Increasing Access To Sexually Transmitted Infection Testing: The Promise of Point-of-Care and Over-the-Counter Tests

Rapid, simple, inexpensive tests that can be used to detect sexually transmitted infections (STI) in symptomatic patients and for asymptomatic screening, especially in women, is a global critical unmet need in all income settings. We sought to review the STI diagnostic unmet need and current landscape of diagnostic tests that are either approved or in development.

Diagnostic certainty will be required to decrease the global burden of STI's particularly in low-resource settings where empiric algorithmic care predominates. Lateral flow assays for syphilis and HIV have been successfully used in low- and middle-income countries. Although the performance of reference lab nucleic acid amplification tests is excellent for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis, such tests remain expensive and globally unavailable due to lack of existing clinical lab infrastructure. Importantly, diagnostic innovations from the COVID-19 pandemic are being leveraged for developing molecular STI point-of-care tests and over-the-counter (OTC) self-tests. In the US and other high-income countries, point-of-care testing of both symptomatic and asymptomatic people would allow for a definitive STI diagnosis, appropriate treatment within a clinical encounter, and decreased antibiotic overuse, a significant global public health problem. Most exciting is the possibility for rapid, high performance self-tests. Inexpensive and rapid STI self-test could significantly increase access to STI care and help decrease health inequity.