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Three liquid level errors and two extraction control failures were generated. Four resolved as negative and were included in
the sensitivity and specificity calculation. One liquid level error failed to resolve and was not included in the sensitivity and
specificity calculation.
Table 9: CT Q
x
Assay Performance Compared to Patient Infected Status (by clinical site)
Specimen
Clinical
Type
Site
Prevalence
1
16.1%
2
11.0%
3
12.3%
FS
8
4
18.1%
5
10.0%
6
8.5%
7
10.0%
1
16.1%
2
11.0%
3
12.3%
FV
9
4
18.1%
5
10.0%
6
8.5%
7
10.0%
1
16.1%
2
11.0%
3
12.3%
FNU
10
4
18.3%
5
10.0%
6
8.5%
7
10.0%
1
16.1%
2
11.0%
3
12.3%
11
FUPT
4
18.3%
5
10.0%
6
8.5%
7
10.0%
n
Sensitivity
95% C.I.
96.0%
155
(79.6% – 99.9%)
(24/25)
88.2%
155
(63.6% – 98.5%)
(15/17)
88.9%
73
(51.8% – 99.7%)
(8/9)
89.5%
105
(66.9% – 98.7%)
(17/19)
100.0%
70
(59.0% – 100.0%)
(7/7)
90.3%
365
(74.2% – 98.0%)
(28/31)
85.7%
70
(42.1% – 99.6%)
(6/7)
100.0%
155
(86.3% – 100.0%)
(25/25)
100.0%
155
(80.5% – 100.0%)
(17/17)
77.8%
73
(40.0% – 97.2%)
(7/9)
94.7%
105
(74.0% – 99.9%)
(18/19)
100.0%
70
(59.0% – 100.0%)
(7/7)
96.8%
365
(83.3% – 99.9%)
(30/31)
100.0%
70
(59.0% – 100.0%)
(7/7)
92.0%
155
(74.0% – 99.0%)
(23/25)
82.4%
155
(56.6% – 96.2%)
(14/17)
88.9%
73
(51.8% – 99.7%)
(8/9)
100.0%
104
(82.4% – 100.0%)
(19/19)
100.0%
70
(59.0% – 100.0%)
(7/7)
93.5%
366
(78.6% – 99.2%)
(29/31)
100.0%
70
(59.0% – 100.0%)
(7/7)
96.0%
155
(79.6% – 99.9%)
(24/25)
82.4%
155
(56.6% – 96.2%)
(14/17)
88.9%
73
(51.8% – 99.7%)
(8/9)
100.0%
104
(82.4% – 100.0%)
(19/19)
100.0%
70
(59.0% – 100.0%)
(7/7)
93.5%
366
(78.6% – 99.2%)
(29/31)
85.7%
70
(42.1% – 99.6%)
(6/7)
Specificity
96.2%
(91.3% – 98.7%)
(125/130)
98.6%
(94.9% – 99.8%)
(136/138)
100.0%
(94.4% – 100.0%)
(64/64)
100.0%
(95.8% – 100.0%)
(86/86)
96.8%
(89.0% – 99.6%)
(61/63)
98.5%
(96.5% – 99.5%)
(329/334)
98.4%
(91.5% – 100.0%)
(62/63)
97.7%
(93.4% – 99.5%)
(127/130)
99.3%
(96.0% – 100.0%)
(137/138)
100.0%
(94.4% – 100.0%)
(64/64)
100.0%
(95.8% – 100.0%)
(86/86)
96.8%
(89.0% – 99.6%)
(61/63)
100.0%
(98.9% – 100.0%)
(334/334)
98.4%
(91.5% – 100.0%)
(62/63)
97.7%
(93.4% – 99.5%)
(127/130)
100.0%
(97.4% – 100.0%)
(138/138)
100.0%
(94.4% – 100.0%)
(64/64)
97.6%
(91.8% – 99.7%)
(83/85)
100.0%
(94.3% – 100.0%)
(63/63)
100.0%
(98.9% – 100.0%)
(335/335)
100.0%
(94.3% – 100.0%)
(63/63)
97.7%
(93.4% – 99.5%)
(127/130)
99.3%
(96.0% – 100.0%)
(137/138)
100.0%
(94.4% – 100.0%)
(64/64)
100.0%
(95.8% – 100.0%)
(85/85)
100.0%
(94.3% – 100.0%)
(63/63)
99.4%
(97.9% – 99.9%)
(333/335)
98.4%
(91.5% – 100.0%)
(62/63)
15
# CT
(+)
and
95% C.I.
GC (+) PPV%
5
82.8% 99.2%
6
88.2% 98.6%
2
100.0% 98.5%
6
100.0% 97.7%
0
77.8% 100.0%
3
84.8% 99.1%
0
85.7% 98.4%
5
89.3% 100.0%
6
94.4% 100.0%
2
100.0% 97.0%
6
100.0% 98.9%
0
77.8% 100.0%
3
100.0% 99.7%
0
87.5% 100.0%
5
88.5% 98.4%
6
100.0% 97.9%
2
100.0% 98.5%
6
90.5% 100.0%
0
100.0% 100.0%
3
100.0% 99.4%
0
100.0% 100.0%
5
88.9% 99.2%
6
93.3% 97.9%
2
100.0% 98.5%
6
100.0% 100.0%
0
100.0% 100.0%
3
93.5% 99.4%
0
85.7% 98.4%
NPV%
continued
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