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BZ IsoMDx COVID-19 kit

Home PRODUCT BZ IsoMDx COVID-19 kit

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