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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VivaDiag Pro SARS CoV 2 Ag Rapid Test

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

Device identification number
2103
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, 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), Influenza A, Influenza A H3N2, Influenza A H5N1, Influenza B, 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.1.1.529 (Omicron), 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)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
VivaDiagTM 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.
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
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.48 % (Nasal swab)
False positives
0.16 % (Nasopharyngeal swab)
False positives
0.74 % (Oropharyngeal swab)
False negatives
5.75 % (Oropharyngeal swab)
False negatives
5.56 % (Nasal swab)
False negatives
4.71 % (Nasopharyngeal swab)
Precision
Evaluated
Accuracy
98.08 % (Oropharyngeal swab)
Accuracy
98.37 % (Nasal swab)
Accuracy
98.04 % (Oropharyngeal)
Accuracy
98.76 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.25 % (Oropharyngeal swab)
Clinical Sensitivity
94.44 % (Nasal swab)
Clinical Sensitivity
95.29 % (Nasopharyngeal swab)
Clinical Specificity
99.26 % (Oropharyngeal swab)
Clinical Specificity
99.84 % (Nasopharyngeal swab)
Clinical Specificity
99.52 % (Nasal 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