US-based medical device company Ortho Clinical Diagnostics (Ortho) has secured the CE mark approval for its VITROS HIV Combo Test to detect HIV-1 acute infection.
The VITROS HIV Combo test kit is the company's fourth generation assay which can detect both HIV-1 and HIV-2 antibodies, as well as the p24 antigen facilitating an early detection of HIV-1 acute infection.
Ortho CEO Robert Yates said: "Ortho is committed to expanding its assay menu and is investing in a pipeline that significantly improves laboratory outcomes for our customers.
"With the launch of the VITROS HIV Combo, test laboratories can provide earlier detection of HIV for the benefit of their patients.
"Additionally, performing this test on VITROS Systems provides the utmost confidence in results."
According to an estimation done by the World Health Organisation (WHO), 37 million people across the world are infected with the HIV virus which has necessitated the start of an antiretroviral treatment immediately after diagnosis to avoid AIDS-related deaths and new infections.
The test is based on the company's patented technologies such as the Intellicheck Technology featuring a suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology.
Comparative studies evaluating the technical and clinical performance of the HIV Combo Test have confirmed its sensitivity and specificity in its function.
The assay sensitivity was tested on the seroconversion panels in which the VITROS HIV Combo has done an early detection of acute HIV infection in five of 34 seroconversion panels.