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    OraSure OraQuick HCV Rapid Antibody Test
    As of May 2026, the World Health Organization (WHO) has prequalified several hepatitis C virus (HCV) rapid test kits, with the most notable recent addition being the first-ever self-test kit. The key prequalified rapid diagnostic tests (RDTs) include the OraQuick HCV Self-Test (also for professional use) and the SD BIOLINE HCV test. 
    Key WHO Prequalified HCV Rapid Test Kits 
    • OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc.): This is the first and only WHO-prequalified self-test for HCV (as of July 2024), which can be used by lay users, notes the WHO. It was originally prequalified for professional use in 2017.
    • SD BIOLINE HCV Test (Standard Diagnostics, Inc. / SD Biosensor): A rapid diagnostic test for professional use, included on the WHO list of prequalified in vitro diagnostics.
    • Rapid Anti-HCV Test (InTec PRODUCTS, INC.): A, listed in the WHO PQDx list. 
    Significance of Prequalification 
    • Quality Assurance: Prequalification ensures these tests meet international standards for safety, quality, and performance.
    • Access: It allows low- and middle-income countries to procure high-quality tests to reach the 2030 goal of diagnosing 90% of HCV cases.
    • Self-Testing: The prequalification of the OraQuick self-test allows for stigma-free, confidential, and convenient testing in non-medical settings. 
    • WHO prequalifies the first self-test for hepatitis C virus
      Jul 10, 2024 — “The availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable ...
      World Health Organization (WHO)
    • WHO prequalification - World Hepatitis Alliance
      Manufacturer. Hepatitis C. HCV NAT. Alinity m HCV. Alinity m HCV. Hepatitis C. HCV rapid diagnostic test. STANDARD Q HCV Ab Test. ...
      World Hepatitis Alliance
    • WHO prequalifies first self-test kit for Hepatitis C virus | UN News
      Jul 10, 2024 — 10 July 2024 Health. The World Health Organization (WHO) announced on Wednesday that it has prequalified the first self-test for t...
      UN News
    • WHO Approves First Self-Test for Hepatitis C - JAMA Network
      Aug 9, 2024 — In July, the World Health Organization (WHO) prequalified the first hepatitis C virus (HCV) self-test. The product, called OraQuic...
      JAMA
    • First hepatitis C self-test prequalified by WHO
      Jul 15, 2024 — Access deeper industry intelligence. The OraQuick HCV self-test is an extension of the OraQuick HCV Rapid Antibody Test, which WHO...
      Clinical Trials Arena
    • Rapid Anti HCV Test (PQDx 0371- ...
      May 12, 2025 — Rapid Anti‐HCV Test with product codes ITPW01152‐TC40, ITPW01152‐TC25, and ITPW01153‐TC40, manufactured by InTec PRODUCTS, INC, Re...
      World Health Organization (WHO)
    • WHO Prequalifies First Self-Test for Hepatitis C Virus
      Jul 12, 2024 — hello and welcome to Medical dialogues I'm anaka Mishra let's look at rtop. Health. news W pre-qualifies for self test for hepatit...
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      YouTube·Medical Dialogues
    • WHO list of Prequalified In Vitro Diagnostic Products
      Apr 28, 2026 — Table_title: WHO list of Prequalified In Vitro Diagnostic Products Table_content: header: | Product name | Product Code | Manufact...
      World Health Organization (WHO)
    • WHO prequalifies the first self-test for hepatitis C virus
      Jul 10, 2024 — “The availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable ...
      World Health Organization (WHO)
    • WHO prequalification - World Hepatitis Alliance
      Manufacturer. Hepatitis C. HCV NAT. Alinity m HCV. Alinity m HCV. Hepatitis C. HCV rapid diagnostic test. STANDARD Q HCV Ab Test. ...
      World Hepatitis Alliance
    • WHO prequalifies first self-test kit for Hepatitis C virus | UN News
      Jul 10, 2024 — 10 July 2024 Health. The World Health Organization (WHO) announced on Wednesday that it has prequalified the first self-test for t...
      UN News
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    WHO prequalifies the first self-test for hepatitis C virus


