Essential medicines and health products

First in vitro diagnostic prequalified through the alternative performance evaluation mechanism

For the first time, WHO has just prequalified an HIV diagnostic test through the independent performance evaluation mechanism. The mechanism was introduced to streamline assessment timelines in order to make health products more readily available and enables WHO to verify aspects of a diagnostic that are considered essential for use in resource-limited settings.

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.

WHO assesses in vitro diagnostic tests for priority conditions according to quality, safety and performance requirements. WHO prequalification outcomes provide an independent technical assessment to other United Nations (UN) agencies as well as to WHO Member States and other interested organizations, to guide their procurement of IVDs.

For more information on the alternative performance evaluation mechanism,
please visit