TM

4x10 mL, 5x25 mL, 6x50 mL, 5x100 mL

TRIGLYCERIDES (S.L) 11410007, 11410002 , 11410008, 11410004

Intended Use Precaution

This reagent is intended for in vitro quantitative determination of triglycerides in To avoid contamination, use clean laboratory wares. Use clean, dry disposable
serum or plasma. pipette tips for dispensing. Close reagent bottles immed iately after use.
- GPO-TOPS methodology Avoid direct exposure of reagent to light.Do not blow into the reagent bottles.
- Linear up to 1000 mg/dL This reagent is only for IVD use and fol low the normal precautions required for
- Contains LCF (Lipaemic clearing factor) which minimizes rerun. hand ling al l laboratory reagents.
Cl inical Significance Waste Management
Triglycerides are simple lipids, formed in the liver by glycerol & fatty acids. They Reagents must be d isposed off in accordance with local regulations.
are transported by VLDL, LDL & constitute about 95% of fat, stored as source of
energy in the tissue & plasma.
Sample
Serum / plasma (free of haemolysis).
Increased levels are found in hyperlipidemias, d iabetes, nephrotic syndrome &
hypothyroidism. Increased levels are risk factor for arteriosclerotic coronary Interferences
disease, peripheral vascular disease, acute pancreatitis & hyperlipoproteinaemia. No interference for
Decreased levels are found in malnutrition & hyperthyroidism. Bilirubin up to 20 mg/dL
Principle Haemoglobin up to 1000 mg/dL
Enzymatic determination of triglyceride is based on fol lowing reactions: Materials Provided
LPL Triglycerides Reagent & Standard.
TGL+H2O ——— > Glycerol + Fatty acid
Materials required but not provided
GK l Pipettes& Tips
Glycerol + ATP ——— > Glycerol-3-phosphate + ADP l Test Tubes & racks
Mg++ l Timer
GPO l Incubator
l Analyzer
Glycerol-3-phospahte+O2 ——— > Dihydroxyacetone phosphate +H2 O2
POD Test Parameters
2H 2 O2+4-Aminoantipyrine+ TOPS ——— > Violet coloured complex
Mode of Reaction End Point
GPO = Glycereol-3-phosphate Oxidase.
Slope of reaction Increasing
LPL = Lipoprotein Lipase
Wavelength I 546 nm (540-560 nm)
GK = Glycerol Kinase
Wavelength II 630 nm
Kit Components Temperature
0
37 C
Reagent/ Product Product Product Product Standard Concentration 200 mg/dL
Component code: code: code: code: Description
11410007 11410002 11410008 11410004 Linearity 1000 mg/dL
Triglycerides 4x10mL 5x25mL 6x50mL 5x100mL Pipes–buffer (pH7.00)5 mmol/L Blank Reagent
TOPS 5.3 mmol/L Potassium
ferrocynate 10 mmol/L Incubation time 5 min
Magnesium Salt 17 mmol/L Sample volume 10 µL
4-Aminoantipyrine 0.9 mmol/L
ATP 3.15mmol/L Lipoprotein Reagent volume 1000 µL
Lipase > 1800 U/L Glycerol Cuvette 1 cm light path
Kinase > 450 U/L Glycerol–3-
phosphate oxidase > 3500 U/L Application parameters for various instrument are available. Please contact
Peroxidase > 450 customer support department for specific information.
Triglycerides1 x 4 mL 1 x 4 mL 1 x 4 mL 1 x 4 mL Triglycerides standard
Standard concentration 200 mg/dL Unit Conversion
Traditional Unit SI Unit Conversion from Traditional to SI
Risk & safety mg/dL x 0.0114
mmol/L
Material Safety data sheets (MSDS) wil l be provided on request.
Calibration
Reagent Preparation
Agappe multicalibrator is recommended for Calibration of this assay on fully
Triglycerides Reagent & Standard are ready to use. auto analyzers.
Reagent Storage Use provided Triglycerides standard for calibration of this assay on Semi auto
analyzer.
The sealed reagents are stable up to the expiry date stated on the label, when
stored at 2- 8 oC and protected from light. Procedure notes
Open Vial Stability Laboratory procedure for Semi Auto Analyzer.
o
Once opened, the reagent is stable up to 4 weeks at 2- 8 C if contamination is
avoided. Blank Standard Sample
On-board Cal ibration Stabil ity Reagent 1000 µL 1000 µL 1000 µL
On-board Calibration stability is 20 days
Standard - 10 µL -
Reagent Deterioration
Sample - - 10 µL
Turbidity or precipitation in any kit component indicates deterioration and the
0
component must be discarded. Values outside the recommended acceptable range Mix and incubate for 5 minutes at 37 C. Measure the change in absorbance
for the Agappe Qualichek Norm & Path control may also be an indication of reagent of standard and sample against reagent blank.
instabil ity and associated results are invalid. Sample should be retested using a
fresh vial of reagent.

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001 : 2015
customersupport@agappe.in | www.agappe.com REV. NO.: ADL/IFU/TGL/LIQ/R02 EN ISO13485: 2016
 TM

4x10 mL, 5x25 mL, 6x50 mL, 5x100 mL

TRIGLYCERIDES (S.L) 11410007, 11410002 , 11410008, 11410004

Calculation 3. Precision
Absorbance of Sample Intra Run
Triglycerides Con. (mg/dL) =————————————x 200 Control Level 1 Control Level 2
Absorbance of Standard n 20 20
Quality control Mean (mg/dL) 184.8 85.1
It is recommended to use Agappe Qualicheck Norm & Path ( 11601001) to verify SD 4.03 2.19
the performance of the assay. Each laboratory has to establish its own internal CV(%) 2.18 2.57
quality control scheme and procedure for corrective action, if control do not recover
within the acceptable range. Inter Run
Reference Range Control Level 1 Control Level 2
It is recommended that each laboratory establish its own reference values. n 20 20
The fol lowing value may be used as guide line. Mean (mg/dL) 184.65 84.56
Male : 60 - 165 mg/dL SD 3.48 2.10
CV(%) 1.89 2.48
Female : 40 -140 mg/dL
Results obtained for patient samples are to be correlated with clinical findings of Accuracy (mg/dL)
patient for interpretation and diagnosis.
Control Expected Value Measured Value
Performance Control Level 1 185± 42 189.5
1. Linearity Control Level 2 75 ± 10 79.2
This reagent is linear up to 1000 mg/dL. Qualichek Norm 110 ± 12 109.6
If the concentration is greater than linearity (1000 mg/dL), d ilute the sample Qualichek Path 210 ± 35 209.4
with normal saline and repeat the assay. Multiply the result with dilution factor.
4. Sensitivity
2. Comparison
Lower detection Limit is 2 mg/dL.
A comparison study has been performed between Agappe reagent and another
international ly available reagent yielded a correlation coefficient of r2= 0.9932 Bibliography
and a regression equation of y = 0.965x.
1. Schettler, G., Nussel, E.; Arav. Med 10, 25 (1975)
2. Jacobs, N.J. , VanDemark, P.J.; Arch, Biochem, Biophy. 88, 250 – 255 (1960)

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT

AGAPPE DIAGNOSTICS LTD.

‘Agappe Hills’, Dist. Ernakulam, Kerala, India-683 562.
Tel. +91 484 2867 000 | Customer Support No.: 1800 425 7151(Toll Free) ISO 9001 : 2015
customersupport@agappe.in | www.agappe.com REV. NO.: ADL/IFU/TGL/LIQ/R02 EN ISO13485: 2016