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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 Ag Rapid Test

Manufactured by AUTOBIO DIAGNOSTICS., LTD., China - https://www.autobio.com.cn/ 

Device identification number
2538
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-08-10 09:53:30 CET
Comments
No additional information.
Assay Type
Immuno-Antigen
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.3 % (3/234)
Fn
12.1 % (14/116)
Precision
Evaluated
Accuracy
95.1 % (333/350)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
87.9 % (102/116) 95%CI(80.8%-92.7%))
Clinical Specificity
98.7 % (231/234)
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