117-118
Update CRP LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXCR-4 . . . . . . . . . 119-120
Update FR LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXRF-4 . . . . . . . . . 121-122
Update R.P.R. CARBON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXRP-4 . . . . . . . . . 123-124
Update WAALER ROSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXWR-4 . . . . . . . . . 125-126
RAPID TESTS
PREGTEST II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTHC2-3 . . . . . . . . . 129-130
-RAPIDROG II-
Amphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTAM-2 . . . . . . . . . 131-132
Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTBA-2 . . . . . . . . . 133-134
Benzodiazepines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTBZ-2 . . . . . . . . . 135-136
Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTCO-2 . . . . . . . . . 137-138
Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTMT-2 . . . . . . . . . 139-140
Morphine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTMO-2 . . . . . . . . . 141-142
Multi 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTDQ-3 . . . . . . . . . 143-146
THC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTTH-3 . . . . . . . . . 147-148
OTHER REAGENTS
New PMR Test Amnicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PMRT-6. . . . . . . . . . . 151-152
Vt : Total volume
Vs : Sample volume
L : Light path length
e : Molar extinction coefficient
PROCEDURE
Reagent 2 : R2
This reagent can be used manually (see method below) and
L-Tartrate 2 mol/L on most analysers. The applications are available on request.
Reagent 3 : R3
Wavelength : 405 nm
Acetate buffer, pH 5.00 5 mol/L
Temperature : 37°C
Cuvette : 1 cm light path.
PRECAUTIONS
Use clean or single glass material only to avoid contamina-
Read against distllled water
tions.
(03/2005)
FTAN-PACI-4
CALCULATION - Interferences
Total ACP : Activity (U/L) = ∆OD/min. x 853 According to SFBC recommendations (Vassault and Coll
NP ACP : Activity (U/L) = ∆OD/min. x 860 1986), studies have been performed to determine the level of
Prostatic fraction (U/L) = Total ACP (U/L) - NP ACP (U/L). interference from different compounds:
Between-run reproducibility
Total acid phosphatase
Serum 1:
n = 15 m= 7.8 U/L CV = 2.3 %
Serum 2 :
n = 15 m = 32.7 U/L CV = 1.1 %
(03/2005)
FTAN-PACI-4
tion, analbuminemia, 3) increased loss: nephritic syndrom, Ambulatory patients Patients at rest
gastrointestinal loss, sever and large burns, bedsore, 4) 3.8 - 5.5 g/dL 3.5 - 5.2 g/dL
increased catabolism: fever, hyperthyroidism... 38 - 55 g/L 35 - 52 g/L
METHOD (6-8)
Note : It is recommended for each laboratory to establish and
Colorimetric maintain its own reference values. The given data here are only
Bromocresol green (BCG) an indication.
PRINCIPLE (6-8)
PROCEDURE
Colorimetric determination of serum albumin using bromocre-
This reagent can be used manually (see method below) and
sol green (BCG) at pH 4.20.
on most analysers.
The applications are available on request.
pH = 4,20
Albumin + BCG Albumin-BCG complex Wavelength : 628 nm
Temperature : 37°C
Cuvette : 1 cm light path
REAGENTS COMPOSITION
Read against reagent blank.
Reagent : R
BLANK STANDARD SAMPLE
Succinate buffer, pH 4.20 87 mmol/L
Bromocresol green 0.2 mmol/L Reagent 1 mL 1 mL 1 mL
Brij 35 7.35 ml/L Distilled water 10 µL - -
Standard - 10 µL -
Standard : Std Sample - - 10 µL
Bovine albumin 5 g/dL
Mix and read the optical density (OD) after a 5 minute incu-
50 g/L
bation. The final colour is stable for at least 15 minutes.
PRECAUTIONS
- The standard contains less than 0.1 % sodium azide. Sodium CALCULATION
azide. Sodium azide can react with copper and lead plumbing
OD Sample g/dL n= 5
to form explosive metal azides.
Regulations currently in use regarding dangerous waste elimi- xn g/L n= 50
nation must be respected. If discharge in the canalisations, OD Standard
rinse with plenty of water. n = standard concentration.
- Use clean or single use glass material only to avoid conta-
minations. CALIBRATION
Albumin standard is traceable until the Certified Reference
STABILITY OF REAGENTS material, CRM 470.
On Cobas Mira, calibration must be performed at least every
When stored at 2-8° C and protected from light, the reagents
15 days, after each change of batch and according to quality
and the standard are stable until the expiry date stated on the
control results. .../...
label.
(03/2005)
FTAN-ALBU-4
(03/2005)
FTAN-ALBU-4
(01/2005)
FTAN-ALSL4/1-3
PRINCIPLE
PROCEDURE
Kinetic determination of alanine aminotransferase (ALT) based
This reagent can be used manually (see method below) and
upon IFCC recommendations :
on most analysers.
ALT
The applications are available on request.
L-Alanine + α-Ketoglutarate Pyruvate+L-Glutamate
LDH Wavelength : 340 nm (334-365)
Pyruvate + NADH + H+ L-Lactate + NAD+ Temperature : 30°C, 37°C
Cuvette : 1 cm light path
ALT = Alanine aminotransferase
LDH = Lactate dehydrogenase Read against distilled water
Working reagent : 1 mL
REAGENTS COMPOSITION
Sample : 100 µL
Reagent 1 : R1
Mix and after a 1 minute incubation, measure the change of
Tris buffer, pH 7.50 110 mmol/L optical density per minute (∆OD/min.) during 3 minutes.
L-Alanine 550 mmol/L
CALCULATION
Reagent 2 : R2 340 nm : Activity (U/L) = ∆OD/min. x 1 746
334 nm : Activity (U/L) = ∆OD/min. x 1 780
LDH 1 200 U/L
365 nm : Activity (U/L) = ∆OD/min. x 3 235
NADH 0.20 mmol/L
QUALITY CONTROL
α-Ketoglutarate 16 mmol/L
To ensure adequate quality, control sera such as ELITROL I
PRECAUTION (normal control) and ELITROL II (abnormal control) are recom-
The reagent 1 contains less than 0.1 % sodium azide. mended.
Lot number
SAMPLES
Serum free of hemolysis. Consult instruction for use
Heparin or EDTA plasma.
In vitro diagnostic medical device
(01/2005)
FTAN-ALAT-3
PRINCIPLE PROCEDURE
Substrate CNP-G3 (2-chloro-4-nitrophenyl-a-maltotrioside) is This reagent can be used manually (see method below) and
directly hydrolyzed by a-amylase to produce CNP monitored at on most analysers.
405 nm during incubation of the reagent with a sample. The applications are available on request.
Wavelength : 405 nm
Amylase Temperature : 37°C, 30°C
5 CNP-G3 3 CNP + 2 CNP-G2 + 3 Maltotriose + 2 Glucose Cuvette : 1 cm light path
PRECAUTIONS CALCULATION
The reagent contains less than 0.1 % sodium azide.
Activity (U/L) = ∆OD/min. x 4 640 at 37°C
This reagent is very sensitive to external contamination
∆OD/min. x 2 715 at 30°C
(saliva, sweat, ...).
Handle with gloves and keep the vial tightly sealed after use. Take dilution factor into account for the calculation of the acti-
Avoid direct exposure to light. vity in urine.
Stability OF REAGENT
When stored at 2-8° C and protected from light, the reagent is QUALITY CONTROL
stable until the expiry date stated on the label. To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
PREPARATION AND STABILITY mended.
OF WORKING REAGENT
The reagent is ready for use. LINEARITY
SAMPLES Up to 900 U/L
Serum. If ∆OD/min. exceeds 0.190 at 405 nm, repeat test using sam-
Heparin plasma. ple diluted 1/10 with sodium chloride solution (9 g/L).
Urine diluted 1/3 with distilled water. Multiply result by 10.
Expiration date
(01/2005)
FTAN-AMSL-2
MDH PROCEDURE
Oxaloacetate + NADH + H+ L-Malate + NAD+
These reagents can be used on most analysers. The applications
MDH = Malate dehydrogenase. are available on request.
Wavelength : 340 nm
Temperature : 37°C
REAGENTS COMPOSITION
Read against distilled water.
Reagent 1: R1
Tris buffer, pH 7.80 (30°C) 100 mmol/L One-reagent procedure
L-Aspartate 330 mmol/L
LDH ≥ 2000 U/L Working reagent : 200 µL
MDH ≥ 1000 U/L Sample : 20 µL
Expiration date
PRINCIPLE PROCEDURE
Kinetic determination of the aspartate aminotransferase (AST) This reagent can be used manually (see method below) and
based upon IFCC recommendations : on most analysers.
The applications are available on request.
AST
L-Aspartate + a-Ketoglutarate Oxaloacetate + L-Glutamate. Wavelength : 340 nm (334-365)
Temperature : 30°C, 37°C
MDH
Oxaloacetate + NADH + H+ L-Malate + NAD+ Cuvette : 1 cm light path
Sample : 100 µL
REAGENTS COMPOSITION
Mix and after a 1 minute incubation, measure the change of
Reagent 1 : R1 optical density per minute (∆OD/min.) during 3 minutes.
Tris buffer, pH 7.80 88 mmol/L
L-Aspartate 260 mmol/L CALCULATION
340 nm : Activity (U/L) = ∆OD/min. x 1 746
334 nm : Activity (U/L) = ∆OD/min. x 1 780
Reagent 2 : R2 365 nm : Activity (U/L) = ∆OD/min. x 3 235
MDH ≥ 600 U/L
QUALITY CONTROL
LDH ≥ 900 U/L
To ensure adequate quality, control sera such as ELITROL I
NADH 0.20 mmol/L
(normal control) and ELITROL II (abnormal control) are recom-
α-Ketoglutarate 12 mmol/L mended.
PRECAUTIONS
The reagent 1 contains less than 0.1 % sodium azide. LINEARITY
If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
diluted 1/10 with sodium chloride solution (9 g/L). Multiply
STABILITY OF REAGENTS
result by 10.
When stored at 2-8° C and protected from light, the reagents
are stable until the expiry date stated on the label.
BIBLIOGRAPHY
Expert panel on enzyme of the IFCC, Clin. Chim. Acta, 70,
PREPARATION AND STABILITY
(1976), F19.
OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1.
SYMBOLS USED ON LABELS :
Stability : 5 days at 20-25°C
Lot number
4 weeks at 2-8°C
Consult instruction for use
SAMPLES
In vitro diagnostic medical device
Serum free of hemolysis.
Heparin or EDTA plasma. Manufacturer’ s address
SAMPLE
Serum free of hemolysis.
Heparin plasma.
.../...
(01/2005)
FTAN-BILI-2
CALCULATION
With Factor : (OD sample - OD sample blank) x F
Total bilirubin Direct bilirubin
mg/dL F = 21.6 F = 16.8
mg/L F = 216 F = 168
µmol/L F = 367 F = 286
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
Total bilirubin : up to 20 mg/dL (200 mg/L) (340 µmol/L)
Direct bilirubin : up to 18 mg/dL (180 mg/L) (306 µmol/L)
BIBLIOGRAPHY
1.Hijmans Van den Bergh A.A., Muller P., Biochem,
77,(1916),90.
2.Walters M.I., Gerarde R.W., Microchem, 15, (1970), 231.
Lot number
Manufacturer’ s address
Temperature limitation
Expiration date
(01/2005)
FTAN-BILI-2
Expiration date
(01/2005)
FTAN-CALA-3
PRINCIPLE PROCEDURE
Colorimetric measurement with ortho-cresolphtalein complexon. This reagent is designed for use with manual method and
The 8-hydroxyquinoline prevents Mg2+ from interference up to commercially available automated analysers but it must be
4 mmol/L (100 mg/L). used only in the one-procedure reagent (with the reagent
containers tightly sealed ). Refer to the application sheet for
REAGENTS COMPOSITION instructions and specifications for use automated analysers.
(08/2004)
FTAN-CALO-2
- Precision
Within-Run
Normal Level :
n = 20 SD = 2.65 CV = 2.74 %
Pathological level :
n = 20 SD = 3.66 CV = 2.58 %
Between-run:
Normal Level :
n = 20 SD = 3.19 CV = 3.42 %
Pathological level :
n = 20 SD = 6.88 CV = 5.11 %
)INTERFERENCES
According to SFBC recommendations, some studies have been
performed to determine the level of interference from different
component :
Bilirubin : No significant interference up to 35 mg/dL
(350 mg/dL)
Haemoglobin : No significant interference up to 2 g/L
(200 mg/L)
Ascorbic Acid : No significant interference up to
40 mg/dL (400 mg/L)
Magnesium : No significant interference up to 100 mg/L
Turbidity : No significant interference up to1000 mg/dL
Triglycerides equivalent (10 g/L)
Cholesterol : No significant interference up to 0.6 g/dL
(6 g/L)
BIBLIOGRAPHY
1.Connerty H.V., Briges A.R., Am. J. Clin. Path, 45, (1966),
290.
2.Cowley B. and al., Clin. Chem., 32, (1986), 894.
3. Corns, C. and Ludman C., Anal. Clin. Biochem., 24, (1987)
345.
4.Vassault, A. Grafmeyer, D. Naudin, et al., Protocole de vali-
dation de techniques. (Document B, stade 3) Ann. Biol. Clin.,
(1986), 44, 686.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(08/2004)
FTAN-CALO-2
PRINCIPLE PROCEDURE
Chloride ions form a coloured complex when reacting with This reagent can be used manually (see method below) and
mercury (II) thiocyanate solution, the intensity of the colour is on most analysers.
proportional to the chloride concentration. The applications are available on request.
REAGENTS COMPOSITION Wavelength : 480 nm
Reagent : R Temperature : 25°C, 30°C, 37°C
Cuvette : 1 cm light path
Mercury (II) thiocyanate 2 mmol/L
Iron (III) Nitrate 20 mmol/L Read against reagent blank.
Nitric acid 29 mmol/L
Standard : Std BLANK STANDARD SAMPLE
Chloride 355 mg/dL
Reagent 1 mL 1 mL 1 mL
100 mEq/L
100 mmol/L Distilled water 10 µL - -
STABILITY OF REAGENTS Standard - 10 µL -
When stored at 20-25° C and protected from light, the reagents Sample - - 10 µL
are stable until the expiry date stated on the label.
PREPARATION AND STABILITY Mix and read the optical density (OD) after a 5 minute incuba-
OF WORKING REAGENT tion.
The reagent is ready for use. The final colour is stable for at least 1 hour.
SAMPLES
CALCULATION
Serum.
OD Sample mg/dL n= 355
Heparin plasma. xn mEq/L n= 100
Urine. OD Standard mmol/L n= 100
BIBLIOGRAPHY
Schoenfeld R.G. and al., Clin. Chem., 10, (1964), 533.
Lot number
Manufacturer’ s address
Temperature limitation
(01//2005)
FTAN-CHSL-6
PERFORMANCE DATA
The following data were obtained using the COBAS MIRA BIBLIOGRAPHY
analyser (37°C) 1.Rifai, N., et al., Lipids, Lipoproteins, and Apolipoproteins.
Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
- Analytical range C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
The reagent is linear from 20 to 600 mg/dL (0.2 to 6 g/L, (2001), 463.
0.5 to 15.5 mmol/L). 2. Naito, H.K., Coronary Artery Disease and Disorders of Lipid
Metabolism. Clinical Chemistry: Theory, Analysis, Correlation,
- Detection limit (6)
4th Ed., Kaplan, L.A., Pesce, A.J., Kazmierczak, S.C. (Mosby,
Determined according to SFBC protocol, the detection limit is Inc. eds. St Louis USA), (2003), 603.
equal to 5 mg/dL (0.05 g/L, 0.13 mmol/L). 3.Allain, C.C., et al., Enzymatic determination of total serum
cholesterol. Clin. Chem., (1974), 20, 470.
- Sensitivity 4.Tietz, N.W. Clinical guide to laboratory tests, 3rd Ed., (W.B.
The average variation of the analytical signal is 1.53 × 10-3 ∆A Saunders eds. Philadelphia USA), (1995), 130.
per mg/dL of cholesterol (or 153 × 10-3 ∆A per g/L, 0.39 ∆A 5.Expert Panel on Detection, Evaluation, and Treatment of
per mmol/L) for a light path of 1 cm. High Blood Cholesterol in Adults (Adult Treatment Panel III),
Executive Summary of the Third Report of the National
- Precision Cholesterol Education Program (NCEP). JAMA, (2001), 285,
2486.
Within-run reproducibility
6.Vassault, A., et al., Protocole de validation de techniques,
Low level : n = 20 m = 117 mg/dL CV = 1,7 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Medium level : n = 20 m = 181 mg/dL CV = 1,3 %
High level : n = 19 m = 283 mg/dL CV = 1,4 % SYMBOLS USED ON LABELS :
- Interferences (6)
The reagent 1 contains less than 0.1 % sodium azide. n = standard concentration.
