US-based diagnostic tests provider Alere has received IVD CE mark approval for Alere q HIV-1/2 Detect assay, a molecular diagnostic at the point of care (POC) that identifies HIV-1 and HIV-2 in less than 60 minutes.
Alere infectious disease global president Avi Pelossof said: "In the absence of HIV testing and timely initiation of ART, one third of infants living with HIV die before their first birthday and half die before the age of two years.
"Before the development of the Alere q technology, early infant testing could only be performed in centralized labs with long lead times, delaying results and the initiation of critical treatment for children."
The Alere q has been developed to operate in diverse and challenging environments and uses a multiplexed real-time polymerase chain reaction (PCR) methodology for amplification and detection of more than one target at the same time.
According to Alere, the test can identify and distinguish between HIV 1 subgroup (M/N), HIV 1 subgroup (O) and HIV 2 and integrates a series of onboard controls with every sample run all in under 60 minutes.
This capability of the test allows in the broadest coverage of subgroups and recombinant circulating forms (CRF’s) of any commercially available molecular diagnostic assay. The assay is currently pending WHO pre-qualification, according to Alere.
Image: Alere receives IVD CE mark for Alere q HIV-1/2 Detect assay for molecular diagnosis of HIV at the POC. Photo: courtesy of PRNewswire/ Alere Inc.