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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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