VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX™ System is an automated qPCR test designed for the simultaneous qualitative detection of DNA from Herpes simplex virus 1 (HSV-1), Herpes simplex virus 2 (HSV-2), and Treponema pallidum (Syphilis) in anogenital and oral skin lesion swab specimens from patients suspected of HSV-1, HSV-2 and T. pallidum infection by their healthcare professional (HCP).

This test is intended to be used as an aid in the diagnosis of infection with the above-mentioned microorganism in combination with patient’s clinical signs and symptoms and/or epidemiological risk factors. Positive results are indicative of the nucleic acid (NA) target’s presence but do not preclude the presence of other pathogens not detected by the test. Negative results do not preclude the presence of the NA targets and should not be used as the sole basis for treatment, or other patient management decisions.

The assay uses the BD MAX™ System for automated extraction of DNA and subsequent qPCR employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System. DNA is extracted from samples, amplified using qPCR and detected using specific primers and fluorescent reporter dye probes for HSV-1, HSV-2 and T. pallidum.

The product is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures (including training on the Real Time PCR instrument (thermocycler) and nucleic acid extraction system).

Avaliable intructions for use:

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