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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Verino Pro SARS CoV 2 Ag Rapid Test

Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd., China - www.vivachek.com 

Device identification number
2100
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Influenza A, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-05-02 03:36:22 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 . The test is for in vitro diagnostic use only. It provides only an initial screening test result. More specific alternative diagnosis methods (molecular diagnostic and / or CT) should be performed in order to obtain the confirmation of SARS-CoV-2 infection.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.01 %
Fn
2.58 %
Precision
Evaluated
Accuracy
99.32 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.42 %
Clinical Specificity
99.99 %
Type of antigen
Nucleocapsid protein

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