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 (RAT)
×No
Format
Near POC / POC
Physical Support
Strip
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
1.9 % (In 100 samples we detected 1,9 false positive. (NPA 98,1%))
False negatives
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