PocDoc Lipids Usability Study for Self-test Use

Vital Signs Solutions Ltd50 enrolled

Overview

This study seeks to expand the approved indication of use for a UKCA approved IVD device. PocDoc lipids is approved for professional use to measure the levels of lipids in a fingerprick blood samples. This study will investigate the usability of the device by untrained lay people in order to expand the device's utility to the self-test setting.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Hyperlipidemias

Interventions

PocDocDIAGNOSTIC_TEST

Point of care digital lipid test

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent form * Subjects are legally competent and capable to understand character, meaning and consequences of the study * Subjects own an approved mobile device (these will be available at the time of the study on the PocDoc website and a link will be contained in the PIS) Exclusion Criteria: * Being unable to give informed consent * \< 18 years or \> 85 years * Legally incompetent * Language barriers potentially compromising an adequate compliance with study procedures

Locations (1)

Vital Signs Solutions Ltd

Cambridge, United Kingdom

Outcomes

Primary Outcomes

Usability

The usability study will pass our acceptance criteria if 95% of the users are able to successfully conduct a PocDoc lipid test, obtaining a result. The PocDoc lipid test is a rapid 5-marker lipid test in lateral flow format that uses a smartphone application to analyse and display the result. Usability is defined as the ability of an individual to navigate the mobile application steps to conduct the rapid lateral flow test, to take a picture of the image and to navigate to the results page of the application to see their results. A successful test is one where the individual successfully completes all steps and gets their result.

Time frame: Day 1 - one single test done at one timepoint

Data from ClinicalTrials.gov

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