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Chembio Diagnostics HIV Self-Test Gets WHO Prequalification Approval

NEW YORK – Chembio Diagnostics said today that it has received World Health Organization approval for its Sure Check HIV Self-Test, a single-use immunochromatographic test for the detection of antibodies to HIV types 1 and 2.

Chembio said that the prequalification signifies that its product meets global standards of quality, safety, and performance, and that the United Nations and other procurement agencies such as PEPFAR (The US President's Emergency Plan for AIDS Relief), Unitaid, and the Global Fund use the designation to make purchasing decisions.

Receipt of WHO prequalification "paves the way for commercialization in a high-growth HIV testing segment," John Sperzel, Chembio’s CEO, said in a statement. "The approval of this test allows global funders and national ministries of health to confidently expand access to HIV self-testing, enabling diagnosis and treatment."

The Sure Check HIV Self-Test provides ease of use, requires a small blood sample, and returns results in 15 minutes, Chembio said. Its design integrates a capillary device and buffer solution, eliminating the need for separate collection devices and buffer solution bottles.

The firm noted that its HIV self-test has been evaluated by the HIV Self-Testing Africa Initiative (STAR), funded by Unitaid with the goal of accelerating self-test adoption by addressing market, regulatory, and policy barriers.

In a comparison of the test's usage by untrained users and trained professionals, it demonstrated sensitivity of 99.4 percent and specificity of 100 percent, the firm said.

Chembio's Sure Check HIV 1/2 Assay has been approved by the US Food and Drug Administration, and is CLIA waived, and CE marked. It has been incorporated into two CE-marked private label versions of HIV self-tests commercialized in 2015, the firm said.

The WHO recently granted prequalification status for HIV tests from other companies. In July, Mylan and Atomo Diagnostics announced that the WHO had granted prequalification approval for the Mylan HIV Self Test

In May, Abbott said it had received WHO prequalification approval for its m-Pima HIV-1/2 VL viral load diagnostic test.