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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



BIOCREDIT COVID-19 Ag Test Nasal

Manufactured by RapiGEN Inc, South Korea - www.rapigen-inc.com/eng 

Device identification number
1963
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), P.1 (Gamma), P.2 (Zeta), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-22 05:05:13 CET
Comments
BIOCREDIT COVID-19 Ag Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasal specimen. This test is for in-vitro professional diagnostic use and intended as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to confirm COVID-19 infection. BIOCREDIT COVID-19 Ag Test Nasal has been evaluated with clinical nasal specimens which were identified with teh RT-PCR test in Korea.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
276000 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
% 0 of 400
Fn
% 10 of 128
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.2 %
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