Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Rapid Antigen Test (Colloidal Gold)

Manufactured by Joinstar Biomedical Technology Co., Ltd, China - www.joinstar.cn 

Device identification number
1333
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
A.23.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Evaluation performed by Paul-Ehrlich Institut on 4th December 2020
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
100 (pg/mL)
Crossreactivity
Evaluated
Fp
1.86 % ((From 215 samples tested there were 4 false positives))
Fn
1.39 % ((From 215 samples tested there were 3 false negatives))
Precision
Evaluated
Accuracy
97.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
98.1 %
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