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INTENDED USE
The kit has been designed for the quantitative determination of
Thyroglobulin autoantibody (TGA) in human serum.
130203007M
100 The method can be used for samples over the range of 10-2800
IU/ml.
The test has to be performed on the Fully-auto
chemiluminescence immunoassay (CLIA) analyzer MAGLUMI
(Including Maglumi 600、Maglumi 1000、Maglumi 1000 Plus、
Maglumi 2000、Maglumi 2000 Plus、Maglumi 3000 and Maglumi
Shenzhen New Industries Lotus Global Co., Ltd
4000).
Biomedical Engineering Co., Ltd 15 Alexandra Road
4/F,Wearnes Tech Bldg, London
Science & Industry Park, UK SUMMARY AND EXPLANATION OF THE TEST
Nanshan,Shenzhen,518057CHINA NW8 0DP Thyroglobulin is a large-size glycoprotein (MW 660,000), whose
Tel. + 86-755-86028224 Tel. + 44-20-75868010 synthesis and release are controlled by TSH. Thyroglobulin is
Fax.+ 86-755-26654850 Fax.+ 44-20-79006187 synthesized in the thyrocytes, which release it into the follicular
volume, where it plays an important part in the production and
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storage of thyroid hormones.
The determination of TGA is mainly used in the diagnosis of
suspected autoimmune thyroiditis. A concomitant elevation of
auto-antibodies to both thyroid peroxidase and Tg is indicative of a
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FOR PROFESSIONAL USE ONLY
Store at 2-8 °C hypertrophic form of autoimmune thyroiditis, namely lymphadenoid
goitre (Hashimoto’s disease), as well as of the atrophic form of
autoimmune thyroiditis.
COMPLETELY READ THE INSTRUCTIONS BEFORE
The determination of TGA is particularly recommended in
PROCEEDING
suspected autoimmune thyroiditis whenever auto-antibodies to
TPO cannot be detected.
Positive findings (low-titred TGA concentrations) are also
encountered in up to 20% of cases with non-autoimmune thyroid
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SYMBOLS EXPLANATIONS disease as well as in healthy persons.
Authorized Representative in the
European community
PRINCIPLE OF THE TEST
Sandwich immunoluminometric assay:
Manufacturer
Use TG antigen to label microbeads, and use purified human TG
antigen to label ABEI. Sample, Calibrator or Control with Buffer
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Consult instructions for use and Nano magnetic microbeads coated with TG antigen are mixed
thoroughly and incubated at 37℃ and cycle washing for 1 time.
Then add ABEI Label, incubation and form a sandwich, then
In vitro diagnostic medical device washing for the 2nd time. Subsequently, the starter reagents are
added and a flash chemiluminescent reaction is initiated. The light
signal is measured by a photomultiplier as RLU within 3 seconds
In vitro diagnostic medical device
and is proportional to the concentration of TGA present in
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samples.
Batch code
KIT COMPONENTS
Catalogue number
Material Supplies
Reagent Integral for 100 determinations
Use by Nano magnetic microbeads: nano magnetic
microbeads coated with goat anti-human IgG 2.5ml
secondary antibody, contains BSA, 0.2%NaN3.
Calibrator Low: bovine serum, 0.2%NaN3 2.5ml
Temperature limitation
Calibrator High: bovine serum, 0.2%NaN3 2.5ml
( store at 2-8 °C)
ABEI Label: mouse anti human IgG secondary
12.5ml
antibody, contains BSA, 0.2%NaN3.
Sufficient for Buffer: contains BSA, 0.2%NaN3. 12.5ml
Diluent: 0.9% NaCl 25ml
All reagents are provided ready-to-use.
Keep away from sunlight
Reagent Vials in kit box
Internal Quality Control: containing BSA,
Keep upright for storage 0.2%NaN3. (target value refer to Quality 2.0ml
Control Information date sheet)
Internal quality control is only applicable with MAGLUMI system.
Instructions for use and target value refer to Quality Control
007130128-V2.0-EN 1/4
Information date sheet. User needs to judge results with their own have any doubt.
standards and knowledge.
Vacuum Tubes
Accessories Required But Not Provided (a) Blank tubes are recommended type for collecting samples.
