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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 Antigen Test Kit (colloidal gold method)

Manufactured by BIOTEKE CORPORATION (WUXI) CO., LTD, China - https://www.bioteke.cn/ 

Device identification number
2067
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
https://www.bioteke.cn/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
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
Evaluated
Crossreactivity
Evaluated
Fp
0.72 %
Fn
3.51 %
Precision
Evaluated
Accuracy
98.47 % ((95%CI: 96.70%~99.44%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.49 ((95%CI: 91.26%~99.04%))
Clinical Specificity
99.28 ((95%CI: 97.43%~99.91%))
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