바이오젠텍

Intended Use

BZ IsoMDx™ TB/NTM kit is an in vitro diagnostic using LAMP(Loop-mediated Isothermal Amplification) assay for qualitative detection of Mycobacterium tuberculosis (MTB) and Non-tuberculous Mycobacterium (NTM) disease from DNA extracted from human sputum

Clinical Evaluation

1) Mycobacterium Tuberculosis

		AdvanSure™ TB/NTM real-time PCR		Total
		Positive	Negative
BZ IsoMDx™ TB/NTM kit	Positive	30	0	30
	Negative	0	30	30
Total		30	30	60

Clinical sensitivity : 100% (30/30)
Clinical specificity : 100% (30/30)

2) Non-Tuberculous mycobacterium

		AdvanSure™ TB/NTM real-time PCR		Total
		Positive	Negative
BZ IsoMDx™ TB/NTM kit	Positive	30	0	30
	Negative	0	30	30
Total		30	30	60

Clinical sensitivity : 100% (30/30)
Clinical specificity : 100% (30/30)

IFU