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As of early 2026, the World Health Organization (WHO) has prequalified several HIV rapid diagnostic tests (RDTs) and self-tests, ensuring they meet global standards for quality, safety, and performance. Key, recently added, and widely used products include Abbott’s Determine HIV-1/2 and Determine HIV Early Detect (4th gen), OraQuick HIV Self-Test, and various rapid tests from manufacturers like SD Biosensor, Mylan, and InTec. 
Key WHO Prequalified HIV Rapid Tests & Self-Tests 
  • Abbott (Determine™):
    • Determine™ HIV-1/2 Ag/Ab Combo: A 4th generation RDT detecting both HIV-1/2 antibodies and the p24 antigen.
    • Determine™ HIV Early Detect: A 4th generation rapid test allowing for early detection of infection.
  • OraSure Technologies:
    • OraQuick ADVANCE™ HIV-1/2 Rapid Antibody Test: Uses oral fluid, fingerstick/venous blood, or plasma.
    • OraQuick HIV Self-Test: A widely used oral-based self-test.
  • InTec Products, Inc.:
    • ADVANCED QUALITY HIV Self-Test: Pre-qualified for self-testing (PQDx #0372-017-01).
  • Mylan / Atomo Diagnostics:
    • Mylan HIV Self Test: A fingerstick-based, all-in-one, rapid self-test.
  • Other Notable Mentions:
    • ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device: Covers multiple subtypes.
    • Urine-based Tests: In April 2025, WHO prequalified the first HIV-1 self-test using urine specimens.
    • Dual Tests: The Determine™ Antenatal Care Panel, which bundles tests for HIV, syphilis, and hepatitis B (HBV). 
Recent Developments 
  • 4th Generation Focus: WHO highlights 4th generation tests, such as Determine HIV Early Detect, for their ability to identify both acute and chronic infections.
  • Regional Manufacturing: In late 2024, WHO prequalified an HIV rapid test packaged in Africa to increase access.
  • Cost-Saving Initiatives: WHO encourages countries to use low-cost, prequalified HIV RDTs, especially as the first test in national algorithms. 
For a full, up-to-date list of all prequalified products, visit the WHO List of Prequalified In Vitro Diagnostics. 
  • 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 triple diagnostic test for HIV ...
    Jul 15, 2025 — WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination...
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  • WHO Prequalification Of InTec HIV Self-Test – Now PQ Listed And ...
    Aug 7, 2025 — We are pleased to annouce that the InTec ADVANCED QUALITY HIV Self-Test has officially received WHO Prequalification on 4 August 2...
    InTec PRODUCTS, INC.
Show all
  • 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: Low-cost, quality-assured HIV tests to sustain access to ...
    May 7, 2025 — HIV testing is an essential health service and is the critical gateway to both prevention and treatment. With several countries fa...
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  • WHO approves packaging and shipping of a prequalified HIV rapid ...
    Dec 12, 2024 — “An estimated 630 000 people die from HIV-related causes, and 1.3 million people acquire HIV annually, the majority of which are i...
    World Health Organization (WHO)
  • WHO prequalifies the first triple diagnostic test for HIV ...
    Jul 15, 2025 — WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination...
    World Health Organization (WHO)
  • WHO Prequalification Of InTec HIV Self-Test – Now PQ Listed And ...
    Aug 7, 2025 — We are pleased to annouce that the InTec ADVANCED QUALITY HIV Self-Test has officially received WHO Prequalification on 4 August 2...
    InTec PRODUCTS, INC.
  • Determine HIV Early Detect | Abbott Point of Care
    FAST4WARD ACUTE HIV DETECTION. Determine™ HIV Early Detect is the first and only WHO pre-qualified 4th generation rapid diagnostic...
    Abbott Point of Care
  • WHO prequalified the first HIV-1 self-test by Urine | WHO
    May 7, 2025 — Latest News * 16 - 18 June, 2026. * 7 May, 2026 - 00:12 (CEST) Active Pharmaceutical Ingredient (API) Prequalified. * 5 May, 2026 ...
    World Health Organization (WHO)
  • Advanced Quality HIV Self_Test_PQDx ...
    The ADVANCED QUALITY HIV Self-Test with product code ITPW02155-TC1, manufactured by InTec Products, Inc., Rest-of-World regulatory...
    World Health Organization (WHO)
  • HIV Self Test Receives WHO Prequalification Approval
    Jul 8, 2019 — Prequalification tells global funders and Ministries of Health that the product meets global standards of quality, safety, and per...
    Pharmacy Times
  • WHO prequalifies 2 additional HIV RDTs, including the first ...
    Apr 30, 2025 — Team Lead at World Health Organization… Published Apr 30, 2025. WHO prequalified two additional HIV rapid tests, including the ver...
    LinkedIn·Irena Prat
  • Rapid Infectious Disease Products - OraSure Technologies
    Infectious Disease Testing. OraSure Technologies is a global leader in infectious disease diagnostics, and our unique infectious d...
    OraSure Technologies, Inc.
  • A step-by-step guide to the OraQuick HIV self-test
    Jan 26, 2022 — did you know that you can test for HIV with a quick swab of the gums oraqu provides results in just 20 minutes from the comfort of...
    1m
    YouTube·Science Animated
This is for informational purposes only. For medical advice or diagnosis, consult a professional. AI responses may include mistakes. Learn more
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Web results

