PHADE

• Research type

  Research Study

• Full title

  A PERFORMANCE EVALUATION OF THE LUMIRADX POINT OF CARE HBA1C DEVICE

• IRAS ID

  280026

• Contact name

  Rory McCrimmon

• Contact email

  r.mccrimmon@dundee.ac.uk

• Sponsor organisation

  LumiraDx UK Ltd

• Duration of Study in the UK

  0 years, 1 months, 27 days

• Research summary

  A performance evaluation study designed to determine whether blood samples tested for HbA1c can be accurately reported by the LumiraDx Point of Care (POC) system. The LumiraDx point of care system consists of the LumiraDx Platform, an in vitro diagnostic instrument, used with single use LumiraDx HbA1c Test Strips. The intended use of the test is as an aid in the the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  20/PR/0216

• Date of REC Opinion

  25 Aug 2020

• REC opinion

  Further Information Favourable Opinion