COVID-19& Influenza A/B& RSV Antigen Combo Rapid Test
Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com
Device identification number
5824
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
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, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Mumps Virus (MuV), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Rhinovirus
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2023-01-09 10:11:18 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
502 TCID50/ml (2×10^2.4 TCID50/mL)
Calibration
Evaluated
Analytical Sensitivity
96.7 %
Analytical Specificity
99.5 %
Analysis of cross reactivity
Evaluated
False positives
0.52 %
False negatives
3.31 %
Precision
Evaluated
Accuracy
98.8 % (COVID-19:98.8%, Influenza A:99.0%, Influenza B:98.8%,RSV:98.4%)
Robustness
Evaluated
Clinical Sensitivity
96.7 % (COVID-19:96.7%, Influenza A:95.3%, Influenza B:91.5%,RSV:90.0%)
Clinical Specificity
99.5 % (COVID-19:99.5%, Influenza A:99.5%, Influenza B:99.6%,RSV:99.0%)
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