The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
The firm said net product revenues fell 11 percent year over year in the fourth quarter.
Researchers showed that the test had equivalent results to a lab-based assay and has the potential for a faster turnaround time.
The test is a lateral flow, in vitro qualitative immunoassay that detects human antibodies to HIV virus type 1 and type 2 in whole blood.
The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.
Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.
In Q3, Chembio closed the acquisition of OpTricon, a privately held developer and manufacturer of hand-held analyzers for rapid diagnostic tests.
The company said its molecular collection systems products saw the highest revenue growth during the quarter as product revenues rose 6 percent overall.
The Vitros HIV Combo test is a fourth-generation test that detects HIV-1 and HV-2 antibodies, and the p24 antigen, resulting in earlier detections of the disease.