Finecare™ 2019-nCoV RBD Antibody Test
Manufactured by Guangzhou Wondfo Biotech Co. Ltd., China - https://en.wondfo.com.cn/
Device identification number
2925
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Cassette
Target type
Antibody
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Finecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters (Model No.: FS-113, FS-114, FS-205) for qualitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen.
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Fluorescence
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
1 AU
Precision
Evaluated
Accuracy
98.99 % (RBD Antibody)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.83 % (RBD Antibody)
Clinical Specificity
99.57 % (RBD Antibody)
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