(03/2005)
FTAN-LDLD-3
METHOD - Storage
Immunoinhibition. Store sera at 4°C before analysis.
Sera are stable 1 to 3 days at 4°C. For longer storage, freeze them
Colorimetric. End point.
at -50°C.
PRINCIPLE
Anti human β-lipoprotein antibody in reagent R1 binds to lipo-
REFERENCE VALUES (4)
proteins (LDL, VLDL and chylomicrons) other than HDL. The The NCEP (American National Cholesterol Education Program)
antigen-antibody complexes formed block enzyme reactions has established the following classification for serum LDL cho-
when reagent R2 is added. Cholesterol esterase and choleste- lesterol levels according to the risk of developing coronary
rol oxidase in reagent R2 react only with HDL-C. Hydrogen heart disease:
peroxide produced by the enzyme reactions with HDL-C yields High < 40 mg/dL (1.04 mmol/L)
a blue colour complex upon oxidative condensation of F-DAOS Low ≥ 60 mg/dL (1.55 mmol/L)
(N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy-4-fluo-
roaniline, sodium salt) and 4-aminoantipyrine in the presence Note : It is recommended for each laboratory to establish and
of peroxidase. maintain its own reference values. The data given here are only an
By measuring the absorbance of the blue colour complex pro- indication.
duced, at the average wavelength of 600 nm, the HDLC
concentration in the sample can be calculated when compared )PROCEDURE
with the absorbance of the HDL-C Calibrator. These reagents can be used on most analysers. The applications
are available on request.
REAGENTS COMPOSITION Wavelength : 600 nm
Reagent 1 : R1 Temperature : 37°C
Good’s buffer, pH 7.0 30 mmol/L Read against reagent blank.
4-Aminoantipyrine 0.9 mmol/L BLANK CALIBRATOR SAMPLE
Peroxidase 2400 U/L Reagent R1 240 µL 240 µL 240 µL
Ascorbate oxidase 2700 U/L Distilled water 2.5 µL - -
Anti human β-lipoprotein antibody Calibrator - 2.5 µL -
Sample - - 2.5 µL
Reagent 2 : R2 Mix and after 4 minutes incubation, measure the absorbance (A1),
Good’s buffer, pH 7.0 30 mmol/L then add:
Cholesterol esterase 4000 U/L Reagent R2 60 µL
Cholesterol oxidase 20000 U/L
F-DAOS 0.8 mmol/L Mix and after 5 minutes incubation, measure the absorbance (A2).
.../...
(03/2005)
FTAN-HDLD-3
CALIBRATION BIBLIOGRAPHY
ELITECH Cholesterol HDL Calibrator should be used for calibra-
1. Rifai, N., Bachorik, P.S., Albers, J.J., Lipids, Lipoproteins, and
tion. It is sold separately with the reference HDLD-0025 (1 x 3 mL)
or HDLD-0030 (4 x 3 mL). Apolipoproteins. Tietz Fundamentals of Clinical Chemistry, 5th
Ed., Burtis, C.A. & Ashwood, E.R. (W.B. Saunders eds.
QUALITY CONTROL Philadelphia USA), (2001), 463.
To ensure adequate quality, control sera are recommended. 2. Naito, H.K., Coronary artery disease and disorders of lipid meta-
bolism, Clinical Chemistry: Concepts and Application, Anderson,
S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (2003),
)PERFORMANCE DATA (37°C) 603.
The following data were obtained using the COBAS MIRA analy-
ser (37°C). 3. Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
Saunders eds. Philadelphia USA), (1995), 404.
- Analytical range 4. Expert Panel on Detection, Evaluation, and Treatment of High
The reagent is linear from 8 to 180 mg/dL (0.08-1.8 g/L, 0.2-4.7 Blood Cholesterol in Adults (Adult Treatment Panel III), Executive
mmol/L). Summary of the Third Report of the National Cholesterol Education
Program (NCEP). JAMA, (2001), 285, 2486.
- Detection limit (5) 5. Vassault A., et al., Protocole de validation de techniques,
Determined according to SFBC protocol, the detection limit is (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
equal to 1.0 mg/dL (10 mg/L, 0.026 mmol/L). 6. Vassault A., et al., Analyses de biologie médicale: spécifications
et normes d’acceptabilité à l’usage de la validation des techniques.
- Sensitivity Ann. Biol. Clin., (1999), 57, 685.
The average variation of the analytical signal is 3.46 m∆A per
mg/dL of HDL cholesterol (346 m∆A per g/L, 134 m∆A per SYMBOLS USED ON LABELS :
mmol/L) for a light path of 1 cm.
Lot number
- Precision
Within-run reproducibility: Consult instruction for use
Low level : n = 20 m = 39 mg/dL CV = 1.6 %
Medium level : n = 20 m = 54 mg/dL CV = 1.4 % In vitro diagnostic medical device
High level : n = 20 m = 78 mg/dL CV = 0.9 %
Manufacturer’s address
Between-run reproducibility:
Low level : n = 20 m = 31 mg/dL CV = 3.5 % Expiration date
Medium level : n = 20 m = 55 mg/dL CV = 3.7 %
High level : n = 20 m = 80 mg/dL CV = 3.4 % Temperature limitation
- Correlation
A comparative study has been performed between Elitech method
on COBAS MIRA and a method validated on another analyser on
60 human sera. The sample concentrations ranged from 8 to 167
mg/dL.
The parameters of linear regression are as follows :
Correlation coefficient (r) : 0.996
Linear regression : y = 1.0367 x - 3 mg/dL
- Interferences (5,6)
According to SFBC recommendations, studies have been perfor-
med to determine the level of interference from different com-
pounds:
Conjugated Bilirubin: No significant interference up to 25 mg/dL
(250 mg/L, 430 µmol/L).
Unconjugated Bilirubin: No significant interference up to 35
mg/dL (350 mg/L, 600 µmol/L).
(03/2005)
FTAN-HDLD-3
PRINCIPLE Mix, wait for 10 minutes and centrifuge at 5 000 r.p.m. for 15
Chylomicrons, Very Low Density Lipoproteins (VLDL) and Low minutes.
Density Lipoproteins (LDL) of serum are precipitated by The supernatant is collected for HDL determination.
Phosphotungstic acid and Magnesium ions. 2) HDL determination :
After centrifugation, High Density Lipoproteins (HDL) are in the The cholesterol PAP kit is used for HDL cholesterol determination
supernatant. Cholesterol included in this phase, is measured by (refer to insert technical data sheet for instruction about prepara-
an enzymatic method. tion of cholesterol reagent).
REAGENTS COMPOSITION This reagent can be used manually (see method below) and on
most analysers.
Reagent 1 : R1
The applications are available on request.
Phosphotungstic acid 14 mmol/L
Wavelength : 500 nm (492-550)
Reagent 2 : R2
Temperature : 37°C
Magnesium chloride 1 mol/L Cuvette : 1 cm light path
Standard : Std Read against reagent blank.
Cholesterol 50 mg/dL
0.50 g/L BLANK STANDARD SAMPLE
1.30 mmol/L
Additional reagent : Cholesterol Reagent 1 mL 1 mL 1 mL
Kit for Cholesterol determination.
Distilled water 50 µL - -
STABILITY OF REAGENTS Standard 50 mg/dL - 50 µL -
When stored at 2-8° C and protected from light, the reagents are Supernatant - - 50 µL
stable until the expiry date stated on the label.
Mix and read the optical density (OD) after a 5 minute incubation.
PREPARATION AND STABILITY The final colour is stable for at least 1 hour.
OF PRECIPITATING REAGENT
CALCULATION
Mix 4 volumes of the reagent 1 with 1 volume of the reagent 2.
OD Sample mg/dL n= 50
Stability : 6 weeks at 20-25°C x n x 1.1* g/L n= 0.50
OD Standard mmol/L n= 1.30
SAMPLES
n = standard concentration
Serum.
Heparin plasma. *1.1 = dilution factor of the sample.
Note : It is recommended for each laboratory to establish and main- In vitro diagnostic medical device
tain its own reference values. The given data here are only an indi-
Manufacturer’s address
cation.
METHOD PROCEDURE
Enzymatic Wavelength : 405 nm (400-440)
Kinetic Temperature : 25° C, 30° C
Cuvette : 1 cm light path
PRINCIPLE Read against distilled water.
Cholinesterase
Butyrylthiocholine + H20 Thiocholine + Butyrate
Working reagent 1 : 3.0 mL
Sample : 20 µL
Thiocholine+5,-5’-Dithio-bis- 2-Nitrobenzoate-5-mercaptothio -
Working reagent 2 : 100 µL
(2-nitrobenzoate) choline + 5-Thio-2-nitrobenzoate
Mix and measure the change of optical density (∆OD) every 30
seconds (∆OD/30 sec.) during 90 seconds.
REAGENTS COMPOSITION
CALCULATION
Reagent 1 : R1
Phosphate buffer, pH 7.40 52 mmol/L
Activity (U/L) = ∆OD/30 sec. x 23 460
5,-5’-Dithiobis-2-nitrobenzoic acid 0. 24 mmol/L
- Interferences
According to SFBC recommendations (Vassault and Coll,1986),
studies have been performed to determine the level of interference
from different compounds:
BIBLIOGRAPHY
Knedel, M., Böttger, R., Eine kinetische Methode zur estimmung
der Aktivität der Pseudocholinesterase. Klin Wochenschr, 45,
(1967),325.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(04/2004)
FTAN-CHES-3
PRINCIPLE SAMPLE
Kinetic determination of the creatine kinase based upon IFCC Serum free of hemolysis.
and DGKC recommendations : Heparin plasma.
CK
Creatine phosphate + ADP Creatine + ATP
HK REFERENCE VALUES
ATP + D-Glucose G-6-P + ADP
30° C 37° C
G-6-PDH
G-6-P + NADP+ D-Gluconate-6-phosphate + NADPH + H+ Women : 15-110 U/L 24-170 U/L
Men : 15-130 U/L 24-195 U/L
CK = Creatine kinase
HK = Hexokinase Note : It is recommended for each laboratory to establish and
G-6-P = D-Glucose-6-phosphate maintain its own reference values. The given data here are only
G-6-PDH = Glucose-6-phosphate dehydrogenase an indication.
Sample : 50 µL
STABILITY OF REAGENT
When stored at 2-8° C and protected from light, the reagents
Mix and wait 3 minutes
are stable until the expiry date stated on the label.
Reagent 2 : 250 µL
PREPARATION AND STABILITY
OF WORKING REAGENT
Mix and after a 2 minute incubation, measure the change of
• One-reagent procedure optical density per minute (∆OD/min.) during 3 minutes.
Mix 4 volumes of reagent 1 with 1 volume of reagent 2.
Stability : 2 days at 20-25° C CALCULATION
2 weeks at 2-8° C • One-reagent procedure
• Two-reagent procedure Activity (U/L) = ∆OD/min. x 4127
The reagents are ready for use.
• Two-reagent procedure
Activity (U/L) = ∆OD/min. x 4127
.../...
(01/2005)
FTAN-CKSL-3
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
If ∆OD/min. exceeds 0.250 at 340 nm, repeat test using serum
diluted 1/10 with sodium chloride solution (9 g/L). Multiply
result by 10.
BIBLIOGRAPHY
1.Mathieu M. et coll. Recommandation pour la mesure de la
concentration catalytique de la créatinine kinase dans le sérum
humain. Ann. Biol. Clin., 40, (1982), 87.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-CKSL-3
PRECAUTIONS LINEARITY
The reagent 1 contains less than 0.1 % sodium azide. If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
diluted 1/10 with sodium chloride solution (9 g/L). Multiply
STABILITY OF REAGENTS result by 10.
When stored at 2-8° C and protected from light, the reagents BIBLIOGRAPHY
are stable until the expiry date stated on the label.
Ann. Biol. Clin., 40, (1982), 99.
PRINCIPLE SAMPLE
The procedure involves measurement of CK activity in the pre- Serum free of hemolysis.
sence of an antibody to CK-M monomer. This antibody com- Heparin plasma.
pletely inhibits the activity of CK-MM and half of the activity of
CK-MB while not affecting the B subunit activity of CK-MB and REFERENCE VALUES
CK-BB. Then we use the CK method to quantitatively determine
30° C 37° C
CK-B activity. The CK-MB activity is obtained by multiplying
0-14 U/L 0-24 U/L
the CK-B activity by two.
The suspicion of myocardial damage is based on the 3 follo-
REAGENT COMPOSITION wing factors :
Total CK 30° C 37° C
Reagent 1 : R1
Female : > 111 U/L > 171 U/L
Imidazole , pH 6.7 125 mmol/L Male : > 131 U/L > 196 U/L
D-Glucose 25 mmol/L CK-MB : > 14 U/L > 25 U/L
N-Acetyl-L-Cysteine 25 mmol/L (CK - MB x 100)
Magnesium acetate 12.5 mmol/L CK-MB ratio : 6-25 %
Total CK
NADP 2.52 mmol/L
EDTA 2.02 mmol/L Note : It is recommended for each laboratory to establish and
Hexokinase ≥ 6 800 U/L maintain its own reference values. The given data here are only
an indication.
Anti-human polyclonal CK-M antibody (sheep) sufficient to
inhibit up to 2 000 U/L of CK-MM.
PROCEDURE
This reagent can be used manually (see method below) and
Reagent 2 : R2
on most analysers.
Creatine phosphate 250 mmol/L The applications are available on request.
ADP 15.2 mmol/L
Wavelength : 340 nm
AMP 25 mmol/L Temperature : 30° C, 37° C
Diadenosine pentaphosphate 103 µmol/L Cuvette : 1 cm light path
G-6-PDH ≥ 8 800 U/L
Read against distilled water.
• One-reagent procedure
PRECAUTIONS
These reagents contain less than 0.1 % sodium azide.
Avoid contamination by using clean laboratory material Working reagent : 1 mL
(pipette, plastic vial for analysers,...). Sample : 40 µL
Discard cloudy reagent.
Mix and after a 3 minute incubation, measure the change of
optical density per minute (∆OD/min.) during 3 minutes.
STABILITY OF REAGENT
When stored at 2-8° C and protected from light, the reagents
• Two-reagent procedure
are stable until the expiry date stated on the label.
Reagent 1 : 1 mL
PREPARATION AND STABILITY Sample : 50 µL
OF WORKING REAGENT :
• One-reagent procedure Mix and wait 5 minutes
Mix 4 volumes of reagent 1 with 1 volume of reagent 2.
Reagent 2 : 250 µL
Stability : 1 day at 20-25° C
2 weeks at 2-8° C Mix and after a 2 minute incubation, measure the change of
• Two-reagent procedure optical density per minute (∆OD/min.) during 3 minutes.
.../...
The reagents are ready for use.
(01/2005)
FTAN-CMSL-2
CALCULATION
• One-reagent procedure
Activity (U/L) = ∆OD/min. x 8254
• Two-reagent procedure
Activity (U/L) = ∆OD/min. x 8254
QUALITY CONTROL
To ensure adequate quality, control sera are recommended.
LINEARITY
Inhibition : up to 2 000 U/L of CK-MM at 37° C.
If ∆OD/min. exceeds 0.075 dilute the sample (one part with
nine parts saline solution), repeat the test and multiply the
result by 10.
Linear up at least 600 U/L.
BIBLIOGRAPHY
1.Mathieu, M. Recommandations pour la mesure de la
concentration catalytique de la Créatine Kinase dans le sérum
humain à + 30 °C. Documents C et C’. Ann.Biol.Clin. 40,
(1982), 99.
2.Neumeier, D., Prellwitz, W., Würzburg, U. et coll. Deter-
mination of creatine kinase isoenzyme MB activity in serum
using immunological inhibition of creatine kinase M subunit
activity. Activity kinetics and diagnostic significance in myocar-
dial infarcton. Clin.Chim.Acta. 73,(1976),445
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-CMSL-2
PRECAUTIONS CALCULATION
a) Total CK activity :
These reagents contain less than 0.1 % sodium azide. Determine total CK activity in serum using the CK-NAC
reagent.
STABILITY OF REAGENTS
b) CK-B activity :
When stored at 2-8° C and protected from light, the reagents
CK-B (U/L) = ∆OD/min x 3 376
are stable until the expiry date stated on the label.
c) CK-MB activity :
PREPARATION AND STABILITY CK-MB (U/L) = CK-B (U/L) x 2
OF WORKING REAGENT d) Percentage of CK-MB activity in sample :
Dissolve the reagent 2 in the suitable volume of reagent 1.
% CK-MB = CK-MB x 100
Stability : 24 hours at 20-25° C Total-CK
3 days at 2-8° C QUALITY CONTROL
SAMPLES To ensure adequate quality, control sera are recommended.
Serum free of hemolysis.
LINEARITY
REFERENCE VALUES Inhibition : up to 2000 U/L of CK-MM at 37° C.
