JHU Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae - POCTRN
null JHU Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae
Use of a Rapid Diagnostic for Chlamydia Trachomatis and Neisseria Gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management
Report of a Randomized Clinical Trial
In emergency departments (EDs), diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeaeare challenging. We conducted a randomized clinical trial to assess rapid C trachomatis and N gonorrhoeaetesting on overtreatment and undertreatment of women evaluated for C trachomatis and N gonorrhoeae.
Women undergoing pelvic examinations and C trachomatis and N gonorrhoeae testing (n=254) were randomized to control or rapid test groups. The control group received standard-of-care C trachomatis and N gonorrhoeaenucleic acid amplification tests of endocervical specimens, with 2- to 3-day turnaround times. For the rapid test group, clinicians collected an extra endocervical swab for GeneXpert C trachomatis and N gonorrhoeae rapid testing, in addition to the standard-of-care nucleic acid amplification test swab. Rapid results were immediately provided, and all patients were treated according to providers’ clinical judgment.
In the rapid test group, 7.9% of patients had positive test results for C trachomatis; 3.9% had positive test results for N gonorrhoeae. In the control standard-of-care group, 10.2% of patients had positive nucleic acid amplification test results for C trachomatis; 5.5% had positive results for N gonorrhoeae. Undertreatment for both C trachomatis and N gonorrhoeae in the ED was 0% for the rapid test group and 43.8% for the control standard-of-care group. Clinicians overtreated 46.5% of uninfected standard-of-care control patients for C trachomatis compared with 23.1% of uninfected rapid test patients. For patients uninfected with N gonorrhoeae, clinicians overtreated 46.7% of standard-of-care control patients compared with 25.4% of rapid test patients. The length of stay did not differ significantly between groups.
Rapid C trachomatis and N gonorrhoeae testing in the ED led to a significant reduction in overtreatment for women without infections compared with the standard-of-care control group. Additionally, in the rapid test group there was significant improvement in appropriate treatment for patients with infections.
RADx: Rapid Acceleration of Diagnostics
In response to the COVID-19 pandemic, the Rapid Acceleration of Diagnostics (RADx®) initiative was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.