FDA approves Johns Hopkins’ new molecular test for vaginitis

22 June 2017 (Last Updated June 22nd, 2017 18:30)

The US Food and Drug Administration (FDA) has approved a new molecular test developed by researchers at the US Johns Hopkins University’s School of Medicine to diagnose vaginitis.

The US Food and Drug Administration (FDA) has approved a new molecular test developed by researchers at the US Johns Hopkins University’s School of Medicine to diagnose vaginitis.

Following a clinical study, the researchers reported that the diagnostic test can accurately differentiate the three common causes of the inflammatory condition of the vagina, compared to standard laboratory tests.

Based on the presence of the genetic footprints of bacteria, yeast and sexually transmitted protozoa called Trichomonas vaginalis, the test employs a real-time polymerase chain reaction (PCR) to increase the amounts of specific DNA sequences from the patient samples.

The test then delivers the result as positive or negative depending on the presence of the amount of DNA to indicate infection.

During the study, PCR was used to amplify and test for the DNA of trichomonas, six species of bacteria, and six types of yeast from vaginal swabs of 1,740 symptomatic women with itching and burning.

"Following a clinical study, the researchers reported that the diagnostic test can accurately differentiate the three common causes of the inflammatory condition."

From each subject, the researchers procured four vaginal swabs, of which two were used in traditional lab testing, one for the new molecular test and one for a separate comparative genetic method to validate the results.

To carry out the molecular test, the researchers prepped and added the samples to a cartridge with PCR reagents, and inserted the cartridge into Becton Dickinson Diagnostics’ (BD) real-time PCR platform called MAX System.

When compared to the standard test, the new method was found to be faster but expensive.

The molecular test is also designed to determine the precise treatment course by testing separately for two species of yeast called Candida glabrata and krusei, which are resistant to certain antifungal treatments.

Licensed to BD, the accuracy of the test will be further evaluated and marketed under the BD MAX Vaginal Panel.