FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

WHO Preapproves HIV Combo Test

Aug. 1, 2016
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Alere’s HIV combo test has received World Health Organization prequalification status.

The fourth-generation test detects both HIV-1/2 antibodies and the HIV-1 p24 antigen.

The WHO prequalification status means it will be available for public sector procurement in poorer nations. — Tamra Sami

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