LumiraDx SARS-CoV-2 Ag Test
Manufactured by LumiraDx UK Ltd., United Kingdom - www.lumiradx.com
Device identification number
1268
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Reader required updated to yes
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
Subclass
Other ()
LOD
32 TCID50/ml
Clinical Sensitivity
97.6 %
Clinical Specificity
96.6 %
Type of antigen
nucleocapsid
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