The first diagnostic prequalified through this new procedure is called m-PIMA HIV-1/2 VL and is produced by Alere Technologies GmbH. It is an in vitro test designed to monitor the response to antiretroviral treatment in HIV-infected individuals, by quantifying HIV nucleic acid in blood plasma specimens.
The product was prequalified by WHO on 8 April 2019.
Public report
Prequalified product list
The alternative evaluation pathway allows manufacturers to opt for the evaluation to be done at a laboratory selected by the manufacturer from a list of Prequalification Evaluating Laboratories.
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