Triglycerides FS*

Diagnostic reagent for quantitative in vitro determination of triglycerides in serum or plasma on

photometric systems

Order Information Warnings and Precautions

Cat. No. Kit size 1. The reagent contains sodium azide (0.95 g/L) as
1 5710 99 10 021 R 5x 25 mL + 1 x 3 mL Standard preservative. Do not swallow! Avoid contact with skin and
1 5710 99 10 026 R 6 x 100 mL mucous membranes.
1 5710 99 10 023 R 1 x 1000 mL 2. The reagent contains animal material. Handle the product as
1 5710 99 10 704 R 8x 50 mL potentially infectious according to universal precautions and
1 5710 99 10 717 R 6 x 100 mL good laboratory practice.
1 5710 99 10 917 R 10 x 60 mL 3. In very rare cases, samples of patients with gammopathy
1 5700 99 10 030 6x 3 mL Standard might give falsified results [6].
4. N-acetylcysteine (NAC), acetaminophen and metamizole
Summary [1,2] medication leads to falsely low results in patient samples.
Triglycerides are esters of glycerol with three fatty acids and are 5. Please refer to the safety data sheets and take the necessary
the most abundant naturally occurring lipids. They are transported precautions for the use of laboratory reagents. For diagnostic
in plasma bound to apolipoproteins forming very low density purposes, the results should always be assessed with the
lipoproteins (VLDL) and chylomicrons. Measurement of patient’s medical history, clinical examinations and other
triglycerides is used in screening of the lipid status to detect findings.
atherosclerotic risks and in monitoring of lipid lowering measures. 6. For professional use only!
Studies have shown that elevated triglyceride concentrations Waste Management
combined with increased low density lipoprotein (LDL) Please refer to local legal requirements.
concentrations constitute an especially high risk for coronary heart
disease (CHD). High triglyceride levels also occur in various Reagent Preparation
diseases of liver, kidneys and pancreas. The reagent and the standard are ready to use.
Materials required but not provided
Method
NaCl solution 9 g/L
Colorimetric enzymatic test using glycerol-3-phosphate-oxidase
General laboratory equipment
(GPO)

Principle Specimen
Serum, heparin plasma or EDTA plasma
Determination of triglycerides after enzymatic splitting with
Stability [4]: 2 days at 20 – 25°C
lipoprotein lipase. Indicator is quinoneimine which is generated
7 days at 4 – 8°C
from 4-aminoantipyrine and 4-chlorophenol by hydrogen peroxide
at least one year at –20°C
under the catalytic action of peroxidase.
Discard contaminated specimens. Freeze only once!
Triglycerides LPL > Glycerol + fatty acid Assay Procedure
GK > Glycerol-3-phosphate + ADP
Glycerol + ATP Application sheets for automated systems are available on
request.
Glycerol-3-phosphate + O2 GPO > Dihydroxyaceton phosphate + H O
2 2
Wavelength 500 nm, Hg 546 nm
2 H2O2 + Aminoantipyrine + 4-Chlorophenol POD Quinoneimine + HCl
Optical path 1 cm
+ 4 H2O Temperature 20 – 25°C/37°C
Measurement Against reagent blank
Reagent
Blank Sample or standard
Components and Concentrations Sample or standard - 10 µL
Good's buffer pH 7.2 50 mmol/L Dist. water 10 µL -
4-Chlorophenol 4 mmol/L Reagent 1000 µL 1000 µL
ATP 2 mmol/L Mix, incubate 20 min. at 20 – 25°C or 10 min. at 37°C.
2+
Mg 15 mmol/L Read absorbance against the blank within 60 min.
Glycerokinase (GK) ≥ 0.4 kU/L
Peroxidase (POD) ≥ 2 kU/L Calculation
Lipoprotein lipase (LPL) ≥ 2 kU/L
With standard or calibrator
4-Aminoantipyrine 0.5 mmol/L
Glycerol-3-phosphate-oxidase (GPO) ≥ 0.5 kU/L A Sample
Standard: 200 mg/dL (2.3 mmol/L) Triglycerides [mg/dL] = × Conc. Std/Cal [mg/dL]
A Std/Cal
Storage Instructions and Reagent Stability
To correct for free glycerol, subtract 10 mg/dL (0.11 mmol/L) from
Reagent and standard are stable up to the end of the indicated
the triglycerides value calculated above.
month of expiry, if stored at 2 – 8°C, protected from light and
contamination is avoided. Do not freeze the reagent! Conversion factor
Note: It has to be mentioned, that the measurement is not Triglycerides [mg/dL] x 0.01126 = Triglycerides [mmol/L]
influenced by occasionally occurring color changes, as long as the
absorbance of the reagent is < 0.3 at 546 nm.

