Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature.

Abstract

Point-of-care tests (POCTs) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae offer the potential for rapid diagnosis and treatment, improving patient outcomes and reducing disease transmission. We sought to compile evidence on the accuracy and clinical utility of molecular-based POCTs and near-POCTs for the detection of C. trachomatis and N. gonorrhoeae. We performed a systematic literature search of 5 electronic databases from January 2009 to January 2024 to understand the performance characteristics and implementation considerations associated with Food and Drug Administration-cleared POCTs and near-POCTs. Results were described in a narrative format. From 3743 identified studies, 64 met our inclusion criteria. As of 2025, there are 4 Food and Drug Administration-cleared POCTs/near-POCTs for detecting C. trachomatis and N. gonorrhoeae, 3 of which are waived by the Clinical Laboratory Improvement Amendments and suitable for use during a patient visit. Evidence suggests that POCTs are most beneficial in symptomatic patients within acute care settings, where they can prevent loss to follow-up and reduce the need for empiric antibiotic treatment. While some POCTs for C. trachomatis and N. gonorrhoeae have achieved regulatory clearance, challenges remain, including the need to expand specimen type clearance to include extragenital specimens, to further improve turnaround times, and to decrease cost for adoption. There is need to optimize the use of POCTs in acute care settings to manage sexually transmitted infections.