SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test
Manufactured by Acon Biotech (Hangzhou) Co. Ltd., China - https://www.aconbio.com/
Device identification number
2594
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, SARS-CoV, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), Other (B.1.618, B.1.640.2, AY.1, AY.4.2, BA.1, BA.1.1, BA.2, BA.3，XE，BA.4，BA.5, BA.2.12.1，BA.2.12, BA.2.75), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-09-20 05:48:08 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Other (Immunochromatography)
LOD
160 TCID50/ml (for SARS-CoV-2)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.29 % (NP swab:1/335(Influ.B))
False positives
0.23 % (Nasal swab:1/430(COVID))
False positives
0.59 % (NP swab: 2/335(Influ.A))
False positives
0.38 % (NP swab:1/257(COVID))
False positives
0.19 % (Nasal swab: 1/505((Influ.B))
False positives
0.39 % (Nasal swab 2/505(Influ.A))
False negatives
4 % (Nasal swab 3/75((Influ.B))
False negatives
1.66 % (NP swab:1/60(Influ.B))
False negatives
1.66 % (NP swab:1/60(Influ.A))
False negatives
2.17 % (NP swab:3/138(COVID))
False negatives
2.66 % (Nasa swab 2/75(Influ.A))
False negatives
2.66 % (Nasal swab :4/150 (COVID))
Precision
Evaluated
Accuracy
99.24 % (NP swab: (Influ.A))
Accuracy
99.31 % (Nasal swab (Influ.A))
Accuracy
99.31 % (Nasal swab (Influ.B))
Accuracy
99.49 % (NP swab:(Influ.B))
Accuracy
98.99 % (NP swab:(SARS-CoV-2))
Accuracy
99.14 % (Nasal swab:(SARS-CoV-2))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.33 % (Nasal swab: (Influ.A))
Clinical Sensitivity
98.33 % (NP swab:(Influ.B))
Clinical Sensitivity
98.33 % (NP swab:(Influ.A))
Clinical Sensitivity
97.83 % (NP swab:(SARS-CoV-2))
Clinical Sensitivity
96 % (Nasal swab: (Influ.B))
Clinical Sensitivity
97.33 % (Nasal swab:(SARS-CoV-2))
Clinical Specificity
99.77 % (Nasal swab:(SARS-CoV-2))
Clinical Specificity
99.6 % (Nasal swab: (Influ.A))
Clinical Specificity
99.8 % (Nasal swab: (Influ.B))
Clinical Specificity
99.61 % (NP swab:(SARS-CoV-2))
Clinical Specificity
99.4 % (NP swab:(Influ.A))
Clinical Specificity
99.7 % (NP swab:(Influ.B))
Type of antigen
Nucleocapsid 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