    World Health Organization (WHO)
    https://www.who.int › News › item
    World Health Organization (WHO)
    https://www.who.int › News › item
    Jul 10, 2024 — The product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick® HCV Rapid ...Read more
    WHO pre-qualified HCV rapid test kits from www.who.int

    WHO prequalification


    World Hepatitis Alliance
    https://www.worldhepatitisalliance.org › 2020/04
    World Hepatitis Alliance
    https://www.worldhepatitisalliance.org › 2020/04
    PDF
    There are currently no HBV DNA tests which have been pre-qualified. However, a number of polyvalent laboratory-based platforms (which can test for multiple ...Read more

    WHO prequalifies first self-test kit for Hepatitis C virus | UN News


    UN News
    https://news.un.org › story › 2024/07
    UN News
    https://news.un.org › story › 2024/07
    Jul 10, 2024 — The World Health Organization (WHO) announced on Wednesday that it has prequalified the first self-test for the hepatitis C virus (HCV).Read more

    WHO Approves First Self-Test for Hepatitis C


    JAMA
    https://jamanetwork.com › JAMA
    JAMA
    https://jamanetwork.com › JAMA
    by S Anderer · 2024 — The World Health Organization (WHO) prequalified the first hepatitis C virus (HCV) self-test. The product, called OraQuick HCV self-test, is an extension of ...Read more
    Missing: pre- ‎qualified

    WHO list of Prequalified In Vitro Diagnostic Products


    World Health Organization (WHO)
    https://extranet.who.int › prequal › in-vitro-diagnostics
    World Health Organization (WHO)
    https://extranet.who.int › prequal › in-vitro-diagnostics
    WHO list of Prequalified In Vitro Diagnostic Products ; Accupower HIV-1 Quantitative RT-PCR. HIV-1111 (ROW version). 0454-140-00 ; ADVANCED QUALITY HIV Self-Test ...Read more

    WHO prequalifies 1st home test for hepatitis C


    Liver Disease News
    https://liverdiseasenews.com › news › who-prequalifies-1...
    Liver Disease News
    https://liverdiseasenews.com › news › who-prequalifies-1...
    Jul 18, 2024 — The World Health Organization prequalified the first self-test kit to detect the hepatitis C virus (HCV) in a home setting.

    WHO list of prequalified in vitro diagnostic products


    Asia Actual
    https://asiaactual.com › uploads › 2019/10 › 190...
    Asia Actual
    https://asiaactual.com › uploads › 2019/10 › 190...
    PDF
    Rapid Anti-HCV Test. ITPW01152-TC40;. ITPW01152-TC25; and. ITPW01153-TC40. RoW ... Test Kit. 1001-0270; 001-0274. CE-mark. OraSure Technologies,. Inc ...Read more

    Wholesale WHO Pre-qualified HCV Rapid Test Kits ...


    InTec PRODUCTS, INC.
    https://www.intecasi.com › who-pre-qualified-hcv-rapid-...
    InTec PRODUCTS, INC.
    https://www.intecasi.com › who-pre-qualified-hcv-rapid-...
    Lateral flow Anti-HCV rapid test kits. Rapid Anti-HCV Test. WHO Pre-qualified. CE-marked. Sensitivity: 99.7%. Specificity: 99.8%.Read more
    WHO pre-qualified HCV rapid test kits from www.intecasi.com

    Rapid Infectious Disease Products


    OraSure Technologies
    https://orasure.com › products-and-services
    OraSure Technologies
    https://orasure.com › products-and-services
    OraSure's first-to-market, innovative products include rapid tests for the detection of HIV, Hepatitis C (HCV) , Ebola, influenza, as well adherence testing ...
    WHO pre-qualified HCV rapid test kits from orasure.com

    First hepatitis C self-test prequalified by WHO


    Clinical Trials Arena
    https://www.clinicaltrialsarena.com › analyst-comment
    Clinical Trials Arena
    https://www.clinicaltrialsarena.com › analyst-comment
    Jul 15, 2024 — The OraQuick HCV self-test is an extension of the OraQuick HCV Rapid Antibody Test, which WHO prequalified for professional use in 2017. This ...Read more
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