If the assay of the total CK exceeds 1200 U/L at 37°C, dilute
30° C 37° C
the sample appropriately with physiological saline before
0-14 U/L 0-24 U/L
assay of CK-MB.
The suspicion of myocardial damage is based on the 3 follo-
Multiply the result by the dilution factor to obtain the correct
wing factors :
value of the isoenzyme.
.../...
(01/2005)
FTAN-CKMB-3
BIBLIOGRAPHY
1.Morison I. M., Clayson J. and Fine J. S. Clin. Chem., 34,
(1988), 535 .
2.Chan D. W; , Taylor E., Frye R. and Blitzer R.L., Clin. Chem.,
31, (1985) 465.
3.Morin L., Clin. Chem., 23/4, (1977), 646.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-CKMB-3
• One-reagent procedure
STABILITY OF REAGENTS
BLANK STANDARD SAMPLE
When stored at 2-8° C and protected from light, the reagents
WR 2 1 mL 1 mL 1 mL
are stable until the expiry date stated on the label.
Distilled water 50 µL - -
Standard - 50 µL -
PREPARATION AND STABILITY Sample - - 50 µL
OF WORKING REAGENTS
Mix and read the optical density (OD) after a 5 minute incubation.
• One-reagent procedure
• Two-reagent procedure
WR 1 : dissolve 3 levels measuring spoonful of the reagent 3
BLANK STANDARD SAMPLE
in the reagent 1.
WR 1 1 mL 1 mL 1 mL
Stability : 7 days at 2-8°C Distilled water 50 µL - -
Standard - 50 µL -
WR 2 : mix 10 volumes of WR 1 with 0.5 volume of the Sample - - 50 µL
reagent 2. Mix and read the optical density (OD1)
Stability : 3 to 4 hours at 20-25°C
Reagent 2 50 µL 50 µL 50 µL
Mix and read the optical density (OD2) after a 5 minute incubation.
• Two-reagent procedure
The final colours are stable for at least 1 hour.
WR 1 : dissolve 3 levels measuring spoonful of the reagent 3
in the reagent 1. CALCULATION
• One-reagent procedure :
Stability : 7 days at 2-8°C
OD Sample µg/dL n= 100
xn
Reagent 2 : ready for use OD Standard µmol/L n = 15.73
• Two-reagent procedure :
SAMPLES OD2 - OD1 Sample µg/dL n= 100
xn
Serum and heparin plasma. OD2 - OD1 Standard µmol/L n = 15.73
Discard hemolyzed samples. n = standard concentration
.../...
(01/2005)
FTAN-CUIV-2
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
Up to 500 µg/dL (5 mg/L) (78.65 µmol/L).
BIBLIOGRAPHY
Abe A., Yamashita S. and Al., Sensitive, Direct Colorimetric
Assay for Copper in Serum, Clin. Chem., 35, (1989),
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-CUIV-2
Determined according to SFBC protocol, the detection limit is Turbidity : No significant interference up to 500 mg/dL
equal to 0.17 mg/dL (1.7 mg/L; 15 µmol/L). Triglycerides equivalent (5 g/L, 5.75 mmol/L).
(04/2004)
FTAN-CRCO-6
creatinine, as little as it may be, can reflect the rejection of the Men Women
transplant. An increase of creatinine serum and urine can be the Serum: 0.8 - 1.3 0.6 - 1.2 mg/dL
sign of muscular necrosis. 8 - 13 6 - 12 mg/L
71 - 115 53 - 106 µmol/L
METHOD (3)
Enzymatic - Colorimetric Urine: 0.8 - 2.0 0.6 - 1.8 g/24h
Kinetic 7.1 - 17.7 5.3 - 15.9 mmol/24h
PRINCIPLE (3) Note : It is recommended for each laboratory to establish and main-
Enzymatic colorimetric determination of creatinine: tain its own reference values. The data given here are only an indi-
cation.
Creatininase
Creatinine + H2O Creatine )PROCEDURE
This reagent can be used on most analysers. The applications are
Creatinase available on request.
Creatine + H2O Sarcosine + Urea
Wavelength: 550 nm
Sarcosine oxidase Temperature: 37°C
Sarcosine + O2 Glycine + HCHO + H2O2 Read against reagent blank
Sample : 100 µL
Reagent 2 : R2
Glupa-C 23 mmol/L
Mix and after a 1 minute incubation, measure the change of
PRECAUTIONS optical density per minute (∆OD/min.) during 3 minutes.
These reagents contain less than 0.1 % sodium azide. • Two-reagent procedure
Sample : 100 µL
STABILITY OF REAGENT
When stored at 2-8 °c and protected from light, the reagents
are stable until the expiry date stated on the label. Mix and wait 1 minute
.../...
(01/2005)
FTAN-GASL-3
LINEARITY
If ∆OD/min. exceeds 0.200 at 405 nm, repeat test using serum
diluted 1/10 with sodium chloride solution (9 g/L). Multiply
result by 10.
BIBLIOGRAPHY
1.Szasz, G. Clin., Chem., 22, (1976), 2051.
2.SFBC, Commission d’enzymologie. Détermination d’une
méthode recommandée pour la détermination dans le sérum
humain de la concentration catalytique de la gamma-glutamyl
transférase à 30 °C. I.S.B, 12/5 (1986) 373
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-GASL-3
PRINCIPLE PROCEDURE
Optimized kinetic determination of g-glutamyl transferase (γ-GT) : This reagent can be used manually (see method below) and
γ-GT on most analysers.
GPNA + glycylglycine L-gGlutamyl- glycylglycine + p-Nitroanilide The applications are available on request.
Wavelength : 405 nm
GNPA : L-γ Glutamyl-p-nitroalinide.
Temperature : 30°C, 37°C
The increase of the absorption at 405 nm, due to the formation of Cuvette : 1 cm light path
the p-nitroanilide, is proportional to the γ-GT activity.
Read against distilled water.
30°C 37°C
Female : 4 - 25 U/L 5 - 32 U/L
Male : 7 - 34 U/L 10 - 45 U/L
CALCULATION
SAMPLES
OD Sample mg/dL n= 100
Serum free of hemolysis. xn g/L n= 1
Heparin fluoride plasma. OD Standard mmol/L n= 5.56
Cerebral spinal fluid (CSF). n = standard concentration
.../...
(01/2005)
FTAN-GHSL-3
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
Up to 600 mg/dL (6 g/L) (33.3 mmol/L).
BIBLIOGRAPHY
1.Peterson, J.L., Young, D.S., Anal Biochem., 23, (1968), 301.
2.Bondar, R.J.L., Mead, D.C., Clin. Chem., 20, (1974), 586.
3.Young, D.S., Pestaner, L.C., Gibberman, V., Clin. Chem., 5,
(1975), 1D.
4.Tietz.Fundamentals of Clinical Chemistry.Chap.23, 447
(2001)
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-GHSL-3
PRECAUTIONS Mix and measure the optical density (OD) after a 10 minute
incubation.
- The reagent contains less than 0.1 % sodium azide. Sodium The measure can be done during 30 minutes.
azide can react with copper and lead plumbing to form explo-
sive metal azides.
Regulations currently in use regarding dangerous waste elimi- CALCULATION
nation must be respected. If discharge in the canalisations, mg/dL n= 100
OD Sample
rinse with plenty of water. xn g/L n= 1
- Use clean or single use glass material only to avoid conta- OD Standard mmol/L n= 5.56
minations.
n = standard concentration
.../...
(02/2004)
FTAN-GPSL-4
To ensure adequate quality, control sera such as ELITROL I According to SFBC recommendations, studies have been per-
(normal control) and ELITROL II (abnormal control) are recom- formed to determine the level of interference from different
mended. compounds:
PERFORMANCE DATA
Bilirubin: Negative bias from 8 mg/dL (80 mg/L,
The following data were obtained using the COBAS MIRA
137 µmol/L).
analyser (37°C)
Haemoglobin: No significant interference up to 0.5 g/dL
- Analytical range (5 g/L).
The reagent is linear from 20 to 400 mg/dL (0.2 to 4 g/L; 1.11
Ascorbic acid: No significant interference at physiological
to 22.2 mmol/L).
concentrations (negative bias from 7 mg/dL;
70 mg/L; 0.39 mmol/L).
- Detection limit (6)
Determined according to SFBC protocol, the detection limit is Turbidity: No significant interference up to 600 mg/dL
equal to 2 mg/dL (0.02 g/L; 0.111 mmol/L). Triglyceride equivalent (6 g/L, 6.9 mmol/L).
Uric acid: No significant interference up to 20 mg/dL
)- Sensitivity (200 mg/L; 1190 µmol/L).
The average variation of the analytical signal is 2.7 × 10-3 ∆A
per mg/dL of glucose (0.27 ∆A per g/L, 48.5 × 10-3 ∆A per
mmol/L) for a light path of 1 cm.
)BIBLIOGRAPHY
1.Sacks, D.B., Carbohydrates. Tietz Fundamentals of Clinical
- Precision Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
Within-run reproducibility on serum Saunders eds. Philadelphia USA), (2001), 427.
Low level : 2.Dods, R.F., Diabetes Mellitus. Clinical Chemistry: Theory,
n = 20 m= 42 mg/dL CV = 1.5 % Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
Medium level : Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 580.
n = 20 m = 109 mg/dL CV = 1.9 % 3.Tietz, N.W., Clinical guide to laboratory tests, 3th Ed., (W.B.
Saunders eds. Philadelphia USA), (1995), 268.
High level :
4.Trinder, P., Determination of glucose in blood using glucose
n = 20 m = 296 mg/dL CV = 1.3 % oxidase with an alternative oxygen acceptor. Ann. Clin.
Biochem., (1969), 6, 24.
Between-run reproducibility on serum 5.Burrin, JM., Price, C.P., Measurement of blood glucose. Ann.
Low level : Clin. Biochem., (1985), 22, 327.
n = 17 m = 41 mg/dL CV = 3.6 % 6.Vassault, A., et al., Protocole de validation de techniques,
Medium level : (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
n = 19 m = 107 mg/dL CV = 3.1 %
High level :
n = 18 m = 298 mg/dL CV = 1.6 % )SYMBOLS USED ON LABELS :
- Correlation
Lot Number
A comparative study has been performed between Elitech
method and another commercial reagent on 84 human serum Consult instruction for use
samples.The parameters of linear regression are as follows :
In vitro diagnostic medical device
Correlation coefficient (r) : 0.999
Linear regression : y = 1.001 x - 3.1 mg/dL Manufacturer’s address
Temperature limitation
Expiration date
(02/2004)
FTAN-GPSL-4
PRECAUTIONS R2 : 100 µL
Discard cloudy reagent.
Avoid contamination by using clean disposable devices Mix and after a 1 minute incubation, measure the change of
(pipettes, plastic vials for analysers, ...). optical density per minute (∆OD/min.) during 3 minutes.
These reagents contain less than 0.1 % sodium azide.
CALCULATION
STABILITY OF REAGENTS One reagent Two reagents
When stored at 2-8° C and protected from light, the reagents 340 nm : Activity (U/L) =∆OD/min. x 5 450 5 979
are stable until the expiry date stated on the label. 334 nm : Activity (U/L) = ∆OD/min. x 5 556 6 095
365 nm : Activity (U/L) = ∆OD/min. x 10 098 11 078
PREPARATION AND STABILITY
OF WORKING REAGENTS QUALITY CONTROL
• One-reagent procedure : To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
Mix 10 volumes of reagent 1 with 1 volume of reagent 2.
mended.
Stability : 8 hours at 20-25° C
5 days at 2-8° C LINEARITY
• Two-reagent procedure : If ∆OD/min. exceeds 0.100 at 340 nm repeat test using serum
The reagents are ready for use. diluted 1/10 with sodium chloride solution (9 g/L).
Multiply result by 10.
SAMPLE
Serum free of hemolysis.
BIBLIOGRAPHY
Deutsche Gesellschaft für Klinische Chemie, Z. Klin. Chem. U.
REFERENCE VALUES
Klin. Biochem., 10, (1972), 182.
30° C 37° C
70 - 190 U/L 80 - 220 U/L SYMBOLS USED ON LABELS:
PRINCIPLE PROCEDURE
Hemoglobin (oxyhemoglobin, methemoglobin, carboxy-hemo- This method below is a manual method for spectrophotometer.
globin) is converted to cyanomethemoglobin according to the Wavelength : 540 nm (546)
following reactions : Temperature : 25° C, 30° C, 37° C
Cuvette : 1 cm light path
Potassium ferricyanide
Hemoglobin Methemoglobin Read against reagent blank.
Potassium cyanide
Methemoglobin Cyanomethemoglobin
Working reagent : 5 mL
PRECAUTIONS CALCULATION
HARMFUL ! Reagent contains guanidin. Risk if swallowed and µg/dL n= 100
irritating for eyes and skin. Wear suitable protective clothing OD Sample
xn mg/L n= 1
and eye/face protection. Avoid contact with eyes. In case of OD Standard µmol/L n= 17.9
contact with eyes , rinse immediately with plenty of water and
seek medical device. n = standard concentration
QUALITY CONTROL
STABILITY OF REAGENTS
To ensure adequate quality, control sera such as ELITROL I
When stored at 2-8° C and protected from light, the reagents (normal control) and ELITROL II (abnormal control) are recom-
are stable until the expiry date stated on the label. mended.
PRINCIPLE
A number of well known factors influence the normal range of
At pH 4.80 ferric iron is released from the transferrin complex. total serum iron in clinically healthy individuals such as diet,
Ascorbic acid acts to reduce the ferric iron to ferrous state sex, age, physical activity, menstrual cycle, pregnancy, envi-
which reacts with Ferrozine® to produce a colored complex. ronmental conditions and diurnal fluctuations.
Interference from cuprous ions is prevented by thiourea.
Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only
REAGENTS COMPOSITION
an indication.
Reagent 1 : R1
Acetate buffer, pH 4.80 100 mmol/L
PROCEDURE
Guanidine 4 mol/L This reagent can be used manually (see method below) and
Thiourea 52.5 mmol/L on most analysers.
The applications are available on request.
Reagent 2 : R2
Ascorbic acid (spoon supplied) Wavelength : 560 nm (550-570)
Temperature : 37°C
Reagent 3 : R3
Cuvette : 1 cm light path
Ferrozine® 40 mmol/L
Read against reagent blank.
Standard : Std
Iron 100 µg/dL BLANK STANDARD SAMPLE
1 mg/L
Working Reagent 1 mL 1 mL 1 mL
17.9 µmol/L
Distilled water 200 µL - -
PRECAUTIONS Standard - 200 µL -
Because the reagent 1 contains guanidine, it is harmful by Sample - - 200 µL
inhalation, if swallowed and irritating to eyes and skin. Wear
suitable protection ; if split, wash thoroughly with water. Mix and read the optical density (OD).
- OD1 OD2
STABILITY OF REAGENTS
When stored at 2-8° C and protected from light, the reagents Then add :
iare stable until the expiry date stated on the label.
R3 50 µL 50 µL 50 µL
PREPARATION AND STABILITY
Mix and read the optical density (OD) within one hour.
OF WORKING REAGENTS
Dissolve one level measuring spoonful (~ 150 mg) of reducing - OD3 OD4
agent (R2) in 50 mL of guanidine reagent 1.
Stability : 3 days at 20-25°C CALCULATION
2 weeks at 2-8°C OD4 - OD2 µg/dL n= 100
xn mg/L n= 1
The reagent 3 is ready for use. OD3 - OD1 µmol/L n= 17.9
(01/2005)
FTAN-FEFR-3
LINEARITY
Up to 500 µg/dL (5 mg/L) (89.5 µmol/L).
BIBLIOGRAPHY
1.Williams and al., Clin. Chem., 23, (1977), 237.
2.Stoockey L., Anal. Chem., 42, (1970), 779.
3.Persijn and al., Clin. Chem. Acta, 35, (1971), 91.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-FEFR-3
PRINCIPLE PROCEDURE
Total Iron-Binding Capacity (TIBC) is evaluated after satura- In a centrifugation tube, introduce :
tion of the transferrin by an iron solution and adsorption of
excess iron on magnesium hydroxide carbonate. After centri- Reagent 1 : 1 mL
fugation iron is measured in the supernatant.
Sample : 0.5 mL
REAGENTS COMPOSITION
Reagent 1 : R1
Mix and incubate for 5 minutes then add :
Iron saturating solution 500 µg/dL
5 mg/L
Reagent 2 : 1 level measuring spoonful
89.5 µmol/L (~ 100 mg) of magnesium
Reagent 2 : R2 hydroxide carbonate.
Magnesium hydroxide carbonate
One measuring spoon (~ 100 mg)
Incubate for 20 minutes, shaking several times during this
Additional reagent :
period. Centrifugate at 3000 r.p.m. during 10 minutes.
