Finger Prick vs venous blood- Aptus Clinical Evaluation

• Research type

  Research Study

• Full title

  Finger Prick vs venous blood- Aptus Clinical Evaluation

• IRAS ID

  234135

• Contact name

  Laurice Edwards

• Contact email

  laurice@entia.co

• Sponsor organisation

  Entia Ltd

• Duration of Study in the UK

  0 years, 5 months, 28 days

• Research summary

  This is a method comparison study that aims to evaluate the clinical performance of the Aptus device. The Aptus device is the first product of Entia Ltd and is intended for point of care testing internationally, particularly within resource limited environments.
  Objectives of the study are to evaluate the accuracy of Hb and Hct measurements of the Aptus device using capillary blood compared to the Hb and Hct measurements done by the DxH 800 blood analyser blood analyzer using venous blood and to evaluate whether the performance of the Aptus device as a point of care device with capillary blood is clinically acceptable.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  18/LO/2191

• Date of REC Opinion

  10 Dec 2018

• REC opinion

  Favourable Opinion