BIOLABO

www.biolabo.fr TRIGLYCERIDES G P O Method

MANUFACTURER: Reagent for quantitative determination of triglycerides
BIOLABO SAS, in human serum and plasma
Les Hautes Rives
02160, Maizy, France REF 80019 R1 2 x 50 mL R2 2 x 50 mL R3 1 x 5 mL
REF 87319 R1 10 x 100 mL R2 10 x 100 mL R3 1 x 5 mL

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TECHNICAL SUPPORT AND ORDERS IVD
Tel : (33) 03 23 25 15 50 Made In France
[email protected] I: corresponds to significant modifications
Latest revision : www.biolabo.fr

INTENDED USE (1) SAFETY CAUTIONS

BIOLABO reagents are designated for professional, in vitro diagnostic
This reagent is designated for professional use in laboratory (manual or
automated method). use (do not pipette with mouth).
It allows the quantification of triglycerides in human serum and plasma · Refer to current Material Safety Data Sheet available on request or
to complete lipids profile. on www.biolabo.fr
· Verify the integrity of the contents before use.
· Waste disposal: Respect legislation in force in the country.
I GENERALITIES
All specimens or reagents of biological origin should be handled as
The increase of triglycerides in blood can be of genetic origin or
potentially infectious. Respect legislation in force in the country.
secondary to other metabolic disorders such as: diabetes mellitus,
hyper and hypothyroidisms, hepatic diseases, acute and chronic
pancreatitis, nephrosis. A rise in triglycerides also represents an REAGENTS PREPARATION
atherogenic risk factor. It is responsible for the opalescence, or even Use a non-sharp instrument to remove aluminium cap.
the cloudiness of the serum. Corticoids and oestrogen/progestin Working reagent: Add promptly the contents of vial R2 into vial R1.
treatments can also aggravate hypertriglyceridemia. Mix gently and wait for complete dissolution.
Vial R3: Ready for use.
PRINCIPLE (4) (5)
Fossati and Prencipe method associated with Trinder reaction. STABILITY AND STORAGE
Reaction scheme is as follows: Stored away from light, well caped in the original vial at 2-8°C,
Lipase when stored and used as described, reagents are stable:
Triglycerides Glycerol + free fatty acids
Unopened:
GK · Until expiry date stated on the label of the kit.
Glycerol + ATP Glycerol 3 Phosphate + ADP Once opened:
· Reconstitute immediately contents of vial R2.
GPO · Standard (vial R3) :
Glycerol 3 Phosphate + O2 DihydroxyacetonePhosphate + H2O2
Transfer requested quantity and store the vial at 2-8°C.
H2O2 + 4-Chlorophenol + PAP POD Quinoneimine (pink) + H2O Once reconstituted:
· Transfer requested quantity and store in the original vial at 2-8°C.
The absorbance measured at 500 (480 – 520) nm is proportional to the ● Working reagent is stable fo1 year when free from contamination.
amount of triglycerides in the specimen. ● Discard reagent if cloudy or if absorbance at 500 nm > 0.200.

REAGENTS ● Don’t use working reagent after expiry date.

R1 TRIGLYCERIDES GPO Buffer

SPECIMEN COLLECTION AND HANDLING (2)
PIPES 100 mmol/L
Magnesium chloride 9.8 mmol/L Serum or plasma (Heparin or EDTA) fasting > 12 hours.
Chloro-4-phenol 3.5 mmol/L Separate from cells within 2 hours.
Preservative
Do not use oxalate, fluoride or citrate.
According to 1272/2008 regulation, this reagent is not classified as Triglycerides are stable in specimen for:
dangerous · 5-7 days at 2-8°C.
R2 TRIGLYCERIDES GPO Enzymes · 3 months at –20°C.
Lipase > 1000 IU/L · many years at –70°C.
Peroxidase (POD) > 1700 IU/L Avoid repeated freezing and thawing.
Glycerol 3 phosphate oxidase (GPO) > 3000 IU/L
Glycerol Kinase (GK) > 660 IU/L
4 - Amino – antipyrine (PAP) 0.5 mmol/L LIMITS (1) (2) (3)
Adenosine triphosphate Na (ATP) 1.3 mmol/L For a more comprehensive review of factors affecting this assay refer to
the publication of Young D.S.
Before reconstitution:
ATTENTION: Acute tox.4: H302 - Harmful if swallowed
P264 : Wash hands thoroughly after handling. MATERIAL REQUIRED BUT NOT PROVIDED
P301+312 : IF SWALLOWED: Call a POISON CENTER or 1. Basic medical analysis laboratory equipment.
doctor/physician if you feel unwell. P330 : Rinse mouth, P501: Dispose 2. Spectrophotometer or Biochemistry Clinical Analyzer
of contents/container in accordance with dangerous goods regulations.
Classification due to : 4-Amino-antipyrine 1 - <2.5%. For more details
refer to current Material Safety Data Sheet (MSDS)
Once reconstituted: Working Reagent is not classified as dangerous
R3 TRIGLYCERIDES GPO Standard 200 mg/dL (2.28 mmol/L)
According to 1272/2008 regulation, this reagent is not classified as
dangerous