Kit for iron determination
(iron CAB or iron Ferrozine®) TIBC determination :
Iron content of the supernatant is measured colorimetrically
STABILITY OF REAGENTS with the iron CAB or iron Ferrozine® method. Take into
When stored at 2-8° C and protected from light, the reagents account the dilution 1 : 3 by the reagent 1 and multiply by 3
are stable until the expiry date stated on the label. each measurement value.
QUALITY CONTROL
PREPARATION AND STABILITY
To ensure adequate quality, control sera such as ELITROL I
OF WORKING REAGENT (normal control) and ELITROL II (abnormal control) are recom-
The reagents are ready for use. mended.
SAMPLES
BIBLIOGRAPHY
Serum free of hemolysis.
Ramsay W.N.M., Clin. Chim. Acta, 2, (1957), 221.
Heparin plasma.
(01/2005)
FTAN-TIBC-3
n = standard concentration
STABILITY OF REAGENTS
When stored at 2-8° C and protected from light, the reagents
QUALITY CONTROL
are stable until the expiry date stated on the label.
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
PREPARATION AND STABILITY mended.
OF WORKING REAGENTS
Dissolve the reagent 2 in the suitable volume of reagent 1.
Stability : 8 hours at 20-25°C
7 days at 2-8°C
.../...
SAMPLES
Heparin or EDTA plasma.
Serum.
Collect capillary or venous blood specimen from patients in a
relaxed position.
Cerebral spinal fluid (CSF).
(01/2005)
FTAN-LACT-2
LINEARITY
Up to 120 mg/dL (1.2 g/L) (13.2 mmol/L).
BIBLIOGRAPHY
1.Kuhnle, H.F. and al., J. Clin. Chem., 16, (1977), 171.
2.Kuhnle, H.F. and al., Clin. Biochem., 35, (1989), 1992.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-LACT-2
Kinetic determination of lactate dehydrogenase (LDH) activity: Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only
LDH an indication.
Pyruvate + NADH + H+ L-Lactate + NAD+
PROCEDURE
REAGENTS COMPOSITION These reagents can be used on most analysers. The applica-
Reagent 1: R1 tions are available on request.
Tris buffer, pH 7.20 (30°C) 100 mmol/L Wavelength : 340 nm
Sodium chloride 255 mmol/L Temperature : 37°C
Pyruvate 2 mmol/L Read against distilled water.
Reagent 2: R2 One-reagent procedure
NADH 1.3 mmol/L
Working reagent : 250 µL
PRECAUTIONS Sample : 3.5 µL
- The reagents contain less than 0.1% sodium azide. Sodium
Mix and after a 25 second incubation, measure the change of
azide can react with copper and lead plumbing to form explo-
absorbance per minute (∆A/min.) during 100 seconds.
sive metal azides.
Regulations currently in use regarding dangerous waste elimi- • Two-reagent procedure
nation must be respected. If discharge in the canalisations,
rinse with plenty of water. R1 : 200 µL
- Use clean or single use laboratory material only to avoid R2 : 50 µL
contaminations.
- High LDH values may induce falsely low results due to the Mix, wait 25 seconds and add:
depletion of the substrate (total consumption of NADH before
reading of the result). If an analyser is used, verify the pre- Sample : 3.5 µL
sence of a depletion factor on the application. Mix and after a 25 second incubation, measure the change of
absorbance per minute (∆A/min.) during 100 seconds.
STABILITY OF REAGENTS
When stored at 2-8°C and protected from light, the reagents
CALCULATION
are stable until the expiry date stated on the label.
At 340 nm, with the one-reagent procedure and the two-rea-
PREPARATION AND STABILITY OF WORKING REAGENT gent procedure for a 1 cm light path cuvette:
One-reagent procedure Activity (U/L) = ∆A/min. x 11496
Mix 4 volumes of the reagent R1 with 1 volume of the reagent R2.
Stability : 2 days at 20-25°C
1 week at 2-8°C .../...
(01/2005)
FTAN-LDSL4/1-3
(01/2005)
FTAN-LDSL4/1-3
PRINCIPLE PROCEDURE
Kinetic determination of the lactate dehydrogenase based This reagent can be used manually (see method below) and
upon IFCC and SFBC recommendations : on most analysers.
The applications are available on request.
LDH
Pyruvate + NADH + H+ L-Lactate + NAD+ Wavelength : 340 nm (334-365)
Temperature : 30°C, 37°C
LDH = Lactate dehydrogenase Cuvette : 1 cm light path
STABILITY OF REAGENTS
When stored at 2-8° C and protected from light, the reagents QUALITY CONTROL
are stable until the expiry date stated on the label. To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
PREPARATION AND STABILITY mended.
OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1. LINEARITY
If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
Stability : 4 days at 20-25°C
diluted 1/5 or 1/10 with sodium chloride solution (9 g/L).
4 weeks at 2-8°C
Multiply result by 5 or 10.
3 mL reagent stability : 4 days at 20-25°C
2 weeks at 2-8°C BIBLIOGRAPHY
Ann. Biol. Clin., 40, (1982), 123.
SAMPLE
Serum free of hemolysis.
SYMBOLS USED ON LABELS:
REFERENCE VALUES
30°C 37°C Lot Number
140 - 280 U/L 200 - 400 U/L
Consult instruction for use
Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only In vitro diagnostic medical device
an indication.
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-LDHP-3
PRINCIPLE PROCEDURE
Magnesium forms a coloured complex with calmagite in alka- This reagent can be used manually (see method below) and
line solution. EGTA eliminates the calcium interference. on most analysers.
The applications are available on request.
REAGENTS COMPOSITION Wavelength : 520 nm (500-550)
Reagent 1 : R1 Temperature : 37°C
Cuvette : 1 cm light path
2-Methyl-2-Amino-1-Propanol 1 mol/L
EGTA 210 µmol/L Read against reagent blank.
STABILITY OF REAGENTS Mix and after a 5 minute incubation read the optical density (OD).
When stored at 2-8° C and protected from light, the reagents The final colour is stable for at least 1 hour.
are stable until the expiry date stated on the label.
CALCULATION
PREPARATION AND STABILITY mg/dL n= 2
OF WORKING REAGENTS OD Sample
xn mg/L n= 20
Use only disposable devices OD Standard µmol/L n= 824
Mix 1 volume of reagent 1 with 1 volume of reagent 2. n = standard concentration.
Stability : 24 hours at 20-25°C Take dilution factor into account for the calculation of magne-
4 days at 2-8°C sium concentration in urine.
PRINCIPLE PROCEDURE
Precipitation - Sodium tungstate. Samples must be treated according to the following way :
Mix and let stand tubes for 5 minutes to lyse completely the
2.038 mmol/L
red cells.
Additional Reagent :
3- Add reagent 1, and mix carefully
Kit for Magnesium Calmagite ref. MAGN-0600.
Réactif 1 200 µL 200 µL 200 µL
PRECAUTIONS
4- Add reagent 2, mix, wait for 5 minutes and centrifuge 10
- IRRITANT ! the reagent 2 contains sulfuric acid
minutes at 3000 rpm.
(1.87%).Risk for eyes and skin. Avoid contact with eyes and
skin. In case of contact rinse immediately with plenty of Reagent 2 200 µL 200 µL 200 µL
water and seek a medical device.
5- Measure supernatant with additional reagent
STABILITY OF REAGENTS Supernatant 200 µL 200 µL 200 µL
When stored at 2-8°C and protected from light, the reagent is
stable until the expiry date stated on the label. Additional reagent 2 mL 2 mL 2 mL
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(01/2005)
FTAN-MGER-2
METHOD
PROCEDURE
Pyrogallol Red
This reagent can be used manually (see method below) and on
most analysers. The applications are available on request.
PRINCIPLE
Proteins in urine and in cerebral spinal fluid bind pyrogallol Wavelength : 598 nm
red in presence of molybdate and forms a coloured complex. Temperature : 37°C
Cuvette : 1 cm light path
REAGENTS COMPOSITION
Read against reagent blank.
Reagent : R
BLANK STANDARD SAMPLE
Pyrogallol red 60 µmol/L
Sodium molybdate 40 µmol/L Working Reagent 1 mL 1 mL 1 mL
Sodium oxalate 1.04 mmol/L
Distilled water 20 µL - -
Sodium benzoate 3.47 mmol/L
Methanol 1 mol/L Standard - 20 µL -
Succinic acid 50 mmol/L Sample - - 20 µL
Standard : Std
Albumin/globulin 100 mg/dL Mix and read the optical density (OD) after a 5 minute incubation.
1 g/L The final colour is stable for at least 1 hour.
PRECAUTIONS
- HARMFUL. The reagent contains methanol (4 %) . Harmful CALCULATION
by inhalation, in contact with skin and if swallowed. OD Sample mg/dL n= 100
- The standard contains less than 0.1 % sodium azide.Sodium xn
OD Standard g/L n= 1
azide can react with copper and lead plumbing to form explo-
sive metal azides. Regulations currently in use regarding dan- n = standard concentration
gerous waste elimination must be respected. If discharge in
the canalisations, rinse with plenty of water. QUALITY CONTROL
- Use clean or single use glass material only to avoid contami- To ensure adequate quality, urine controls with a normal level
nations. and a pathological level are recommended.
STABILITY OF REAGENTS
)PERFORMANCES DATA
The following data were obtained using the COBAS MIRA
When stored at 2-8° C and protected from light, the reagent analyser (37°C).
and the standard are stable until the expiry date stated on the
label. • Linearity
The reagent is linear up to 200 mg/dL (2 g/L).
PREPARATION AND STABILITY OF WORKING REAGENT
• Detection limit
The reagent is ready for use.
According to the SFBC, the detection limit is equal to 4
SAMPLES mg/dL (0.04 g/L).
Urine. • Precision : Between-run
Cerebral Spinal Fluid (CSF).
CSF
n = 8 CV = 4 %
REFERENCE VALUES
Normal urine
Urine : 10 - 140 mg/24 h
n = 8 CV = 6.4 %
Cerebral Spinal Fluid : 80 - 320 mg/L
Pathological urine
)Note : It is recommended for each laboratory to establish n = 8 CV = 5.4 % .../...
and maintain its own reference values. The given data here
are only an indication.
(11/2004)
FTAN-PRTP-4
)INTERFERENCES
According to SFBC recommendations, some studies have
been performed to determine the level of interference from
different components:
On urine:
Urea: No significant interference up to 20 g/L
On CSF:
Haemoglobin: Important interference
BIBLIOGRAPHY
1.Watanabe Nobuko, Kamei S., Ohkubo A. and Al. - Urinary
Protein as Measured with a Pyrogallol Red-Molybdate
Complex, Manually and a Hitachi 726 Automated Analyser.
Clin. Chem., 32, (1986), 1551.
2.Vassault, A., et al., Protocole de validation de techniques,
(Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Lot number
Manufacturer’ s address
Expiration date
Temperature limitation
(11/2004)
FTAN-PRTP-4
p-Nitrophenylphosphate + H2O p-Nitrophenol + Note : It is recommended for each laboratory to establish and
Inorganic phosphate maintain its own reference values. The given data here are only
an indication.
ALP = Alkaline phosphatase
LINEARITY
If ∆OD/min. exceeds 0.250 at 405 nm, repeat the test using
serum diluted 1/10 with sodium chloride solution (9 g/L).
Multiply result by 10.
BIBLIOGRAPHY
1.Scandinavian Society for Clinical Chemistry, Committee on
Enzymes, Recommended methods for the determination of
four enzymes in blood. Scand. J. Clin. Lab. Invest. 33, 291
(1974).
2.German Society for Clinical Chemistry, Standard method for
determination of alkaline phosphatase (AP) activity. J. Clin.
Chem. Clin. Biochem. 10, 290 (1972).
Lot number
Manufacturer’ s address
Temperature limitation
Expiration date
(01/2005)
FTAN-PASL-3
PRINCIPLE PROCEDURE
Kinetic determination of the alkaline phosphatase based upon This reagent can be used manually (see method below) and
DGKC and SCE recommendations : on most analysers.
ALP The applications are available on request.
p-Nitrophenylphosphate + H2O p-Nitrophenol Wavelength : 405 nm (410)
+Inorganic phosphate Temperature : 25°C, 30°C, 37°C
Cuvette : 1 cm light path
ALP = Alkaline phosphatase Read against distilled water.
REAGENTS COMPOSITION
Working reagent : 1 mL
Reagent 1 : R1 Sample : 20 µL
Diethanolamine buffer, pH 10.2 1 mol/L
Magnesium Chloride 0.5 mmol/L
Mix and after a 1 minute incubation, measure the change of
Reagent 2 : R2 optical density per minute (∆OD/min.) during 3 minutes.
p-Nitrophenylphosphate 10 mmol/L
CALCULATION
pH of the working reagent 9.80 405 nm : Activity (U/L) = ∆OD/min. x 2 750
410 nm : Activity (U/L) = ∆OD/min. x 2 910
PRECAUTIONS
HARMFUL ! Reagent 1 contains diethanolamine. Danger of QUALITY CONTROL
serious damage to health by prolonged exposure if swallowed. To ensure adequate quality, control sera such as ELITROL I
Risk of serious damage of eyes. Wear suitable protective clo- (normal control) and ELITROL II (abnormal control) are recom-
thing and eye/face protection. Avoid contact with eyes. In case mended.
of contact with eyes , rinse immediately with plenty of water
and seek medical device. LINEARITY
The reagent 1 contains less than 0.1 % sodium azide. If ∆OD/min. exceeds 0.250 at 405 nm, repeat the test using
Avoid direct exposure to light. serum diluted 1/10 with sodium chloride solution (9 g/L).
Multiply result by 10.
STABILITY OF REAGENTS
When stored at 2-8° C and protected from light, the reagents BIBLIOGRAPHY
are stable until the expiry date stated on the label. Z. Klin. Chem. U. Klin. Biochem, 8, (1970), 658, 10, (1972),
182.
PREPARATION AND STABILITY
OF WORKING REAGENT SYMBOLS USED ON LABELS :
Dissolve the reagent 2 in the suitable volume of reagent 1.
Stability : 24 hours at 20-25°C Lot number
7 days at 2-8°C
Consult instruction for use
SAMPLES In vitro diagnostic medical device
Serum free of hemolysis.
Heparin plasma. Manufacturer’ s address
Temperature limitation
REFERENCE VALUES
Expiration date
25°C 30°C 37°C
Children 110 - 720 U/L 145 - 950 U/L 180 - 1200 U/L
Adults 60 - 170 U/L 80 - 220 U/L 100 - 290 U/L
(01/2005)
FTAN-PALC-3
component. An elevation of serum phosphate can occur in Serum: 2.7 - 4.5 mg/dL
vitamin D intoxication, hypoparathyroïdism and renal failure. 27 - 45 mg/L
A decrease of serum phosphate is bound to vitamin D defi-
0.87 - 1.45 mmol/L
ciency and hyperparathyroidism.
Urine : 400 -1300 mg/24h
METHOD 12.9 - 42.0 mmol/24h
Phosphomolybdate.
U.V. End point. Note : It is recommended for each laboratory to establish and
maintain its own reference values. The given data here are only
PRINCIPLE (2)
an indication.
Determination of inorganic phosphorus is made according to
the following reaction : PROCEDURE
Phosphorus
This reagent can be used manually (see method below) and
Ammonium molybdate + Sulfuric acid Phosphomolyb-
on most analysers. The applications are available on request.
date complex
- Correlation
SYMBOLS USED ON LABELS :
A comparative study has been performed between Elitech
method and another commercial reagent on 36 human serum
Lot Number
samples. Sample concentrations were between 1.85 and 26.1
mg/dL. The parameters of linear regression are as follows Consult instruction for use
Correlation coefficient (r) : 0.9993
In vitro diagnostic medical device
Linear regression : y = 1.0540 x - 0.327 mg/dL
Manufacturer’s address
- Interferences (5)
Temperature limitation
According to SFBC recommendations, some studies have been
performed to determine the level of interference from different Expiration date
compounds:
Unconjugated Bilirubin : Positive bias from 12 mg/dL of biliru
bin (120 mg/L, 205 µmol/L).
Conjugated bilirubin : No significant interference up to 21
mg/dL (210 mg/L, 360 µmol/L).
(04/2004)
FTAN-PHOS-6
): Important modification from the previous version
lower than 40 g/L oedemas can be observed. Ambulatory patients Patients at rest
Hyperproteinemia can be seen, for example, in case of hyper- 6.4 - 8.3 g/dL 6.0 - 7.8 g/dL
immunoglobulinemia (multiple myeloma, infection).
64 - 83 g/L 60 - 78 g/L
METHOD (4-5)
- Correlation
A comparative study has been performed between Elitech Lot Number
method and another commercial reagent on 54 human serum
samples. The sample concentrations were between 1.38 and Consult instruction for use
14.29 g/dL.
