COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette（Nasal Swab）
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
4120
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 7, Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, 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) Type A, Rhinovirus, Rhinovirus A
Pathogens detected
Influenza A, Influenza B, Respiratory Syncytial V (RSV), 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
BA2.12, BA1.1.529, BA.4, BA.2.75, BA.5
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-10-31 09:32:55 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
AU
Calibration
Not evaluated
Analytical Sensitivity
98.17 %
Analytical Specificity
99.61 %
Analysis of cross reactivity
Evaluated
False positives
2 % (2 false positive result is observed in 109 negative samples confirmed by RT-PCR)
False negatives
1 % (1 false negative results are observed in 260 positive samples confirmed by RT-PCR)
Precision
Evaluated
Accuracy
99.18 %
Robustness
Evaluated
Clinical Sensitivity
98.17 %
Clinical Specificity
99.61 %
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