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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



NowCheck COVID-19 Ag Test

Manufactured by Bionote, Inc, South Korea - bionote.co.kr 

Device identification number
1242
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
https://www.finddx.org/wp-content/uploads/2021/03/Bionote_Nasal_Ag-Public-Report_20210330-v1.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
247 TCID50/ml
Crossreactivity
Evaluated
Fp
0.57 % (3/527)
Fn
9 % (2/22)
Reproducibility
Evaluated
Clinical Sensitivity
90.91 %
Clinical Specificity
99.43 %

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