SARS-CoV-2/RSV/Adenovirus/Influenza A+B Antigen Combo Rapid Test Kit
Manufactured by Hangzhou Fanttest Biotech Co Ltd, China
Device identification number
25663
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, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Adenovirus 1; Adenovirus 2; Adenovirus 4; Adenovirus 5; Adenovirus 55; Staphylococcus aureus; Coxsackie virus CA16e; Coxsackie virus B5;ovirus 55; Staphylococcus aureus; Coxsackie virus CA16e; Coxsackie virus B5; Coxsackie virus A24; Enterovirus EV 70; ), 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 A, Rhinovirus B, SARS-CoV
Pathogens detected
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Adenovirus 1; Adenovirus 2; Adenovirus 4; Adenovirus 5; Adenovirus 55; Staphylococcus aureus; Coxsackie virus CA16e; Coxsackie virus B5;ovirus 55; Staphylococcus aureus; Coxsackie virus CA16e; Coxsackie virus B5; Coxsackie virus A24; Enterovirus EV 70; ), 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 A, Rhinovirus 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.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2024-12-11 11:29:22 CET
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
Colloidal gold
LOD
100 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
97.69 %
Analytical Specificity
99.11 %
Analysis of cross reactivity
Evaluated
False positives
0.88 %
False negatives
2.3 %
Precision
Evaluated
Accuracy
98.79 %
Robustness
Evaluated
Clinical Sensitivity
97.69 %
Clinical Specificity
99.11 %
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