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This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test employs semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 positive for BV, and samples with a score of 2 indeterminate for BV. Detect the presence of Candida albicans and Candida glabrata DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. Diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections. Detect and type active HSV shedding.
This test is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections with active viral shedding; it also differentiates HSV-1 from HSV-2. Negative HSV NAA results indicate lack of viral shedding but do not confirm absence of previous infection.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
