Alere Inc, Waltham, Mass, a leading maker of rapid diagnostic tests, has received IVD CE marking in Europe for the Alere q HIV-1/2 Detect assay, the first molecular diagnostic at the point of care (POC) that identifies HIV-1 and HIV-2 in less than 60 minutes.
Molecular testing of HIV nucleic acids is required for acute detection as well as accurate Early Infant Diagnosis (EID). Current antibody POC tests cannot discriminate between a mother's and infant's antibodies to detect if a newborn has become infected with HIV.
"The Alere q will allow us to immediately initiate anti-retroviral therapy in HIV-positive infants, and reduce morbidity and mortality in this vulnerable population," says Landon Myer, MD, PhD, professor, School of Public Health and Family Medicine, University of Cape Town. "This robust platform can be easily transported to even the most remote primary care clinic, whether on the back of a motorcycle, car or truck, making this point of care technology uniquely well suited to applications in the field."
The platform was designed and engineered to operate in diverse and challenging environments and is battery-powered. The fully automated analyzer and cartridge system completely eliminates the complexity of molecular diagnostics for the operator. Since sample manipulation between extraction, isolation, amplification, and detection is not required, it eliminates processing errors and contamination concerns.
It 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 test 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 all in under 60 minutes. This ensures the broadest coverage of subgroups and recombinant circulating forms (CRF's) of any commercially available molecular diagnostic assay. The technology is also being investigated for potential applications for the diagnosis and monitoring of other infectious diseases, such as hepatitis C, tuberculosis, and Ebola.
According to UNAIDS, almost 90% of HIV-infected children currently live in sub-Saharan Africa, and an estimated 90% of infections in children are acquired through mother-to-child transmission (MTCT) of HIV. The World Health Organization (WHO) recommends that all HIV-exposed infants have HIV viral load testing at 4 to 6 weeks of age or at the earliest opportunity thereafter, and that antiretroviral therapy be initiated in infants diagnosed with HIV infection.
The Alere q HIV-1/2 Detect assay is currently pending WHO pre-qualification.
[Source: Alere Inc]