SARS-CoV-2 Antigen Test Kit (colloidal gold method) saliva
Manufactured by BIOTEKE CORPORATION (WUXI) Co. Ltd., China - https://www.bioteke.cn/
Device identification number
2146
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.bioteke.cn/
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
175 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.5 %
False negatives
7.2 %
Precision
Evaluated
Accuracy
95.42 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.8 %
Clinical Specificity
97.5
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