Triglycerides FS – Page 1 *fluid stable

Calibrators and Controls Reference Range [2]
For the calibration of automated photometric systems, DiaSys Desirable: < 200 mg/dL (fasting) (2.3 mmol/L)
TruCal U calibrator is recommended. The assigned values of Borderline high: 200 – 400 mg/dL (2.3 – 4.5 mmol/L)
TruCal U have been made traceable to the reference method gas Elevated: > 400 mg/dL (4.5 mmol/L)
chromatography-isotope dilution mass spectrometry (GC-IDMS). Each laboratory should check if the reference ranges are
DiaSys TruLab N and P or TruLab L controls should be assayed transferable to its own patient population and determine own
for internal quality control. Each laboratory should establish reference ranges if necessary.
corrective action in case of deviations in control recovery.
Cat. No. Kit size Clinical Interpretation [3]
TruCal U 5 9100 99 10 063 20 x 3 mL Epidemiological studies have observed that a combination of
5 9100 99 10 064 6 x 3 mL plasma triglycerides > 180 mg/dL (> 2.0 mmol/L) and HDL-
TruLab N 5 9000 99 10 062 20 x 5 mL cholesterol < 40 mg/dL (1.0 mmol/L) predict a high risk of CHD.
5 9000 99 10 061 6 x 5 mL
Borderline levels (> 200 mg/dL) should always be regarded in
TruLab P 5 9050 99 10 062 20 x 5 mL
5 9050 99 10 061 6 x 5 mL association with other risk factors for CHD.
TruLab L Level 1 5 9020 99 10 065 3 x 3 mL
TruLab L Level 2 5 9030 99 10 065 3 x 3 mL Literature
Performance Characteristics 1. Rifai N, Bachorik PS, Albers JJ. Lipids, lipoproteins and
apolipoproteins. In: Burtis CA, Ashwood ER, editors. Tietz
Measuring range Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B
The test has been developed to determine triglyceride Saunders Company; 1999. p. 809-61.
concentrations within a measuring range from 2 - 1000 mg/dL 2. Cole TG, Klotzsch SG, McNamara J. Measurement of
(0.02 – 11.3 mmol/L). When values exceed this range, samples triglyceride concentration. In: Rifai N, Warnick GR,
should be diluted 1 + 4 with NaCl solution (9 g/L) and the result Dominiczak MH, eds. Handbook of lipoprotein testing.
multiplied by 5. Washington: AACC Press, 1997. p. 115-26.
3. Recommendation of the Second Joint Task Force of
Specificity/Interferences European and other Societies on Coronary Prevention.
No interferences were observed by ascorbic acid up to 3 mg/dL, Prevention of coronary heart disease in clinical practice. Eur
conjugated bilirubin up to 30 mg/dL, by unconjugated bilirubin up Heart J 1998;19: 1434-503.
to 9 mg/dL and hemoglobin up to 500 mg/dL. For further 4. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
information on interfering substances refer to Young DS [5]. 1st ed. Darmstadt: GIT Verlag; 2001; p. 46-7.
Sensitivity/Limit of Detection 5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
The lower limit of detection is 2 mg/dL. Association for Clinical Chemistry Press 2000.
Precision (at 37°C) 6. Bakker AJ, Mücke M. Gammopathy interference in clinical
Intra-assay precision Mean SD CV chemistry assays: mechanisms, detection and prevention.
n = 20 [mg/dL] [mg/dL] [%] Clin Chem Lab Med 2007; 45(9):1240-1243.
Sample 1 55.5 0.301 0.54
Sample 2 212 1.69 0.80
Manufacturer
Sample 3 447 3.09 0.69 DiaSys Diagnostic Systems GmbH
IVD Alte Strasse 9 65558 Holzheim Germany
Inter-assay precision Mean SD CV
n = 20 [mg/dL] [mg/dL] [%]
Sample 1 88.9 0.795 0.89
Sample 2 235 3.61 1.54
Method Comparison
A comparison of DiaSys Triglycerides FS (y) with a commercially
available test (x) using 95 samples gave following results:
y = 0.969 x - 0.092 mg/dL; r = 0.9999

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