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    • Anti-HCV Rapid Kit...

    Anti-HCV Rapid Kit Sensitivity criteria reviewed

    Written by Ruby Khatun Khatun Published On 2017-07-22T09:15:26+05:30  |  Updated On 22 July 2017 9:15 AM IST
    Anti-HCV Rapid Kit Sensitivity criteria reviewed

    Drugs Controller General (India), Directorate General of Health Services had revised specification /criteria of acceptance for quality test for Anti-HCV (Rapid Kit) vide Office Order of even no. dated 13 Jun. 2017. According to the order, the Technical Experts Committee had reviewed the criteria for acceptance and has recommended the following criteria of acceptance of sensitivity and specificity for the said kits:






































    AnalyteEL1SA I CLIA / ELFA / ECLIA / CMIA / MEIA etc.Rapid Kit
    SensitivitySpecificitySensitivitySpecificity
    Anti-HIV-1/2 and / or HIV-1 p24Ag100%≥98%100%≥98%
    HBsAg100%≥98%100%≥98%
    Anti-HCV100%≥98%99%≥98%

    Drugs Controller General (India), has now issued a corrigendum regarding revised specification / criteria of of Sensitivity of Rapid Anti-HCV diagnostic kit and which is as follows. The new criteria

    In place of: Anti-HCV (Rapid Kit) —Sensitivity- 99%

    Read as: Anti-HCV (Rapid Kit) —Sensitivity- ≥99%

    The acceptance criteria for the other immunodiagnostic kits will remain same according to the fresh notice.

    Attached below are relevant notifications concerning the issue.

    http://www.cdsco.nic.in/writereaddata/Corrigendum%20For%20Acceptance%20Criteria.pdf

    http://www.cdsco.nic.in/writereaddata/OFFICE%20ORDER%20for%20revised%20specification.pdf
    Anti HCVAnti HIV 1criteriadiagnostic kitDirectorate General of Health ServicesDrugs Controller General of IndiaHbsAgRapid KitSensitivitySpecificity

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    Ruby Khatun Khatun
    Ruby Khatun Khatun
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