Chembio Diagnostics receives WHO Prequalification approval for HIV self-test
Chembio Diagnostics announced its SURE CHECK HIV Self-Test has received World Health Organization Prequalification approval. The WHO Prequalification of In Vitro Diagnostics is a comprehensive assessment of individual IVDs through a standardized process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review. It signifies that the product meets global standards of quality, safety and performance, and is used by United Nations and other procurement agencies such as PEPFAR, UNITAID, and the Global Fund to make purchasing decisions. The SURE CHECK HIV Self-Test provides unparalleled ease of use -- using the world's smallest blood sample required by any rapid HIV test -- and provides results in 15 minutes. The unique design of the SURE CHECK HIV Self-Test integrates the capillary device and buffer solution, eliminating the need for separate collection devices and buffer solution bottles required by other HIV self-tests. The SURE CHECK HIV Self-Test, which detects antibodies to HIV 1 and HIV 2, demonstrated sensitivity of 99.4% and specificity of 100%, when comparing untrained HIV self-test users to trained professionals. The essential element of Chembio's newly WHO Prequalified HIV Self-Test is the company's SURE CHECK HIV 1/2 Assay that is FDA approved, CLIA waived, CE marked, WHO Prequalified, and trusted by health care professionals across the globe. Chembio's SURE CHECK HIV 1/2 Assay was also incorporated into two CE marked private label versions of HIV self-tests that both commenced European commercialization in 2015. In 2016, the WHO published global HIV self-testing guidelines, recommending that HIV self-testing be offered as an additional approach to HIV testing services. Chembio's SURE CHECK HIV Self-Test was evaluated by the HIV Self-Testing Africa Initiative that is funded by UNITAID, with the goal of accelerating self-test adoption by addressing market, regulatory and policy barriers. SURE CHECK HIV Self-Test was found to have superior acceptability and performance, facilitating widespread adoption.