The LumiraDx HbA1c test is an in vitro diagnostic test for the quantitative determination of haemoglobin A1c (IFCC mmol/mol and NGSP %) in human capillary and venous whole blood samples (EDTA). The LumiraDx HbA1c Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing.
HbA1c is used for the monitoring of long-term glycaemic control in individuals with diabetes mellitus, and as an aid in screening and identifying patients who may be at risk for developing diabetes. The LumiraDx HbA1c test is for Professional Use Only. For patients ≥2 years of age.
The measurement of HbA1c allows physicians and pharmacists to monitor patients with diabetes, or as an aid to screen and identify those at risk for developing diabetes.
The LumiraDx HbA1c test is a smart, automated, highly portable solution designed to improve access and ease of use in community-based healthcare settings.
The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run.
The workflow process is comprised of a simple sample collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in <7 minutes from sample application.
The method comparison was performed using 2 Test Strip lots with fresh whole blood samples sourced from patients presenting to outpatient clinics or research facilities with suspected or confirmed diabetes, or from normal healthy donors. Each sample was compared to the same fresh whole blood sample tested on the Tosoh G8. The data was analysed by Passing Bablok regression. The analyses are summarised below:
* See LumiraDx HbA1c Test Product Insert for additional details
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.
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