NCT07031882暂停不适用
Liberty Analyzer WBC System: Reference Interval Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Entia Ltd
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
研究概览
简要总结
The purpose of this study is to establish the reference intervals for WBC and granulocytes for the Liberty Analyzer WBC System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥21 years old at the time of study entry
- •Able to provide written informed consent
排除标准
- •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)
- •Hepatitis B/C
- •G6PD Deficiency
- •Sickle Cell Disease/Trait
- •Inflammatory Bowel Disease (IBD)
- •Eptein Barr virus
- •CMV Cytomegalovirus
- •Myelodysplastic Syndromes (MDS) / CMML
- •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
研究组 & 干预措施
Healthy volunteers
干预措施: Liberty Analyzer WBC System (Device)
结局指标
主要结局
To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
时间窗: 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.
时间窗: Through study completion, an average of 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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