Blood Testing at Entia

Blood Donation of Healthy Blood for Prototype Testing at Entia

The investigators are recruiting healthy volunteers to donate a finger prick blood sample or a small venous sample to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Affinity

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1X 8LU
    • Entia Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, enrolled by invitation only

Description

Inclusion Criteria:

• aged 18 years and above
• healthy with no known conditions

Exclusion Criteria:

• Has a known health condition, including blood-borne diseases
• Inadequate understanding of the English language (written and verbal) that would require a translator

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Capillary Sample; This group donates finger prick blood samples to Entia for the purpose of development.	Diagnostic test: Affinity; Blood Analyser
Venous Sample; This group donates venous blood samples to Enta, taken by a registered nurse.	Diagnostic test: Affinity; Blood Analyser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in counts of the device tested blood vs the gold standard tested blood.	Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results when tested on Entia's analyser.	3 years

Collaborators and Investigators

• Sponsor: Entia Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2021
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (ACTUAL): October 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 298186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No