COVID-19 Antigen Rapid Test
Manufactured by Guangzhou Weimi Bio-Tech Co., Ltd., China - https://www.weimibio.cn/
Device identification number
3459
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cartridge, Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), SARS-CoV
Pathogens detected
Other (None)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), Other (BA1.1.1, BA.1, BA.2, B1.617.2)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
250 TCID50/ml
Analytical Sensitivity
100 %
Analytical Specificity
100 %
False positives
0 %
False negatives
4.59 %
Accuracy
99.02 %
Clinical Sensitivity
95.41 %
Clinical Specificity
100 %
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