ellume·lab is a new hand-held, versatile digital device designed for healthcare professionals at the point-of-care. The device offers a wide range of accurate rapid diagnostic tests for common illnesses. In addition, the ellume·lab features a suite of digital tools designed to support effective clinical decision making and enhance patient engagement.
We are excited to be launching ellume·lab into the U.S. in 2021 with our FDA Emergency Use Authorized COVID Antigen test.*
Diagnostic Tests
The ellume·lab diagnostic test range comprises of highly accurate, rapid fluorescent immunoassay tests for healthcare professionals at the point-of-care. Two tests can be performed simultaneously, allowing clinics to increase testing throughput. All tests are easy to use due to simple, animated, on-screen instructions and provide results in 15 minutes.
ellume·lab’s COVID Antigen test (for active infections) is now authorized for use in the U.S., with the COVID Serology test (for recent or past infections) undergoing clinical validation in a CLIA-waived setting. Further tests, including a Flu A+B and a Flu A+B / RSV test, have undergone clinical studies and are being prepared for launch.
Digital Features
ellume·lab provides a suite of digital tools to assist clinical decision making and enhance patient engagement. The tools have been designed by doctors for intuitive and efficient clinician use, with patient needs in mind: apps to calculate BMI and drug dosages, capture consent for clinical photography and share information with patients during and after the consultation via email. All ellume·lab digital tools are HIPAA compliant and offer cloud connectivity.
Key Features
- Highly accurate & rapid diagnostics
- 2 testing ports to run tests simultaneously
- Suitable for all ages, child adaptor provided
- Objective on-screen results
- Useful digital tools
- Portable and battery charged
- Secure, HIPAA compliant cloud connection
- Simple and intuitive to use
- Patient-friendly user interface design & functionality
- On-device and online training for easy & efficient new user training
- No device calibration required
*This product has not been FDA cleared or approved, but has been authorized by the FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.