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Table 8: CT Q
x
Assay Performance Compared to Patient Infected Status (by specimen type and symptomatic status)
Specimen
Symptomatic
Type
Status
FS
A
S
Total
FV
A
S
Total
FNU
A
S
Total
FUPT
A
S
Total
MS
A
S
Total
MNU
A
S
Total
MUPT
A
S
Total
Total
Note: For female subjects, infections localized to the endocervix or urethra have been reported in the literature
(16-20). Analyses were performed on the endocervical swab specimens and female UPT and neat urine specimens to
further characterize the ten negative female endocervical swabs (105/115) and the eight negative female UPT and
neat urine specimens (107/115).
•
Of the 115 female subjects defined as positive by the PIS algorithm, ten had infections localized to the urethra
as indicated by the urine reference result (i.e, BD ProbeTec ET CT/AC assay and other NAAT endocervical swab
specimens were negative, BD ProbeTec ET CT/AC assay and other NAAT urine specimens were positive.) The
BD ProbeTec CT Q
x
•
Of the 115 female subjects defined as positive by the PIS algorithm, three had infections localized to the
endocervix as indicated by the endocervical reference result (i.e, BD ProbeTec ET CT/AC assay and other NAAT
urine specimens were negative, BD ProbeTec ET CT/AC assay and other NAAT endocervical swab specimens were
positive.) The BD ProbeTec CT Q
1
Ten of the 115 endocervical swab specimens that were positive by PIS were positive in the reference urine NAATs only.
2
Of the 994 female subjects enrolled in the study, one subject did not provide a vaginal swab specimen.
3
Of the 994 female subjects enrolled in the study, one neat urine specimen was excluded for noncompliant urine specimen
storage.
4
Three of 115 neat urine specimens that were positive by PIS were positive in the reference swab NAATs only.
5
Of the 994 female subjects enrolled in the study, one Q
storage.
x
6
Three of 115 Q
UPT urine specimens that were positive by PIS were positive in the reference swab NAATs only.
n
Sensitivity
93.0%
450
(53/57)
89.7%
543
(52/58)
91.3%
993
(105/115)
1
98.2%
449
(56/57)
94.8%
544
(55/58)
96.5%
2
993
(111/115)
93.0%
450
(53/57)
93.1%
543
(54/58)
93.0%
993
3
4
(107/115)
94.7%
450
(54/57)
91.4%
543
(53/58)
93.0%
993
5
6
(107/115)
88.6%
215
(31/35)
93.9%
257
(62/66)
92.1%
472
(93/101)
100.0%
215
(35/35)
97.0%
257
(64/66)
98.0%
472
(99/101)
100.0%
215
(35/35)
97.0%
257
(64/66)
98.0%
472
(99/101)
94.5%
5388
(721/763)
assay was negative for nine of the ten endocervical swab specimens from these subjects.
x
assay was negative for UPT and neat urine for these three subjects.
95% C.I.
Specificity
98.0%
(83.0% – 98.1%)
(385/393)
98.6%
(78.8% – 96.1%)
(478/485)
98.3%
(84.6% – 95.8%)
(863/878)
(90.6%
99.5%
– 100.0%)
(390/392)
99.0%
(85.6% – 98.9%)
(481/486)
99.2%
(91.3% – 99.0%)
(871/878)
100.0%
(83.0% – 98.1%)
(393/393)
99.0%
(83.3% – 98.1%)
(480/485)
99.4%
(86.8% – 96.9%)
(873/878)
99.5%
(85.4% – 98.9%)
(391/393)
99.0%
(81.0% – 97.1%)
(480/485)
99.2%
(86.8% - 96.9%)
(871/878)
98.9%
(73.3% – 96.8%)
(178/180)
97.9%
(85.2% – 98.3%)
(187/191)
98.4%
(85.0% – 96.5%)
(365/371)
(90.0%
98.9%
– 100.0%)
(178/180)
99.5%
(89.5% – 99.6%)
(190/191)
99.2%
(93.0% – 99.8%)
(368/371)
(90.0%
98.9%
– 100.0%)
(178/180)
97.4%
(89.5% – 99.6%)
(186/191)
98.1%
(93.0% – 99.8%)
(364/371)
98.9%
(92.6% – 96.0%)
(4575/4625)
x
UPT urine specimen was excluded for noncompliant urine specimen
14
95% C.I.
PPV% NPV%
(96.0% – 99.1%)
86.9
(97.0% – 99.4%)
88.1
(97.2% – 99.0%)
87.5
(98.2% – 99.9%)
96.6
(97.6% – 99.7%)
91.7
(98.4% – 99.7%)
94.1
(99.1% – 100.0%) 100.0
(97.6% – 99.7%)
91.5
(98.7% – 99.8%)
95.5
(98.2% – 99.9%)
96.4
(97.6% – 99.7%)
91.4
(98.4% – 99.7%)
93.9
(96.0% – 99.9%)
93.9
(94.7% – 99.4%)
93.9
(96.5% – 99.4%)
93.9
(96.0% – 99.9%)
94.6
98.5
(97.1% – 100.0%)
(97.7% – 99.8%)
97.1
(96.0% – 99.9%)
94.6
(94.0% – 99.1%)
92.8
(96.2% – 99.2%)
93.4
(98.6% – 99.2%)
93.5
Error
Initial/
Final
99.0
2/0
98.8
1/1
98.9
3/1
99.7
0/0
99.4
0/0
99.5
0/0
99.0
0/0
99.2
0/0
99.1
0/0
99.2
0/0
99.0
0/0
99.1
0/0
97.8
1/0
97.9
1/0
97.9
2/0
100.0
0/0
99.0
0/0
99.5
0/0
100.0
0/0
98.9
0/0
99.5
0/0
99.1
5/1
7
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