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BZ IsoMDx™ TB/NTM kit

Home PRODUCT BZ IsoMDx™ TB/NTM kit

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