Scribd Logo
Upload

Welcome to Scribd!

  • 56 views

    HDL Dir

    Uploaded by

    mrashrafi
    This document provides instructions for using a direct method to analyze HDL-C (high-density lipoprotein cholesterol) levels. It describes the analytical procedure, reagents, method, calculation, performance, and expected values. The procedure is an enzymatic-colorimetric endpoint method using two reagents, R1 and R2. Samples and calibrators are incubated with each reagent and the absorbance read to calculate the HDL-C concentration based on the change in absorbance compared to the calibrator. Normal HDL-C values are above 35 mg/dL.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    HDL Dir

    Uploaded by

    mrashrafi
    56 views2 pages
    This document provides instructions for using a direct method to analyze HDL-C (high-density lipoprotein cholesterol) levels. It describes the analytical procedure, reagents, method, calculation, performance, and expected values. The procedure is an enzymatic-colorimetric endpoint method using two reagents, R1 and R2. Samples and calibrators are incubated with each reagent and the absorbance read to calculate the HDL-C concentration based on the change in absorbance compared to the calibrator. Normal HDL-C values are above 35 mg/dL.

    Original Description:

    HDL_DIR

    Original Title

    HDL_DIR

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides instructions for using a direct method to analyze HDL-C (high-density lipoprotein cholesterol) levels. It describes the analytical procedure, reagents, method, calculation, performance, and expected values. The procedure is an enzymatic-colorimetric endpoint method using two reagents, R1 and R2. Samples and calibrators are incubated with each reagent and the absorbance read to calculate the HDL-C concentration based on the change in absorbance compared to the calibrator. Normal HDL-C values are above 35 mg/dL.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    56 views2 pages

    HDL Dir

    Uploaded by

    mrashrafi
    This document provides instructions for using a direct method to analyze HDL-C (high-density lipoprotein cholesterol) levels. It describes the analytical procedure, reagents, method, calculation, performance, and expected values. The procedure is an enzymatic-colorimetric endpoint method using two reagents, R1 and R2. Samples and calibrators are incubated with each reagent and the absorbance read to calculate the HDL-C concentration based on the change in absorbance compared to the calibrator. Normal HDL-C values are above 35 mg/dL.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 2

    HDL- C Direct

    Direct Method
    Cat.No
    150116
    150100
    150101
    150104
    150102
    150103
    150105

    Package Size
    6 x 10 mL
    2 x 10mL
    4 x 25 mL
    2 x 17 mL
    3 x 100 mL
    1 x100 mL
    Hit I 3 x 20 mL
    1 x 20 mL
    Hit I 3 x 50 mL
    1 x 50 mL
    Hit II 3 x 100 mL
    5 x 50 mL
    AU 3 x 50 mL
    3 x 17 mL

    ANALYTICAL PROCEDURE
    This is the standard procedure, Instrument
    Applications are available upon request.
    Wavelength
    Temperature
    Cuvette

    600 nm (sub 700)


    37C
    1 cm light path

    Read against reagent blank

    METHOD
    Enzymatic-colorimetric. End point.

    REAGENTS
    R1:

    Goods buffer, pH 7.0


    H-DAOS
    Goods buffer, pH 7.0
    CE*
    COD
    POD
    4-AA**

    R2:

    20 mmol/L
    0.8 mmol/L
    20 mmol/L
    > 250 U/L
    > 5000 U/L
    > 11000 U/L
    2.6 mmol/L

    (RBL)

    RBL
    CALIBRATOR SAMPLE
    Reagent R1
    240 L
    240 L
    240 L
    Calibrator
    2,5 L
    Sample
    2,5 L
    Mix well, incubate for 5 min, read A1 and then add
    Reagent R2
    80 L
    80 L
    80 L
    Mix well, incubate for 5 min,then read A2

    A = (A2 A1) Sample or Calibrator - (A2 A1) RBLl

    * Cholesterinesterase
    ** 4-Aminoantipyrin

    CALCULATION

    STABILITY
    The sealed reagents are stable up to the indicated
    expiry date if stored at 2 to 8C.

    with calibrator

    PREPARATION
    R1 and R2 are ready for use. Store at 2-8C.
    Do not freeze !