The parameters of linear regression are as follows : In vitro diagnostic medical device
Correlation coefficient (r) : 0.9968
Manufacturer’s address
Linear regression : y = 0.96 x + 0.18 g/dL
Temperature limitation
Expiration date
(08/2004)
FTAN-PRTB-3
CALCULATION
PRECAUTIONS Asample
- This reagent contains less than 0.1 % sodium azide. Sodium xn n = standard concentration
azide can react with copper and lead plumbing to form explo- Astandard
sive metal azides. Regulations currently in use regarding dan-
gerous waste elimination must be respected. If discharge in
the canalisations, rinse with plenty of water. .../...
- Use clean or single use laboratory equipment only to avoid
contaminations.
(01/2005)
FTAN-TGMLN-8
On Cobas Mira, calibration must be performed at least every According to SFBC recommendations, studies have been per-
2 weeks, and after each change of batch, or quality control formed to determine the level of interference from different
compounds:
results.
Total Bilirubin : Negative bias from 25 mg/dL (250 mg/L, 430
µmol/L).
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I Conjugated Bilirubin : Negative bias from 15 mg/dL (150
(normal control) and ELITROL II (abnormal control) are recom- mg/L, 250 µmol/L).
mended. Ascorbic acid : No significant interference up to 2 mg/dL (20
mg/L, 0.11 mmol/L).
PERFORMANCE DATA Haemoglobin : Positive bias from 0.25 g/dL (2.5 g/L).
The following data were obtained using the COBAS MIRA Glucose : No significant interference up to 500 mg/dL (5.0
analyser (37°C). g/L, 28 mmol/L).
Uric acid : No significant interference up to 22 mg/dL (220
- Analytical range mg/L, 1.3 mmol/L).
The reagent is linear from 25 to 1000 mg/dL (0.25 to 10 g/L),
(0.3 to 11.5 mmol/L).
BIBLIOGRAPHY
- Detection limit (5) 1. Naito, H.K., Coronary Artery Disease and Disorders of Lipid
Determined according to SFBC protocol, the detection limit is Metabolism. Clinical Chemistry: Theory, Analysis, Correlation,
equal to 5 mg/dL (0.05 g/L, 0.06 mmol/L). 4th Ed., Kaplan, L.A., Pesce, A.J., Kazmierczak, S.C. (Mosby,
Inc. eds. St Louis USA), (2003), 603.
- Sensitivity 2.Expert Panel on Detection, Evaluation, and Treatment of
The average variation of the analytical signal is 1.0 × 10-3 ∆A High Blood Cholesterol in Adults (Adult Treatment Panel III),
per mg/dL of Triglycerides (or 100 × 10-3 ∆A per g/L, 88 m∆A Executive Summary of the Third Report of the National
per mmol/L) for a light path of 1 cm. Cholesterol Education Program (NCEP). JAMA, (2001), 285,
2486.
- Precision 3.Fossati, P., Prencipe, L., Serum triglycerides determined colo-
rimetrically with an enzyme that produces hydrogen peroxide.
Within-run reproducibility
Clin. Chem., (1982), 28, 2077.
Low level : n = 20 m = 52 mg/dL CV = 1.6 %
Medium level : n = 20 m = 114 mg/dL CV = 1.3 % 4.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed. (W.B.
High level : n = 20 m = 278 mg/dL CV = 1.4 % Saunders eds. Philadelphia USA), (1995), 610.
5.Vassault, A., et al., Protocole de validation de techniques.
Between-run reproducibility (Document B, stade 3) Ann. Biol. Clin., (1986), 44, 686.
Medium level : n = 76 m = 113 mg/dL CV = 4.3 %
High level : n = 80 m = 281 mg/dL CV = 3.4 %
SYMBOLS USED ON LABELS :
- Correlation
Lot number
A comparative study has been performed between Elitech
method and another commercial reagent on 96 human serum Consult instruction for use
samples. The sample concentrations were between 20 and
1050 mg/dL. The parameters of linear regression are as fol- In vitro diagnostic medical device
lows :
Manufacturer’s address
Correlation coefficient (r) : 0.997
Linear regression : y = 0.943 x + 9 mg/dL Expiration date
Temperature limitation
(01/2005)
FTAN-TGMLN-8
(01/2005)
FTAN-TRIG-2
LINEARITY
Up to 1 000 mg/dL (10 g/L) (11.4 mmol/L).
BIBLIOGRAPHY
1.Buccolo G., David M., Clin. Chem., 19, (1973), 476.
2.Werner M., Gabrielson D.G., Eastman G., Clin Chem., 21,
(1981), 268.
3.Annoni G., Bottasso B.M., Ciaci D., Donato M.F., Tripoli A.,
lab. J.J. Res. Lab. Med., 9, (1982), 115.
Lot number
Manufacturer’ s address
Expiration date
Temperature limitation
(01/2005)
FTAN-TRIG-2
PRINCIPLE SAMPLES
Enzymatic determination of urea according the following reaction : Serum.
Urease Heparin plasma.
Urea + H2O 2NH3 + CO2 Urine diluted 1/100 in distilled water.
(Do not use anticoagulants containing fluoride or ammonium ions).
In an alkaline medium, in the presence of salicylate and sodium
hypochlorite, ammonium ions react to produce a green compound.
REFERENCE VALUES
REAGENTS Serum, plasma : 15 - 50 mg/dL
0.15 - 0.50 g/L
Reagent 1 : R1 2.50 - 8.33 mmol/L
Urease ≥ 30 000 U/L Urine : 20 - 35 g/24 h
Phosphate buffer, pH 6.70 120 mmol/L 333 - 583 mmol/24 h
Sodium Salicylate 60 mmol/L
Sodium nitroprussiate 3.5 mmol/L Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only
EDTA 1.34 mmol/L
an indication.
Reagent 2 : R2
Sodium hypochlorite 45 mmol/L PROCEDURE
Sodium hydroxyde 1 mol/L This reagent can be used manually (see method below) and
Standard : Std on most analysers.
The applications are available on request.
Urea 50 mg/dL
0.5 g/L Wavelength : 578 nm
8.325 mmol/L Temperature : 37°C
Cuvette : 1 cm light path
Take the dilution factor into account for the calculation of urea
concentration in urine.
(01/2005)
FTAN-URCO-2
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
Up to 200 mg/dL (2 g/L) (33.3 mmol/L).
BIBLIOGRAPHY
1.Chaney, A.L., Clinical Chem. and al., 8, (1962), 130.
2.Reiss. D. and al., Bull. Soc. Pharm. Bordeaux, 104, (1965),
Lot number
Manufacturer’ s address
Expiration date
Temperature limitation
(01/2005)
FTAN-URCO-2
Mix and wait 25 seconds: According to SFBC recommendations, some studies have been
performed to determine the level of interference from different
Distilled water 2,5 µL compounds:
Standard 2,5 µL
Sample 2,5 µL Bilirubin: No significant interference up to 60 mg/dL (600
mg/L, 1027 µmol/L).
Mix and read the variation of absorbance (∆A) between 25 Haemoglobin: No significant interference up to 500 mg/dL
seconds and 75 seconds. (5 g/L).
Ascorbic acid: No significant interference up to 23 mg/dL
CALCULATION (230 mg/L, 1.3 mmol/L).
∆Asample Turbidity: No significant interference up to 600 mg/dL
xn n = standard concentration Triglycerides equivalent (6 g/L, 6.9 mmol/L) .
∆Astandard
Glucose: No significant interference up to 500 mg/dL (5 g/L, 28
Take the dilution factor into account for the calculation of urea mmol/L).
concentration in urine. Methyldopa: No significant interference up to 5 mg/dL (50
mg/L)
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
BIBLIOGRAPHY
(normal control) and ELITROL II (abnormal control) are recom- 1.Newman, D.J., Price C.P., Non protein Nitrogen Metabolite. Tietz
mended. Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. &
Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 414.
PERFORMANCE DATA 2.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
The following data were obtained using the COBAS MIRA Saunders eds. Philadelphia USA), (1995), 622.
analyser (37°C) 3.First, M.R, Renal function. Clinical Chemistry: Theory, Analysis,
Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J., Kazmierczak, S.C.,
- Analytical range (Mosby Inc. eds St Louis USA), (2003), 477 and appendix.
The reagent is linear from 10 to 300 mg/dL ( 0.1 to 3 g/L, 4.Bretaudière, J.P., et al., Direct Enzymatic Determination of Urea in
1.67 to 50 mmol/L). Plasma and Urine with a Centrifugal Analyzer. Clin. Chem., (1976),
22, 1614.
- Detection limit (6)
5.Fawcett, J.K., Scott, J.E., A Rapid and Precise Method for the
Determined according to SFBC protocol, the detection limit is Determination of Urea. J. Clin. Path., (1960), 13, 156.
equal to 5.5 mg/dL (0.055 g/L, 0.92 mmol/L).
6.Vassault, A., et al., Protocole de validation de techniques
(Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
- Sensitivity
The average variation of the analytical signal is 1.33 ∆A/min. 7.Vassault, A., et al., Analyses de biologie médicale: spécifications
per mg/dL of urea (0.133 ∆A/min. per g/L, 8 m∆A/min. per et normes d'acceptabilité à l'usage de la validation des techniques.
mmol/L) for a light path of 1 cm. Ann. Biol. Clin. (1999), 57, 685
- Precision
Within-run reproducibility SYMBOLS USED ON LABELS:
Low level : n = 20 m = 28 mg/dL CV = 2.8 %
Medium level : n = 20 m = 51 mg/dL CV = 3.3 %
Lot Number
High level : n = 20 m = 159 mg/dL CV = 3.9 %
Consult instruction for use
Between-run reproducibility
Low level : n = 20 m = 29 mg/dL CV = 3.2 % In vitro diagnostic medical device
Medium level : n = 15 m = 50 mg/dL CV = 3.8 %
High level : n = 20 m = 158 mg/dL CV = 4.4 % Manufacturer’s address
PRINCIPLE PROCEDURE
Enzymatic determination according to the following reactions : This reagent can be used manually (see method below) and
on most analysers.
Urease
Urea + H20 2NH3 + CO2 The applications are available on request.
GlDH
Wavelength : 340 nm
2NH4+ + 2α-Ketoglutarate + 2NADH 2L-Glutamate + Temperature : 37°C, 30° C
2NAD+ + 2H20
Cuvette : 1 cm light path
1 month at 2-8°C
SYMBOLS USED ON LABELS:
SAMPLES
Serum. Lot number
Heparin plasma.
Consult instruction for use
Urine diluted 1/100 in distilled water.
(Do not use anticoagulants containing fluoride or ammonium ions). In vitro diagnostic medical device
REFERENCES VALUES
Manufacturer’ s address
Serum, plasma : 15 - 50 mg/dL
0.15 - 0.50 g/L Expiration date
2.50 - 8.33 mmol/L
Urine : 20 - 35 g/24 h Temperature limitation (01/2005)
333 - 583 mmol/24 h FTAN-URUV-2
METHOD (4)
Enzymatic - colorimetric.
REFERENCE VALUES (3)
(01/2005)
FTAN-AUML-4
- Interferences (6)
CALCULATION
According to SFBC recommendations, studies have been per-
Asample formed to determine the level of interference from different
xn n = standard concentration compounds:
Astandard
Bilirubin: No significant interference up to 30 mg/dL (300
Take the dilution factor into account for the calculation of uric mg/L, 510 µmol/L)
acid concentration in urine. Haemoglobin: Positive bias from 0.05 g/dL (0.5 g/L).
Glucose: No significant interference up to 0.5 g/dL (5 g/L, 28
QUALITY CONTROL mmol/L).
To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are recom- Ascorbic acid: Negative bias from less than 1 mg/dL (10
mended. mg/dL, 0.056 mmol/L).
Turbidity: Positive bias from 370 mg/dL Triglyceride equiva-
PERFORMANCE DATA lent (3.7 g/L, 4.25 mmol/L).
The following data were obtained using the COBAS MIRA
analyser (37°C)
BIBLIOGRAPHY
- Analytical range 1.First, M.R., Renal Function. Clinical Chemistry: Theory,
The reagent is linear from 0.5 to 25 mg/dL (5 to 250 mg/L, 30 Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
to 1500 µmol/L). Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 477-
appendix.
- Detection limit (6) 2.Newman, D. J., Price, C. P., Non protein Nitrogen Metabolite.
Determined according to SFBC protocol, the detection limit is Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
equal to 0.2 mg/dL (2 mg/L, 13 µmol/L). C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
(2001), 414.
- Sensitivity 3.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed, (W.B.
The average variation of the analytical signal is 21 × 10-3 ∆A Saunders eds. Philadelphia USA), (1995), 624.
per mg/dL of uric acid (2.1 × 10-3 ∆A per mg/L, 350 ∆A per
µmol/L) for a light path of 1 cm. 4.Fossati, P., et al., Use of 3,5-dichloro-2-hydroxy-benzenesul-
fonic acid/4-aminophenazone chromogenic system in direct
- Precision enzymatic assay of uric acid in serum and urine. Clin. Chem.,
Within-run reproducibility (1980), 26, 227.
Medium level: n = 10 m = 4.5 mg/dL CV = 1.0 % 5.Kaplan, L.A., Pesce, A.J., Examination of Urine. Clinical
High level: n = 10 m = 11 mg/dL CV = 0.7 % Chemistry: Theory, Analysis, Correlation, 4th Ed., Kaplan, L.A,
Pesce, A.J., Kazmierczak, S.C., (Mosby Inc. eds St Louis USA),
(2003), 1092.
Between-run reproducibility
6.Vassault, A., et al., Protocole de validation de techniques
Medium level: n = 18 m = 4.8 mg/dL CV = 1.8 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
High level: n = 18 m = 8.9 mg/dL CV = 2.7 %
Temperature limitation
Expiration date
(01//2005)
FTAN-AUML-4
PRINCIPLE PROCEDURE
Enzymatic determination of uric acid according to the follo- Wavelength : 510 nm (492-550)
wing reactions : Temperature : 37°C
Cuvette : 1 cm light path
Uricase
Uric acid + 2H2O + O2 Allantoine + CO2 + H2O2
Read against reagent blank.
Peroxidase
2H2O2 + 4-Aminoantipyrine + DHBS Red quinone BLANK STANDARD SAMPLE
+ H2O + HCl
Working Reagent 1 mL 1 mL 1 mL
DHBS = 3,5-Dichloro-2-Hydroxybenzenesulfonic acid
Distilled water 25 µL - -
STABILITY OF REAGENTS
LINEARITY
When stored at 2-8° C and protected from light, the reagents
are stable until the expiry date stated on the label. Up to 25 mg/dL (250 mg/L) (1487.5 µmol/L).
PRINCIPLE
Zinc, in a pH 8.60 buffer system, forms with specific com- Note : It is recommended for each laboratory to establish and
plexant 5-Br-PAPS a stable coloured complex. The interferen- maintain its own reference values. The data given here are only
ces, due to oligoelements present in the sample, are elimina- an indication.
ted using particular reaction condition and specific masking
agents. PROCEDURE
This reagent can be used manually (see method below) and on
REAGENTS COMPOSITION most analysers.
The applications are available on request.
Reagent 1 : R1
Wavelength : 560 nm
Buffer, pH 8.60 200 mmol/L
Temperature : 25°C, 30°C, 37°C
Additives Cuvette : 1 cm light path.
Reagent 2 : R2
Read against reagent blank.
Complexant 5-Br-PAPS 0.1 mmol/L
BLANK STANDARD SAMPLE
Reagent 3 : R3
Reaction enhancer 200 mmol/L WR 2 1 mL 1 mL 1 mL
Standard : Std Distilled water 50 µL - -
Zinc 200 µg/dL Standard - 50 µL -
2 mg/L Sample - - 50 µL
30.6 µmol/L
Mix and read the optical density (∆OD).
STABILITY OF REAGENTS The final colour is stable for at least 1 hour.
When stored at 2-8° C and protected from light, the reagents
are stable until the expiry date stated on the label. CALCULATION
µg/dL n= 200
PREPARATION AND STABILITY OD Sample
xn mg/L n= 2
OF WORKING REAGENTS OD Standard µmol/L n= 30.6
WR1 : Dissolve one level measuring spoonful of reagent 3 in
n = standard concentration.
the reagent 1.
Stability : 30 days at 2-8°C QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I
WR2 : Mix 10 volumes of WR 1 with 1 volume of the reagent 2. (normal control) and ELITROL II (abnormal control) are recom-
Stability : 10 days at 2-8°C mended.
SAMPLES LINEARITY
Up to 2 000 µg/dL (20 mg/L) (306 µmol/L).
Serum or plasma not hemolyzed ; use only heparin salts as
anticoagulants.
BIBLIOGRAPHY
Urine collected during 24 hours period.
Centrifuged seminal fluid : centrifuge the sample at 3000 1.Homsher R. and Zak, B., Clin. Chem., 31/8, (1985), 1310.
r.p.m. for 10-15 minutes. 2.Makino T. and al., Clinica Chimica Acta, 120, (1982), 127.
