ADDIS ABABA, Ethiopia (29 September 2020)

The African Society for Laboratory Medicine (ASLM), the Clinton Health Access Initiative, Inc. (CHAI), and the World Health Organization (WHO), through the Faith-Based Action for Scaling Up Testing and Treatment for Epidemic Response (FASTER) program supported by the US Centers for Disease Control and Prevention, Catholic Relief Services, and PEPFAR, have partnered to develop an online Diagnostic Evidence Hub where national reference laboratories, regulatory authorities, and country diagnostics stakeholders can access detailed performance data and field evaluations of new, WHO-prequalified diagnostic products.

This online evidence platform, hosted on ASLM’s website, https://aslm.org/diagnostic-hub/, seeks to increase the transparency of and improve ease of access to publicly available technical data, including peer-reviewed studies and meta-analyses, to accelerate in-country registration and adoption of new, impactful, quality-assured diagnostic products. The materials featured on the Diagnostic Evidence Hub will cover a range of disease areas, including WHO prequalified point of care (POC) products for HIV viral load and early infant diagnosis of HIV, HIV self-testing, as well as tuberculosis and malaria diagnostics. By providing national reference laboratories and country diagnostics stakeholders with easy access to key information on the technical performance of diagnostic products, the Diagnostic Evidence Hub seeks to reduce the need for individual countries to repeat similar large-scale performance evaluations, thereby accelerating in-country regulatory approval, registration, and uptake of new and innovative products.

‘The Diagnostic Evidence Hub is timely and crucial as it brings the important performance data for in-vitro diagnostic products to inform in-country registration and adoption of much needed diagnostics,’ said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention. ‘This effort aligns well with our Africa Collaborative Initiative to Advance Diagnostics launched in 2019.’

‘This site offers a rich library of data and performance studies from wide variety of settings that are often sought for by regulatory bodies and national reference laboratories in order to inform decisions for adopting innovative technologies,’ said Dr Lara Vojnov, Diagnostic Advisor at WHO. ‘This can reduce some unnecessary repeat technical evaluations that may not add much new information.’

For more information about ASLM, please visit: http://www.aslm.org.

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