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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay)

Manufactured by Diasia Biomedical Technology Co. Ltd., China - www.diasia.com.cn 

Device identification number
2096
CE Marking
Yes
HSC common list (RAT)
×No
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
A.23.1
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Only change that has been made is regarding the specimen type
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Quantitative
Time
3 minutes
Detection Principle
Fluorescence
LOD
997.5 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.75 % (141 specimens were negative by both test reagent and control reagent, and there is 4 specimen of fal)
False negatives
0.66 % (149 specimens were negative by both test reagent and control reagent, and there is 1 specimen of fal)
Precision
Evaluated
Accuracy
98.31 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.24 %
Clinical Specificity
99.33 %
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