Dilute supernatant 1:100 with normal saline.
SYMBOLS USED ON LABELS :
REFERENCE VALUES Lot Number
Serum, plasma : 68 - 107 µg/dL
0.68 - 1.07 mg/L Consult instruction for use
10.4 - 16.4 µmol/L
In vitro diagnostic medical device
Urine : 150 - 1 200 µg/24 h
2.3 - 18.4 µmol/24 h Manufacturer’s address
Centrifuged seminal fluid : 2 - 10 mg/dL Temperature limitation
20 - 100 mg/L (01/2005)
0.3 - 1.5 mmol/L Expiration date FTAN-ZINC-2
PRINCIPLE VALUES
BILICAL is a calibrator intended to be used for the quantitative deter- Total Bilirubin: x,x mg/dL
mination of total and direct bilirubin in human serum or plasma, Direct Bilirubin: x,x mg/dL
using Elitech reagents.
- Use only clean or single use glass material to avoid contaminations. In vitro diagnostic medical device
- Discard cloudy calibrator.
Manufacturer’s address
PREPARATION Temperature limitation
Carefully open the vial, avoiding the loss of lyophilizate, and pipette
Expiration date
in exactly 5 mL of distilled water.
Carefully close the vial and dissolve the contents completely by occa-
sional gentle swirling within 30 minutes avoiding the formation of
Cal Calibrator
foam.
If not use in a short time, this preparation could be aliquoted and sto-
red at -20°C.
Avoid direct light, which would affect stability of bilirubin.
PROCEDURE
To calibrate with BILICAL follow the procedure described in the ins-
truction for use of the corresponding Elitech reagent.
(11/2004)
FVBL-BIEN-3
LOT XXXXX
For in vitro diagnostic use only XX/XX
PRINCIPLE LIMITATIONS
Cholesterol LDL Calibrator is intended for the calibration of The calibrator has been validated with ELITECH Cholesterol
LDL Cholesterol assays (manual method or automated analy- LDL Direct SL reagent. Users should verify its suitability with
sers) using ELITECH Cholesterol LDL Direct SL reagent. other reagents.
COMPOSITION VALUES
- The Cholesterol LDL calibrator is prepared from human The LDL cholesterol concentration of this lot is:
serum.
- The LDL cholesterol concentration is lot specific. * X.XX g/L
* XXX mg/dL
TRACEABILITY
Concentration value for Cholesterol LDL Calibrator is defined
according to the US CDC LDL-Cholesterol reference method (β-
Quantification method).
SYMBOLS USED ON LABELS :
PRECAUTIONS
- Respect the normal precautions and good laboratory prac- Lot number
tice. All human material should be considered as potentially
infectious. Consult instruction for use
All products derived from blood are prepared exclusively from
the blood of donors tested individually and found to be nega- In vitro diagnostic medical device
tive for HbsAg and antibodies to HCV and HIV1/HIV2.
However, handle cautiously as potentially infectious. Manufacturer’ s address
- Use only clean or single use glass material to avoid contami-
nations. Expiration date
- Discard cloudy calibrator.
Temperature limitation
STABILITY AND STORAGE
- When stored at 2-8°C and protected from light, the calibra-
tor is stable until the expiry date stated on the label.
- Reconstituted calibrator is stable 7 days at 2-8°C.
- After opening, the vials should be kept correctly and tightly
capped to prevent contamination and evaporation.
PREPARATION
Carefully open the vial, avoiding the loss of lyophilizate, and
pipette in exactly 1 mL of distilled/deionized water.
Carefully close the vial and dissolve the contents completely
by occasionnal gentle swirling avoiding formation of foam.
PROCEDURE
To calibrate with Cholesterol LDL Calibrator follow the proce-
dure described in the instruction for use of the ELITECH
Cholesterol LDL Direct SL reagent.
(11/2004)
FVBL-LDLD-1
LOT XXXX
XXXX/XX
Caution, control material contains less than 0.1 % sodium Consult instruction for use
azide. In vitro diagnostic medical device
DESCRIPTION Note: Store calibrator tightly capped and protected from light when not
ELICAL 2 is a lyophilized calibrator prepared from human serum. The in use.
concentrations and activities of the calibrator components have been
adjusted to en-sure optimal calibration of the clinical chemistry re- PROCEDURE
agents. To calibrate with ELICAL 2 follow the procedure de-scribed in the ins-
tructions for use of the corresponding reagent.
After reconstitution
Stability of the components:
Between 15- 25°C: 8 hours
Between 2-8° C: 2 days
Between -25 and -15°C: 4 weeks (When frozen once)
Exceptions:
(02/2004)
FTBL-CALI2-2
PRINCIPLE Note:
ELITROL I and II are multiparametric control sera in-tended A light green colour of control sera is without influence on the
for accuracy control of clinical chemistry re-agents. control values.
Store control sera tightly capped after reconstitution.
DESCRIPTION
PROCEDURE
ELITROL I and ELITROL II are lyophilised control sera prepa- Elitrol I and ELITROL II are handled as samples accord-ing to
red from human serum. The concentrations and activities the instructions use of each reagent. It is recom-mended to
have been adjusted to be in the normal range or at the normal use these sera together with samples, at least once a day and
threshold (ELITROL I) or in the patho-logical range (ELITROL after each calibration.
II).
CONTROL VALUES
PRECAUTIONS
The concentrations and activities of the components are lot-
Respect the normal precautions and good laboratory practice. specific. The exact values are given in the data sheet enclosed
All human material should be considered as potentially infec- in the kit.
tious.
All products derived from blood are prepared exclusively from Individual laboratories may not obtain the mean values as
the blood of donors tested individually and found to be nega- listed for each lot. Technique, equipment and experimen-
tive for HbsAg and antibodies to HCV and HIV1/HIV2. tal error may produce slightly diffe-rent values. However
However, handle cautiously as potentially infectious. the values should fall within the expected range. Each
laboratory should deter-mine their own mean values for
this product.
PREPARATION
Carefully open the vial, avoiding the loss of lyophilizate, and SYMBOLS USED ON LABEL:
pipette in exactly 5 mL of distilled/deionized water.
Carefully close the vial and dissolve the contents com-pletely
Lot Number
by occasional gentle swirling within 30 minutes avoiding the
formation of foam. Consult instruction for use
Important : With the exception of alkaline phosphatase, all
enzymes can be measured immediately. To activate the alka- In vitro diagnostic medical device
line phosphatase, incubate the reconstituted control serum for
Manufacturer’s address
one hour at 25° C.
Temperature limitation
STABILITY AND STORAGE
Prior to reconstitution, when stored at 2-8°C, the reagent is Expiration date
stable until the expiry date stated on the label.
After reconstitution
- Stability of the components:
Between 15- 25°C: 12 hours
Between 2-8°C: 5 days
Between -25 and -15°C: 1 month (when frozen once)
Exceptions:
- Stability of total bilirubin (when stored protected from light):
Between 15- 25°C: 8 hours
Between 2-8°C: 24 hours
Between -25 and -15°C: 2 weeks (When frozen once)
(04/2004)
FTAN-CONT-3
PRINCIPLE PREPARATION
The CHOLESTEROL HDL calibrator is designed to be used Bring the calibrator to room temperature before reconstitu-
with HDL Cholesterol Direct test for the quantitative determi- tion.
nation of high density lipoprotein cholesterol (HDL Vial should be opened carefully to avoid loss of freeze-dried
Cholesterol) in serum. powder.
Add exactly 3 mL of distilled water.
PRODUCT DESCRIPTION Mix by gently rotating and allow to stand until dissolution is
complete (20 minutes) . Then mix the content by gently swir-
The CHOLESTEROL HDL calibrator is prepared from human
ling the bottle. Do not shake, to avoid foam formation.
serum.
The control is freeze-dried for extended shelf-life.
STABILITY AND STORAGE
Prior to reconstitution, when stored at 2-8 °C and protected
PRECAUTION from light, the HDL Cholesterol is stable until the expiry date
Not to be used internally in humans or animals. stated on the label.
Do not use reagents past the expiration date stated on each
After reconstitution
vial label.
The reconstituted calibrator is stable for 7 days at 2-8 °C.
Do not use the reagents for any other purpose than described
herein.
Human serum material was used in the manufacture of this VALUES
product. The raw human serum used was tested and found - The values are based on the US CDC HDL-cholesterol refe-
negative for HBsAg, anti-HIV antibodies and anti HCV antibody. rence method.
Because no test can offer complete assurance that products
derived from human blood will not transmit infectious agents, * XXX mg/dL
it’s recommended that this product should be handled with * XX.X g/L
the same biohazard precautions used for patient specimens.
Lot Number
Manufacturer’s address
Temperature limitation
Expiration date
(03/2005)
FVBL-HDLD-4
TRACEABILITY
Concentration value for Cholesterol Standard 200 mg/dL is
traceable to the Standard Reference Material SRM 1951a (of
the National Institute of Standards and Technology).
PRECAUTIONS
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Cholesterol Standard 200 mg/dL follow the
procedure described in the instruction for use of the corres-
ponding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Cholesterol
reagents. Users should verify its suitability with other rea-
gents.
(01/2004)
FTSB-CHOL200-3
PRECAUTIONS
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Creatinine Standard 2 mg/dL follow the pro-
cedure described in the instruction for use of the correspon-
ding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Creatinine
reagents. Users should verify its suitability with other rea-
gents.
(01/2005)
FTSB-CREN2-2
PRECAUTIONS
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Glucose Standard 100 mg/dL follow the pro-
cedure described in the instruction for use of the correspon-
ding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Glucose rea-
gents. Users should verify its suitability with others glucose
methods.
(01/2004)
FTSB-GLUP100-1
PRECAUTIONS
- Utiliser une verrerie propre ou à usage unique afin d'éviter
toute contamination.
- Rejeter tout standard présentant un trouble.
STABILITE ET CONSERVATION
- Le standard conservé à 2-8°C et à l'abri de la lumière est sta-
ble jusqu'à la date de péremption figurant sur l'étiquette.
- Après utilisation, le flacon doit immédiatement et correcte-
ment être refermé afin d'éviter toute contamination ou évapo-
ration.
PREPARATION
Le standard est prêt à l'emploi.
MODE OPERATOIRE
Pour calibrer avec le Standard Microprotein 20 mg/dL suivre
les instructions de la fiche technique du réactif ELITECH ser-
vant au dosage.
LIMITATIONS
Ce standard a été validé avec les réactifs Microprotein ELI-
TECH. Les utilisateurs doivent s'assurer qu'il peut être utilisé
avec les autres méthodes de quantification des microprotéines.
(07/2004)
FTSB-PRTP20-1
PRECAUTIONS
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Microprotein Standard 100 mg/dL follow the
procedure described in the instruction for use of the corres-
ponding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Microprotein
reagents. Users should verify its suitability with other rea-
gents.
(07/2004)
FTSB-PRTP100-1
PRECAUTIONS
- Triglycerides Standard contains less than 0.1% of sodium
azide. Sodium azide may react with lead and copper plumbing
to form explosive metal azides. Regulations currently in use
regarding the dangerous waste elimination must be respected.
If discharge in the canalisations, rinse with plenty of water.
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Triglycerides Standard 200 mg/dL follow the
procedure described in the instruction for use of the corres-
ponding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Triglycerides
reagents. Users should verify its suitability with other rea-
gents.
(01/2004)
FTSB-TRIG200-1
PRECAUTIONS
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Urea Standard 50 mg/dL follow the proce-
dure described in the instruction for use of the corresponding
ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Urea reagents.
Users should verify its suitability with others urea methods.
(01/2004)
FTSB-URUV50-1
PRECAUTIONS
-HARMFUL !
Uric Acid Standard contains 0.15% of sodium azide. Sodium
azide may react with lead and copper plumbing to form explo-
sive metal azides. Regulations current in use regarding the
dangerous waste elimination must be respected. If discharge
in the canalisations, rinse with plenty of water.
R21: Harmful in contact with skin.
R22: Harmful if swallowed.
S26: In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.
S28: In case of contact with skin, rinse immediately with
plenty of water.
S45: In case of accident, or if you feel unwell, seek im-media-
tely medical advice (show the label where possi-ble).
- Use only clean or single use glass material to avoid contami-
nations.
- Discard cloudy reagent.
PREPARATION
The standard is ready for use.
(01/2004)
FTSB-ACUR6-1
For in vitro diagnostic use only Réf. : LXAS - 0115 100 Tests
CALIBRATION BIBLIOGRAPHY
The ASO detection limit is calibrated to the International stan- 1. Haffejee . Quarterly Journal of Medicine 1992. New series
dard WHO. 84; 305: 641
2. Ahmed Samir et al. Pediatric Annals 1992; 21: 835
)QUALITY CONTROL 3. J Spaun et al. Bull Wld Hlth Org 1961; 24: 271.
Positive and negative controls are recommended to monitor 4. The association of Clinical Pathologists 1961. Broadsheet
the performance of the procedure, as well as a comparative 34
pattern for a better result interpretation 5. B Picard et al. La Presse Medicale 1983; 23: 2
)REFERENCE VALUES 6. Luis Borque et al. Journal of Clinical Immunoassay. 1992;
15(3): 182.
Adults : <_ 200 IU/mL 7. Young DS. Effects of Drugs on clinical laboratory test, 4th
Children ( < 5 years old ) : <_ 100 IU/mL ed; AACC Press, 1995.
Note : It is recommended for each laboratory to establish and SYMBOLS USED ON THE LABELS:
maintain its own reference values. The data given here only an
indication. Lot number
-Interferences
Some studies have been performed to determine the level of
inter-ference from different compounds :
LIMITATION
1.False positive results may be obtained in conditions such as,
rheumatoide arthritis, scarlet fever, tonsilitis, several strepto-
coccal infections and healthy carriers.
2. Early infections and children from 6 months to 2 years may
cause false negative results.
3.A single ASO determination does not produce much
informa-tion about the actual state of the disease. Titrations at
biweekly intervals during 4 or 6 weeks are advisable to follow
the disease evolution.
4.Clinical diagnosis should not be made on findings of a sin-
gle test result, but should integrate both clinical and labora- (03/2005)
tory data. FTAN-LXAS-4
For in vitro diagnostic use only Réf. : LXCR - 0115 100 Tests
Plastic stirrers 100 Note : Delay on reading the results may result in over-surestima-
Glass slide 1 tion of the CRP level.
PRECAUTIONS SEMI-QUANTITATIVE TEST
-The reagent and controls contain 0.095 % sodium azide. Procedure :
Sodium azide can react with copper and lead plumbing to form
explosive metal azides. 1.Make serial two fold dilutions of the sample ( found pre-
Regulations currently in use regarding dangerous waste elimi- viously positive) in the saline solution (NaCl 0.9 %)
nation must be respected. If discharge in the canalisations, 2.Proceed for each dilution as in qualitative method.
rinse with plenty water.
Reading and interpretation
-Components from human origin have been tested and found
The titer, is defined as the highest dilution showing the positive
to be negative for the presence of HBsAg, HCV, and antibody
result.
to HIV(1/2). However handle cautiously as potentially infec-
The approximate CRP concentration in the patient sample is
tious.
calculated as follow :
-Use clean or single use laboratory equipment only to avoid
6 x CRP Titer = mg/L
contaminations.
(03/2005)
FTAN-LXCR-4
CALIBRATION BIBLIOGRAPHY
The CRP detection limit is calibrated to the Reference Material
CRM 470/RPPHS. 1. Lars-Olof Hanson et al. Current Opinion in Infectious disea-
ses 1997; 10: 196
2. M.M. Pepys. The Lancet 1981; March 21: 653
)QUALITY CONTROL
3. Chetana Vaishnavi. Immunology and Infectious Diseases
Positive and negative controls are recommended to monitor
1996; 6: 139
the performance of the procedure, as well as a comparative
4. Yoshitsugy Hokama et al. Journal of Clinical Laboratory
pattern for a better result interpretation
Status 1987; 1: 15
5. S. Yamamoto et al. Veterinary Immunology and
)REFERENCE VALUES Immunopathology 1993; 36: 257
Serum : <_ 6 mg/L 6. Charles Wadsworth et al. Clinica Chimica Acta; 1984: 138:
309.
Note : It is recommended for each laboratory to establish and 7. Young DS. Effects of Drugs on clinical laboratory test, 4th
maintain its own reference values. The data given here only an ed; AACC Press, 1995.
indication.
SYMBOLS USED ON THE LABELS:
PERFORMANCE DATA
Lot number
-Detection limit
The detection limit is 6 (5-10) mg/L Consult instruction for use
- Interferences
Some studies have been performed to determine the level of
interference from different compounds :
LIMITATION
1. High CRP concentration samples may give negative results
(Prozone effect). In this case, re-test the sample again using a
drop of 20 µL of sample.
2. The strength of agglutination is not indicative of the CRP
concentration in the samples tested.
