One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)
Manufactured by Getein Biotech Inc., China - en.bio-gp.com.cn
Device identification number
2183
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Saliva
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples or saliva samples from patients suspected of COVID-19 infection by a healthcare provider.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
200 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.9 % ((5 of 170))
False negatives
2.9 % ((5 of 170))
Precision
Evaluated
Accuracy
98.13 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.06 %
Clinical Specificity
98.71 %
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