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