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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 - https://www.beierbio.com/ 

Device identification number
2653
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
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-10-25 05:14:33 CET
Comments
IFU: http://www.beierbio.com/en/uploadfile/2020-10-23/4976409d-2b1c-4f47-8495-07d8e83b5a40.pdf
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
130 TCID50/ml
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
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