VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2106
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit is for the rapid, qualitative detection of antibodies against SARS-CoV-2 in human whole blood (from fingerstick or venipuncture), serum or plasma.
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Fluorescence
LOD
30 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 326 negative Sample were tested and 0 of them were false positive
False negatives
1.77 % (169 positive Sample were tested and 3 of them were false negative.)
Precision
Evaluated
Accuracy
99.39 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.22 %
Clinical Specificity
99.9 %
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