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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



1copy™ COVID-19 MDx Kit Professional

Manufactured by 1drop Inc, South Korea - www.1drop.co.kr/ 

Device identification number
2921
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Targets
nucleocapsid protein, spike protein,
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), P.1 (Gamma), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The 1copy™ COVID-19 MDx Kit Professional is an In vitro diagnostic medical device intended to diagnose COVID-19 infection by detecting S gene and N gene of SARS-CoV-2 via loop-mediated isothermal amplification (LAMP) in upper respiratory specimens, nasopharyngeal swabs, collected from patients suspected of COVID-19. 1POT™ Professional device, used with 1copy™ COVID-19 MDx Kit Professional, is an in-vitro diagnostic system intended for the qualitative detection of nucleic acids via loop-mediated isothermal amplification (LAMP) from SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of COVID-19.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
LAMP
Measurement
Qualitative
Time
20 minutes
LOD
100 cpr
Clinical Sensitivity
93.3 %
Clinical Specificity
99.5 %

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements