SARS-CoV-2 and Influenza Viruses A/B Rapid Test Cassette For self-testing use only
Manufactured by Beijing Applied Biological Technologies Co. Ltd., China - https://www.x-abt.com/
Device identification number
3167
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Endemic human coronavirus (HKU1,OC43,NL63,229E), Adenovirus (2,4,5,7,55), Enterovirus (A,B,C,D), Measles virus, Human cytomegalovirus, Rotavirus, Norovirus, Chlamydia pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Candida albicans SARS), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Pathogens detected
Influenza A, Influenza B, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Chemiluminescence
LOD
200 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.01 %
False negatives
18.18 %
Precision
Evaluated
Accuracy
96.43 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
81.82 %
Clinical Specificity
99.99 %
Type of antigen
Nucleocapside 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