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  • Covid-19 Home Testing Using Rapid Antigen Tests (Rats)

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    Ramkumar Sundaram
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    The document provides information on COVID-19 home testing kits that have been validated by the Indian Council of Medical Research (ICMR). Six rapid antigen home/self-test kits are listed that were found to meet ICMR's criteria of having a sensitivity of 50% or more and a specificity of 95% or more. The document provides the name of the company, kit, lot number, test sample, and links to instructions and demonstration videos for each validated kit. It also lists two additional rapid antigen home test kits that were validated but not approved by ICMR.

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    COVID_Home_Test_Kit_05082021

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    The document provides information on COVID-19 home testing kits that have been validated by the Indian Council of Medical Research (ICMR). Six rapid antigen home/self-test kits are listed that were found to meet ICMR's criteria of having a sensitivity of 50% or more and a specificity of 95% or more. The document provides the name of the company, kit, lot number, test sample, and links to instructions and demonstration videos for each validated kit. It also lists two additional rapid antigen home test kits that were validated but not approved by ICMR.

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    © All Rights Reserved
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    14 views2 pages

    Covid-19 Home Testing Using Rapid Antigen Tests (Rats)

    Uploaded by

    Ramkumar Sundaram
    The document provides information on COVID-19 home testing kits that have been validated by the Indian Council of Medical Research (ICMR). Six rapid antigen home/self-test kits are listed that were found to meet ICMR's criteria of having a sensitivity of 50% or more and a specificity of 95% or more. The document provides the name of the company, kit, lot number, test sample, and links to instructions and demonstration videos for each validated kit. It also lists two additional rapid antigen home test kits that were validated but not approved by ICMR.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    भारतीय आयर्ु विज्ञान अनसु ध

    ं ान पररषद
    स्वास््य अनुसध
    ं ान र्वभाग, स्वास््य और पररवार
    कल्याण मंत्रालय, भारत सरकार
    Indian Council of Medical Research
    Department of Health Research, Ministry of Health
    and Family Welfare, Government of India

    Date:05.08.2021
    COVID-19 Home Testing using Rapid Antigen Tests (RATs)
    Please Note:
     Acceptance criteria:
     For already approved RAT kits with alternate sample:
    Concordance between already approved RAT and home/self test: 95% and above
     For new RAT kits as home/self test:
    Sensitivity: 50% and above; Specificity: 95% and above
     Below listed kits have been validated with the mentioned batch number only. Responsibility for batch to batch consistency
    does not lie with ICMR.
     US-FDA approved Antigen based COVID-19 Home/Self tests are exempted from ICMR validation.

    Till date, 6 Rapid Ag based Home / Self Test Kits have been validated and the following
    are found to be satisfactory

    S. No Name of company Name of the kit Lot no. / Test Guidance Documents
    Batch no. Sample
    1. Mylab Discovery CoviSelfTM AG00003-A- Nasal swab A. Link For IFU in English and
    Solutions Ltd., Pune (PathoCatch) COV 0421001E Hindi - http://coviself.com/ifu/
    (Maharashtra), India ID-19 OTC AG00003-A- B. Video Link for
    Antigen LF device 0421002E demonstration video along with
    illustrated Video In English and
    AG00003-A-
    Hindi http://coviself.com/video/
    0421003E
    2. Abbott Rapid PanBio COVID- 41ADF315A Nasal swab Link for IFU, Hindi | English
    Diagnostics 19 Antigen Rapid 41ADF316A Link for Demonstration Video
    Division, Chicago Test Device 41ADF317A
    (Alere Medical Pvt.
    Ltd., Gurugram)
    3. Meril Diagnostics CoviFind MRDLF13022 Nasal swab A. Link For IFU
    Pvt. Ltd., Vapi COVID-19 Rapid 1 https://www.merillife.com/
    (Gujarat), India Ag Self Test assets/pdfs/medical-
    devices/Covifind-IFU.pdf
    B. Video link for
    demonstration
    https://youtu.be/dA_A0cZ_
    _4M

    1|Page
    भारतीय आयर्ु विज्ञान अनसु ध
    ं ान पररषद
    स्वास््य अनुसध
    ं ान र्वभाग, स्वास््य और पररवार
    कल्याण मंत्रालय, भारत सरकार
    Indian Council of Medical Research
    Department of Health Research, Ministry of Health
    and Family Welfare, Government of India

    Annexure I

    Rapid Ag based Home / Self Test Kits kits validated, NOT approved by ICMR

    S. No Name of Company Name of Kit India/ Other Name of the supplier


    countries
    1. Trivitron Healthcare MyCoviTest Self Test India Trivitron Healthcare Pvt. Ltd.
    Pvt. Ltd. Kit
    2. Oscar Medicare Pvt. OSKIT Corona Ag India Oscar Medicare Pvt. Ltd.
    Ltd., Delhi Home Test
    3. Oscar Medicare Pvt. OSKIT Corona Ag India Oscar Medicare Pvt. Ltd.
    Ltd., Haridwar Home Test
    (Uttarakhand)

    2|Page

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