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    Diacon N: (Assayed Universal Control Serum Normal)

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    Khadhraoui Jamel
    1. The lyophilized universal control serum must be reconstituted carefully by adding exactly 5 ml of distilled water and letting it stand for 30 minutes while completely dissolving the contents by gentle swirling. 2. Each blood donation used in producing the control was tested and found non-reactive for hepatitis B, HIV, and hepatitis C. However, as infectious agents cannot be definitively excluded, the control should be handled with the same precautions as patient specimens. 3. The reconstituted control is stable for 2-8 days at 2-8°C or 14 days at -20°C in the dark for bilirubin, and stable for 2 days at 2-8°C or 30 days at

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    Diacon N: (Assayed Universal Control Serum Normal)

    Uploaded by

    Khadhraoui Jamel
    285 views1 page
    1. The lyophilized universal control serum must be reconstituted carefully by adding exactly 5 ml of distilled water and letting it stand for 30 minutes while completely dissolving the contents by gentle swirling. 2. Each blood donation used in producing the control was tested and found non-reactive for hepatitis B, HIV, and hepatitis C. However, as infectious agents cannot be definitively excluded, the control should be handled with the same precautions as patient specimens. 3. The reconstituted control is stable for 2-8 days at 2-8°C or 14 days at -20°C in the dark for bilirubin, and stable for 2 days at 2-8°C or 30 days at

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    1. The lyophilized universal control serum must be reconstituted carefully by adding exactly 5 ml of distilled water and letting it stand for 30 minutes while completely dissolving the contents by gentle swirling. 2. Each blood donation used in producing the control was tested and found non-reactive for hepatitis B, HIV, and hepatitis C. However, as infectious agents cannot be definitively excluded, the control should be handled with the same precautions as patient specimens. 3. The reconstituted control is stable for 2-8 days at 2-8°C or 14 days at -20°C in the dark for bilirubin, and stable for 2 days at 2-8°C or 30 days at

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    285 views1 page

    Diacon N: (Assayed Universal Control Serum Normal)

    Uploaded by

    Khadhraoui Jamel
    1. The lyophilized universal control serum must be reconstituted carefully by adding exactly 5 ml of distilled water and letting it stand for 30 minutes while completely dissolving the contents by gentle swirling. 2. Each blood donation used in producing the control was tested and found non-reactive for hepatitis B, HIV, and hepatitis C. However, as infectious agents cannot be definitively excluded, the control should be handled with the same precautions as patient specimens. 3. The reconstituted control is stable for 2-8 days at 2-8°C or 14 days at -20°C in the dark for bilirubin, and stable for 2 days at 2-8°C or 30 days at

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    CONTROL PREPARATION its own mean value for this control.

    WARNINGS AND PRECAUTIONS


    1. The lyophilisate is vacuum sealed, therefore the vial
    should be opened very carefully to avoid loss of Each individual blood donation used for production of
    dried material. DIACON N Control was found to be non-reactive when
    2. Add exactly 5 ml of dist. water (inaccurate tested with approved methods for HbsAg, anti-HIV 1+2
    reconstitution of the control and error in assay and anti-HCV. As there is no possibility to exclude
    Liquid Reagents – ready to use
    technique can cause erroneous results.) definitely that products derived from human blood
    3. Close the vial carefully and let the control stand for transmit infectious agents, it is recommended to handle
    Lyophilized Serum Control 30 min. the control with the same precautions used for patient
    specimens.
    4. Dissolve contents completely by swirling gently,
    avoiding the formation of foam. Do not shake!
    DIACON N CONTROL STABILITY AND STORAGE WASTE MANAGEMENT
    (Assayed Universal Control Storage: at 2 – 8°C Please refer to local legal requirements.
    Serum Normal) Stability: until date of expiration
    Stability after reconstitution:
    Single Reagent
    20–25°C 2 - 8°C -20°C
    Bilirubin (in the dark): - 2 days 14 days
    Lyophilized universal control serum for the use in GPT 2 hours 2 days 30 days
    tests for the quantitative in vitro determination of GOT 8 hours 2 days 30 days
    various analytes on photometric systems. CK-NAC, CK-MB 4 hours 7 days 30 days
    Other Analytes: 8 hours 7 days 30 days
    CLOSE IMMEDIATELY AFTER USE
    Do not use the product if there is visible evidence of
    DIA030012 1 x 5 ml DIACON N microbial growth in the vial.
    DIA030010 3 x 5 ml DIACON N Improper handling and/or storage of the control can
    DIA030011 5 x 5 ml DIACON N affect results. DIAGNOSTICA Products : Rte de Gabes Km 9 Z.I Thyna Al
    DIA030014 10x 5 ml DIACON N FREEZE ONLY ONCE! Jadida SFAX TUNISIA
    DIA030015 12 x 5 ml DIACON N Phone: 00 216 74 687 940
    LOT SPECIFIC ASSAY DATA Fax: 00 216 74 687 932
    Values and Expiry Date are LOT specific. E-mail: contact@diagnostica-products.com
    COMPOSITION Please refer to table with Lot specific assay data. Web : www.diagnostica-products.com
    COMPONENTS: ASSAY VALUES AND RANGES
    Pooled human serum
    The assay values and ranges provided for each
    Purified human and animal components
    analyte listed are derived using DIAGNOSTICA reagents
    Purified drugs
    or reagents from other manufacturers.
    Non organic components
    Stabilisers It is recommended that each laboratory establishes

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