Intended Use
BZ QPCR COVID-19 kit is an in vitro diagnostic medical device for qualitative detection of coronavirus disease (COVID-19) from RNA extracted from human nasopharyngeal swab, oropharyngeal swab and sputum using real-time RT-PCR (Reverse transcription-Polymerase Chain Reaction).
Clinical Evaluation
|
Comparator #1 |
Total |
Positive |
Negative |
BZ QPCR COVID-19 kit |
Positive |
2 |
0 |
2 |
Negative |
0 |
5 |
5 |
Total |
2 |
5 |
7 |
Clinical sensitivity : 100% (2/2)
Clinical specificity : 100% (5/5)
Positive % agreement : 100.00% (95% CI : 15.81 to 100.00%)
Negative % agreement : 100.00% (95% CI : 47.82 to 100.00%)
|
Comparator #2 |
Total |
Positive |
Negative |
BZ QPCR COVID-19 kit |
Positive |
32 |
0 |
32 |
Negative |
1 |
30 |
31 |
Total |
33 |
30 |
63 |
Clinical sensitivity : 96.97 (32/33)
Clinical specificity : 100% (30/30)
Positive % agreement : 96.97% (95% CI : 84.24 to 99.92%)
Negative % agreement : 100.00% (95% CI : 88.43 to 100.00%)
IFU