3. Clinical diagnosis should not be made on findings of a sin-
gle test result, but should integrate both clinical and labora-
tory data.
(03/2005)
FTAN-LXCR-4
For in vitro diagnostic use only Réf. : LXRF- 0115 100 Tests
Negative control C - 1x 1 ml
Note : Delay on reading the results may result in over-surestima-
Animal serum
tion of the RF level.
Plastic stirrers 100
Glass slide 1 SEMI-QUANTITATIVE TEST
Procedure :
PRECAUTIONS
1.Make serial two fold dilutions of the sample ( found pre-
-The reagent and controls contain 0.095 % sodium azide.
viously positive) in the saline solution (NaCl 0.9 %).
Sodium azide can react with copper and lead plumbing to form
2.Proceed for each dilution as in qualitative method.
explosive metal azides.
Regulations currently in use regarding dangerous waste elimi- Reading and interpretation
nation must be respected. If discharge in the canalisations, The titer, is defined as the highest dilution showing the positive
rinse with plenty water. result.
-Components from human origin have been tested and found The approximate RF concentration in the patient sample is cal-
to be negative for the presence of HBsAg, HCV, and antibody culated as follow :
to HIV(1/2). However handle cautiously as potentially infec- 8 x RF Titer = IU/mL
tious.
-Use clean or single use laboratory equipment only to avoid …/…
contaminations.
STABILITY OF REAGENTS
When stored at 2-8°C and protected from light, the reagent
and controls are stable until the expiry date stated on the
(03/2005)
label.
FTAN-LXRF-4
Do not freeze.
)CALIBRATION BIBLIOGRAPHY
The FR latex detection limit is calibrated to the International
1. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1.
RF reference WHO 64/2 Rheumatoid Arthritis Serum.
2. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34:
951.
)QUALITY CONTROL 3. Robert H Shmerling et al. The American Journal of Medicine
Positive and negative controls are recommended to monitor
1991; 91: 528.
the performance of the procedure, as well as a comparative
4. Adalbert F. Schubart et al. The New England Journal of
pattern for a better result interpretation
Medicine 1959; 261: 363.
REFERENCE VALUES 5. Charles M. Plotz 1956; American Journal of Medicine;
21:893.
Serum : <_ 8 IU/mL 6. Young DS. Effects of drugs on clinical laboratory test, 4th
ed. AACC Press, 1995.
Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here only an
indication. SYMBOLS USED ON THE LABELS :
- Sensitivity : 98 %
- Specificity : 97 %
- Interferences
Some studies have been performed to determine the level of
interference from different compounds :
LIMITATION
1-The incidence of false positive results is about 3-5 %.
Individuals suffering from infectious mononucleosis, hepatitis,
syphilis as well as elderly people may give positive results.
2-Diagnosis should not be solely based on the results of
Waaler Rose method but also should be complemented with a
RF-Latex test along with the clinical examination.
3-Results obtained with a Waaler Rose method do not compare
with those obtained with RF- Latex method. Differences in the
results between methods do not reflect
(03/2005)
FTAN-LXRF-4
(03/2005)
FTAN-LXRP-4
)CALIBRATION BIBLIOGRAPHY
The reagent sensitivity is calibrated against the "Human 1. Georges P.Schmid .Current Opinion in Infectious Diseases
Reactive Serum" from CDC (Centre for Disease Center). 1994; 7:34-40.
2. Sandra A. Larsen et al. Clinical Microbiology Reviews 1995
; 8 (1)-21.
)QUALITY CONTROL
3. Sandra A. Larsen et al. A manual of Test for Syphilis
Positive and negative controls are recommended to monitor
American Public Health Association 1990 : 1-192.
the performance of the procedure, as well as a comparative
4. Marry W. Perryman et al. Journal of Clinical Microbiology.
pattern for a better result interpretation
1982; 16: 286-290.
5. Young DS. Effects of Drugs on clinical laboratory test, 4th
)PERFORMANCE DATA ed; AACC Press, 1995.
-Detection limit
The detection limit has been defined for the dilution at 1/16. SYMBOLS USED ON THE LABELS :
LIMITATION
1-As with tests based on reagins determination, the RPR
syphilis test may produce false positive results. These can be
linked to diseases such leprosy, systemic lupus erythemato-
sus (SLE) infectious mononucleosis, maleria, viral pneumonia.
Any positive result must be confirmed by another serological
assay (e.g TPHA).
Final diagnosis will only be reached after correlation of the
results with clinical signs.
2-Contaminated sera and excessive reaction times may cause
false positive results.
3-At the end of each daily use, remove the needle from the
antigen bottle, rinse it carefully with distilled water and air-
day it. The antigen suspension kept in the dispensing bottle
may lose some of its stability in the long term, therefore it is
recommended to pour it back in its original container at the
end of the procedure. Carefully rinse bottle and needle with
distilled water, then air dry them.
(03/2005)
FTAN-LXRP-4
For in vitro diagnostic use only Ref.: LXWR - 0115 100 Tests
(03/2005)
FTAN-LXWR-4
)CALIBRATION BIBLIOGRAPHY
The Waaler rose detection limit is calibrated to the
1. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1.
International RF reference WHO 64/2 Rheumatoid Arthritis
2. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34:
Serum.
951.
3. Robert H Shmerling et al. The American Journal of
)QUALITY CONTROL Medicine 1991; 91: 528.
Positive and negative controls are recommended to monitor 4. Koritz T N et al. Journal of Inmmunological Methods.
the performance of the procedure, as well as a comparative 1980; 32; 1.
pattern for a better result interpretation 5. Assameh S N et al. Journal of Immunological Methods
1980; 34: 205.
REFERENCE VALUES 6. Young DS. Effects of drugs on clinical laboratory test, 4th
ed. AACC Press, 1995
Serum : <_ 8 UI/mL
Note : It is recommended for each laboratory to establish and SYMBOLS USED ON LABELS :
maintain its own reference values. The data given here only an
indication. Lot number
- Interferences
Some studies have been performed to determine the level of
interference from different compounds :
LIMITATION
1-The incidence of false positive results is about 3-5 %.
Individuals suffering from infectious mononucleosis, hepatitis,
syphilis as well as elderly people may give positive results.
2-Diagnosis should not be solely based on the results of
Waaler Rose method but also should be complemented with a
RF-Latex test along with the clinical examination.
3-Results obtained with a Waaler Rose method do not compare
with those obtained with RF- Latex method. Differences in the
results between methods do not reflect differences in the abi-
lity to detect rheumatoid factors.
(03/2005)
FTAN-LXWR-4
INTERPRETATION OF RESULTS
NOTES: - Specificity :
The shade of red color in the test line region (T) will vary No cross-reaction was observed with the following hormones,
depending on the concentration of hCG present. However, at the following concentrations :
neither the quantitative value nor the rate of increase in hCG
can be determined by this qualitative test. hFSH 1 000 mU/mL (reference: 2nd IRP LH 80/552)
hLH 300 mU/mL (reference: 1st IRP FSH 92/510)
QUALITY CONTROL hTSH 1 000 µU/mL (reference: 1st IRP TSH 94/674)
Each reaction device has its own quality control indicator.
- Interferences :
After performing the test a coloured band has to appear on the
Studies have been performed to determine potential interfe-
(C) area. If not :
rences on negative and positive results.
• either the procedure has not been carefully followed None of the following substances interfere significantly up to
• or the reaction device has been deteriorated. the concentrations indicated below :
Repeat the test using a new reaction device.
Hemoglobin : 0.4 g/dL (4 g/L)
EXPECTED VALUES Bilirubin : 30 mg/dL (300 mg/L; 513 µmol/L)
hCG level concentration in urine and serum of pregnant Uric acid : 0.2 g/dL (2 g/L; 11.9 mmol/L)
Glucose : 2 g/dL (20 g/L; 110 mmol/L)
woman rises very rapidly, frequently exceeding 100 mIU/ml
Ascorbic acid : 20 mg/dL (200 mg/L)
after the first missed menstrual period and peaking in the
Acetaminophen : 20 mg/dL (200 mg/L)
30,000 - 100,000 mIU/ml range by 10-12 weeks into pre-
Salicylic acid : 20 mg/dL (200 mg/L)
gnancy.
Atropine : 20 mg/dL (200 mg/L)
LIMITATION OF THE TEST Caffeine : 20 mg/dL (200 mg/L)
1- If the test is negative or doubful whereas the pregnancy is Gentisic acid : 20 mg/dL (200 mg/L)
still suspected, repeat the test on a fresh specimen obtained
48-72 hours later and confirm by a quantitative test and/or BIBLIOGRAPHY
other clinical information.
2-Positive results can be observed in absence of pregnancy 1.Batzer FR. Fertility and Sterility 1980; 34:1.
for hCG concentrations close to 10 mIU/mL in the following 2.Catt KJ, Dufan ML, Vaitukaitis JL. J. Clin. Endocrinol.
cases : Metab. 1975; 40:537.
- Natural abortions 3.Baunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Am.
- Elevated physiological hCG levels of non-pregnant women J. Obstet. Gynecol. 1976; 126:678.
- Drugs comprising hCG 4.Lenton EA, Neal LM, Sulaiman R. Fertility and Sterility
3- Patients with trophoblastic or non-trophoblastic diseases 1982; 37:773.
(breast cancer, testicular tumors, prostate cancer, lung can- 5.Engvall E. Methods in Enzymology 1980; 70:419.
cer, etc...) may have elevated hCG levels which could give 6.Uotila M, Ruoslahti E, Engvall EJ. E. J. Immunol. Methods
positive results in absence of pregnancy. 1981; 42:11.
4- False- negative can occur for very high concentrations of 7.Steier JA, Bergsjo P, Myking OL. Am. J. Obstet. Gynecol.
hCG (> 600 000 mIU/mL). 1984; 64:391.
8.Dawood MY, Saxena BB, Landesman R. Am. J. Obstet.
PERFORMANCE CHARACTERISTICS Gynecol. 1977; 50:172.
- Sensitivity : 9.Braunstein GD, Vaitukaitis JL, Carbone PP. Ann. Inter.
Urine : 20 mU/mL Med. 1973; 78:39.
Serum : 10 mU/mL
The sensitivity has been tested according to the reference SYMBOLS USED ON THE LABELS:
material WHO 4th IRP hCG (75/589).
Lot Number
- Precision :
Urine : Comparative Studies were performed on 130 positive Consult instruction for use
and 178 negative urine specimens using
PREGTEST II versus a reference hCG rapid test. In vitro diagnostic medical device
Both studies demonstrated a 100% correlation.
Serum : Comparative Studies were performed on 169 positive Manufacturer’s address
and 250 negative serum specimens using PREGTEST II ver-
sus a reference hCG rapid test. Both studies demonstrated a Temperature limitation
100 % correlation.
Expiration date
METHOD
Immuno-chromatography Result area
Qualitative Control (C) Test (T) Sample well
PRINCIPLE
The Rapidrog II-Amphetamine (AMP) is a rapid immunoassay for the
qualitative detection of d-amphetamine in human urine at a cut-off C T
concentration of 1000 ng/mL, before confirmation with a reference
method. The membrane is pre-coated with drug conjugate on the test
band (T) and a colored mouse anti-amphetamine mono-clonal anti-
body-colloidal gold conjugate pad is placed at the right end. In the
absence of drug in the urine, the conjugated anti-amphetamine
monoclonal-colloidal gold moves upward on the membrane chromato-
graphically by capillary action, to react with the immobilized drug
conjugate zone (T) and generate a red line. Presence of the colored line
indicates a negative result, while its absence indicates a positive TEST PROCEDURE
result. 1. Allow test devices and urine sample to equilibrate to room tempe-
When the drug is present in the urine, it competes with the antigen rature (20-30°C) prior to testing. Do not open pouches until ready to
on the test band (T) for limited gold conjugate. When a sufficient perform the assay.
concentration of drug is present, it will fill the limited antibody bin-
ding sites. This will prevent attachment of the colored antibody-colloi- 2. Remove the test device from foil pouch (bring the device to room
dal gold conjugate to the drug conjugate zone on the test band region. temperature before opening the pouch to avoid condensation of mois-
A control band with a different antigen/antibody reaction is also ture on the membrane).
added to the immunochromatographic membrane strip at the control
region (C) to indicate that the test has performed properly. 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
120 µl) without air bubbles into the sample well of the test de-vice.
Cut-off: Use a separate pipette and device for each sample or control (to avoid
- The cut-off concentration of the test Rapidrog II-Amphetamine is cross-contamination).
1000 ng/mL.
- The method of reference for the confirmation of the presence or the 4. Read result between 3 to 8 minutes after the addition of sample.
absence of amphetamine in the urines is Gas Chromatography cou- Do not read result after 8 minutes.
pled with the Mass Spectrometry (GC/MS). This technique detects
and quantifies in a specific way amphetamine (d, l) and derivates.
NIDA (National In statue on Drug Abuse) recommends cut-off concen-
tration of 500 ng/ml for amphetamine for the GC/MS.
…/…
(01/2004)
FTAN-RTAM-2
* Specificity:
QUALITY CONTROL The specificity for the Rapidrog II - Amphetamine was tested by
The result is invalid if no line appears in the control region. Under no adding various substances in drug-free normal human urines.
circumstances should a positive sample be identified until the control The following compounds produced positive results when tested at
line forms in the viewing area. If the control line does not form, the levels equal to or greater than the concentrations listed below:
test result is inconclusive, the test should be repeated.
Good laboratories practice recommends the use of control materials d-amphetamine 1000 ng/mL
to ensure proper kit performance. l-amphetamine 20000 ng/mL
(+/-)3,4-methylene-dioxyamphetamine 1000 ng/mL
Methylene-dioxymethamphetamine 10000 ng/mL
RESULTS
1. If two colored lines appear, one in the test C T The following compounds produced negative results when tested at
region, the other in the control region, the 100 µg/mL:
result is NEGATIVE. Intensity of lines could be Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin, As-par-
different, and even if the line in the test region tame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine, Chloroquine,
(T) is very weak, the result must be interpreted (+/-)-Chlorpheniramine,Chlorpheniramine,Creatine,
such as negative. Dexbrompheniramine,Dextromethorphan,4-
C T Dimethylaminoantipyrine, Dopamine, Erythromycin, Ethanol,
2. If only one colored line appears in the Furosemide, Glucose, Guaiacol Glyceryl Ether, Hemoglobin,
control region (C), the result is POSITIVE. Imipramine, (+/-)-Isoproterenol, Lidocaine, (+)-Naproxen, Oxalic Acid,
The absence of a test line indicates a positive Penicillin-G, Pheniramine, Phenothiazine, Phenylethylamine,
result. Procaine, Quinidine, Ranitidine, Riboflavin, Sodium Chloride,
Sulindac, Thioridazine, Trifluoperazine, Trimethobenzamide,
LIMITATION OF THE TEST Tyramine, Vitamin C.
1.Warning : A positive result with any of the tests indicates the pre-
sence of a drug/metabolite only, and does not indicate or meas-ure BIBLIOGRAPHY
intoxication. This immunological assay is qualitative; and provides 1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man,
only a preliminary analytical test result. This result can-not be used Biomedical Publications, (1982).
for any legal consequence. A more specific alternative chemical 2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
method like GC/MS (preferred confirmatory method) must be used in (NIDA), Research Monograph 73, (1986).
order to obtain a confirmed analytical result. Clinical consideration 3.Fed. Register, Department of Health and Human Services, Man-
and professional judgment should be applied to any drug. datory Guidelines for Federal Workplace Drug Testing Programs,
(1988), 53, 69, 11970.
2.If it is suspected that the samples have been tampered with, a new 4.McBay, A.J., Clin. Chem. (1987), 33, 33.
specimen should be collected and the test should be repeated. If a cli- 5.Gilman, A.G., Goodman, L.S.,The Pharmacological Basis of
nician has some indication that the urine be adulterated, there are Therapeutics, (eds. MacMillan Publishing, New York, NY), (1980).
available test devices detecting the manipulation. 6.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
3.There is a possibility that technical or procedural errors as well as Saunders eds. Philadelphia USA), (2001), 636.
other substances and factors not listed may interfere with the test 7.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-sa.ch/agsa
and cause wrong results. See SPECIFICITY.
