Development of Point of Care INR Monitor (RDE04)

• Research type

  Research Study

• Full title

  Blood donation for the development and optimisation of the second generation Microvisk INR testing system for the measurement of PT/INR in patients on Warfarin Therapy.

• IRAS ID

  172921

• Contact name

  James Seale

• Contact email

  jim.seale@wales.nhs.uk

• Sponsor organisation

  Microvisk Ltd

• Duration of Study in the UK

  2 years, 0 months, 3 days

• Research summary

  This study is to further develop and optimise the design and manufacturing process of a handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy. The device comprises of a handheld instrument and a disposable test strip and reports how blood coagulation is working in terms of standardised units called International Normalised Ratio (INR). A single drop of fresh whole blood will be added to the strip and the INR result displayed on the instrument. Blood samples are to be collected from patients attending an INR clinic who are on Warfarin Therapy. The samples are to be used in a series of experiments in the laboratory to test the Microvisk Point Of Care (POC) INR Monitors accuracy, precision, stability and robustness.

• REC name

  Wales REC 5

• REC reference

  15/WA/0060

• Date of REC Opinion

  20 Feb 2015

• REC opinion

  Favourable Opinion