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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
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
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
Commercial Status
Commercialised
Last Update
2021-06-29 01:04:21 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
Crossreactivity
Evaluated
Fp
0.92 % (46 / 5000 Übersetzungsergebnisse 1 false positives in 166 people tested)
Fn
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