fluorecare SARS-CoV-2 Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
2181
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
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
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colloidal gold
LOD
5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
2 %
Precision
Evaluated
Accuracy
99.13 ( (97.48%～99.82%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.33 % ( (77.93%～99.18%))
Clinical Specificity
99.68 % ( (98.24%～99.99%))
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