Medical Diagnostic Laboratories LLC (MDL) is a CLIA certified infectious disease laboratory that specializes in high-complexity, state-of-the-art, automated DNA-based molecular analyses. By using molecular techniques, MDL is able to provide clinicians from many different specialties valuable tailored diagnostic information to assist in the detection, diagnosis, evaluation, and treatment of viral, fungal, and bacterial infections.

The Femeris Women’s Health Research Center within MDL was established to translate women’s health research into diagnostic tests, the metronidazole resistance reflex assay for Trichomonas vaginalis is currently only commercially available through MDL. This companion assay will be performed at no additional charge when Trichomonas vaginalis is detected in a patient’s specimen. This new assay will provide another tool for clinicians to make appropriate decisions pertaining to treatment regimens to achieve an effective cure. This diagnostic assay is currently patent-pending before the US Patent and Trademark Office.

Trichomonas vaginalis, a flagellated protozoan parasite, is the most common non-viral sexually transmitted pathogen with more than seven million cases of trichomoniasis each year in the US. Trichomonas vaginitis is associated with a number of serious clinical complications in pregnant women, such as an increased risk for pre-term labor and delivery of low-birth-weight neonates, as well as an overall association with HIV transmission. Patients are normally treated with a single oral dose of metronidazole, an antibiotic used to treat infections caused by anaerobic bacteria and parasites. Although generally effective, some T. vaginalis strains are resistant to metronidazole. If metronidazole treatment fails, the only other approved treatment is the related drug tinidazole. Therefore, identifying T. vaginalis resistance to metronidazole can help guide clinicians in prescribing an effective therapy for their Trichomonas vaginitis patients at the time of diagnosis.

Although metronidazole treatment is reported to be 85%-95% effective, recent reports suggest that between 2.5% and 10% of clinical T. vaginalis isolates exhibit some degree of metronidazole resistance. Currently, very few facilities, such as the Centers for Disease Control and Prevention (CDC), can determine metronidazole susceptibility for T. vaginalis. A viable culture of T. vaginalis must be obtained using a specialized collection and transport device.

MDL can now detect metronidazole resistance in a subset of T. vaginalis positive specimens by Real-Time PCR. Their new assay detects a T. vaginalis gene mutation highly associated with metronidazole resistance with a 91% positive predictive value (PPV). This test was developed using 100 well characterized T. vaginalis isolates from the CDC.

Source: Medical Diagnostic Laboratories LLC