Establishment of Pediatric Reference Intervals for Mindray Hematology Parameters for Worldwide Application in Clinical Laboratories
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 691
- 试验地点
- 1
- 主要终点
- Eosinophil number
研究概览
简要总结
This study is a collaborative initiative between the CALIPER (Canadian Laboratory Initiative on Pediatric Reference Intervals) program at the Hospital for Sick Children (HSC) and Mindray Medical International Limited to establish a database of pediatric reference intervals for hematology parameters on BC-6800Plus.
详细描述
The purpose of this study is to establish accurate and robust ethnic-, age- and sex-specific reference intervals for hematology parameters during childhood and adolescence on the Mindray analyzer (BC-6800Plus).
Subjects will be recruited for this study through the CALIPER initiative and will include healthy children and adolescents in the community and in outpatient clinics at the Hospital for Sick Children (HSC). Since all participants will be recruited through the CALIPER initiative, the CALIPER consent forms will be used to obtain consent from each child and their parent/guardian. These forms obtain consent to use the samples to develop reference intervals for a range of tests. This study aims to measure hematology parameters in these samples and is therefore encompassed within the CALIPER consent. Recruitment will focus on subjects from three ethnic groups: Caucasians, Hispanics, and South Asians. A total of 960 subjects will be recruited for this study through the CALIPER initiative. The total sample size was determined by considering the requirement of 60-120 samples per partition for five age groups (0-<1 years, 1-<5 years, 5-<10 years, 10-<15 years, 15-<19 years). Each age group will consist of an equal number of females and males. Additional samples may be required if data analysis suggests further age and/or sex partitioning for specific parameters.
Each subject will provide a blood sample, which will be collected through the CALIPER initiative. These samples will be analyzed as part of this study in a secondary-use/retrospective fashion. Specifically, fresh whole blood specimens will be collected in K2EDTA tubes, placed in biohazard bags, stored on ice, and analyzed on the Mindray hematology platform within 8 hours of collection. All available hematology parameters for the BC-6800Plus will be measured (37 report and 48 research hematology parameters, as per the user manual). All procedures will be performed according to the user manual. Mindray quality control materials will be used to monitor the performance of the assays during the study. HSC will retain all quality controls data, maintenance record and reagents/calibrators lot numbers. Quality controls will be run daily and analysis of the CALIPER samples will proceed only after all the quality control (QC) data are acceptable.
Data analysis will be performed by the CALIPER team in accordance with Clinical & Laboratory Standards Institute (CLSI) EP28-A3c guidelines on defining, establishing, and verifying reference intervals in the clinical laboratory. The statistical approach for reference interval establishment has been described in-depth previously. In brief, analyte concentrations will be plotted against age and colour-coded by sex. Following visual inspection, extreme outliers will be removed and suspected age- and sex-specific partitions will be confirmed using the Harris and Boyd statistical method. Normality of data will be qualitatively assessed using quantile-quantile plots and quantitatively assessed using the Shapiro-Wilk's test. If skewed, the Box-Cox transformation will be applied in an effort to transform the data to a normal distribution. Outliers will be subsequently identified and removed using the Tukey or adjusted Tukey method for Gaussian and non-Gaussian data distributions, respectively. Reference intervals for partitions with ≥120 participants will be calculated using the nonparametric method. Reference intervals for partitions with ≥40 and <120 participants (60 for group 0-<1 years and 1-<5 years, 120 for group 5-<10 years, 10-<15 years and 15-<19 years) will be calculated using the robust method. 90% percent confidence intervals will also be calculated for the lower and upper limit of each reference interval. Ethnic-specific reference intervals will be calculated if sample size for each ethnic group is adequate. Otherwise, reference value distributions for South Asian and Hispanic children will be compared to those of Caucasian children.
