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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgG/IgM Device

Manufactured by AMS UK (NI) Ltd

Manufacturer website
CE Marking
yes
Detection Principle
Immunochromatography-Antibody
Format
Rapid diagnostic test
Target
Antibody
Commercial Status
Commercialised
Last Update
15/07/2020
Test Type
Manual assay
Test Type Result
Qualitative
Format
test cassette
Specimen
Plasma, Serum, Whole blood
Antigen IgG
yes
Antigen IgM
yes
Antigen IgA
no
Reader
not required
Time (Min)
10 min
Analysis of Cross Reactivity
evaluated
Precision
evaluated
Sensitivity Percent
IgG 91.8% , IgM 95.7%
Specificity Percent
IgG 96.4%, IgM 97.3%
Accuracy Percent
Ig G 95.0%, IgM 96.7%

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