An Adaptive Pilot Study to Assess Usability of Blood Collection Device in the Home Environment

boston microfluidics, usability of home collection device

The NeoTainer is a blood collection, storage and transportation device intended to be used both in a healthcare setting by a trained healthcare worker and in a home or other non-healthcare settings. The NeoTainer eliminates the need for a patient to visit a phlebotomy lab and eliminates the cost associated with a phlebotomy drawn vacutainer sample. The device in development allows patients to self-collect a sample using a finger-stick of blood drawn at their convenience in the privacy of their own home. The device also permits testing to be done at different times of day as well as fasting and non-fasting without the burden of visiting a doctor’s office or blood laboratory. It is expected that this product will have a dramatic impact on a primary care physician’s ability to better manage patients who that are non-compliant with required sample collections. Major lab companies have massive back end testing capacity and already produce high quality test results using a few drops of blood, yet they are underutilized. The NeoTainer will drive the expansion of blood testing into underserved and unserved markets. The current study has been designed to evaluate different proposed prototypes of the investigational NeoTainer device and lancets, both commercial and investigational, for usability and performance.

Your Impact

At home blood collection has the potential to decentralize health care and empower individuals to be in control of their healthcare by testing when and where they want. Feedback from users will drive changes to advance this technology, making it an easy to use device.

Eligibility Criteria

Study Tasks

Ethics

This study has been approved by the New England IRB (IRB00000755 )

Keywords