Liberty Analyzer WBC System: Reference Interval Study

Not yet recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT07031882
• Lead Sponsor: Entia Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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