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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
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-01-20 03:09:15 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[1] . The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing[3].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. Not for at-home testing
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 AU
LOD
75.5
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.01 %
Fn
2.58 %
Precision
Evaluated
Accuracy
99.32 % (Nasal swab)
Accuracy
99.32 % (Nasopharyngeal swab)
Accuracy
99.32 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.42 % (Nasal swab)
Clinical Sensitivity
97.42 % (Nasopharyngeal swab)
Clinical Sensitivity
97.42 % (Oropharyngeal swab)
Clinical Specificity
99.99 % (Nasal swab)
Clinical Specificity
99.99 % (Nasopharyngeal swab)
Clinical Specificity
99.99 % (Oropharyngeal swab)
Type of antigen
Nucleocapsid protein
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