TABLE 5.

Test Performance of Visby Medical Sexual Health Test by Organism in an Evaluation of a Rapid Point-of-Care Molecular Test for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis From Self-Collected Vaginal Swabs

	Organism	Click Device Result	Patient Infected Status Designation			Sensitivity (95% CI*)	Specificity (95% CI*)	Overall Accuracy (95% CI*)
			Positive	Negative	Total
			n	n	n
Symptomatic and asymptomatic combined	CT (n = 1457)	Positive	122	22	144	97.6 (93.2–99.2)	98.3 (97.5–98.9)	98.3 (97.5–98.8)
		Negative	3	1310	1313
		Total	125	1332	1457
	NG (n = 1468)	Positive	37	8	45	97.4 (86.5–99.5)	99.4 (98.8–99.7)	99.2 (95.5–99.9)
		Negative	1	1422	1423
		Total	38	1430	1468
	TV (n = 1449)	Positive	121	41	162	99.4 (98.9–99.7)	96.9 (95.8–97.7)	97.1 (96.1–97.8)
		Negative	1	1286	1287
		Total	122	1327	1449

*As determined by patient-infected status designation. The denominator for estimates is based on subjects in the evaluable population for the specified organism (n).

95% CI indicates 95% Wilson confidence interval.

Table adapted from Ref. 49s.