Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Test

Manufactured by LumiraDX, United Kingdom - www.lumiradx.com 

Device identification number
1146
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://www.lumiradx.com/uk-en/what-we-do/diagnostics/test-technology/Antigen-test
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
Detection Principle
Immunofluorescence
LOD
32 TCID50/ml
Crossreactivity
no crossreactivity with Human coronavirus 229E; Human coronavirus OC43; Human coronavirus NL63; MERS coronavirus; Adenovirus (e.g. C1 Ad. 71); Human Metapneumovirus (hMPV); Parainfluenza virus Type 1; Parainfluenza virus Type 2; Parainfluenza virus Type
Accuracy
96.9 %
Clinical Sensitivity
97.6 %
Clinical Specificity
96.6
Type of antigen
nucleocapsid protein (N-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