Datametrex AI Ltd V.DM

iONEBIO INC’s iLAMP Novel-CoV19 Detection Kit

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Datametrex AI Limited  iONEBIO INC’s iLAMP Novel-CoV19 Detection Kit 

https://static1.squarespace.com/static/5b14233145776ec728809ad5/t/5e8e4ae54955f72efb340f33/1586383590967/iONEBIO+Clinical+Investigation+Report.pdf


18. Conclusion 1) This clinical investigation is a Retrospective, Single- blind, Single- institution, Comparative Investigation with a purpose to assess clinical performance of the ‘iLAMP Novel- CoV19 Detection Kit’ in detecting nCoV- 19 from human airway specimens. (Nasopharyngeal, Oropharyngeal, Sputum) The trials and analysis have been systematically conducted at Dankook University Hospital In- Vitro Diagnostics Department under the supervision of an IVD specialist, using Biorad CFX- 96 real- time PCR Platform. 2) This clinical investigation utilized residual specimens from visiting nCoV- 19 patients of Dankook University Hospital of which RT- PCR based diagnosis has been manifested in advance. Based on test subject selection criteria, total of 60 specimens (30- Positive, 30- Negative) have been used. In order for evaluation of clinical specificity and clinical sensitivity, 60 trials have been conducted to make evident of the following conclusion. The tested ‘iLAMP Novel- CoV19 Detection Kit’ displayed excellent results in sensitivity and specificity to nCoV- 19, exceeding the pre- set objectives of target sensitivity and target specificity. 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.