The study evaluated the effectiveness of Affirm assay – the only Food and Drug Administration (FDA) approved diagnostic test for identifying pathogens associated with bacterial vaginitis, compared with new a test known as the Aptima assay.
The study evaluated 766 women, and the results showed that the Affirm assay produced both false positive and false negative results.
The Aptima assay, however, detected 36% more TV-infected women, and yielded a sensitivity of 100% with no false positives.
The Aptima assay uses a special type of amplification for the detection of TV.
The clinical trials of Aptima assay were recently completed and it has been submitted to the FDA for approval.