SARS-CoV-2 Antigen Test Kit (colloidal gold method)
Manufactured by Bioteke Taizhou Biotechnology Co. Ltd., China - www.bioteke.cn/
Device identification number
1487
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
175
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2
False negatives
3
Precision
Evaluated
Accuracy
98.58 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.95 %
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test colloidal gold
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