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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Device

Manufactured by AMS UK (NI) Ltd

Manufacturer website
CE Marking
Yes
Detection Principle
ImmunoAssay-Antigen
Format
Rapid diagnostic test
Target
Antigen
Commercial Status
Commercialised
Last Update
05/11/2020
Comments
https://www.amslabs.co.uk/coronavirus
Additional Information
Information provided by manufacturer
Test Type
Point-Of-Care test
Test Type Result
qualitative
Format
immunochromatography, lateral flow test cassette
Specimen
nasal swab, saliva
Reader
not required
Time (Min)
15
Fp
0.90%
Fn
9.10%
Sensitivity Percent
90.9
Accuracy Percent
97.5
Type of Antigen
Not found

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