Liberty Analyzer WBC System: Reference Interval Study (REFINE)

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

Study Overview

• Status: Suspended
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Liberty Analyzer WBC System

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Exercise & Sport Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Non-diseased adults.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• History or current diagnosis of cardiovascular disease
• History or current use of radiotherapy of the chest or abdomen
• History or current diagnosis of the following conditions known to affect the CBC differential count:
• Immune Thrombocytopenic Purpura (ITP)
• Systemic Lupus Erythematosus (SLE)
• Rheumatoid Arthritis (RA)
• Antiphospholipid Syndrome (APS)
• Sjogren's Syndrome
• Tuberculosis (TB)
• HIV
• Hepatitis B/C
• G6PD Deficiency
• Sickle Cell Disease/Trait
• Inflammatory Bowel Disease (IBD)
• Eptein Barr virus
• CMV Cytomegalovirus
• Myelodysplastic Syndromes (MDS) / CMML
• Asplenia

Participants who meet the following criteria will be excluded a posteriori:

• Hemoglobin, hematocrit, red cell and/or total white blood cell count obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
• Iron, ferritin, transferrin, total Iron Binding Capacity (TIBC) and/or transferrin saturation results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
• Alanine aminotransferase (ALT), aspartate aminotransferase ( AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), total bilirubin, conjugated bilirubin, albumin and/or total protein results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
• Creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), sodium, potassium, chloride and/or bicarbonate results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
• C-reactive protein (CRP) results obtained by standard laboratory analysis of the participant's venous blood sample, that fall outside of the applicable reference interval in use at the study site.
• Self-report to be taking medication(s) that are subsequently identified as interfering substances for the Liberty Analyzer WBC System

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Device: Liberty Analyzer WBC System; Participants will donate capillary samples to be analysed by the Liberty Analyzer System WBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Entia Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: June 19, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CTM-PRO-00174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined by study management group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No