COVID-19/Influenza A+B /RSV Antigen Combo Rapid Test Cassette（Colloidal Gold ）
Manufactured by Jiangsu Diagnostics Biotechnology Co. Ltd., China - http://www.diagnostics-bio.com
Device identification number
5842
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, 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, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B
Pathogens detected
Other (-)
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), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2023-01-31 03:17:36 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
160 TCID50/ml (SARS-CoV-2)
Calibration
Evaluated
Analytical Sensitivity
100 % (NP swab InF A)
Analytical Specificity
100 % (NP swab InF A)
Analysis of cross reactivity
Evaluated
False positives
% NP swab InF A
False negatives
0.21 % (NP swab InF A)
Precision
Evaluated
Accuracy
98.62 % (NP swab RSV)
Accuracy
99.31 % (NP swab SARS-CoV-2)
Accuracy
98.62 % (NP swab InF B)
Accuracy
98.97 % (NP swab InF A)
Robustness
Evaluated
Clinical Sensitivity
98.17 % (NP swab InF B)
Clinical Sensitivity
98.86 % (NP swab SARS-CoV-2)
Clinical Sensitivity
98.04 % (NP InF A)
Clinical Sensitivity
98.19 % (NP swab RSV)
Clinical Specificity
99.21 % (NP swab InF B)
Clinical Specificity
100 % (NP swab InF A)
Clinical Specificity
100 % (NP swab SARS-CoV-2)
Clinical Specificity
99.19 % (NP swab RSV)
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