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concerning true and false positive organism results subtracted. The exact binomial two-sided 95%
confidence interval was calculated for each point estimate.
A total of 698 results were available for analysis*. Overall Clinical Sensitivity or PPA could be
calculated from 475 results. The overall Clinical Specificity or NPA was calculated from 190 full
negative samples. In total 462 true positive and 204 true negative DiagCORE Respiratory Panel 2
results were found, as well as 13 false negative and 17 false positive results.
Table 1. DiagCORE Respiratory Panel 2 Clinical Sensitivity and Specificity or Positive Percent
Agreement and Clinical specificity or Negative Percent Agreement, with 95% Confidence
Intervals
Overall
Viruses
Adenovirus
Bocavirus
Coronavirus 229E
Coronavirus HKU1
Coronavirus OC43
Coronavirus NL63
Human
Rhinovirus/Enterovirus
Human
Metapneumovirus
Influenza A H3N2
Influenza A H1N1
Influenza A H1-2009
strain (pandemic)
Influenza B
Parainfluenza Virus 1
(PIV 1)
Parainfluenza Virus 2
(PIV 2)
Parainfluenza Virus 3
(PIV 3)
Parainfluenza Virus 4
(PIV 4)
Respiratory Syncytial
Virus
DiagCORE Respiratory Panel 2
TP/
Sensitivity
/PPA
TP+FN
95.4%-
462/475
97.30%
98.4%
85.8%-
35/38
97.20%
99.5%
51.0%-
4/4
100.00%
100.0%
37.6%-
4/5
80.00%
96.4%
67.6%-
8/8
100.00%
100.0%
72.2%-
10/10
100.00%
100.0%
74.2%-
22/24
91.70%
97.7%
86.1%-
56/59
94.9%
98.3%
85.1%-
22/22
100.00%
100.0%
90.4%-
36/36
100.00%
100.0%
88.3%-
29/29
100.00%
100.0%
64.5%-
11/12
91.70%
98.5%
90.6%-
55/56
98.20%
99.7%
83.2%-
19/19
100.00%
100.0%
43.8%-
3/3
100.00%
100.0%
70.1%-
9/9
100.00%
100.0%
43.6%-
5/6
83.30%
97.0%
91.8%-
100/103
97.10%
99.0%
TN/
Specificity
95% CI
TN+FP
187/190
98.40%
659/662
99.50%
693/694
99.90%
693/693
100.00%
690/690
100.00%
688/688
100.00%
674/674
100.00%
629/639
98.40%
676/676
100.00%
662/662
100.00%
669/669
100.00%
688/688
100.00%
642/642
100.00%
696/696
100.00%
695/695
100.00%
689/689
100.00%
691/692
99.90%
595/595
100.00%
DiagCORE Respiratory Panel 2 Instructions for Use
95% CI
/NPA
95.5%-
99.5%
98.7%-
99.,8%
99.2%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
97.1%-
99.1%
99.4%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
99.4%-
100.0%
99.5%-
100.0%
99.5%-
100.0%
99.4%-
100,0%
99.2%-
100.0%
99,4%-
100.0%
47
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