A Performance Evaluation of the Lumiradx Point of Care HbA1c Device

Overview

In patients who have diabetes, symptoms of diabetes or attending a diabetic clinic the study will evaluate agreement between the HbA1c measurements from the LumiraDx POC HbA1c assay and the Tosoh G8, as an aid in the monitoring of diabetes Mellitus

This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx Point of Care (POC) HbA1c test when used in patients presenting for assessment or monitoring of diabetes. The LumiraDx POC HbA1c test is a quantitative immunoassay providing results near to the patient in under 10 minutes. The accuracy of the LumiraDx POC HbA1c test will be assessed using capillary whole blood, and venous blood, by comparison to the HbA1c results obtained from the same individuals as analysed by trained laboratory professionals using a CE marked laboratory reference device. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies. Adult males and females attending out-patient, community diabetes and research clinics for HbA1c measurements will be included in the study. Subjects may also be invited to take part via the diabetes research register or by invitation from independent clinical research sites. All subjects recruited will be willing and able to give written informed consent. Approximately 400 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation requires a minimum of 360 valid subjects in total. After obtaining written informed consent, up to 24mL of venous blood will be obtained from venepuncture into anticoagulated blood tubes. Capillary blood samples should be collected via fingerstick. Finger stick blood should be collected using the transfer loop and placed in the sample tube before addition to the strip for immediate measurement of HbA1c on the LumiraDx POC instrument (one after the other). Of the drawn blood tubes, one tube is used immediately with the LumiraDx POC HbA1c test. To do this, the clinical staff member lyses a small sample using the lysis kit and then places the sample on the Test Strip which has already been inserted into the LumiraDx POC Instrument. After approx. 8 minutes, the result is displayed on the screen. The HbA1c results obtained will be used in a set of comparative analyses designed to determine the performance characteristics of the LumiraDx HbA1c test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.

Conditions

Interventions

Eligibility

Locations (4)

Outcomes