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- Biochemistry Reagent
- AutoPure T LDL C is a reagent kit for direct quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and plasma on automated clinical chemistry analyzers. AutoPure T LDL C is a ready to use, two liquid reagent system.
- Liquid
- 18 Months
- Other
- Reagents
- Other
- ACC9065
- Industrial
- Industrial Lab Chemicals
- 95%
- AutoPure T LDL C is a reagent kit for direct quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and plasma on automated clinical chemistry analyzers.
- AutoPure T LDL C is a ready to use, two liquid reagent system.
- With AutoPure T LDL C, the assay is linear upto 450 mg/dl (11.637 mmo1/1).
AutoPure T LDL C is a ready to use, two liquid reagent system.
Shelf - Life
Stable till the expiry date indicated on the label, when stored at 2 - 8 C.
On - Board Reagent Stability
Do not freeze the reagent.
Components & Concentration of Working Solution
Components Concentration
R1
- Detergent 1
- 4-am i noanti pyrine 0.5 mmol/l
- Cholesterol oxidase 1.2 U/ml
- Cholesterol esterase
- Peroxidase
- Good's buffer solution; pH 6.3
R2
- Detergent 2
- N, N-bis(4 sulfobutyl) m toluidine disodium salt (DSBmT) 1.0mmol/l
- Good's buffer solution; pH 6.3
Serum or plasma should not remain at 15- 30C for more than 14 hours. If assay is not completed within 14 hours, serum or plasma may be stored at 2 - 8C upto 1 week. If specimens need to be stored for more than 1 week, they may be preserved at less than -70C upto 3 months.
Calculations
Fully automated systems automatically calculate the LDLC concentration of each sample
Result in mmo1/1 = Result in mgdl x 0.02586
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 LDL C Calibrator from Accurex. Other commercially available LDL-C calibrators have not been tested with this assay and cannot be supported by Accurex Biomedical Pvt. Ltd. Refer to the T LDL-C Calibrator kit package insert for a description of assignment procedures and instructions. The value of the T LDL 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
- 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
Expected Values
Serum/Plasma
The following NCEP cutpoints for patient classification are used for the prevention and management of coronary heart disease :
Desirable | <130 mg/dl ( 3.36 mmol/l) |
Borderline | 130-159 mg/dl ( 3.36-4.11 mmol/l) |
High Risk | >160 mg/dl (4.14 mmol/l) |
Note:
Expected range varies from population to population. It is therefore recommended that each laboratory should establish its own normal range.
Performance Characteristics Linearity
With AutoPure T LDL C the assay is linear upto
450 mg/dl (11.637 mmo1/1). Determine samples with higher concentrations via the rerun function. On analyzers without rerun function, manually dilute sample with higher concentrations using 0.9% NaCI 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 20 mg/dl of conjugated & unconjugated bilirubin, 1293 mg/di of triglycerides, 500 mg/dl of haemoglobin, 50 mg/di 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 ( <130 mg/dl) | 98.1 | 0.72 | 0.73 | 98.1 | 2.2 | 2.27 |
Mid (130-159 mg/dl) | 146.5 | 0.96 | 0.66 | 142.7 | 2.8 | 1.95 |
High (>160 mg/dl) | 209.8 | 0.62 | 0.62 | 207.3 | 3.6 | 1.73 |
Co-Relation Studies
A comparison of LDL-C determination using AutoPure T LDL-C and the Reference method gave the following co-relation (mg/d[) :
Linear regression
y = 0.95x -1- 3.02
r = 0.96
No. of samples measured : 54
References
- Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological and Biomedical Laboratories", 1988.
- National Committee for Clinical Laboratory Standards, Preparation and Testing of Reagent Water in the Clinical Laboratory Third edition: Approved Guideline NCCLS Document C3-A3, 1997.
- Gotta, 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. J. Clin. Invest. 1990; 85:1234.
- Castel', W.P. et al. HDL Cholesterol and other lipids in Coronary Heart Disease, Circulation 1977; 55:767.
- Barr; D.P. et al. 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.
- Bachorik, P.S. et al. National Cholesterol Education Program Recommendations for Measurement of Low Density Lipoprotein Cholesterol: Executive Summary. Clin. Chem. 1995; 41(10):1414.
- National Committee for Clinical Laboratory Standards, Internal Quality Control Testing: Principles and Definitions, Approved Guideline NCCLS Document C24-A, Number 6, Vol. 11, 1991.
- National Committee for Clinical Laboratory Standards, Procedures for the Handling and Processing of Blood Specimens, Approved Guideline NCCLS Document H18-A, Number 12, Vol. 10, 1990.
- Tietz, N.W. Clinical Guide to Laboratory Tests, W.B. Saunders Co., Philadelphia, PA., 256(1986).
- National Committee for Clinical Laboratory Standards, National Evaluation Protocols for Interference Testing, Evaluation Protocol, Proposed Guideline NCCLS Document EP7-P Number 7, Vol. 6, No. 13, August 1986.
- Young, D.S. Effects of Drugs on Clinical Laboratory Tests, 3rd ed. AACC Press, Washington, D.C., 3-104 (1990).
- EXW ABPL
- Paypal, Letter of Credit at Sight (Sight L/C), Letter of Credit (L/C), Cheque, Cash in Advance (CID), Cash Against Delivery (CAD)
- 10000 Per Day
- 2 Days
- Yes
- packaging : Empity
- Africa, Middle East, Western Europe, Eastern Europe, South America, North America, Central America, Australia, Asia
- All India
- certification : iso
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