Diagnosing Bacterial Vaginosis

In 2018, Quantigen completed a multi-center study designed to develop a molecular-based diagnostic for bacterial vaginosis. With expert contributions from its various partners, including RDI (Van Nuys, CA) and Coriell Life Sciences (Philadelphia), Quantigen tested vaginal swab samples from 550 symptomatic and 50 asymptomatic patients using a panel of real-time PCR assays designed to both healthy lactobacilli and BV-associated microorganisms. The qPCR results for this microbial panel were compared to Nugent scoring for each patient, with supporting Amsel data serving to ascribe a diagnosis to Nugent "intermediates." The result was a molecular diagnostic for BV with high sensitivity and specificity (both > 90%) relative to Nugent -- one that also eliminates ambiguous intermediate calls.

Because Quantigen’s BV test uses the same vaginal swab required to test for other syndromic conditions (aerobic vaginitis, bacterial STIs, and candidiasis), physicians can choose to order a Comprehensive panel from a single specimen collection. In this way, they can receive a specific diagnosis for women with non-specific symptoms that do not clearly point to a definitive cause. Promptly initiatiating the most appropriate treatment is thereby possible within just a day or so of sample collection.

Quantigen’s recently-refined panel is manageably small, consisting of 6 pathogenic and two non-pathogenic (i.e., “healthy”) microbes:

Key collaborators:

• Coriell Life Sciences
• Thermo-Fisher Scientific
• The Research and
  Development Institute
• PrimeX Laboratories
• The clinic of Dr. Farid Yashapour
  (San Fernando, CA)