A Narrative Review of Where We Are With Point-of-Care Sexually Transmitted Infection Testing in the United States

Abstract

Background: Point-of-care (POC) tests enable immediate diagnosis and targeted treatment of sexually transmitted infections (STIs), which could accelerate control of ongoing epidemics. Although older nucleic acid amplification tests have improved the accuracy of laboratory-based tests for STIs, newer POC tests can facilitate control efforts. We sought to review the performance and time to result of POC assays for STIs in the last 10 years.

Methods: The authors performed a PubMed, US National Library of Medicine, National Center for Biotechnology Information search for POC tests for STIs or sexually transmitted diseases.

Results: Diagnostic technology for POC assays for STIs has achieved high sensitivity and specificity (>90%) using recent molecular advances in the last 10 years. Three POC tests for chlamydia and gonorrhea and 2 for trichomonas have been cleared by the Food and Drug Administration and can provide rapid results during the clinical encounter. Two POC assays for syphilis are now cleared by the Food and Drug Administration. Other similar POC assays are in development. These "fast followers" have faster time to result and will extend the diagnostic armamentarium at POC.

Conclusions: New technology has improved the performance accuracy of STI POC diagnostics. Innovation in device format has resulted in accurate POC assays, which can decrease the time to result and accelerate the detection and treatment of STIs during the clinical encounter. The full implementation potential of these newer tests will depend on the ability of these tests to achieve Clinical Laboratory Improvement Amendments-waived status so they can be performed by nonlaboratorians with no previous training.