SARS-CoV-2 Neutralizing Antibody Rapid Test
Manufactured by VivaChek Biotech (Hangzhou) Co. Ltd., China - www.vivachek.com
Device identification number
2117
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
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)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Respiratory Syncytial V (RSV)
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
SARS-CoV-2 Neutralizing Antibody Rapid Test is for the rapid, qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood(from venipuncture or fingerstick), serum or plasma. The VivaDiagTM SARS-CoV-2 Neutralizing Antibody Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
30 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 326 negative Sample were tested and 0 of them were false positive
False negatives
2.36 % (169 positive Sample were tested and 4 of them were false negative.)
Precision
Evaluated
Accuracy
99.19 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.63 %
Clinical Specificity
100 %
Type of antigen
Other
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