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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

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

Device identification number
1962
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal 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
2022-06-07 09:13:42 CET
Comments
BIOCREDIT COVID-19 Ag is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in human nasopharynx. 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 has been evaluated with clinical nasopharyngeal specimens which were identified with the RT-PCR test in Korea and Romania.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Quantitative
Time
10 minutes
Subclass
Membrane-based
LOD
562 PFU/mL
LOD
5.62*10^2 PFU/ml
Crossreactivity
Evaluated
Fp
0 % 0 of 100 - Korea
Fp
0 % 0 of 124 - Romania
Fn
9.72 % (7 of 72 - Korea)
Fn
1.86 % (2 of 107 - Romania)
Precision
Evaluated
Precision
Evaluated
Accuracy
95.93 % (Korea)
Accuracy
99.13 % (Romania)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.1 % (Romania)
Clinical Sensitivity
90.2 % (Korea)
Clinical Specificity
100 % (Romania)
Clinical Specificity
100 % (Korea)
Type of antigen
Nucleocapsid protein
Notes
The epitope of two antibodies used for BIOCREDIT COVID-19 Ag is the NDT region(44- 175aa) of SARS-CoV-2 nucleocapsid.

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