Alere, a global leader in rapid diagnostics, today announced that its Alere™ q HIV-1/2 Detect assay has been awarded World Health Organization (WHO) prequalification, making it available for public sector procurement.
The Alere q HIV-1/2 Detect is the first-ever molecular diagnostic that identifies HIV-1 and HIV-2 at the point of care (POC) in less than 60 minutes, and the first testing application on the Alere q platform.
The Alere q is a portable molecular diagnostic platform designed for use at the point of care. The WHO prequalification is for the Alere q instrument and its first application, the Alere q HIV-1/2 Detect cartridge.
The Alere q HIV-1/2 Detect assay has the ability to detect and differentiate between HIV-1 and HIV-2 using just 25 µl of whole blood or plasma. An immediate and urgent application for this test is Early Infant Diagnosis (EID).
Diagnosing HIV in infants via molecular, as opposed to antibody testing, is critical because babies born to HIV-positive mothers have the mother’s protective antibodies in their blood, and current POC antibody tests are not able to discriminate between a mother’s and an infant’s antibodies to detect if a newborn is infected with HIV.
With WHO prequalification, the Alere q HIV-1/2 Detect can be actively deployed by global health organizations in developing countries. The test will be used by health workers to identify infants born with HIV infection, and link them to antiretroviral therapy (ART).
"Children with HIV are significantly – and tragically – less likely to receive ART compared to adults1, and traditional methods of EID do not address this gap because they don’t allow for immediate linkage to care," said Avi Pelossof, Alere Global President of Infectious Disease.
"Now, countries with the highest burden of HIV infection will have broader access to the Alere q HIV-1/2 Detect, which delivers lab-accurate results in 52 minutes. This will empower health workers to diagnose HIV while the mother and newborn are present, and immediately initiate ART if needed – giving these children a fighting chance to survive and thrive."
"Currently, most newborns in developing countries are screened for HIV infection via dry blood spot testing, but because health workers have to wait 3 to 6 weeks for results many potentially HIV-positive infants are lost to follow-up and remain untreated," said Landon Myer, M.D., Ph.D., Associate Professor, School of Public Health and Family Medicine, University of Cape Town.
"Now that point-of-care molecular EID can be implemented as part of national guidelines, health workers have a powerful tool to help meet WHO goals for timely viral HIV screening of newborns."
Alere q uses a multiplexed real-time polymerase chain reaction (PCR) methodology that allows amplification and detection of more than one target at the same time. In the case of the Alere q HIV-1/2 Detect, the assay can identify and distinguish between HIV-1 subgroup (M/N), HIV-1 subgroup (O) and HIV-2 and incorporates a series of onboard controls with every sample run in 52 minutes.
This ensures the broadest coverage of subgroups and recombinant circulating forms of any commercially available molecular diagnostic assay. The Alere q was designed and engineered to operate in diverse and challenging environments and can be battery-powered.
The clinical evidence for Alere q HIV-1/2 Detect assay in EID was demonstrated in a 2014 study published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). Results showed that five clinics in Mozambique used the assay, with high sensitivity and specificity, to diagnose HIV in infants, expediting the initiation of ART.2
Prior to WHO prequalification, the Alere q instrument was IVD CE marked (self-certified) on August 1, 2014 and the Alere q HIV-1/2 Detect assay received IVD CE certification on February 12, 2015.