Lucira COVID-19 All-In-One Test Kit
Manufactured by Lucira Health, United States - www.lucirahealth.com
Device identification number
1374
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Nucleic acid
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Lucira COVID-19 All-In-One Test Kit utilizes RT-LAMP technology to detect RNA of the N gene for SARS-CoV-2.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Reader Required
No
Method
LAMP
Measurement
Qualitative
Time
30 minutes
LOD
900 copies/ml
False positives
94 %
False negatives
98 %
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