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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 (self-test)

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

Device identification number
2758
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal 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, 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
for self test and home test
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
75.5 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0.97 %
Precision
Evaluated
Accuracy
99.83 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
99.13 %
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