DLH Researcher Co-Authors Paper Studying Performance of Rapid, Point-of-Care STI Test

DLH researcher Toni Waymer is among the authors of a new paper published in The Lancet Infectious Diseases titled “Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study.”

The timely diagnosis and treatment of sexually transmitted infections (STIs) are crucial to their control, and the medical community has long sought a point-of-care diagnostic test that could detect curable STIs such as chlamydia, gonorrhea, and trichomonas quickly. The availability of rapid tests, delivered at the point-of-care, would reduce inappropriate antibiotic use and limit the need for complex laboratory instrumentation.

In the study, the authors measured the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. Women who presented at ten clinical sites across seven US states were enrolled and provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using a provided guide. Meanwhile, patient-infected status was derived by testing clinician-collected vaginal specimens via traditional diagnostic procedures (involving laboratory instrumentation).

98.5% of enrollees had a valid result on either the first or repeat test, showing excellent sensitivity and specificity. The results are a cause for optimism, showing that this innovative and easy-to-use test could represent an important advancement in the treatment and diagnosis of treatable sexually-transmitted infections.

More information is available via The Lancet Infectious Diseases.