Self‐obtained vaginal swabs are not inferior to provider‐performed endocervical sampling for emergency department diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis

Abstract

Objective Provider‐performed endocervical sampling (PPES) in the diagnosis of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) may be difficult to perform in a busy emergency department (ED) due to patient preference, availability of the pelvic examination room, or provider availability. Our objective was to assess if self‐obtained vaginal swabs (SOVS) were noninferior to PPES in the ED diagnosis of NG/CT using a rapid nucleic acid amplification test (NAAT). Methods We conducted a prospective observational cohort study in a single ED. Participants were adult female English‐ and Spanish‐speaking patients in whom the ED provider felt that NG/CT testing was warranted. Each patient had SOVS and PPES performed. For SOVS, a research associate reviewed a one‐page handout describing the procedure but gave no other assistance. Patients answered survey questions regarding acceptability of SOVS and symptomatology. We established a minimum sensitivity of 90% for SOVS to be considered clinically noninferior to standard PPES. Results A total of 533 patients completed enrollment and answered survey questions, 515 of whom had laboratory results for both SOVS and PPES. There were 86 patients with a positive result: 29 with NG, 47 with CT, and 10 with coinfection. SOVS had a sensitivity of 95% (95% confidence interval = 88% to 99%) for the detection of NG/CT when compared to PPES. SOVS were felt to be an acceptable collection method in 93% of patients and 75% preferred SOVS to PPES. Conclusion SOVS are noninferior to PPES in NG/CT diagnosis using a rapid NAAT in ED patients and surveys indicate high patient acceptability.

Self-sampling strategies (with/without digital innovations) in populations at risk ofChlamydia trachomatisandNeisseria gonorrhoeae: a systematic review and meta-analyses

“…Eighty per cent of studies (36 of 45) detected newly diagnosed positive CT/GC infections and 42.2% of studies (19 of 45) measured test accuracy 16 17 20 22–55. Seventeen studies reported 2×2 table values 22 28 30–33 35 36 38–43 51–53. We excluded four studies where reference test was unclear/not reported 22 31–33…”

“…Seventeen studies reported 2×2 table values 22 28 30–33 35 36 38–43 51–53. We excluded four studies where reference test was unclear/not reported 22 31–33…”

“…We generated pooled diagnostic accuracy values (table 2) and SROC curves (figure 3) by sampling site and study population for CT/GC from 13 studies 28 30 32 35 38–43 51…”

Vaginal Swabs Are Non-inferior to Endocervical Swabs for Sexually Transmitted Infection testing in the Emergency Department

“…There have been limited studies assessing the utility of patient-administered vaginal swabs for STI testing in the ED; however, some studies have shown comparable or even higher sensitivities from using intravaginal swabs compared to endocervical swabs. 6,7,9 Allowing an asymptomatic patient to collect her own vaginal swab for STI testing limits the demands on resources and personnel in the ED, since a traditional pelvic exam can be time and resource intensive. Performing a pelvic exam often requires moving the patient to a pelvic exam room, cleaning an additional room, finding a chaperone for the patient, and adding time to the clinician's workload.…”

“…8 One small previous study demonstrated that patient self-collected vaginal swabs were not inferior for detecting C. trachomatis and N. gonorrhoeae in a single ED. 9 The use of vaginal swabs for STI testing in the ED provides an option for a patient-collected sample in appropriate situations. This can reduce the need for the more invasive procedure of a pelvic exam, saving time and resources, and perhaps promoting patient autonomy and reducing patient stress.…”