T HDL Cholesterol (Direct) 320

T HDL Cholesterol (Direct) 320

Product Details:

  • Usage AutoPure T HDL C is a ready to use, two liquid reagent system. With AutoPure T HDL C, the assay is linear upto 150 mg/dl (3.89 mmol/l
  • Taste Other
  • Appearance Biochemistry Reagent
  • Other Names Biochemistry Reagent
  • Shape other
  • Smell Other
  • Physical Form Liquid
  • Supply Ability : 10000 Kit Per Day
38770 INR/Kit
X

Price And Quantity

  • 1 Kit
  • 38770 INR/Kit

Product Specifications

  • AutoPure T HDL C is a ready to use, two liquid reagent system. With AutoPure T HDL C, the assay is linear upto 150 mg/dl (3.89 mmol/l
  • Other
  • Reagents
  • Biochemistry Reagent
  • other
  • Biochemistry Reagent
  • 100
  • Other
  • Liquid
  • ACC9076
  • Biochemistry Reagent
  • 18 Months
  • Other

Trade Information

  • EXW ABPL
  • Paypal, Cash Against Delivery (CAD), Cash in Advance (CID), Cheque, Letter of Credit (L/C), Letter of Credit at Sight (Sight L/C)
  • 10000 Kit Per Day
  • 2 Days
  • packaging : Empity
  • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
  • All India
  • certification : iso

Product Description

Introduction
  • AutoPure T HDL C is a reagent kit for direct quantitative determination of high-density lipoprotein cholesterol (HDL C) in human serum and plasma on automated clinical chemistry analyzers.
  •  AutoPure T HDL C is a ready to use, two liquid reagent system.
  •  With AutoPure T HDL C, the assay is linear upto 150 mg/dl (3.89 mmol/l
Reagent Storage, Stability & Handling

AutoPure T HDL-C is a ready to use, two liquid reagent system. 

Shelf - Life
Stable till the expiry date indicated on the label, when stored at 20 - 80C.
On - Board Reagent Stability
R1 : 60 days at 20 - 80 C after opening. Protect the reagent from light and contamination.
R2 : 60 days at 20 - 80 C after opening. Protect the reagent from light and contamination.

Do not freeze the reagent

Expected Values
  • Serum/Plasma
  • The expected values for serum HDL-Cholesterol are as follows :
  • Men: 30 - 70 mg/dl
  • Women: 30 - 85 mg/d

Note:

Expected range varies from population to population. It is therefore recommended that each laboratory should establish its own normal range. According to NCEP, HDL C values greater than or equal to 40 mg/dl are considered desirable and greater than or equal to 60 mg/dl are considered to offer some protection against coronary heart disease. Values below 40 mg/dl are considered to be a significant independent risk factor for coronary heart disease 

Specimen Collection & Preservation

Collect sample using standard sampling tube. Serum, EDTA treated or sodium heparinized plasma are the recommended specimens. 12-14 hours fasting specimen is required.

Serum or plasma should not remain at 150 - 300 C longer than 14 hours. If assay is not completed within 14 hours, serum or plasma may be stored at 20 - 80C upto 1 week. If specimens need to be stored for more than 1 week, they may be preserved at less than -700 C upto 3 months 

Procedure

AutoPure T HDL-C can be used on various automated analyzers. The procedure described below is for a BS200SS auto-analyzer 

Calculations

Fully automated systems automatically calculate the HDL-C concentration of each sample.

Result in mmol/l = Result in mg/dl x 0.0259

Application Sheets

Application sheets for the popular fully automated analyzers are provided along with the kit. For additional system applications, contact our local Accurex representative 

Calibration

For calibration, it is recommended to use T HDL-C Calibrator from Accurex. Other commercially available HDL-C calibrators have not been tested with this assay and cannot be supported by Accurex Biomedical Pvt. Ltd. Refer to the T HDL-C Calibrator kit package insert for a description of assignment procedures and instructions. The value of the T HDL-C Calibrator was assigned by procedures traceable to National Reference System for Cholesterol (NRS/CHOL). Calibration material have concentrations around the medical decision level. 

Calibration frequency :

Re-calibration is recommended

  •  Whenever the reagent lot is changed
  •  As per the requirements of quality control procedures 
Quality Control

Each batch of AutoPure T HDL-C is assayed with multiple quality control sera prior to release.

To ensure adequate quality control, it is recommended that the laboratory should use a normal and an abnormal commercial reference control serum. It should be realized that the use of quality control material checks both reagent and instrument functions together. The value of these controls should fall within the specified limits. If control values fall outside specified limits, each of the below criteria should be cross-checked and corrected :

  •  Proper instrument function  wavelength setting, light source and temperature control
  •  Cleanliness of probes & cuvettes
  •  Bacterial contamination of wash water used by the instrument
  •  Expiry date of the reagent kit
Performance Characteristics
Linearity
With AutoPure T HDL-C, the assay is linear upto 150 mg/dl (3.89 mmol/l). Determine samples with higher concentrations via the rerun function. On analyzers without rerun function, manually dilute sample with higher concentrations using 0.9% NaCl or distilled / deionized water (e.g. 1 + 4). Multiply the result by the appropriate dilution factor (e.g. 5).
Interference

There is no significant interference in samples containing upto 60 mg/dl of conjugated & unconjugated bilirubin, 1800 mg/dl of triglycerides, 1000 mg/dl of haemoglobin, 100 mg/dl ascorbic acid & 5000 mg/dl gamma globulins

Precision

Reproducibility was determined using three levels of pooled human sera as shown below : 

 

Within run

Between run

Serum pool

Mean mg/dL

SD mg/dL

CV

Mean mg/dL

SD mg/dL

CV

Low ( <40 mg/dl)

32.9

0.3

0.8

32.8

0.4

1.3

Mid (40-59 mg/dl)

50.6

0.2

0.5

50

0.7

1.5

High (>60 mg/dl)

101.4

0.7

0.7

100.1

1.1

1.1

 Co-Relation Studies

A comparison of HDL-C determination using AutoPure T HDL-C and the Designated Comparison Method (DCM) gave the following co-relation (mg/dl) :

Linear Regression

y = 0.99x + 2.81

r = 0.996

No. of samples measured : 52

References

  •  Gotto, A.M. Lipoprotein Metabolism and the Etiology of hyperlipidemia. Hospital Practice 1988; 23 Suppl; 1 4-13.
  •  Crouse, J.R. et al. Studies of low density lipoprotein molecular weight in human beings with coronary artery disease. J. Lipid. Res. 1985;26:566.
  •  Badimon, J.J. et al. Regression of Artherosclerotic Lesions by High Density Lipoprotein Plasma Fraction in the cholesterol-Fed Rabbit.
  • Clin. Invest. 1990; 85:1234.
  •  Castelli, W.P. et al. HDL Cholesterol and other Lipids in Coronary Heart Disease. Circulation 1977; 55:767.
  •  Barr, D.P., Russ, E.M., Eder, H.A. Protein-lipid relationships in human plasma. Am. J. Med. 1951; 11:480.
  • Gordon, T. et al. High density lipoprotein as a protective factor against coronary heart disease. Am. J. Med.1977; 62:707.
  • Williams, P., Robinson, D., Baily, A. High density lipoprotein and coronary risk factor. Lancet 1979; 1:72.
  •  Kannel, W.B., Castelli, W.P., Gordon, T. Cholesterol in the prediction of artherosclerotic disease; New perspectives based on Framingham study. Ann. Intern. Med. 1979; 90:85 
  • National Institutes of Health Publication No. 93-3095, September (1993).
  •  Tietz, N.W. Clinical Guide to Laboratory Tests, W.B. Saunders Co., Philadelphia, 2015.
  •  Special Communication, Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) JAMA 2001; 285 (19):2486:2497 
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