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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ND COVID-19 Ag Test

Manufactured by NDFOS Co. Ltd., South Korea - www.ndfos.com 

Device identification number
2678
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
POC based Immunochromatography
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Time
15 minutes
LOD
TCID50/ml 1.25x1,584.893
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
5.9 %
Precision
Evaluated
Accuracy
98.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.37 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein

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