MAGLUMI Reaction Module REF: 630003 (b) Please ask SNIBE for advice if special additive must be used in
MAGLUMI Starter 1+2 REF: 130299004M sample collecting.
MAGLUMI Wash Concentrate REF: 130299005M
Specimen Conditions
MAGLUMI Light Check REF: 130299006M
• Do not use specimens with the following conditions:
Please order accessories from SNIBE or our representative.
(a) heat-inactivated specimens;
(b) Cadaver specimens or body fluids other than human serum;
(c) Obvious microbial contamination.
• Use caution when handling patient specimens to prevent cross
Preparation of the Reagent Integral contamination. Use of disposable pipettes or pipette tips is
Before the sealing is removed, gentle and careful horizontal recommended.
shaking of the Reagent Integral is essential (avoid foam formation!) • Inspect all samples for bubbles. Remove bubbles with an
Remove the sealing and turn the small wheel of the magnetic applicator stick prior to analysis. Use a new applicator stick for
microbeads compartment to and fro, until the colour of the each sample to prevent cross contamination.
suspension has changed into brown. Place the Integral into the • Serum specimens should be free of fibrin, red blood cells or
reagent area and let it stand there for 30 min. During this time, the other particulate matter.
magnetic microbeads are automatically agitated and completely • Ensure that complete clot formation in serum specimens has
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resuspended. taken place prior to centrifugation. Some specimens,
Do not interchange integral component from different especially those from patients receiving anticoagulant or
reagents or lots! thrombolytic therapy, may exhibit increased clotting time. If the
specimen is centrifuged before a complete clot forms, the
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Storage and Stability
presence of fibrin may cause erroneous results.
Sealed: Stored at 2-8℃ until the expiry date.
calibrators standardized against the W.H.O.1st International discussion of onboard sample storage constraints.
Reference Preparation 65/93.
Storage
2) 2-Point Recalibration • If testing will be delayed for more than 8 hours, remove serum
Via the measurement of calibrators, the predefined master curve is from the serum separator, red blood cells or clot. Specimens
adjusted (recalibrated) to a new, instrument-specific measurement removed from the separator gel, cells or clot may be stored up
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Reagents). Shipping
Every 2 weeks and/or each time a new Integral is used • Before shipping specimens, it is recommended that specimens
(recommendation). be removed from the serum separator, red blood cells or clot.
After each servicing of the Fully-auto chemiluminescence When shipped, specimens must be packaged and labeled in
immunoassay (CLIA) analyzer MAGLUMI. compliance with applicable state, federal and international
If controls are beyond the expected range. regulations covering the transport of clinical specimens and
The room temperature has changed more than 5 ℃ infectious substances. Specimens must be shipped frozen
(recommendation). (dry ice). Do not exceed the storage time limitations identified
in this section of the package insert.
SPECIMEN COLLECTION AND PREPARATION
Sample material: serum WARNING AND PRECAUTIONS FOR USERS
Collect 5.0ml venous blood into Blood Collection Tube. Standing at
room temperature,centrifuging, separating serum part.
The serum sample is stable for up to 12 hours at 2-8℃. More than For use in IN-VITRO diagnostic procedures only.
12 hours, please packed, -20 ℃ can be stored for 30 days. Package insert instructions must be carefully followed.
Avoid repeated freezing and thawing, the serum sample can be Reliability of assay results cannot be guaranteed if there are
only frozen and thawed two times. Stored samples should be any deviations from the instructions in this package insert.
thoroughly mixed prior to use (Vortex mixer).
Please ask local representative of SNIBE for more details if you Safety Precautions
007130128-V2.0-EN 2/4
CAUTION: This product requires the handling of human Samples with concentrations above the measuring range can be
specimens. diluted. After manual dilution, multiply the result by the dilution
The calibrators in this kit are prepared from bovine serum factor. After dilution by the analyzers, the analyzer software
products. However, because no test method can offer automatically takes the dilution into account when calculating the
complete assurance that HIV, Hepatitis B Virus or other sample concentration.
infectious agents are absent; these reagents should be Availability of sample dilution by analyzer please refers to the
considered a potential biohazard and handled with the same MAGLUMI analyzer user software program. Dilution settings
precautions as applied to any serum or plasma specimen. please follow MALGUMI analyzer operating instructions.
