fluorecare SARS-CoV-2 Neutralizing Antibody Test Kit (Fluorescence Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
2168
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.microprofit-bio.com
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunochromatography
Measurement
Quantitative
Time
15 minutes
Detection Principle
Fluorescence
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
4.3 %
Precision
Evaluated
Accuracy
100 % (( Neutralizing Antibody))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.06 % ( (95% CI 90.50-97.84%))
Clinical Specificity
99 % ( (95% CI 94.55-99.98%))
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