BiologyWorks
Manufactured by BiologyWorks Inc., United States - www.biologyworks.com
Device identification number
2744
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Specimen
Anterior nasal swab, Nasal swab
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
BiologyWorks has significant and scalable manufacturing capacity for this product and can quickly deliver in Europe and around the world.
Assay Type
Unknown
Reader Required
Yes
Method
LAMP
Measurement
Qualitative
Time
45 minutes
LOD
30000 cpm
Analytical Sensitivity
99.5 % (99.5)
Analytical Specificity
100 %
Clinical Sensitivity
97.3 %
Clinical Specificity
100 %
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