SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Wuhan Healthcare Biotech Co. Ltd., China - http://www.healthcare-biotech.com/
Device identification number
2444
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Product already tested by customers with positive outcomes
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
AU 1500
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3.2 %
Precision
Evaluated
Accuracy
96.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.8 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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