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    Accucare Control Sera

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    Subodh
    This document summarizes the intended use, precautions, reconstitution, storage, stability, and target values of Accucare control serum Level 2. It is a lyophilized human control serum intended for use as a quality control to verify the accuracy of clinical chemistry assays. It contains inactivated human material and its components are stable for various time periods when stored properly. Target values are provided for various analytes determined using specific methods.

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    Accucare Control Sera

    Uploaded by

    Subodh
    189 views2 pages
    This document summarizes the intended use, precautions, reconstitution, storage, stability, and target values of Accucare control serum Level 2. It is a lyophilized human control serum intended for use as a quality control to verify the accuracy of clinical chemistry assays. It contains inactivated human material and its components are stable for various time periods when stored properly. Target values are provided for various analytes determined using specific methods.

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    This document summarizes the intended use, precautions, reconstitution, storage, stability, and target values of Accucare control serum Level 2. It is a lyophilized human control serum intended for use as a quality control to verify the accuracy of clinical chemistry assays. It contains inactivated human material and its components are stable for various time periods when stored properly. Target values are provided for various analytes determined using specific methods.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    189 views2 pages

    Accucare Control Sera

    Uploaded by

    Subodh
    This document summarizes the intended use, precautions, reconstitution, storage, stability, and target values of Accucare control serum Level 2. It is a lyophilized human control serum intended for use as a quality control to verify the accuracy of clinical chemistry assays. It contains inactivated human material and its components are stable for various time periods when stored properly. Target values are provided for various analytes determined using specific methods.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 2

    ACCUCARE

    CONTROL SERUM
    LEVEL – 2

    For quality control of clinical chemistry assays.

    INTENDED USE

    Accucare control serum Level 2 is a lyophilized human control serum manufactured under strict quality
    control standards. It is intended for use as an Assayed Quality Control serum to verify the Accuracy of
    Laboratory measurement procedures.
    The most constituent and activities of ACCUCARE Control Serum - are in the pathologic range.

    PRECAUTIONS

    The components of this serum has been tested negative for the presence of HBsAg , HCV and antibody to
    HIV (1/2). However handle cautiously as potentially infectious.
    Use adequate protection (overall gloves, glasses)
    Do note pipette by mouth.
    In case of contact with skin or eyes thoroughly wash affected area with plenty of water and seek medical
    advice.

    RECONSTITUTION

    Remove the aluminium seal and carefully lift the rubber stopper, avoiding any loss of the lyophilized
    material.
    Remove the stopper and add exactly 5 ml distilled water.
    Close bottle carefully make sure that the freeze dried material is thoroughly in contact with water and let
    stand for 30 minutes. Dissolve contents completely by swirling gently, avoiding the formation of foam. Do
    not shake. The reconstituted control serum is to be treated like the serum specimen.

    STORAGE AND STABILITY


    The unopened vial is stable till the expiry date printed on the vial label. When stored tightly closed at
    2-8*C and contaminations are prevented during their use. Do not use over the expiry date.
    The components of the reconstituted control serum are stable for
    At least 8 hours at +25°C
    At least 3 days at +4°C
    At least 1 month at -20°C when frozen once
    Discard if found turbid or contaminated.

    LIMITATIONS.
    CK is sensitive to light and temperature.

    Note: For determination of alkaline phosphatase, allow the fully reconstituted control serum to stand for
    one hour at +25°C before performing the assay.

    Target values are the mean of values obtained during several determination of each analyte and the range
    are + /- 2 Standard deviations.
    It is recommended that each laboratory validate each new batch specific values before use. For an optimal
    use each laboratory must establish their own target and range. These target values must be periodically
    retested.

    ACCUCARE
    Control Serum
    LEVEL- 2
    Lyophilized, Human Matrix

    Value sheet 100121 10-2012

    Component Method Targe Range +/- 2 SD Units


    t
    Albumin BCG 3.27 2.78-3.76 g/dL
    ALP IFCC-AMP 109.3 90.1-128.5 IU/L
    ALT (SGPT) IFCC-Without PDP 110 90.7-129.5 IU/L
    AST (SGOT) IFCC-Without PDP 60 48-72 IU/L
    BUN (Urea nitrogen) Urease / GLDH 25.2 22.3-28.1 mg/dL
    Calcium Arsenazo III 8.93 8.22-9.64 mg/dL
    Chloride Mercuric thiocyanate 96.1 91.9-100.3 Mmol/L
    Cholesterol CHOD-POD 172 146-199
    mg/dL
    Creatinine Alkaline picrate 2.33 1.92-2.74 mg/dL
    CK IFCC 591 487-695 IU/L
    CK-MB IFCC Immunoinhibition 110 85-135 IU/L
    Direct HDL Cholesterol Detergent 50 40-60 mg/dL
    Direct LDL Cholesterol Detergent 75 60-90 mg/dL
    Glucose GOD-POD 444 375-513 mg/dL
    LDH-L Lactate 405 334-477 IU/L
    Lipase Resorufin ester 32 24-40 IU/L
    Potassium Turbidimetric 5.6 5.0-6.2 mEq/L
    Phosphorus Molybdate 8.05 6.79-9.31 mg/dL
    Sodium Colorimetric 142 132-152 mEq/L
    Triglycerides GPO-PAP 442 353-531 mg/dL
    Total protein Biuret 5.38 4.96-5.80 g/dL
    Urea Berthelot 54.1 47.9-60.2 mg/dL
    Uric acid Uricase 5.98 5.06-6.90 mg/dL

    Lab Care Diagnostics (India) Pvt Ltd.


    C1 Type, Shed No 3225, Chemical zone ,GIDC Sarigam,Sarigam-396155, Dist VALSAD. GUJARAT.
    Email : [email protected]

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