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
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Coronaviruses (HCoV)
Lineages detected
Commercial Status
Commercialised
Last Update
2021-09-03 02:21:03 CET
Comments
Evaluation Paul-Ehrlich-Institut 4th December , 2020
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
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
Spike 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