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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Rapid SARS-CoV-2 Antigen Test Card

Manufactured by Xiamen Boson Biotech Co. Ltd, China - http://www.bosonbio.com/ 

Device identification number
1278
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, 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.1.616 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), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-05-02 04:42:31 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
130 TCID50/ml
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
97.83 % (Nasal swab)
Accuracy
98.59 % (Nasopharyngeal swab)
Accuracy
97.84 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.19 % (Nasal swab)
Clinical Sensitivity
96.08 % (Nasopharyngeal swab)
Clinical Sensitivity
96.23 % (Oropharyngeal swab)
Clinical Specificity
99.2 % (Nasal swab)
Clinical Specificity
99.14 % (Nasopharyngeal swab)
Clinical Specificity
99.2 % (Oropharyngeal swab)
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