The Alere q HIV-1/2 Detect assay has received European regulatory approval—known as IVD CE marking. The point-of-care test is portable, battery-operated and simple to use. Unlike current point-of-care HIV tests, the Alere q can determine whether HIV antibodies found in a newborn belong to the infant or the mother, since it detects actual HIV nucleic acids as opposed to just antibodies. It can produce results in under an hour.

“The Alere q will allow us to immediately initiate antiretroviral therapy in HIV-positive infants, and reduce morbidity and mortality in this vulnerable population,” Landon Myer, MD, PhD, a professor in the School of Public Health and Family Medicine at the University of Cape Town, South Africa, said in a press release. “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 approval was based on a 2012 study that found the Alere q had a 98.5 percent rate of correctly identifying HIV-positive cases and a 99.9 percent rate of correctly identifying HIV-negative cases.

The test can distinguish between HIV-1 subgroup M/N and subgroup O, as well as HIV-1 and HIV-2.

Alere q’s technology is being investigated for use in identifying other infectious diseases, including hepatitis C, tuberculosis and Ebola.

To read the press release, click here.