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TRIGB
Triglycerides/Glycerol Blanked
Order information
Analyzer(s) on which cobas c pack(s) can be used
11877771 216 Triglycerides/Glycerol Blanked (12 x 120 tests) System‑ID 07 6868 5 Roche/Hitachi cobas c 311, cobas c 501/502
10166588 130 Precimat Glycerol Code 509
10759350 190 Calibrator f.a.s. (12 x 3 mL) Code 401
10759350 360 Calibrator f.a.s. (12 x 3 mL, for USA) Code 401
12149435 122 Precinorm U plus (10 x 3 mL) Code 300
12149435 160 Precinorm U plus (10 x 3 mL, for USA) Code 300
12149443 122 Precipath U plus (10 x 3 mL) Code 301
12149443 160 Precipath U plus (10 x 3 mL, for USA) Code 301
10781827 122 Precinorm L (4 x 3 mL) Code 304
11285874 122 Precipath L (4 x 3 mL) Code 305
05117003 190 PreciControl ClinChem Multi 1 (20 x 5 mL) Code 391
05947626 190 PreciControl ClinChem Multi 1 (4 x 5 mL) Code 391
05947626 160 PreciControl ClinChem Multi 1 (4 x 5 mL, for USA) Code 391
05117216 190 PreciControl ClinChem Multi 2 (20 x 5 mL) Code 392
05947774 190 PreciControl ClinChem Multi 2 (4 x 5 mL) Code 392
05947774 160 PreciControl ClinChem Multi 2 (4 x 5 mL, for USA) Code 392
04489357 190 Diluent NaCl 9 % (50 mL) System‑ID 07 6869 3
04593138 190 cobas c pack MULTI
On request Open/Close tool
English GK
TRIGB
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Reagents - working solutions 6. Unscrew the screw cap of the bottle in position C on the right side of the
cobas c pack MULTI using the Open/Close tool.
R1 TRIS buffer: 0.15 mol/L, pH 7.6; magnesium sulfate: 17.5 mmol/L;
7. Pour exactly 15 mL of the content of bottle 2 (R2) into the opened bottle
EDTA, disodium salt: 10 mmol/L; 4‑chlorophenol: 3.5 mmol/L; of the cobas c pack (position C).
potassium hexacyanoferrate (II): 6 µmol/L; sodium cholate: 0.15 %;
hydroxypolyethoxy‑n‑alkanes: 0.12 %; ATP: ≥ 1 mmol/L; glycerol 8. Close the bottle tightly using the Open/Close tool.
kinase (Geobacillus stearothermophilus): ≥ 0.4 U/mL; glycerol 9. Leave position A empty.
phosphate oxidase (microbial): ≥ 5 U/mL; (horseradish): The TRIGB cobas c pack is now ready for use.
peroxidase ≥ 0.3 U/mL; preservative Note
R2 TRIS buffer: 0.15 mol/L, pH 7.6; magnesium sulfate: 17.5 mmol/L; Use only the cobas c pack MULTI. Always use a new cobas c pack MULTI
when preparing fresh reagent. Never reuse accessories designed for single
EDTA, disodium salt: 10 mmol/L; 4‑chlorophenol: 3.5 mmol/L; use, as this may result in reagent contamination and could affect test
potassium hexacyanoferrate (II): 6 µmol/L; sodium cholate: 0.15 %; results. If the cobas c pack MULTI bottles are not filled correctly, this may
hydroxypolyethoxy‑n‑alkanes: 0.12 %; lipase (Pseudomonas result in faulty reagent pipetting and could cause erroneous results.
species): ≥ 6 U/mL; 4‑aminophenazone: 0.7 mmol/L; preservative Storage and stability
Precautions and warnings TRIGB
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory Shelf life at 2‑8 °C: See expiration date
reagents. on cobas c pack
Disposal of all waste material should be in accordance with local guidelines. label.
Safety data sheet available for professional user on request.
On‑board in use and refrigerated on the analyzer: 2 weeks
For USA: Caution: Federal law restricts this device to sale by or on the
order of a physician. Diluent NaCl 9 %
This kit contains components classified as follows in accordance with the Shelf life at 2‑8 °C: See expiration date
Regulation (EC) No. 1272/2008: on cobas c pack
Peroxidase label
EUH 208 May produce an allergic reaction. On‑board in use and refrigerated on the analyzer: 12 weeks
Product safety labeling follows EU GHS guidance. Specimen collection and preparation
Reagent preparation and cobas c pack MULTI assembly For specimen collection and preparation only use suitable tubes or
Reagent handling collection containers.
Only the specimens listed below were tested and found acceptable.
R1 Connect one Bottle 1a (Enzymes) to one Bottle 1 (Buffer) using Serum
one of the enclosed adapters. Mix by gentle inversion. Plasma: Li-heparin and K2‑EDTA plasma.
R2 Connect one Bottle 2a (Lipase/4‑Aminophenazone) to one Bottle 2 The sample types listed were tested with a selection of sample collection
tubes that were commercially available at the time of testing, i.e. not all
(Buffer) using one of the enclosed adapters. Mix by gentle available tubes of all manufacturers were tested. Sample collection systems
inversion. from various manufacturers may contain differing materials which could
One set of Roche/Hitachi bottles yields two cobas c packs. affect the test results in some cases. When processing samples in primary
tubes (sample collection systems), follow the instructions of the tube
Labeling the cobas c pack MULTI manufacturer.
Turn the barcode labeled side of a new cobas c pack MULTI toward you. Centrifuge samples containing precipitates before performing the assay.
Affix the supplied TRIGB barcode label directly over the existing barcode See the limitations and interferences section for details about possible
label. sample interferences.
