COVID-19 + Flu A&B +RSV Antigen Combo Rapid Test Cassette（Nasal Swab /Nasopharyngeal Swab）
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
24752
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
Other (Nucleoprotein)
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Bordetella Pertussis, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mumps Virus (MuV), Mycobacterium Tuberculosis, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Influenza A, Influenza B, Respiratory Syncytial V (RSV), SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Other
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, Other (BA.2,BA.2.10,BA.2.12, BA.2.12.1, BA.5 ,BA.2.75, BF.7, BJ.1 ,XBB, XBB.1 and XBB.1.5), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2023-03-14 11:19:31 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
1000 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
93.64 %
Analytical Specificity
96.67 %
Analysis of cross reactivity
Evaluated
False positives
9 tests (Tested 270 negative samples, 9 samples are false positive.)
False negatives
7 tests (Tested 110 positive samples, 7 samples are false negative. )
Precision
Evaluated
Accuracy
95.79 %
Robustness
Evaluated
Clinical Sensitivity
93.64 %
Clinical Specificity
96.67 %
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