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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LumiraDx SARS-COV-2 Antigen Pool Test

Manufactured by LumiraDx UK Ltd, United Kingdom - www.lumiradx.com 

Device identification number
2342
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Other
Physical Support
Strip
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-01 05:47:18 CET
Comments
All the entered information is for NP swabs. For nasal swabs we have the following information; PPA 93,8% NPA 98,8%
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
LOD
32 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.9 % (In 100 samples we detected 1,9 false positive. (NPA 98,1%))
Fn
7.3 % (In 100 samples we detected 7,3 false negatives. (PPA 92,7%))
Precision
Evaluated
Accuracy
97.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.7 %
Clinical Specificity
98.1 %
Type of antigen
Nucleoprotein

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