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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 Detection Kit (Colloidal Gold Method)

Manufactured by Xiamen Jiqing Biomedical Technology Co. Ltd., China - www.wikang.com.cn 

Device identification number
1588
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Card, Microtiter plate
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus Nl63 (HCoV-Nl63), Coronaviruses (HCoV), SARS-CoV
Pathogens detected
Coronaviruses (HCoV)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2023-01-13 01:47:43 CET
Comments
Update the date
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
Analytical Sensitivity
%
Analytical Specificity
%
Accuracy
96.67 % (95% CI: 94.56% to 98.12%)
Clinical Sensitivity
85.15 % (95% CI: 76.69% to 91.44%)
Clinical Specificity
100 % (95% CI: 98.95% to 100.00%)

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