TABLE 2.

Clinical performance compared with PIS by gender, sample type, and symptom status

Sample type	Total	Sensitivity % (no. of true positives detected by cobas MG/total no. of true positives)	95% CI	Specificity % (no. of true negative samples identified/total no. of true negatives)	95% CI	Prevalence (%)	PPV (%)	NPV (%)
Female participants
Urine
Symptomatic	636	85.0 (34/40)	70.9–92.9	96.0 (572/596)	94.1–97.3	6.3	58.6	99.0
Asymptomatic	463	89.5 (17/19)	68.6–97.1	98.4 (437/444)	96.8–99.2	4.1	70.8	99.5
Overall	1,099	86.4 (51/59)	75.5–93.0	97.0 (1,009/1,040)	95.8–97.9	5.4	62.2	99.2
Vaginal swab (both clinician and self-collected)
Symptomatic	639	97.5 (39/40)	87.1–99.6	96.3 (577/599)	94.5–97.6	6.3	63.9	99.8
Asymptomatic	462	94.7 (18/19)	75.4–99.1	98.0 (434/443)	96.2–98.9	4.1	66.7	99.8
Overall	1,101	96.6 (57/59)	88.5–99.1	97.0 (1,011/1,042)	95.8–97.9	5.4	64.8	99.8
PreservCyt samples
Symptomatic	638	80.0 (32/40)	65.2–89.5	97.8 (585/598)	96.3–98.7	6.3	71.1	98.7
Asymptomatic	460	94.7 (18/19)	75.4–99.1	99.8 (440/441)	98.7–100	4.1	94.7	99.8
Overall	1,098	84.7 (50/59)	73.5–91.8	98.7 (1,025/1,039)	97.8–99.2	5.4	78.1	99.1
Endocervical swab
Symptomatic	637	85.0 (34/40)	70.9–92.9	97.7 (583/597)	96.1–98.6	6.3	70.8	99.0
Asymptomatic	462	78.9 (15/19)	56.7–91.5	99.3 (440/443)	98.0–99.8	4.1	83.3	99.1
Overall	1,099	83.1 (49/59)	71.5–90.5	98.4 (1,023/1,040)	97.4–99.0	5.4	74.2	99.0
Male participants
Urine
Symptomatic	343	100 (31/31)	89.0–100	96.8 (302/312)	94.2–98.2	9.0	75.6	100
Asymptomatic	702	100 (29/29)	88.3–100	97.9 (659/673)	96.5–98.8	4.1	67.4	100
Overall	1,045	100 (60/60)	94.0–100	97.6 (961/985)	96.4–98.4	5.7	71.4	100
Meatal swab (both clinician- and self-collected)
Symptomatic	343	90.3 (28/31)	75.1–96.7	96.5 (301/312)	93.8–98.0	9.0	71.8	99.0
Asymptomatic	695	79.3 (23/29)	61.6–90.2	98.5 (656/666)	97.3–99.2	4.2	69.7	99.1
Overall	1,038	85 (51/60)	73.9–91.9	97.9 (957/978)	96.7–98.6	5.8	70.8	99.1