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Breaking Ground: WHO Prequalifies First Hepatitis C Self-Test

 Breaking Ground: WHO Prequalifies First Hepatitis C Self-Test

The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, a significant step in expanding access to testing and diagnosis and accelerating global efforts to eliminate hepatitis C. Here are the key details:

Product Details:

The self-test is called OraQuick HCV self-test and is manufactured by OraSure Technologies.

  1. It is an extension of the pre-qualified OraQuick® HCV Rapid Antibody Test, initially prequalified by WHO in 2017 for professional use.
  2. The self-test version is specifically designed for use by lay users, providing a single kit with all necessary components for self-testing.

Recommendation and Impact:

WHO recommended HCV self-testing (HCVST) in 2021 to complement existing HCV testing services in countries.

  • Implementation projects, supported by Unitaid, have shown high acceptability and feasibility, empowering people through personal choice and access to stigma-free self-care services.

Global Goal:

Only 36% of the 50 million people living with hepatitis C had been diagnosed by the end of 2022.

The addition of this self-test to the WHO prequalification list aims to expand HCV testing and treatment services, contributing to the global goal of HCV elimination.

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