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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Coretests COVID-19 Ag Test

Manufactured by Core Technology Co., Ltd, China - www.coretests.com 

Device identification number
1919
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 08:12:51 CET
Comments
COVID-19 Ag Test is the chromatographic immunoassay test used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab specimens. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody. Using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the novel coronavirus antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain novel coronavirus antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area .Regardless of the presence of novel coronavirus antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as: 1.verification that sufficient volume is added. 2.that proper flow is obtained 3. and as a control for the reagents.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
22.5 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.4 %
Fn
1.9 %
Precision
Evaluated
Accuracy
99.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.1 %
Clinical Specificity
99.6 %
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