0
home

T LDL Cholesterol (Direct) 320

home
T LDL Cholesterol (Direct) 320
T LDL Cholesterol (Direct) 320
Price And Quantity
  • Kit/Kits
  • 1
  • Kit/Kits
  • 81424 INR
    Product Specifications
    • Liquid
    • Biochemistry Reagent
    • Other
    • Other
    • Biochemistry Reagent
    • 18 Months
    • 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.
    • other
    • Reagents
    • Other
    • ACC9065
    • Industrial
    • Industrial Lab Chemicals
    • 95%
      Product Description
      Introduction
      • 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).
      Reagent Storage, Stability & Handling

      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

      • R1 : 60 days at 2 - 8C after opening. Protect the reagent from light and contamination.
      • R2 : 60 days at 2 - 8C after opening. Protect the reagent from light and contamination.

      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
      Specimen Collection & Preservation
      Collect sample using standard sampling tube. Serum, EDTA treated or sodium heparinized plasma are the recommended specimens. Patients are not required to fast prior to blood collection.

      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

      Quality Control

      Each batch of AutoPure T LDL 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

      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).
      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 Per Day
      • 2 Days
      • Yes
      • packaging : Empity
      • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
      • All India
      • certification : iso
      Related Products
      Turbilatex CRP Infinite
















      Send Inquiry
      Urea 200
















      Send Inquiry
      Turbilatex ASO Infinite
















      Send Inquiry
      CS  Lyse 500ml CBC 360 Neo















      Send Inquiry
      Total Protein 100















      Send Inquiry
      Biochemistry Diagnostic Reagents













      Send Inquiry
      right arrow
      left arrow
      Contact Us

      212, Udyog Mandir No. 17/C, Bhagoji Keer Marg, Mahim, Mumbai, Maharashtra, 400016, India
      Phone :+918045479256