SARS-CoV-2/ Flu A/ Flu Ag FIA Test
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2120
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Beta Coronavirus OC43 (HCoV-OC43), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2/Flu A/Flu B Ag FIA Test is for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen, the influenza A and influenza B virus antigens in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
75.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.31 % (631 negative Sample were tested and 2 of them were false positive)
False negatives
1.96 % (102 positive Sample were tested and 2 of them were false negative.)
Precision
Evaluated
Accuracy
99.32 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.06 %
Clinical Specificity
99.68 %
Type of antigen
Nucleoprotein
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