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BZ QPCR COVID-19 kit

Home PRODUCT BZ QPCR COVID-19 kit

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