Assay Change – BD Affirm™ VPIII Vaginosis

Effective Monday, July 22nd, Women’s Health Laboratories will begin converting our molecular testing approach for the detection of Vagionosis. We will be transitioning from the previous Access Genetics PCR based assay to the FDA-approved Becton Dickenson (BD) Affirm™ VPIII Microbial Identification System. The BD Affirm™ VPIII Assay identifies three vaginitis pathogens/pathogen groups (Candida sp, Gardnerella vaginalis, and Trichomonas vaginalis) using a single swab. The BD Affirm™ VPIII Microbial Identification Test is a DNA test that uses DNA probes that bind to the DNA of the target organisms, providing conclusive molecular evidence of the presence of the pathogen in the sample tested. The testing method has been FDA approved for over 15 years for the testing of vaginal fluid specimens from patients with clinical symptoms of vaginitis/vaginosis. Testing may be ordered for all three pathogens in one panel, or as separate tests for each individual pathogen. Results are typically available within 24 hours of receipt of the specimen at Women’s Health Laboratories.

Assay Change – illumigene® Group B Strep

Effective Tuesday, August 13th, Women’s Health Laboratories will begin converting our molecular testing approach for the detection of Group B Streptococcus. We will be transitioning from the previous Access Genetics PCR based assay to the FDA-approved illumigene® Group B Streptococcus (GBS). The illumigene® assay uses a combined bacterial culture/nucleic acid amplification approach for the detection of GBS colonization in pregnant women. This approach is the testing approach recommended by the Centers for Disease Control as well as several professional organizations. Following culture for 18-24 hours, the illumigene® GBS Assay uses loop-mediated isothermal nucleic acid amplification technology, specifically targeting the Streptococcus agalactiae genome.

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