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WHO prequalifies first self-test for Hepatitis C Virus

by Haruna Gimba
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By Muhammad Amaan

The World Health Organisation (WHO) has prequalified the first Hepatitis C Virus (HCV) self-test which can provide critical support in expanding access to testing and diagnosis.

The organisation said in a statement on Wednesday that it would accelerate global efforts to eliminate hepatitis C.

It stated that “the product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick® HCV Rapid Antibody Test initially prequalified by WHO in 2017 for professional use.

“The self-test version, specifically designed for use by lay users, provides individuals with a single kit containing the components that are needed to perform the self-test.”

The organisation noted that it recommended HCV Self-Testing (HCVST) in 2021 to complement existing HCV testing services in countries.

According to the global body, the recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.

The statement quoted Dr Meg Doherty, the WHO Director, Department of Global HIV, Hepatitis and STI Programmes, as saying “every day 3500 lives are lost to viral hepatitis.”

Doherty also said that of the 50 million people living with hepatitis C, only 36 per cent had been diagnosed, and 20 per cent on curative treatment by the end of 2022.

“The addition of this product to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services, ensuring more people receive the diagnoses and treatment they need, and ultimately contributing to the global goal of HCV elimination,” the director said.

According to her, WHO’s Prequalification (PQ) programme for In-Vitro Diagnostics (IVDs) evaluates a range of tests, including those used for the detection of antibodies to HCV.

Doherty said that the programme assesses IVDs against quality, safety and performance standards, noting that it is a cornerstone in supporting countries achieve high-quality diagnosis and treatment monitoring.

Dr Rogério Gaspar, the WHO Director, Department of Regulation and Prequalification, said that the availability of a WHO prequalified HCV self-test enables low- and middle-income countries have access to safe and affordable self-testing options.

Gaspar said it is essential to achieving the goal of 90 per cent of all people with HCV to be diagnosed.

“This achievement contributes to improving access to quality-assured health products for more people living in low-income countries,” he added.

He reiterated WHO’s commitment to continue to assess additional HCV self-tests, support evidence-based implementation and work with communities to expand available options to all countries.

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