SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
1967
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
www.microprofit-bio.com
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunochromatography
Time
15 minutes
Detection Principle
Colloidal gold
LOD
49 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
7 %
Precision
Evaluated
Accuracy
96.11 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.93 % (Clinical sensitivity at Ct<40=342/368=92.93% (95%CI:89.82%~95.33%))
Clinical Specificity
100 % (Clinical specificity = 300/300 = 100% (95%CI:98.78% ~100%))
Type of antigen
Nucleoprotein
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