(02/2004)
FTAN-RTBA-2
PRINCIPLE
The Rapidrog II-Benzodiazepines (BZO) is a rapid immunoassay for C T
the qualitative detection of benzodiazepines in human urine at a cut-
off of 300 ng/mL (determined for Oxazepam), before confirmation with
a reference method. The membrane is pre-coated with drug conjugate
(Oxazepam) on the test band (T) and a colored mouse anti-BZO
(Oxazepam) monoclonal antibody-colloidal gold conjugate pad is pla-
ced at the right end. In the absence of drug in the urine, the conjuga-
ted anti-benzodiazepines monoclonal-colloidal gold moves upward on
the membrane chromatographically by capillary action, to react with TEST PROCEDURE
the immobilized drug conjugate zone (T) and generate a red line. 1. Allow test devices and urine sample to equilibrate to room tem-
Presence of the colored line indi-cates a negative result, while its perature (20-30°C) prior to testing. Do not open pouches until ready
absence indicates a positive result. When the drug is present in the to perform the assay.
urine, it competes with the antigen on the test band (T) for limited
gold conjugate. 2. Remove the test device from foil pouch (bring the device to room
When a sufficient concentration of drug is present, it will fill the limi- temperature before opening the pouch to avoid condensation of mois-
ted antibody binding sites. This will prevent attachment of the colored ture on the membrane).
antibody-colloidal gold conjugate to the drug conjugate zone on the
test band region. 3. Holding the dropper vertically, dispense 3 full drops of specimen
A control band with a different antigen/antibody reaction is also (~ 120 µl) without air bubbles into the sample well of the test de-vice.
added to the immunochromatographic membrane strip at the control Use a separate pipette and device for each sample or control (to avoid
region (C) to indicate that the test has performed properly. cross-contamination).
CLINICAL SIGNIFICANCE This method detects and quantifies in a specific way benzoylecgonine
Cocaine or methylbenzoylecgonine is a natural alkaloid extracted but also ester methyl-ecgonine, ecgonine. NIDA (National Institue on
from the sheets of the Coka. It is a powerful stimulating Central Drug Abuse) recommends cut-off concentration of 150 ng/mL for
Nervous System (CNS), its sympathico-mimetic properties similar to benzoylecgonine for GC/MS.
the action of the amphetamines make of it a dangerous drug. Its the-
rapeutic applications like local anaesthetic are renounced because of STORAGE AND STABILITY
these addictive effects. This stimulation leads to a state of euphoria, The device stored at 2-30°C is stable until the expiration date state on
of physical and intellectual excitation, by a feeling of abolished tired- the label.
ness, self-confidence (effects known as "positive") and is accompanied
by physical demonstrations such as dilation by the pupils, tremors, SPECIMEN COLLECTION
fever and sweats. Its strong toxicity associated with the psychological Fresh urine does not require any special handling or pretreatment.
effects involves the appearance of the following symptoms: anxiety, Urine samples should be collected such that testing can be performed
mental confusion, psychosis, convulsions and disorders cardiac. As as soon as possible after the specimen collection, preferably during
for any addictive substance the tolerance with cocaine is significant the same day.
and induces the need for increasing the amounts to obtain the initial Urine specimens and all materials coming in contact with them
effect. The dependence which it involves is more psychic than physi- should be handled and disposed of as if capable of transmitting infec-
cal. Cocaine can either be smoked (cocaine bases or ace) or "sniff" (cut tion.
hydrochlorate of cocaine) or injected by venous way (only or mixed Specimen storage:
with heroin), more rarely swallowed. The effects are intense but short. The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
The cocaine, whose half-life is half hour at one hour and half, is -20°C for a longer period of time. Specimens that have been refrigera-
quickly metabolized by the liver mainly in benzoylecgonine, methyl ted must be equilibrated to room temperature prior to testing.
ecgonine ester and ecgonine. The norcocaine obtained by demethyla- Specimens previously frozen must be thawed, equilibrated to room
tion appears only in the cases of acute intoxication (overdose). These temperature, and mixed thoroughly prior to testing.
different metabolites are the mainly, which are excreted in the urine
a few hours after the catch. The duration of detection of cocaine PROVIDED MATERIAL
(trace) in the urine is very short; on the other hand the time of reten- The device consists in a reaction membrane inserted in a plastic case.
tion of its metabolites in particular for the benzoylecgonine is 24 to 96 It is packaged in a sealed foil pouch also containing a disposable sam-
hours. ple dropper and a desiccant bag.
PRINCIPLE
The Rapidrog II-Cocaine (COC) is a rapid immunoassay for the quali- C T
tative detection of benzoylecgonine in human urine at a cut-off
concentration of 300 ng/mL, before confirmation with a reference
method. The membrane is pre-coated with drug conjugate on the test
band (T) and a colored mouse anti-cocaine monoclonal antibody-col-
loidal gold conjugate pad is placed at the right end. In the absence of
drug in the urine, the conjugated anti-cocaine monoclonal-colloidal
gold moves upward on the membrane chromatographically by capil- TEST PROCEDURE
lary action, to react with the immobilized drug conjugate zone (T) and 1. Allow test devices and urine sample to equilibrate to room tempe-
generate a red line. Presence of the colored line indicates a negative rature (20-30°C) prior to testing. Do not open pouches until ready to
result, while its absence indicates a positive result. When the drug is perform the assay.
present in the urine, it competes with the antigen on the test band (T)
for limited gold conjugate. 2. Remove the test device from foil pouch (bring the device to room
When a sufficient concentration of drug is present, it will fill the limi- temperature before opening the pouch to avoid condensation of mois-
ted antibody binding sites. This will prevent attachment of the colored ture on the membrane).
antibody-colloidal gold conjugate to the drug conjugate zone on the
test band region. 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
A control band with a different antigen/antibody reaction is also 120 µl) without air bubbles into the sample well of the test device. Use
added to the immunochromatographic membrane strip at the control a separate pipette and device for each sample or control (to avoid
region (C) to indicate that the test has performed properly. cross-contamination).
(01/2004)
FTAN-RTCO-2
…/…
(02/2004)
FTAN-RTMT-2
(02/2004)
FTAN-RTMT-2
CLINICAL SIGNIFICANCE - The method of reference for the confirmation of the presence or the
The term opiates (also called morphine derivatives) gathers various absence of morphinic derivatives in the urines is Gas
natural or semi alkaloids synthetic derived from opium, resin extrac- Chromatography coupled with Mass Spectrometry (GC/MS). This
ted from the soporific poppy (Papaver somniferum). Morphine is a technique detects and quantifies in a specific way free or glucuronide
powerful analgesic subjected to the regulation of the narcotics. morphine but also its derivatives. NIDA (National Institute on Drug
Codeine, codethyline and pholcodine (of semi-synthetic origin) and Abuse) recommends cut-off concentration of 300 ng/mL for morphine
opium (officinal, dyeing, syrups) are used in many pharmaceutical and codeine for GC/MS.
preparations for their antitussives or antidiarrheic properties.
However therapeutic deviations exist. The heroin (or diacetylmor- STORAGE AND STABILITY
phine) synthesized from morphine is only used at toxicomaniac ends. The device stored at 2-30°C is stable until the expiration date state on
The action of opiates on the Central Nervous System (depressors of the label.
the CNS) results in a state of euphoria, absence, anxiety, feeling to be
well, but with strong amounts or of prolonged use, their toxicity SPECIMEN COLLECTION
results in various effects: reduction in coordination, absence of will, Fresh urine does not require any special handling or pretreatment.
respiratory depression, hypothermia and coma. The morphinic deri- Urine samples should be collected such that testing can be performed
vatives tolerance is significant; it induces the need for increasing the as soon as possible after the specimen collection, preferably during
amounts to obtain the initial effect. The dependence is as well physi- the same day.
cal as psychic and results in a state of lack at the time of withdrawal. Urine specimens and all materials coming in contact with them
The opiates have a complexe metabolism, whose morphine represents should be handled and disposed of as if capable of transmitting infec-
the "major structure". Indeed it is as well the main metabolite of the tion.
others derived as their "precursor". Heroin is quickly metabolized in Specimen storage:
morphine (half life of a few minutes). Codeine (methyl-3-morphine), The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
codethyline (ethyl-3 morphine) and pholcodine are also transformed -20°C for a longer period of time. Specimens that have been refrigera-
into morphine. Morphine is metabolized on morphine-3-glucuronide ted must be equilibrated to room temperature prior to testing.
(70%) by the liver. Free or glucuronide morphine (morphine-3-glucu- Specimens previously frozen must be thawed, equilibrated to room
ronide) and codeine are the main urinary metabolites. The duration temperature, and mixed thoroughly prior to testing.
of detection of morphine and these metabolites in the urine is 1 to 2
days. PROVIDED MATERIAL
The device consists in a reaction membrane inserted in a plastic case.
METHOD It is packaged in a sealed foil pouch also containing a disposable sam-
Immuno-chromatography ple dropper and a desiccant bag.
Qualitative
Result area
PRINCIPLE Control (C) Test (T) Sample well
The Rapidrog II-Morphine (MOR) is a rapid immunoassay for the qua-
litative detection of morphine in human urine at a cut-off concentra-
tion of 300 ng/mL, before confirmation with a reference method. The
membrane is pre-coated with drug conjugate on the test band (T) and C T
a colored mouse anti-morphine monoclonal antibody-colloidal gold
conjugate pad is placed at the right end. In the absence of drug in the
urine, the conjugated anti-morphine monoclonal-colloidal gold moves
upward on the membrane chromatographically by capillary action, to
react with the immobilized drug conjugate zone (T) and generate a red
line. Presence of the colored line indicates a negative result, while its
absence indicates a positive result. TEST PROCEDURE
When the drug is present in the urine, it competes with the antigen 1. Allow test devices and urine sample to equilibrate to room tempe-
on the test band (T) for limited gold conjugate. When a sufficient rature (20-30°C) prior to testing. Do not open pouches until ready to
concentration of drug is present, it will fill the limited antibody bin- perform the assay.
ding sites. This will prevent attachment of the colored antibody-colloi-
dal gold conjugate to the drug conjugate zone on the test band region. 2. Remove the test device from foil pouch (bring the device to room
A control band with a different antigen/antibody reaction is also temperature before opening the pouch to avoid condensation of mois-
added to the immunochromatographic membrane strip at the control ture on the membrane).
region (C) to indicate that the test has performed properly.
3. Holding the dropper vertically, dispense 3 full drops of specimen (~
Cut-off : 120 µl) without air bubbles into the sample well of the test device. Use
- The cut-off concentration of the test Rapidrog II-Morphine is 300 a separate pipette and device for each sample or control (to avoid
ng/mL. cross-contamination).
1/4
(03/2004)
FTAN-RTDQ-3
Cut-off :
Sample wells
The method of reference for the confirmation of the presence or the
absence of morphine, cocaine, THC, amphetamine (or/and their
metabolits) in the urines is Gas Chromatography coupled with the
Mass Spectrometry (GC/MS). This technique detects and quantifies in
a specific way:
-11-nor-∆9-Tetrahydrocannabinolcarboxilic acid and its derivates for TEST PROCEDURE
the cannabis 1. Allow test devices and urine sample to equilibrate to room tem-
- morphine and its derivates (codeine, codethyline…) perature (20-30°C) prior to testing. Do not open pouches until ready
- cocaine and its derivates (ecgonine, benzolecgonine…) to perform the assay to avoid condensation of moisture on the mem-
- d-amphetamine, l-amphetamine, metamphetamine brane.
The NIDA recommends cut-off concentration for GC/MS of 15 ng/ml 2. Removed the test device from foil pouch.
for THC, 150 ng/mL for benzolecgonine, 300 ng/mL for morphine and
500 ng/mL for amphetamine. 3. Holding the dropper vertically, dispense slowly 3 full drops of spe-
cimen (~ 120 µl) without air bubbles into each sample wells of the test
The cut-off concentrations of the test Rapidrog II-Multi 4 are: device. Take care that in both strips afterwards red color moves over
- THC (THC-carboxylic acid) 50 ng/ml the membrane. Use a separate pipette and device for each sample or
- MOR 300 ng/ml control (to avoid cross-contamination).
- COC (benzoylecgonine) 300 ng/ml
- AMP (d-amphetamine) 1000 ng/ml 4. Read the result after 5 minutes.
C- C -C -C Rapidrog II -Multi
GC/MS Sensitivity
C- C -C -C 4
1- T -3 COC 12 12 > 99 %
2- -4
1- T -3
AMP 10 10 > 99 %
2- -4
MOR 15 15 > 99 %
THC 29 29 > 99 %
2. Specificity:
Urines samples detected negative with GC/MS, HPLC or with an-
Invalid Test Valid Test other immunological technique of tracking (EMIT) were analysed with
the test Rapidrog II-Multi 4.
COC : (-)
THC : (-)
AMP : (-) Rapidrog
EMIT GC/MS HPLC Specificity
MOR : (-) II-Multi 4
21 21 > 99 %
COC -
22 21 > 95,4 %
1-MOR 3-COC 1-MOR 3-COC
2-AMP 4-THC 2-AMP 4-THC AMP - - 22 22 > 99 %
19 19 > 99 %
MOR -
20 20 > 99 %
8 8 > 99 %
THC -
C- C -C -C C- C -C -C 13 13 > 99 %
1- T -3 1- T -3
2- -4 2- -4
BIBLIOGRAPHY
1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man.
Biomedical Publications, Davis, CA, (1982).
2.Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse
(NIDA), Research Monograph 73, (1986).
3.Ellenhorn, M.J., Barceloux, D.G., Medical Toxicology. (Elsevier
Science Publishing Company, Inc., New York), (1988).
4.Fed. Register, Department of Health and Human Services,
Mandatory Guidelines for Federal Workplace Drug Testing Pro-grams,
(1988), 53, 69,11970,.
5.Gilman, A. G., Goodman, L. S., The Pharmacological Basis of 4/4
Therapeutics, (MacMillan Publishing eds., New York, NY), (1980). (03/2004)
FTAN-RTDQ-3
…/…
(01/2004)
FTAN-RTTH-3
* Specificity:
The specificity for the Rapidrog II -THC was tested by adding vari-ous (01/2004)
substances in drug-free normal human urines. FTAN-RTTH-3
The following compounds produced positive results when tested at
levels equal to or greater than the concentrations listed below:
METHOD
Qualitative and colorimetric
PRINCIPLE 7-9 ( )
It does not contain latex. A clinical study was performed on 114 samples of vaginal
secretions provided by 104 patients.
MATERIAL NOT PROVIDED The PMR test was compared with the clinical diagnosis and
Speculum DAO method (Enzymatic activity of DiAmine Oxidase present
at high concentration in amniotic liquid).
PRECAUTIONS The sensitivity of PMR test is significantly superior to that
1- Read carefully the insert before proceeding to the analysis. obtained with DAO quantitative method.
2- Do not use the test if the packaging is damaged.
3- Do not use tests which have been badly stored. Amnicator DAO
4- Respect the expiry date. Sensitivity (%) 97.50 90.20
5- After use, dispose of test material in accordance with local Specificity (%) 93.30 96.60
regulations for potentially infectious materials.
These results were compared to others studies in the litera-
STORAGE AND STABILITY ture :
When stored at the room temperature and protected from light .../...
the devices are stable until the expiry date stated on the label.
(03/2005)
FTAN-PMRT-6
1- Methods of pH BIBLIOGRAPHY
Samples Sensitivity Specificity “Reliability”
1. Filet, J.P. et coll., Evaluation de trois méthodes diagnosti-
number (%) (%) (%)
ques dans la rupture prématurée des membranes. Rev. Fr.
Reference (1) 104 97.50 93.30 93.80 Gynecol. Obstet., (1994), 89, 123.
2. Gillibrand, P.N., Premature rupture of the membranes and
Reference (7) 39 100 92.30 -
prematurity. J. Obstet. Gynaecol. Br. Commonw., (1967), 74,
Reference (8) 100 95 93.70 90.30 678.
Reference (9) 45 91 73 - 3. Drife, J.O., Preterm rupture of the membranes. Br. Med. J.,
(1982), 285, 583.
4. Pauersterin, C., Premature rupture of the membranes.
1- Methods DAO : Clinical Obstetrics, John Wiley & Sons and Churchill
Livingstone, (1987), 367.
Samples “Reliability” Sensitivity 5. Pritchard, J., MacDonald, P., Williams Obstetrics, 16ème
Etudes ed., Appleton-Century-Crofts, (1980), 407.
number (%) (%)
6. Berland, M., Magnin, G., La rupture prématurée des mem-
Reference (1) 104 20 µU/ml 92.10 90.20 branes. Encycl.Méd.Chir., (Paris), (1982), Obst., 5072 B10, 5.
Study A 272 70 UI/ml 95.80 91.40 7. Mills, A.M., Garrioch, D.B., Use of Nitrazine yellow swab test
in the diagnosis of rupture membrane, Br. J. Obstet. Gynaecol.,
Study B - - 91 - (1977), 84, 138.
Study C - - 96 - 8. Friedman, M.L., MacElin, T.W., Diagnosis of ruptured fetal
membranes. Clinical study and review of literature. Am.J.
Study D - - 99 - Obstet Gynecol., 1969, 104, 544.
Study E 160 25 U/Bdl 87.40 - 9. Garite T., Gocke S. Diagnosis of preterm rupture of membra-
nes : is testing for alpha fetoprotein better than ferning or nitra-
zine ? Am. J. Perinatol., (1990), 7, 276.
LIMITATIONS (3,7,8)
Do not reuse
(03/2005)
FTAN-PMRT-6