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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test

Manufactured by Beijing North Institute of Biotechnology Co. Ltd.

Device identification number
3009
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Beta Coronavirus HKU1 (HCoV-HKU1)
Information on antigen epitope targeted by the antibodies used in the design of the device
clone1 binding site:INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab.
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
150 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.98 AU
False negatives
2.19 AU
Precision
Evaluated
Accuracy
97.67 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.74 %
Clinical Specificity
99.33 %
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