3 x 53/3 x 20 mL
HDL-C DIRECT 12023015
Intended Use Ascorbic acid up to 50 mg/dL
This reagent is intended for in vitro quantitative determination of HDL Cholesterol Triglyceride up to 1000 mg/dL
in serum *(when triglyceride in a sample exceeds 1000 mg/dL, dilute the sample 1+9 with
- Selective Inhibition Method saline, repeat the assay and multiply result by 10)
-Linear up to 150 mg/dL
Materials provided
Clinical Significance HDL-C Direct R1 & R2 Reagents
Total blood cholesterol levels have long been known to be related to coronary heart
disease (CHD). In recent years, in addition to total cholesterol, high density
Reagents required but not provided
lipoprotein cholesterol (HDL-C) has become an important tool used to assess an Multicalibrator (Product Code: 11610001), Qualicheck Norm (Product Code:
individual risk of developing CHD since a strong negative relationship between 11601003), Qualicheck Path ( Product Code: 11601002)
HDL-C concentration and the incidence of CHD was reported. Unit Conversion
Principle Conversion from
Trad itional Unit SI Unit
The reaction between cholesterol other than HDL & enzyme for cholesterol assay Trad itional to SI
is suppressed by the electrostatic interaction between polyanions& cationic mg/dL mmol/L x 0.026
substances. Hydrogen peroxide is formed by the free cholesterol in HDL by Calibration
cholesterol oxidase. Oxidative condensation of EMSE and 4-AA is caused by Agappe Multicalibrator (Product Code: 11610001) is recommended for calibration
hydrogen peroxide in the presence of peroxidise, and the absorbance of the resulting of the assay.
red-purple quinine is measured to obtain the cholesterol value in HDL
Quality control
Polyanions
Other lipoproteins than HDL——————> Suppress reaction with enzyme It is recommended to use Qualicheck Norm (Product Code: 11601003) or Qualicheck
Cationic substances Path (Product Code: 11601002) to verify the performance of the measurement
Cholesterol esterase procedure. Each Laboratory has to establish its own internal quality control scheme
HDL (cholesterol esters) + H2O ————————> HDL (free cholesterol) +Free fatty and procedures for corrective action if controls do not recover within the acceptable
acids tolerance.
cholesterol oxidase Reference Range
HDL (free cholesterol) + O2 + H+—————————> Cholestenone + H2O2
It is recommended that each laboratory should establish its own reference values.
Peroxidase The following value may be used as guide line.
2H2O2 + 4-AA + EMSE + H3 + O ———————> Violet quinone + 5H2O
Male : 35-80 mg/dL
Kit Components Female : 42- 88 mg/dL
Reagent/ Product Code Description Results obtained for patient samples are to be correlated with clinical findings of
Component 12023015 patient for interpretation and diagnosis.
HDL-C 3 x 53 mL N—Ethyl-N-(3-methylphenyl)-
Performance
Direct R1 N’succinylethyenediame(EMSE) 1. Linearity
HDL-C 3 x 20 mL Cholesterol Oxidase The reagent is linear up to 150 mg/dL. If the concentration is greater than linearity
Direct R2 4-Aminoantipyrin(4-AA) (150 mg/dL), dilute the sample with normal saline and repeat the assay. Multiply
Risk & Safety the result with dilution factor.
Material Safety data sheets (MSDS) will be provided on request 2. Comparison
Reagent Preparation A comparison study has been performed between Agappe reagent and another
HDL-C Direct R1 & R2 Reagents are ready to use. internationally available reagent yielded a correlation coefficient of r2= 0.9848 and
a regression equation of y = 0.9854x.
Reagent Storage and Stability
3. Precision
The sealed reagents are stable upto the expiry date stated on the label, when stored
at 2-8OC, protected from light. Do not freeze. Intra Run Inter Run
Open Vial Stability Control Level 1 Level 2 Level 1 Level 2
Once opened the reagents are stable up to 90 days if contamination is avoided. n 20 20 20 20
Mean (mg/dL) 67.1 27.1 66.48 27.16
On-board Calibration Stability
Calibration is stable for 20 days. SD 0.87 0.85 1.21 0.55
CV(%) 1.30 3.14 1.82 2.04
Reagent Deterioration
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range Accuracy (mg/dL)
for the Agappe Qualicheck Norm & Path control may also be an indication of
Control Expected Value Measured Value
reagent instability and associated results are invalid. Sample should be retested
using fresh vial of reagent. Control Level 1 65 ± 9.8 69.7
Control Level 2 24 ± 6.6 26.6
Precaution
To avoid contamination, use clean laboratory wares. Close reagent bottles Qualicheck Norm 30 ± 4.5 32
immediately after use. Avoid direct exposure of reagent to light. Do not blow into Qualicheck Path 85 ± 15.5 83.9
the reagent bottles.
This reagent is only for IVD use and follow the normal precautions required for 4. Sensitivity
hand ling all laboratory reagents.
Lower detection Limit is 1 mg/dL
Waste Management
Bibliography
Reagents must be disposed off in accordance with local regulations.
1. Williams P et al., High density lipoprotein and coronary risk factor, Lancet.
Sample 1:72 (1979)
Fresh serum (Do not use lipemic or hemolysed sample) 2. Gordon,T.Castelli, W.P.Hjortland, M.C. et al. Am.J.Med 62, 707-714 (1977)
Interferences 3. Rifai, N.andWarnick, G.R., Ed. Laboratory Measurement of Lipids, Lipoproteins
No interference for and Apolipoproteins AACC Press. Washington, DC,USA,1994
Bilirubin up to 40 mg/dL 4. American Heart Association,2009,NCEP,2009
Haemoglobin up to 500 mg/dL
‘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/HDLC/CLP/R00 EN ISO 13485:2016