All samples, biological reagents and materials used in the
assay must be considered potentially able to transmit QUALITY CONTROL
infectious agents. They should therefore be disposed of in Observe quality control guidelines for medical laboratories
accordance with the prevailing regulations and guidelines of Use suitable controls for in-house quality control. Controls
the agencies holding jurisdiction over the laboratory, and the should be run at least once every 24 hours when the test is in
regulations of each country. Disposable materials must be use, once per reagent kit and after every calibration. The
incinerated; liquid waste must be decontaminated with control intervals should be adapted to each laboratory’s
sodium hypochlorite at a final concentration of 5% for at individual requirements. Values obtained should fall within the
least half an hour. Any materials to be reused must be defined ranges. Each laboratory should establish guidelines
autoclaved using an overkill approach. A minimum of one for corrective measures to be taken if values fall outside the
hour at 121℃ is usually considered adequate, though the range.
users must check the effectiveness of their decontamination
cycle by initially validating it and routinely using biological
LIMITATIONS OF THE PROCEDURE
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indicators.
1) Limitations
It is recommended that all human sourced materials be
Assay results should be utilized in conjunction with other clinical
considered potentially infectious and handled in accordance
and laboratory data to assist the clinician in making individual
with the OSHA Standard on Bloodborne Pathogens 13.
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patient management decisions.
Biosafety Level 214 or other appropriate biosafety practices
A skillful technique and strict adherence to the instructions are
should be used for materials that contain or are suspected
necessary to obtain reliable results.
of containing infectious agents.
Procedural directions must be followed exactly and careful
This product contains Sodium Azide; this material and its
technique must be used to obtain valid results. Any modification of
container must be disposed of in a safe way.
the procedure is likely to alter the results.
Safety data sheets are available on request.
Bacterial contamination or repeated freeze-thaw cycles may affect
the test results.
Handling Precautions
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• Do not use reagent kits beyond the expiration date.
2) Interfering Substances
• Do not mix reagents from different reagent kits.
No interference with test results is seen by concentrations of
• Prior to loading the Reagent Kit on the system for the first time,
bilirubin<66mg/dl, haemoglobin<1690mg/dl or triglycerides<
the microbeads requires mixing to re-suspend microbeads
2000mg/dl.
that have settled during shipment.
• For microbeads mixing instructions, refer to the KIT
3) HAMA
COMPONENTS, Preparation of the Reagent Integral section
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Compound Concentration Cross reactivity
TMA 100 IU/ml 10%
TRAb 200 IU/ml 5%
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4) Recovery
Consider calibrator high of known concentration as a sample,
dilute it by 1:2 ratio with diluents, and measure its diluted
concentration for 10 times. Then calculate the recovery of
measured concentration and expected concentration. The
recovery should be within 90% -110%.
Expected Mean Measuring Recovery
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754.86 IU/ml 769.96 IU/ml 102%
5) Linearity
Use TGA calibrator to prepare the six-point standard curve,
measuring all points’ RLU except point A, and then do
four-parameter linear fitting in double logarithm coordinate, the
absolute linear correlation coefficient(r) should be bigger than
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0.9800.
Calibrator Concentration Absolute linear
Point IU/ml correlation coefficient (r)
A 0
B 40 r=0.9984
C 100
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D 250
E 700
F 2800
6) Method comparison
A comparison of MAGLUMI TGA(y) with a commercially available
TGA(x) using clinical samples gave the following
correlations(IU/ml):
Linear regression
y=0.7091x+13.068
r=0.9845
REFERENCES
1. Bomet H,Madec AM,Rodlen P,Latter R,Haond P,Allannlc H,
Orglazzl J,Evaluation of anti-TPO antlbody determlnation in
Varlous cllnlcal situations.In P.Carayon (Ed):Thyroperoxldase
and Thyrold Autolmmunlty 1990; 207: 315-320
2. Bussen SS,Steck T.Thyrold antibodles and their relation to
antithrombin antibodles,anticardlollpin antibodles and
007130128-V2.0-EN 4/4