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 ; ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/ Serum /Plasma). IHI- ...Read more

WHO prequalifies the first triple diagnostic test for HIV ...


World Health Organization (WHO)
https://www.who.int › News › item
World Health Organization (WHO)
https://www.who.int › News › item
Jul 15, 2025 — On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) ...Read more
WHO pre-qualified HIV rapid tests from www.who.int
Missing: pre- ‎| Show results with: pre-
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Web results

WHO: Low-cost, quality-assured HIV tests to sustain access ...


European AIDS Treatment Group
https://www.eatg.org › hiv-news › who-low-cost-qualit...
European AIDS Treatment Group
https://www.eatg.org › hiv-news › who-low-cost-qualit...
May 7, 2025 — WHO encourages countries to adopt low-cost WHO pre-qualified HIV rapid tests as the first test in their testing strategy and update their national algorithms ...Read more

Determine HIV Early Detect


Abbott Point of Care
https://www.globalpointofcare.abbott › Home › Products
Abbott Point of Care
https://www.globalpointofcare.abbott › Home › Products
FAST4WARD ACUTE HIV DETECTION. Determine™ HIV Early Detect is the first and only WHO pre-qualified 4th generation rapid diagnostic test (RDT).Read more
WHO pre-qualified HIV rapid tests from www.globalpointofcare.abbott

Wholesale WHO Pre-qualified HIV Rapid Tests,WHO ...


InTec PRODUCTS, INC.
https://www.intecasi.com › who-pre-qualified-hiv-rapid-t...
InTec PRODUCTS, INC.
https://www.intecasi.com › who-pre-qualified-hiv-rapid-t...
InTec PRODUCTS,INC. is professional WHO pre-qualified HIV rapid tests manufacturer and exporter. Our Products is committed to provide reliable and high ...
WHO pre-qualified HIV rapid tests from www.intecasi.com

WHO prequalifies 2 additional HIV RDTs, including the first ...


LinkedIn · Irena Prat
170+ reactions · 1 year ago
LinkedIn · Irena Prat
170+ reactions · 1 year ago
WHO prequalified two additional HIV rapid tests, including the very first HIV-1 self-test intended to be used on urine specimens.
Missing: pre- ‎qualified

List of HIV Diagnostic test kits and equipments classified ...


theglobalfund.org
https://www.theglobalfund.org › media › psm_pro...
theglobalfund.org
https://www.theglobalfund.org › media › psm_pro...
PDF
It includes products recommended for use after technical evaluation by WHO Prequalification of Diagnostics. Programme, Regulatory Authoritities of GHTF f0unding ...Read more
Missing: pre- ‎| Show results with: pre-

Wondfo's HIV Self-Test is Pre-Qualified by WHO


Wondfo
https://en.wondfo.com › news › index134
Wondfo
https://en.wondfo.com › news › index134
Wondfo HIV Self-Test is pre-qualified by the World Health Organization (WHO), which marks a milestone for Wondfo to help improving accessibility.Read more

Rapid Infectious Disease Products


OraSure Technologies, Inc.
https://orasure.com › products-and-services
OraSure Technologies, Inc.
https://orasure.com › products-and-services
The OraQuick™ HIV Self-Test is the first and only oral fluid rapid over‑the‑counter (OTC) HIV test approved in the U.S. It can detect antibodies to both HIV‑1 ...Read more

HIV Self Test Receives WHO Prequalification Approval


Pharmacy Times
https://www.pharmacytimes.com › Clinical › HIV
Pharmacy Times
https://www.pharmacytimes.com › Clinical › HIV
The Mylan HIV Self Test detects the presence or absence of HIV type 1 and type 2 antibodies through a fingerstick using the built-in safety lancet. It uses 1/5 ...Read more
Missing: pre- ‎qualified
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