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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VivaDiag SARS CoV 2 Ag Rapid Test

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

Device identification number
1246
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal 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), Influenza A, Influenza B, 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, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
VivaDiag 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, nasopharyngeal swab specimen. 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. 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
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colorimetry
LOD
675 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.43 % (Nasal swab)
False positives
Nasopharyngeal swab
False negatives
1.16 % (Nasal swab)
False negatives
Nasopharyngeal swab
Precision
Evaluated
Accuracy
99.26 % (Nasopharyngeal swab)
Accuracy
99.26 % (Nasal swab)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.84 (Nasal swab)
Clinical Sensitivity
98.84 % (Nasopharyngeal swab)
Clinical Specificity
99.57 (Nasal swab)
Clinical Specificity
99.57 % (Nasopharyngeal swab)
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