Sample stability claims were established by experimental data by the
manufacturer or based on reference literature and only for the
temperatures/time frames as stated in the method sheet. It is the
responsibility of the individual laboratory to use all available references
and/or its own studies to determine specific stability criteria for its
laboratory.
Stability in serum: 2 days at 20‑25 °C5
10 days at 4 °C6
3 months at -20 °C7
several years at -70 °C7
Stability in plasma: 2 days at 20‑25 °C5
15 days at 4 °C8
Filling the cobas c pack MULTI
3 months at -20 °C7
1. Turn the cobas c pack MULTI toward you as shown previously.
several years at -70 °C7
2. Position A of the cobas c pack is now in the center, position B on the
left side, position C on the right side of the cobas c pack. Materials provided
3. Unscrew the screw cap of the bottle in position B on the left side of the See “Reagents – working solutions” section for reagents.
cobas c pack MULTI using the Open/Close tool.
Materials required (but not provided)
4. Pour exactly 15 mL of the content of bottle 1 (R1) into the opened bottle
of the cobas c pack (position B). ▪ See “Order information” section
5. Close the bottle tightly using the Open/Close tool. ▪ General laboratory equipment
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Assay Calibration
For optimum performance of the assay follow the directions given in this
document for the analyzer concerned. Refer to the appropriate operator’s Calibrators S1: Precimat Glycerol
manual for analyzer‑specific assay instructions. S2: C.f.a.s.
The performance of applications not validated by Roche is not warranted Calibration mode Linear
and must be defined by the user.
Calibration frequency 2‑point calibration
Application for serum and plasma
- after 24 hours on board
cobas c 311 test definition - after cobas c pack change
Assay type 1‑Point - after reagent lot change
- as required following quality control
Reaction time / Assay points 10 / 57
procedures
Wavelength (sub/main) 700/505 nm
Calibration interval may be extended based on acceptable verification of
Reaction direction Increase calibration by the laboratory.
Units mmol/L (mg/dL, g/L) Traceability: This method has been standardized against SRM 909b and
triolein standards.
Reagent pipetting Diluent (H2O)
Quality control
R1 100 µL – For quality control, use control materials as listed in the "Order information"
R2 100 µL – section.
Sample volumes Sample Sample dilution In addition, other suitable control material can be used.
The control intervals and limits should be adapted to each laboratory’s
Sample Diluent (NaCl) individual requirements. Values obtained should fall within the defined
Normal 2 µL – – limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits.
Decreased 4 µL 15 µL 150 µL
Follow the applicable government regulations and local guidelines for
Increased 2 µL – – quality control.
cobas c 501 test definition Calculation
Roche/Hitachi cobas c systems automatically calculate the analyte
Assay type 1‑Point concentration of each sample.
Reaction time / Assay points 10 / 70
Conversion factors:
Wavelength (sub/main) 700/505 nm
mmol/L x 88.5 = mg/dL mmol/L x 0.885 = g/L
Reaction direction Increase
mg/dL x 0.0113 = mmol/L mg/dL x 0.01 = g/L
Units mmol/L (mg/dL, g/L)
Limitations - interference
Reagent pipetting Diluent (H2O)
Criterion: Recovery within ± 10 % of initial values at triglyceride levels of
R1 100 µL – 2.3 mmol/L (203 mg/dL).
R2 100 µL – Icterus:9 No significant interference up to an I index of 60 for conjugated
and 50 for unconjugated bilirubin (approximate conjugated bilirubin
Sample volumes Sample Sample dilution concentration: 1026 µmol/L or 60 mg/dL; approximate unconjugated
Sample Diluent (NaCl) bilirubin concentration: 855 µmol/L or 50 mg/dL).
Normal 2 µL – – Hemolysis:9 No significant interference up to an H index of 400
(approximate hemoglobin concentration: 248 µmol/L or 400 mg/dL).
Decreased 4 µL 15 µL 150 µL Lipemia:9 The L index correlates with sample turbidity but not with
Increased 2 µL – – triglycerides level. Extremely lipemic samples (triglycerides greater than
3000 mg/dL) can produce a normal result.10
cobas c 502 test definition Prozone Check: The flag > Kin is an indicator for extremely high
triglyceride concentrations in the sample. False normal results are due to
Assay type 1‑Point oxygen depletion during assay reaction.
Reaction time / Assay points 10 / 70 Drugs: No interference was found at therapeutic concentrations using
Wavelength (sub/main) 700/505 nm common drug panels.11,12
Exception: Intralipid is directly measured as analyte in this assay and leads
Reaction direction Increase to high triglyceride results.
Units mmol/L (mg/dL, g/L) Acetaminophen intoxications are frequently treated with N‑Acetylcysteine.
Reagent pipetting Diluent (H2O) N‑Acetylcysteine at a plasma concentration above 499 mg/L and the
Acetaminophen metabolite N‑acetyl‑p‑benzoquinone imine (NAPQI)
R1 100 µL – independently may cause falsely low results.
R2 100 µL – Venipuncture should be performed prior to the administration of
Metamizole. Venipuncture immediately after or during the administration of
Sample volumes Sample Sample dilution Metamizole may lead to falsely low results. A significant interference may
Sample Diluent (NaCl) occur at plasma Metamizole concentrations above 0.1 mg/mL.
Normal 2 µL – – In very rare cases, gammopathy, in particular type IgM (Waldenström’s
macroglobulinemia), may cause unreliable results.13
Decreased 4 µL 15 µL 150 µL For diagnostic purposes, the results should always be assessed in
Increased 4 µL – – conjunction with the patient’s medical history, clinical examination and other
findings.
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