Roche has commercially launched the cobas HIV-1/HIV-2 test for use on the automated cobas 6800/8800 Systems in countries that accept CE mark.
Designed to qualitatively detect and differentiate HIV-1 from HIV-2, the new test is expected to enable healthcare professionals to provide treatment options depending on the subtype infections.
The in-vitro nucleic acid amplification test is approved for plasma and serum to enable flexible PCR testing and its dried blood spot (DBS) collection card has also been authorised as a sample type to facilitate testing in rural areas.
The test also includes a dual target technology for the detection of HIV-1 and can be used to confirm the infection in an individual with specimens reactive for HIV-1 or HIV-2 antibodies or antigens.
Roche Molecular Diagnostics head Uwe Oberlaender said: "As the leader in HIV diagnostics, Roche is committed to providing technologies to help providers and patients improve their treatment decisions.
"The ability to more accurately differentiate subtype infection is a significant advancement in controlling and eradicating the HIV/AIDS epidemic."
The greater sensitivity of PCR technology of the test is expected to minimise the period of detection to around one week compared to the duration of two and four weeks required by existing tests.
Based on PCR technology, the fully integrated and automated cobas 6800 and cobas 8800 systems are designed for molecular testing in viral load monitoring, donor screening, women's health, and microbiology.
In addition to the new cobas HIV-1/HIV-2, the systems can accommodate various molecular assays such as cobas HCV, cobas HBV, cobas CMV, cobas HPV, cobas MPX, cobas WNV, and cobas HEV.
Image: cobas 6000-analysis module. Photo: courtesy of F Hoffmann-La Roche Ltd.