VIASURE Mycoplasma Genitalium with Macrolide Resistance Assay for BD MAX™ System is an automated qPCR test designed for the qualitative detection of DNA from Mycoplasma genitalium and specific point mutations (conferred by base substitutions in 23S rRNA) implicated in macrolide resistance in vaginal swabs and male and female urine specimens from patients suspected of M. genitalium infection by their healthcare professional (HCP).

This test is intended to be used as an aid in the diagnosis of infection with M. genitalium and the detection of potential resistance to macrolides 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’ NA 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 M. genitalium and mutations at the 23S rRNA gene associated to macrolide resistance.

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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