VivaDiag Wellion SARS-CoV-2 Antigen Rapid Test
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2163
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal 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), 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
Clinical Evaluation Study from Germany is available and uploaded.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
675 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4.54 % ((154 positive samples were tested and 7 of them were false negative))
False negatives
0 % (431 negative samples were tested and 0 of them were false positive)
Precision
Not evaluated
Accuracy
98.8 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.45 % ( (Antigen))
Clinical Specificity
99.99 % ( (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