LumiraDx Instrument

IVD

LumiraDx instrument capillary finger stick application or nasal swab sample application

Reshaping the healthcare journey for you and your patients at the Point of Need with LumiraDx

LumiraDx puts powerful diagnostics in your hands. The portable, multimodal system is designed to make testing easy, efficient and more accessible. With a simple instrument workflow and no need for phlebotomy there are minimal training requirements. Nine assays let you gain fast, reliable results from a simple finger stick or nasal swab sample right at the Point of Need - for actionable insights in minutes where you want them.

Powered by actively controlled microfluidic technology, this cutting-edge system supports testing across various conditions, specimen types, and technologies all within a compact, user-friendly instrument.¹

LumiraDx features at a glance

One system many possibilities

With nine assays that help you to detect and treat some of the most burdensome conditions, LumiraDx becomes your trusted daily companion in primary care and other decentralised settings.

True portability

The instrument is compact, lightweight and battery powered¹ with room temperature storage of tests^2-10. LumiraDx can be used right where the patient is, making diagnostics accessible in a wide range of settings.

Simple workflow

The intuitive, standardised interface on LumiraDx provides step-by-step guidance throughout the testing process, making it easy to use and easy to learn. The fast, reliable, connected results support clinical decision-making at the point of need.¹

Benefits at a glance

More flexibility and improved access to care at the Point of Need

Portable

Compact, lightweight and battery-powered¹
No need for test refrigeration just room temperature storage^2-10
Convenient and flexible with everything you need in one carry case¹

Consolidate clinical chemistry and immunoassay tests on one system

Versatile

Perform multiple tests on a single instrument¹
Nine assays enable you to detect and treat infectious and cardiovascular diseases, diabetes and coagulation disorders^2-10
Grow your capabilities as new assays are added

Easy to use with minimal training

Simple

Multiple sample types, including direct finger stick and swab samples, no phlebotomy required and only one drop to run a test¹
A simple and intuitive user interface provides step-by-step guidance through the easy-to-learn test workflow¹

Fast results help support quicker treatment decisions

Impactful

Actively controlled microfluidic technology uniting diagnostic testing across a wide range of disease areas, technologies and specimen types¹
Reduce unnecessary follow-up visits, patient wait times and support quicker treatment decisions with rapid results at the Point of Need^11,12,13
Enhance efficiency and optimise care pathways^11,12,13

Connectivity for centralised control of decentralised testing

Connected

Remotely manage and configure instruments¹⁴
Manage and demonstrate policy compliance¹⁴
Secure, simple workgroup provisioning¹⁴
Secure integration into the patient’s electronic records1

Actively controlled microfluidics technology

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Show video transcript

The future of diagnostics.

It is never compromising speed for Reliability.
It's testing for multiple analytes within a single user-friendly system and getting results you can trust within minutes.
It's point of care that can go almost anywhere.

It's LumiraDx, a next generation diagnostics system that combines a broad test menu across a wide range of disease areas by leveraging the power of actively controlled microfluidics. LumiraDx consolidates the diagnostic technologies from multiple point of care systems into a small portable instrument to deliver both speed and performance in minutes. The LumiraDx test strip was engineered to be universally applicable across different types of diseases, technologies, and specimen types, and efficient for manufacturing in high volumes.

Here's how it works.

Once a single droplet of a specimen is added to the test strip and detected, the active microfluidics take over, distributing the specimen into channels so that the specimen and reagents can be mixed and assays and onboard controls can be run simultaneously.

Let’s take the example of the SARS-CoV-2 antigen test strip.

Inside the strip two assay particles, one magnetic and one fluorescent, are actively mixed with a specimen and bind with any target antigen present to create a sandwich complex. In the reading zone, a magnetic field grabs a hold of such sandwich complexes, while an air wash removes any residual sample and unbound fluorescent particles. This ensures a clear signal for optical determination of whether the antigen is present in the specimen.

The on-screen results can then be sent electronically to the patient's record. The instrument is designed to run a variety of different assay formats and specimen types. LumiraDx diagnostic testing solutions are being deployed globally by governments, leading health care institutions, pharmacies, care homes and community outreach programs. It's compact enough to deliver reliable results almost anywhere because the future of diagnostics should be one that benefits everyone, everywhere. LumiraDx, next generation point of care.

Overview

Ordering information

LumiraDx training centre

Get the most out of the LumiraDx system with these helpful instructional videos to support the proper use of the Instrument and assays, including setup, connectivity, correct sample application and assay training videos.

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Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

References

LumiraDx Platform User Manual V5E English (version 11, 2023-07)
LumiraDx Product Insert Nt-proBNP (version 3, 2023-07)
LumiraDx Product Insert HbA1c (version 8, 2024-01)
LumiraDx Product Insert CRP (version 5, 2024-02)
LumiraDx Product Insert D-Dimer (version 11, 2023-07)
LumiraDx Product Insert INR (version 4, 2024)
LumiraDx Product Insert SARS-CoV-2 Ag Ultra (version 1, 2022-07)
LumiraDx Product Insert SARS-CoV-2 Ag (version 14, 2022)
LumiraDx Product Insert SARS-CoV-2 & RSV (version 3, 2023-08)
LumiraDx Product Insert SARS-CoV-2 & Flu A/B (version 5, 2022)
Bachtiger P, Kelshiker MA, Petri CF, et al. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Jan 28;30(1):e100718.
Price CP, Fay M, Hopstaken RM. Point-of-Care Testing for D-Dimer in the Diagnosis of Venous Thromboembolism in Primary Care: A Narrative Review. Cardiol Ther. 2021 Oct 23;10(1):27-40.
Patzer KH, Ardjomand P, Göhring K, et al. Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction. J Diabetes Sci Technol. 2018;12(3):687-694.
LumiraDx Connect User Manual (version 7, 2025-01)

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LumiraDx Instrument