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AutoPure T HDL-C is a ready to use, two liquid reagent system.
Do not freeze the reagent
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
AutoPure T HDL-C can be used on various automated analyzers. The procedure described below is for a BS200SS auto-analyzer
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 for the popular fully automated analyzers are provided along with the kit. For additional system applications, contact our local Accurex representative
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
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 :
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
Reproducibility was determined using three levels of pooled human sera as shown below :
Low ( <40 mg/dl)
Mid (40-59 mg/dl)
High (>60 mg/dl)
A comparison of HDL-C determination using AutoPure T HDL-C and the Designated Comparison Method (DCM) gave the following co-relation (mg/dl) :
y = 0.99x + 2.81
r = 0.996
No. of samples measured : 52