2019-nCoV Neutralising Antibody
Manufactured by Prestige Diagnostics UK Ltd., United Kingdom - https://www.prestigediagnostics.co.uk/
Device identification number
2227
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Fingertip, Lateral flow
Target type
Antibody
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Adenovirus, Enterovirus A71 (EV-A71), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The 2019-nCoV Neutralization Antibody device is a rapid chromatographic immunoassay intended for the qualitative detection of neutralization antibodies against viral spike glycoprotein
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
500 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.29 % ((3/131))
False negatives
2.27 % ((2/88))
Precision
Evaluated
Accuracy
97.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Clinical Specificity
98.5 %
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