바이오젠텍

Intended Use

BZ IsoMDx COVID-19 kit is an in vitro diagnostic using RT-LAMP(Real time Reverse Transcription Loop-mediated Isothermal Amplification) assay for qualitative detection of coronavirus disease (COVID-19) from RNA extracted from human nasopharyngeal swab, oropharyngeal swab and sputum

Clinical Evaluation

		Allplex™ 2019-nCoV Assay		Total
		Positive	Negative
BZ IsoMDx COVID-19 kit	Positive	22	0	22
	Negative	0	20	20
Total		22	20	42

Clinical sensitivity : 100% (22/22)
Clinical specificity : 100% (20/20)


IFU