VivaDiag SARS-CoV-2 Ag FIA Test
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2105
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4
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, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The VivaDiag SARS-CoV-2 Ag FIA Test is a fluorescent immunochromatographic assay for the rapid and qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab or throat swab specimen that is automatically analyzed.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
135 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 431 negative Sample were tested and 0 of them were false positive
False negatives
3.03 % (66 positive Sample were tested and 2 of them were false negative.)
Precision
Evaluated
Accuracy
99.6 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.97 % ((Antigen))
Clinical Specificity
99.9 % ((Antigen))
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