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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 KIT

Manufactured by Beijing Beier Bioengineering Co. Ltd., China - http://www.beierbio.com/en/ 

Device identification number
2326
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
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), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), 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
Positiv evaluiert durch das PEI: https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/evaluierung-sensitivitaet-sars-cov-2-antigentests-04-12-2020.pdf?__blob=publicationFile&v=46 https://handelshaus-lerch.de/wp-content/uploads/2021/05/COVID-19-Antigen-Schnelltestkit-Nasal-DE.pdf
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
130 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.92 % (46 / 5000 Übersetzungsergebnisse 1 false positives in 166 people tested)
False negatives
1.94 % (6 false negatives in 308 people tested)
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.5 %
Clinical Specificity
99.7 %
Type of antigen
Nucleoprotein

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