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    Cormay Lipase: Diagnostic Kit For Determination of Lipase Activity

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    Nghi Nguyen
    This document provides information on the Cormay Lipase diagnostic kit for determining lipase activity. The kit uses a colorimetric method to measure the lipase-catalyzed production of methylresorufin from a chromogenic substrate, allowing the quantification of lipase activity in a serum sample. The kit is intended for use on automated analyzers and provides reagents, controls, reference values, and performance characteristics for the lipase assay.

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    Cormay Lipase: Diagnostic Kit For Determination of Lipase Activity

    Uploaded by

    Nghi Nguyen
    55 views2 pages
    This document provides information on the Cormay Lipase diagnostic kit for determining lipase activity. The kit uses a colorimetric method to measure the lipase-catalyzed production of methylresorufin from a chromogenic substrate, allowing the quantification of lipase activity in a serum sample. The kit is intended for use on automated analyzers and provides reagents, controls, reference values, and performance characteristics for the lipase assay.

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    1-309

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    This document provides information on the Cormay Lipase diagnostic kit for determining lipase activity. The kit uses a colorimetric method to measure the lipase-catalyzed production of methylresorufin from a chromogenic substrate, allowing the quantification of lipase activity in a serum sample. The kit is intended for use on automated analyzers and provides reagents, controls, reference values, and performance characteristics for the lipase assay.

    Copyright:

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

    Cormay Lipase: Diagnostic Kit For Determination of Lipase Activity

    Uploaded by

    Nghi Nguyen
    This document provides information on the Cormay Lipase diagnostic kit for determining lipase activity. The kit uses a colorimetric method to measure the lipase-catalyzed production of methylresorufin from a chromogenic substrate, allowing the quantification of lipase activity in a serum sample. The kit is intended for use on automated analyzers and provides reagents, controls, reference values, and performance characteristics for the lipase assay.

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    of 2

    CORMAY LIPASE

    DIAGNOSTIC KIT
    FOR DETERMINATION OF
    LIPASE ACTIVITY

    PROCEDURE
    Kit name Cat. No The reagents are ready to use.
    CORMAY LIPASE 1-309 CORMAY LIPASE is intended for automated analysers.
    Applications for particular analysers are available on request.
    INTRODUCTION
    Lipase is a digestive enzyme released into the intestine from the REFERENCE VALUES 4
    pancreas where it breaks down triglycerides into fatty acids and Normal range 13 – 60 U/l 0.22 – 1.0 μkat/l
    glycerol prior to absorption. Lipase measurements are used in the
    It is recommended for each laboratory to establish its own reference
    diagnosis and treatment of diseases of the pancreas such as acute
    ranges for local population.
    pancreatitis, obstruction of the pancreatic duct and pancreatic
    tumours.
    QUALITY CONTROL
    For internal quality control it is recommended to use the CORMAY
    METHOD PRINCIPLE
    SERUM HN (Cat. No 5-172) and CORMAY SERUM HP
    The colorimetric method is based on a lipase specific degradation of
    (Cat. No 5-173) with each batch of samples.
    a chromogenic substrate. The specific lipase substrate-DGGMR
    For the calibration of automatic analysers systems the CORMAY
    [1,2-o-dilauryl-racglycero-3-glutaric acid-(6’-methylresorufin) ester]
    MULTICALIBRATOR LEVEL 1 (Cat. No 5-174; 5-176) or
    is cleaved by the catalytic action of lipase to form 1,2-o-dilauryl-
    LEVEL 2 (Cat. No 5-175; 5-177) is recommended.
    racglycerol and an unstable intermediate, glutaric acid-(6-methyl
    The calibration curve should be prepared every 7 weeks, with change
    resorufin) ester. This decomposes spontaneously in alkaline solution
    of reagent lot number or as required e.g. quality control findings
    to form glutaric acid and methylresorufin. The lipase activity in the
    outside the specified range.
    specimen is proportional to the production of methylresorufin in the
    reaction and can be determined photometrically.
    PERFORMANCE CHARACTERISTICS
    These metrological characteristics have been obtained using
    REAGENTS
    automatic analyser Biolis 24i Premium. Results may vary if
    Package
    a different instrument is used.
    1-Reagent 4 x 25 ml
     Sensitivity: 6 U/l (0,10 µkat/l).
    2-Reagent 2 x 25 ml
     Linearity: up to 1000 U/l (16,67 µkat/l).
    The reagents when stored at 2-8 C are stable up to expiry date For higher concentration dilute the sample with 0.9% NaCl and
    printed on the package. The reagents are stable for 7 weeks on board repeat the assay. Multiply the result by dilution factor.
    the analyser at 2-10 C. Protect from light and avoid contamination!
     Specificity / Interferences
    Concentrations in the test Haemoglobin up to 0.16 g/dl, ascorbate up to 62 mg/l, bilirubin
    1-Reagent up to 15 mg/dl and triglycerides up to 750 mg/dl do not interfere
    TAPS [N-Tris(hydroxymethyl)methyl-3- with the test.
    100 mM
    aminopropanesulfonic acid] 