    HDL - C [mg / dl ] =

    A sample
    Conc. Cal. [mg / dl ]
    A calibrator

    Stability after opening :


    At least 3 months
    at 2 to 8 C, if contamination is avoided
    On board stability is at least 4 weeks at 2 8C

    CALIBRATION & QUALITY CONTROL


    WARNINGS AND PRECAUTIONS
    1.When discarding the reagents, dispose them
    according to local or federal regulations.
    2.Avoid contact with eyes and skin. If contacted,
    flush eyes or rinse skin with a large amount of
    water. If irritation persists, consult a physician.

    For the calibration of automated analyzers Greiner


    special calibrator or the Multicalibrator is recommended,
    for quality control use Greiner Unitrol-I and -II ,
    respectively the special Greiner lipid control.

    NOTES
    HDL-C Calibrator is not provided with the kit. Refer
    to the instruction sheet in the Calibrator kit.

    10.2006

    Page 1/2

    Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


    www.greiner-diagnostic.com

    PERFORMANCE

    BIBLIOGRAPHY

    - Analytical range
    The measurable range is 1-200 mg/dL HDL-cholesterol.
    If the obtained value exceeds 200 mg/dL, repeat the test
    using serum diluted 1/10 with 0.9% sodium chloride.
    Multiply result by 10.

    1.

    2.
    - Sensitivity
    The lowest detectable value is 1 mg/dL
    3.

    - Precision
    Within series
    n = 30

    Mean value
    [mg/dL]

    CV
    [%]

    32.6
    47.3
    68.5

    0,65
    0,78
    0,65

    Sample 1
    Sample 2
    Sample 3

    4.

    - Correlation
    A comparative study has been performed between the
    Greiner method and another commercial reagent on 100
    human serum samples. The parameters of linear
    regression are as follows:

    5.

    Rifai N, Bachorik PS, Albers JJ. Lipids, lipoproteins


    and apolipoproteins. In: Burtis CA, Ashwood ER,
    editors. Tietz Textbook of Clinical Chemistry. 3rd ed.
    Philadelphia: W.B Saunders Company; 1999. p.
    809-61.
    Recommendation of the Second Joint Task Force of
    European and other Societies on Coronary
    Prevention. Prevention of coronary heart disease in
    clinical practice. Eur Heart J 1998;19: 1434-503.
    Wiebe DA, Warnick GR. Measurement of highdensity lipoprotein cholesterol. In: Rifai N, Warnick
    GR, Dominiczak MH, eds. Handbook of lipoprotein
    testing. Washington: AACC Press, 1997:p.127-44.
    Nauck M, Maerz W, Wieland H. New
    immunoseparation-based homogenous assay for
    HDL-cholesterol compared with three homogenous
    and two heterogeneous methods for HDLcholesterol. Clin Chem 1998;44:1443-51.
    Schaefer EJ, McNamara J. Overview of the
    diagnosis and treatment of lipid disorders. In: Rifai
    N, Warnick GR, Dominiczak MH, eds. Handbook of
    lipoprotein
    testing.
    Washington:
    AACC
    Press;1997.p.25-48.

    Correlation coefficient
    r = 0.996
    Linear regression
    y = 1.000 x + 2.0 mg/dL

    SYMBOLS USED

    INTERFERENCES
    - Ascorbic Acid: no interference up to 100 mg/dL
    - Bilirubin: no interference up tol 40 mg/dL
    - Triglycerides: no interference up to 1000 mg/dL
    - Hemoglobin: no interference up to 500 mg/dL

    For in vitro diagnostic medical use

    Batch Code

    EXPECTED VALUES
    Normal values are > 35 mg/dl (0.9 mmol/l)
    Clinical Interpretation:
    Epidemiological studies have shown that for men values
    < 35 mg/dl (< 0.9 mmol/l), and for women
    values < 43 mg/dl (< 1.0 mmol/l) stand for increased
    coronary risk factors, especially if triglyrerides
    are > 180 mg/dl (> 2 mmol/l).

    Use by
    Temperature limitation

    10.2006

    Page 2/2

    Greiner Diagnostic GmbH - Unter Gereuth 10 D-79353 Bahlingen Germany


    www.greiner-diagnostic.com

    You might also like