SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
1968
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2023-02-01 02:57:37 CET
Comments
www.microprofit-bio.com
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunochromatography
Time
15 minutes
Detection Principle
Fluorescence
LOD
25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
4.3 %
Precision
Evaluated
Accuracy
97.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.65 % (Clinical sensitivity at Ct<40=352/368=95.65% (95%CI:93.04%~97.49%))
Clinical Specificity
100 % (Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%))
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