Liberty Analyzer WBC System: Reference Interval Study

NCT ID: NCT07031882

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy volunteers

Liberty Analyzer WBC System

Intervention Type DEVICE

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

Interventions

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Liberty Analyzer WBC System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hannah Rawlinson-Smith

Role: CONTACT

+447599481041

Entia Clinical Team

Role: CONTACT

+447599481041

Other Identifiers

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CTM-PRO-00174

Identifier Type: -

Identifier Source: org_study_id

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