Clinical Investigation Report- iLAMP Novel- CoV19 Detection I am not a subject matter expert but I found this interesting report published by
Dankook University Hospital https://static1.squarespace.com/static/5b14233145776ec728809ad5/t/5e8e4ae54955f72efb340f33/1586383590967/iONEBIO+Clinical+Investigation+Report.pdf
A few interesting comments on pages 3
Through fast & accurate diagnosis of the 2019- nCoV, the tested iONEBIO RT- LAMP PCR kit allows appropriate prescription of antiviral agents to patients, reduces unnecessary usage of antiviral agents and hospitalization period, while enabling efficient and early- stage quarantining of patients to prevent the spread of the virus.
Conclusion on page 13
3) This medical device has satisfied the evaluation standard as a 20- minute rapid
in- vitro diagnostic system for Coronavirus 2019 N- gene qualitative detection utilizing the Real- time RT- LAMP PCR method. This medical device displayed enhanced accuracy and speed compared to the conventional Real- time PCR method. Through this clinical investigation, the effectiveness of this medical device has been proven in terms of clinical sensitivity and clinical specificity, designating as a completely developed product adequate for sales or exportation to suffice the demands for early- stage nCoV- 19 detection.