LumiraDx HbA1c
LumiraDx HbA1c Test Achieves CE Mark
LumiraDx continues to increase the repertoire of tests available on their point of care testing platform with diagnostic testing solutions being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease.
LumiraDx has 30+ tests, either on the market or in development, covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform.
Addressing the Growing Global Need for Diabetes Screening and Monitoring with its Next-Generation Point of Care Diagnostic Platform
- Rapid microfluidic immunofluorescence assay intended for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes
- The automated, quantitative fingerstick assay is run on the highly portable LumiraDx Platform and designed for near-patient testing with connected results in under seven minutes
- Rising global rates of diabetes presents growing need for broader access and an easier, more connected solution for HbA1c testing in community-based healthcare settings such as primary care and retail pharmacy
- Available on the same Point of Care (POC) Platform as LumiraDx’s high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool, SARS-CoV-2 Ag Ultra as well as INR, D-Dimer and CRP tests
Performance
The LumiraDx HbA1c test has a reportable range of 20 – 130 mmol/mol HbA1c (4.0 – 14.0% HbA1c). In an external, multi-site clinical study, the test achieved precision, expressed as mean paired replicate %CV, of ≤2.50% in both capillary and venous whole blood. The LumiraDx HbA1c test is designed to address the growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting.
Chief Executive Message
Ron Zwanziger, LumiraDx’s Chief Executive Officer commented, “With our growing test menu, the LumiraDx Platform is able to quickly and accurately support clinicians with a variety of diagnostic and treatment decisions at the point of care. HbA1c is an important addition to our Platform not only for our existing pharmacy and primary care customers, but for new customers looking to consolidate their current testing needs into one centralized and streamlined, connected Platform that delivers lab comparable performance.”
Impact
The increase in global health expenditure due to diabetes has been considerable in recent years, growing from USD 232 billion in 2007 to USD 966 billion in 2021 for adults aged 20–79 years – an increase of 316% over the last 15 years. By offering both broader access and an easier, more connected solution for HbA1c testing, patients who might be at risk of developing diabetes may begin to manage their condition sooner, potentially leading to less strain on healthcare systems.
LumiraDx Next Generation Point of Care Diagnostic Platform
LumiraDx is a next-generation point of care diagnostics company that is transforming community-based healthcare.
- Simple and intuitive user interface that provides step-by-step testing workflow
- Weighs only 1.1kg, uses rechargeable battery or mains power, and is capable of going wherever the patient is located
- Integrates several technologies and sample types in a single Instrument
- Offers lab-comparable results in minutes at the point of care
- Pinpoint accuracy
- On-strip position sensors
- Precise sample fluidic control
- Fluorescence measurement
- System controls cover strip positioning, electronics, optics, temperature, haematocrit and Test Strip expiry
- Enzyme and immunoassay on a single platform
- Lot Calibration File instant transfer to instrument by RFID tag
Read more about the testing system, case studies and test repertoire here:
More information about the HbA1c LumiraDx test can be accessed here: