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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 (GICA)

Manufactured by MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd., China - www.medcaptain.com 

Device identification number
1711
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
100 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
1.35 %
Precision
Evaluated
Accuracy
94.7 % (Antigen)
Accuracy
98.87 %
Accuracy
98.85%
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.65 % (Antigen)
Clinical Specificity
99 %
Type of antigen
Nucleocapsid protein

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