Verino Pro SARS CoV 2 Ag Rapid Test
Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd, China, China - https://www.vivachek.com/en/index.html
Device identification number
2472
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-07-22 10:41:39 CET
Comments
Verino Pro SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.52 % (nasal )
Fp
0.33 % (nasopharyngeal)
Fp
0.52 % (oropharyngeal)
Fn
1.32 % (nasal)
Fn
1.32 % (oropharyngeal)
Fn
1.22 % (nasopharyngeal)
Precision
Evaluated
Accuracy
98.68 % (nasal:)
Accuracy
98.68 % (oropharyngeal:)
Accuracy
98.78 % (nasopharyngeal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.33 % (nasopharyngeal)
Clinical Sensitivity
96.69 % (oropharyngeal)
Clinical Sensitivity
96.69 % (nasal)
Clinical Specificity
99.48 % (oropharyngeal)
Clinical Specificity
99.67 % (nasopharyngeal)
Clinical Specificity
99.48 % (nasal)
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