SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal)
Manufactured by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD., China
Device identification number
4099
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV, SARS-CoV-2
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.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-09-29 09:02:26 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
Yes
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Quantitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
500 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
93.55 %
Analytical Specificity
99.9 %
Analysis of cross reactivity
Evaluated
False positives
0 strips
False negatives
8 strips
Precision
Evaluated
Accuracy
98.61 %
Robustness
Evaluated
Clinical Sensitivity
93.55 %
Clinical Specificity
99.9 %
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