NCT07031882
Liberty Analyzer WBC System: Reference Interval Study
Enrolling by Invitation
Not specifiedAges 21+ObservationalEntia Ltd
~300 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Liberty Analyzer WBC System
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
Measured over Through study completion, an average of 1 day
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Aged ≥21 years old at the time of study entry
Able to provide written informed consent
Exclusion
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
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
What this trial measures
- 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