Oversight Authority (additional information)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0-<19 years
排除标准
- •History of chronic illness
- •Use of prescription medications within 2 weeks of collection
- •Acute illness within 7 days of collection
- •Pregnancy
结局指标
主要结局
Eosinophil number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Eosinophil percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Middle fluorescent ratio
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Basophil number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Granulocyte number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hemoglobin Concentration
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet-large cell ratio
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Lymphocyte number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Monocyte percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature reticulocyte fraction
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red blood cell count
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Volume
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red Blood Cell Distribution Width - Coefficient of Variation
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Nucleated red blood cell percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet Distribution Width
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Basophil percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Neutrophil number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Granulocyte percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
High fluorescent ratio
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Hemoglobin
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red Blood Cell Distribution Width - Standard Deviation
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hematocrit
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet count
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Platelet Fraction
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet-large cell count
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
White Blood Cell count
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Neutrophil percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte Hemoglobin Expression
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Hemoglobin Concentration
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Nucleated red blood cell (NRBC) number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Platelet Volume
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Lymphocyte percentage
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Monocyte number
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Low fluorescent ratio
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Plateletcrit
时间窗: Within 8 hours of sample collection
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
次要结局
- High fluorescent Cell percentage(Within 8 hours of sample collection)
- Immature Eosinophil percentage(Within 8 hours of sample collection)
- High forward scatter NRBC ratio(Within 8 hours of sample collection)
- Platelet-to-lymphocyte ratio(Within 8 hours of sample collection)
- Macrocyte percentage(Within 8 hours of sample collection)
- Optical White Blood Cell count(Within 8 hours of sample collection)
- Total nucleated cell counts - DIFF(Within 8 hours of sample collection)
- Low forward scatter NRBC ratio(Within 8 hours of sample collection)
- Reticulocyte Production Index(Within 8 hours of sample collection)
- High fluorescent Cell number(Within 8 hours of sample collection)
- Optical Red Blood Cell count(Within 8 hours of sample collection)
- White blood cell counts - Differential (DIFF)(Within 8 hours of sample collection)
- Immature Eosinophil number(Within 8 hours of sample collection)
- Microcyte count(Within 8 hours of sample collection)
- Microcyte percentage(Within 8 hours of sample collection)
- Platelet Distribution Width Standard Deviation(Within 8 hours of sample collection)
- Immature Platelet Count(Within 8 hours of sample collection)
- DIFF scattergram, mean neutrophil distribution-side scatter intensity(Within 8 hours of sample collection)
- DIFF scattergram, mean lymphocyte distribution-side scatter intensity(Within 8 hours of sample collection)
- Mean Hemoglobin Distribution Width of Red Blood Cell(Within 8 hours of sample collection)
- Infected Red Blood Cell permillage(Within 8 hours of sample collection)
- Optical Platelet count(Within 8 hours of sample collection)
- Platelet count - Impedance(Within 8 hours of sample collection)
- Neutrophil-to-lymphocyte ratio(Within 8 hours of sample collection)
- Total nucleated cell counts(Within 8 hours of sample collection)
- Infected Red Blood Cell count(Within 8 hours of sample collection)
- Mean Reticulocyte Volume(Within 8 hours of sample collection)
- Red Blood Cell Fragment Count(Within 8 hours of sample collection)
- High fluorescent Immature Platelet Fraction(Within 8 hours of sample collection)
- Dimorphic population, larger distribution RBC count(Within 8 hours of sample collection)
- White blood cell count - white cell nucleated basophil channel (WNB)(Within 8 hours of sample collection)
- Macrocyte count(Within 8 hours of sample collection)
- Red Blood Cell Fragment Percentage(Within 8 hours of sample collection)
- DIFF scattergram, mean lymphocyte distribution-side fluorescent intensity(Within 8 hours of sample collection)
- DIFF scattergram, mean monocyte distribution-forward scatter intensity(Within 8 hours of sample collection)
- Dimorphic population, smaller distribution mean corpuscular volume(Within 8 hours of sample collection)
- Mean Corpuscular Hemoglobin of Reticulocyte(Within 8 hours of sample collection)
- Mean Platelet Concentration(Within 8 hours of sample collection)
- DIFF scattergram, mean neutrophil distribution-side fluorescent light intensity(Within 8 hours of sample collection)
- DIFF scattergram, mean lymphocyte distribution-forward scatter intensity(Within 8 hours of sample collection)
- Dimorphic population, smaller distribution RBC count(Within 8 hours of sample collection)
- Mean Platelet Matter Content(Within 8 hours of sample collection)
- Hypochromic Red Blood Cell percentage(Within 8 hours of sample collection)
- DIFF scattergram, mean neutrophil distribution-forward scatter intensity(Within 8 hours of sample collection)
- DIFF scattergram, mean monocyte distribution-side scatter intensity(Within 8 hours of sample collection)
- DIFF scattergram, mean monocyte distribution-side fluorescent light intensity(Within 8 hours of sample collection)
- Dimorphic population, larger distribution mean corpuscular volume(Within 8 hours of sample collection)
- Hyperchromic Red Blood Cell percentage (Hyper%)(Within 8 hours of sample collection)
研究者
Khosrow Adeli
Head of Clinical Biochemistry
The Hospital for Sick Children