(P103) EVALUATION OF A POINT-OF-CARE PCR STI TESTING DEVICE AMONG YOUNG WOMEN IN SOUTH AFRICA

Background:
Globally, adolescent girls and young women (AGYW) experience a significant burden of sexually transmitted infections (STIs) and STI-associated sequelae; however, in many settings, syndromic management remains the standard of care. As part of ARISE, a prospective cohort study evaluating STI testing and expedited partner therapy among symptomatic and asymptomatic cisgender women in Johannesburg, South Africa, we evaluated the performance characteristics of a single-use point-of-care (POC) PCR test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV).

Methods:
From March to November 2023, we collected vaginal swabs, provider-collected or self-collected, for POC PCR testing (Visby Medical™ Sexual Health Test) from a subset of ARISE participants at enrollment and quarterly follow-up visits, in addition to provider-collected endocervical swabs for per-protocol STI testing with GeneXpert (Cepheid). We assessed validity and reliability by calculating sensitivity, specificity, and concordance-Cohen’s kappa, between the POC PCR test and GeneXpert (as the gold standard) for CT, GC, and TV, overall and stratified by vaginal swab collection method.

Results:
A total of 216 vaginal swabs were analyzed, of which 97 were provider-collected and 119 were self-collected. The overall sensitivity, specificity, and kappa for the POC PCR test were CT: 95.2%, 90.2%, 0.81; GC: 100%, 97.5%, 0.86; and TV: 100%, 86.9%, 0.41. Performance characteristics for provider-collected swabs (CT: 96.7%, 100% 0.98; GC: 100%, 100%, 1.0; TV: 100%; 97.6%, 0.85) and self-collected swabs (CT: 93.9%, 82.6%; 0.68; GC: 100%, 95.4%, 0.78; TV: 100%, 77.6%, 0.21) were generally similar, with slightly lower sensitivity and kappa for self-collected swabs.

Conclusion:
Sensitivity and specificity of this single-use POC PCR test were high, with similar sensitivity between self-collected and provider-collected samples. Greater access to POC STI testing platforms is urgently needed to facilitate STI testing among symptomatic and asymptomatic individuals, treat STIs, and prevent STI-associated sequelae among AGYW.