TG_DT_220_IFU_80019-87319_EN_V02_20220516
QUALITY CONTROL CALIBRATION (7)
· REF 95010 EXATROL-N Level I · REF 95015 Multicalibrator traceable to SRM 909b2
· REF 95011 EXATROL-P Level II · Standard (vial R3): With manual procedure.
· External quality control program. The calibration frequency depends on proper instrument functions and
It is recommended to control in the following cases: on the preservation of reagent.
· At least once a run. Make a new calibration when changing reagent batch, if quality control
· At least once within 24 hours. results are found out of the range and after maintenance operations
· When changing vial of reagent.
· After maintenance operations on the instrument. PROCEDURE
If control is out of range, apply following actions:
Manual method
1. Prepare a fresh control and repeat the test.
2. If control is still out of range, use a new vial of calibrator or a fresh Let stand reagent and specimens at room temperature.
calibrator and repeat the test.
3. If control is still out of range, repeat the tests with a new vial of Reagent 1000 µL
reagent.
If control is still out of range, please contact BIOLABO technical Blank, Calibrator, control or specimen 10 µL
support or your local Agent.
Mix well. Let stand for 10 minutes at room temperature or 5 minutes at 37°C.
REFERENCE INTERVAL (6) Record absorbance at 500 nm (480-520) against reagent blank.
Color is stable for 1 h.
Serum or Plasma mg/dL [ mmol/L ]
1- Performances with manual procedure should be validated by user.
Reference range 35-160 [ 0.40-1.82 ] 2- Kenza applications and other applications proposal are available
on request.
Each laboratory should establish its own normal ranges for the
population that it serves. CALCULATION
Serum or plasma:
PERFORMANCES
On Kenza 240TX, 37°C, 505nm Abs (Assay)
Result = x Calibrator concentration
Detection limit: approx. 1 mg/dL Abs (Calibrator)
Precision:
Within-run Low Normal High Between run Low Normal High REFERENCES
N = 20 level level level N = 20 level level level (1) TIETZ N.W. Text book of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
Ashwood, W.B. Saunders (1999) p. 809-857.
Mean mg/dL 41 102 206 Mean mg/dL 59 123 223 (2) Clinical Guide to Laboratory Test, 4thEd., N.W. TIETZ (2006) p. 1074-1077.
S.D. mg/dL 1.0 3.0 0.5 S.D. mg/dL 0.31 5.2 8.4 (3) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995)
p.3-573 to 3-589
C.V. % 2.5 2.7 2.5 C.V. % 5.4 4.3 3.8 (4) Fossati P., Prencipe L., Clin. Chem. (1982), 28, p.2077-2080.
(5) Trinder P. Ann. Clin. Biochem. (1969), 6, p.27-29.
Analytical Sensitivity: approx. 0.125 abs at 500 nm for 100 mg/dL
(6) TIETZ N.W. Text book of clinical chemistry, 2nd Ed. C.A. Burtis, E.R.
(manual procedure, 500 m, 1cm pathlength) Ashwood, W.B. Saunders (1994)p. 1030-1058 et p. 1073-1080.
On Cobas Mira, 505 nm, 37°C: (7) SRM: Standard Reference Material ®
Measuring Range: between 10 and 700 mg/dL
Comparison studies with commercially available reagent:
Realised with human specimens (n=75) between 25 and 350 mg/dL
y = 1.0182 x – 0.0302 r = 0.9958
Interferences:
Ascorbic acid Negative interference from 1 mg/dL
Total bilirubin Positive interference from 100 µmol/L
Haemoglobin No interference up to 300 µmol/L
Glucose No interference up to 1260 mg/dL
Other substances may interfere (see § Limits)

IVD H2O

Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

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