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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Neutralising Antibody

Manufactured by Prestige Diagnostics UK (NI) Ltd, United Kingdom - https://www.prestigediagnostics.co.uk/ 

Device identification number
2227
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Cassette, Fingertip, Lateral flow
Target
Antibody
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Pathogens detected
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
2021-06-10 05:52:31 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
Crossreactivity
Evaluated
Fp
2.29 % ((3/131))
Fn
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