Liberty Analyzer WBC System: Reference Interval Study

NCT07031882 | Not Yet Recruiting

• 1 other identifier: CTM-PRO-00174
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to establish the reference intervals for WBC and granulocytes for the Liberty Analyzer WBC System.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.

  Through study completion, an average of 1 day

• To establish the 95% reference interval for absolute granulocytes for the Liberty Analyzer WBC System, reported with 90% confidence intervals.

  Through study completion, an average of 1 day

Study Arms (1)

Healthy volunteers

Device: Liberty Analyzer WBC System

Interventions

Liberty Analyzer WBC System DEVICE

Participants will donate capillary samples to be analysed by the Liberty Analyzer System WBC

Healthy volunteers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-diseased adults.

You may qualify if:

• Aged ≥21 years old at the time of study entry
• Able to provide written informed consent

You may not qualify if:

• Inadequate use and understanding of the English language, requiring a translator
• Undergone tattooing or body piercing within the 7 days prior to the study visit
• Undergone vaccination within the 7 days prior to the study visit
• Episode of upper respiratory infection within the 30 days prior to the study visit
• Use of oral corticosteroid medications within the 30 days prior to the study visit
• Undergone surgery within the 90 days prior to the study visit
• Been hospitalised within the 90 days prior to the study visit
• Donated blood or plasma within the 90 days prior to the study visit
• Pregnant at the time of the study visit
• Breastfeeding at the time of the study visit
• Current diagnosis of anemia (including iron deficiency anemia, vitamin deficiency anemia, aplastic anemia and/or hemolytic anemia)
• Current diagnosis of high blood pressure
• Current diagnosis of diabetes mellitus
• History or current diagnosis of chronic kidney disease or end-stage renal disease
• History or current diagnosis of cancer

Sponsors & Collaborators

• Entia Ltd: lead

Central Study Contacts

Hannah Rawlinson-Smith

CONTACT

+447599481041; hannah.rawlinson-smith@entia.co

Entia Clinical Team

CONTACT

+447599481041; clinical@entia.co

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 22, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06