COVID-19 Antigen Rapid Test Kit
Manufactured by Beijing Beier Bioengineering Co. Ltd., China - https://www.beierbio.com
Device identification number
2769
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, MERS-CoV, Other (Legionella pneumophila, Streptococcus pneumoniae, Streptococcus pyogenes), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
AA95-175
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-12-12 04:45:26 CET
Comments
This product was evaluated and approved by Paul-Ehrlich-Institute in Germany and Centralne Laboratorium Kliniczne Uniwersyteckie Centrurn Kliniczne, Poland
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
130 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4 %
False negatives
4 %
Precision
Evaluated
Accuracy
98.59 % (95% CI 97.23% to 99.39%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.36 % (95% CI 90.95% to 99%)
Clinical Specificity
96.36 % (95% CI 97.77% to 99.76%)
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