/COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device
Manufactured by Joinstar Biomedical Technology Co. Ltd., China - www.joinstar.cn
Device identification number
2875
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
100pg/mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.8 (4 false positives in 500 negatives)
False negatives
3.92 (4 false negatives in 102 positives)
Precision
Evaluated
Accuracy
98.7 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 % (Antigen)
Clinical Specificity
99.2 % (Antigen)
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