SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Manufactured by Wuhan HealthCare Biotechnology Co. Ltd., China - http://www.healthcare-biotech.com/
Device identification number
2742
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Evaluated in Germany (approved by BFARM/PEI AT997/21) and Italy (approved by Ministry of Health). The antigen test is not affected by the variants, and there is no reduction in Sensitivity, Specificity, Cross reactions, Precision and Limit of Detection (LoD) compared to the information stated in the production phase and in the technical file.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
150 TCID50/ml (Swab (mL) - rNp 10 pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Nasal Swab
False positives
0 % Nasopharyngeal Swab
False negatives
3.3 (Nasopharyngeal Swab)
False negatives
3.2 % (Nasal Swab)
Precision
Evaluated
Accuracy
98.6 (Nasopharyngeal Swab)
Accuracy
98.4 % (Nasal Swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.8 % (Nasal Swab)
Clinical Sensitivity
96.7 % (Nasopharyngeal Swab)
Clinical Specificity
100 % (Nasal Swab)
Clinical Specificity
100 % (Nasopharyngeal Swab)
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