Liberty Analyzer WBC System: Reference Interval Study (REFINE)

Entia

Status: Not yet enrolling

Conditions: Healthy Volunteers

Treatments: Device: Liberty Analyzer WBC System

Study type: Observational

Funder types: Industry

Identifiers

NCT07031882

CTM-PRO-00174

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Healthy volunteers

Treatment:

Device: Liberty Analyzer WBC System