바이오젠텍

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