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