LumiraDx SARS-CoV-2 RNA STAR Complete
Manufactured by LumiraDx UK Ltd., United Kingdom - www.lumiradx.com
Device identification number
2645
CE Marking
✓Yes
HSC common list (RAT)
×No
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
*Extraction-free amplification in 20 min or less! Templates for validated Realtime-Thermocyclers and more information regarding LOD data, as well as sensitivity and specificity can be found in our IFU under lumiradx.com in Fast Lab Solution areaan be found in our IFU under lumiradx.com in Fast Lab Solution area.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
20 minutes
LOD
50 cpr
Positive control
yes
Negative control
yes
Clinical Sensitivity
95.45 %
Clinical Specificity
98.31 %
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