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    List of Igg Elisa/Clia Kits For Covid 19 Validated by Icmr Identified Validation Centres

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    Karthik T
    The document lists IgG ELISA/CLIA kits for COVID-19 that have been validated by ICMR along with the manufacturers. It recommends the tests for serosurveys to understand population exposure and surveys in high-risk groups. The ELISA tests have been validated in labs but performance may vary in field conditions. Only listed batches have been validated and manufacturers are responsible for consistency. US-FDA approved tests can be used after DCGI approval. Contact details are provided for companies licensed for COVID Kavach IgG ELISA.

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    List of Igg Elisa/Clia Kits For Covid 19 Validated by Icmr Identified Validation Centres

    Uploaded by

    Karthik T
    77 views2 pages
    The document lists IgG ELISA/CLIA kits for COVID-19 that have been validated by ICMR along with the manufacturers. It recommends the tests for serosurveys to understand population exposure and surveys in high-risk groups. The ELISA tests have been validated in labs but performance may vary in field conditions. Only listed batches have been validated and manufacturers are responsible for consistency. US-FDA approved tests can be used after DCGI approval. Contact details are provided for companies licensed for COVID Kavach IgG ELISA.

    Original Title

    ELISA_CLIA_Kits_List_24062020

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    The document lists IgG ELISA/CLIA kits for COVID-19 that have been validated by ICMR along with the manufacturers. It recommends the tests for serosurveys to understand population exposure and surveys in high-risk groups. The ELISA tests have been validated in labs but performance may vary in field conditions. Only listed batches have been validated and manufacturers are responsible for consistency. US-FDA approved tests can be used after DCGI approval. Contact details are provided for companies licensed for COVID Kavach IgG ELISA.

    Copyright:

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

    List of Igg Elisa/Clia Kits For Covid 19 Validated by Icmr Identified Validation Centres

    Uploaded by

    Karthik T
    The document lists IgG ELISA/CLIA kits for COVID-19 that have been validated by ICMR along with the manufacturers. It recommends the tests for serosurveys to understand population exposure and surveys in high-risk groups. The ELISA tests have been validated in labs but performance may vary in field conditions. Only listed batches have been validated and manufacturers are responsible for consistency. US-FDA approved tests can be used after DCGI approval. Contact details are provided for companies licensed for COVID Kavach IgG ELISA.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Date: 24.06.

    2020

    LIST OF IgG ELISA/CLIA KITS FOR COVID 19 VALIDATED BY ICMR


    IDENTIFIED VALIDATION CENTRES

    Sl. No Name of Company Name of the Kit *Batch Number


    1. Zydus Cadila Healthcare Ltd., COVID Kavach ELISA IgG CoV2HI GG96-001
    Ahmedabad (Gujarat), India CoV2HI GG96-002
    CoV2HI GG96-003
    2. Euroimmun US Inc., USA Euroimmun Anti- SARS-COV-2 E200420AW
    ELISA IgG
    3. Calbiotech Inc., USA Erbalisa COVID-19 IgG ELISA CVG6087

    4. YHLO iFlash, China SARS-CoV-2 CLIA C86095G-20200206


    C86095G-20200210

    The IgG ELISA and CLIA tests are recommended only for the following purpose:

    i. Serosurveys to understand the proportion of population exposed to infection including


    asymptomatic individuals. Depending upon the level of seroprevalence of infection,
    matching public health interventions can be implemented for prevention and control of the
    disease.

    ii. Survey in high risk or vulnerable populations (health care workers, frontline workers,
    immunocompromised individuals, individuals in containment zones etc) to know who has
    been infected in the past and has now recovered.

    Please Note:

     The ELISA tests have been validated in the laboratory. However, the performance of the test may be
    subject to variation under field conditions.
     *Above listed ELISA tests are validated with the mentioned batch number only. Responsibility for
    batch to batch consistency lies with the manufacturer.
     IgG ELISA / CLIA tests which are US-FDA approved can be used directly after due marketing
    approval from DCGI.
     Names and contact details of the manufacturers of COVID Kavach IgG ELISA is enclosed
    for reference.

    1|Page
    ICMR has transferred COVID Kavach ELISA IgG technology to below mentioned pharma companies:
    S.No. Name of Company Contact Details
    Zydus Cadila Healthcare Ltd Vivek Kant Tripathi
    1 Zydus Corporate Park, 4th Floor, B Wing,
    Scheme No. 63, Survey No. 536,
    Near Vaishnodevi Circle, Sarkhej-Gandhinagar Highway,
    Ahmedabad-382481, Gujarat, India
    Mobile: +919717273066
    Email:[email protected]
    Meril Diagnostics Pvt. Ltd Paparaidu Sanapala
    2 Dy. General Manager(Technical Head)
    Vapi-Gujarat
    Mobile: +9195741 44456
    Email:[email protected]
    Voxtur Bio Ltd. Dr Veeraal Gandhi, Chairman
    3 Plot No. A-1, Royal Compound, Tamanman Kaman
    Bhivandi Road, Vasai, Palghar,
    Mumbai-401208
    Mobile: +91-9819720123
    Email: [email protected]
    Trivitron Healthcare Pvt. Ltd Nitin Sawant, President
    4 D -134, MIDC, Industrial Area, Shirvane,
    Opposite Dr. D YPatil University, Nerul,
    Navi Mumbai – 400706
    Mobile: +91 8291282827
    Email: [email protected]
    J.Mitra & Co. Pvt Ltd Sangeeta Gupta, Head Technical
    5 A-180, Okhla Industrial Area, Phase-1,
    New Delhi - 110020, INDIA
    Mobile:+918800192205
    Email : [email protected]
    Karwah Enterprises Pvt Ltd Dr. Vivek Varma, Head – Operations
    6 Rapid Diagnostic Group of Companies
    B-82, Industrial Area, G.T. Karnal Road,
    New Delhi – 110033
    Mobile: +91 9535998155
    Email: [email protected]
    Avecon Healthcare Pvt Ltd Rajesh Aggarwal
    7 Plot No. 338, Industrial Growth Centre
    Saha, Haryana- 133104
    Mobile: + 91 9315445391
    Email : [email protected]

    2|Page

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