    sodium hydroxide 40 mM  Precision


    sodium deoxycholate 34 mM Repeatability (run to run) Mean SD CV
    2-Reagent n = 20 [U/l] [U/l] [%]
    tartaric acid 9.5 mM
    level 1 29.11 0.69 2.37
    sodium hydroxide 19 mM
    level 2 94.82 0.85 0.89
    colipase 460 IU/ml
    2-propanol 0.65 M
    Reproducibility (day to day) Mean SD CV
    DGGMR [1,2-o-dilauryl-rac-glycero-3-glutaric acid-
    0.4 mM n = 80 [U/l] [U/l] [%]
    (6’-methylresorufin)-ester]
    level 1 29.55 2.83 9.56
    level 2 92.27 3.98 4.32
    Warnings and notes
     Products for in vitro diagnostic use only.  Method comparison
     The reagents must be used only for the purpose intended by A comparison between lipase values determined at Biolis 24i
    suitably qualified laboratory personnel, under appropriate Premium (y) and at COBAS INTEGRA 400 (x) using 39 samples
    laboratory conditions. gave following results:
     Products contain sodium azide (< 0.1%) as a preservative. y = 0.9934 x - 2.4851 U/l;
    Avoid contact with skin and mucous membranes. R = 0.9909

    ADDITIONAL EQUIPMENT WASTE MANAGEMENT


     automated analyser; Please refer to local legal requirements.
     general laboratory equipment;

    SPECIMEN
    Serum, heparinized plasma free from hemolysis.
    Sample may be stored for up to 5 days at 2-8°C or 24 hours at
    20-25°C.
    Nevertheless it is recommended to perform the assay with freshly
    collected samples!

    CORMAY LIPASE page 1


    LITERATURE
    1. Tietz NW et al. Lipase in serum-the elusive enzyme: An
    overview. Clin Chem 1993;39:746-756.
    2. Steinberg WM, Goldstein SS,Davies ND et al. Diagnostic assays
    in acute pancreatitis. (Review). Ann Intern Med 1985; 102:576-
    580.
    3. Leybold A, Junge W. Importance of colipase for the
    measurement of serum lipase activity. Adv clin Enzymol
    1986;4:60-67.
    4. Alan H. B. Wu, Tietz Clinical Guide to Laboratory Tests, W.B.
    Saunders Company, 4th edition, 676 (2006).

    Date of issue: 09. 2012.

    MANUFACTURER

    PZ CORMAY S.A.
    22 Wiosenna Street,
    05-092 Łomianki, POLAND
    tel.: +48 (0) 22 751 79 10
    fax: +48 (0) 22 751 79 14
    http://www.cormay.pl

    09/12/09/12
    CORMAY LIPASE page 2

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