Mindray Pediatric Hematology Reference Intervals Study
- Conditions
- Establish Hematology Reference Intervals
- Interventions
- Diagnostic Test: Hematology Parameters
- Registration Number
- NCT04758208
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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.
- Detailed Description
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)
* This study is regulated by 'Canada: Health Canada'
* This study has been reviewed and approved by 'Canada: Ethics Review Committee'
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 691
- 0-<19 years
- History of chronic illness
- Use of prescription medications within 2 weeks of collection
- Acute illness within 7 days of collection
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy CALIPER Participants Hematology Parameters Healthy community children and adolescents recruited through the CALIPER initiative as well as healthy children and adolescents recruited from outpatient clinics at the Hospital for Sick Children through the CALIPER initiative. Blood samples from these participants will be tested on the Mindray BC-6800Plus device to measure hematology parameters and establish reference intervals.
- Primary Outcome Measures
Name Time Method Eosinophil number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Eosinophil percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Middle fluorescent ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hemoglobin Concentration Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet-large cell ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Volume Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Basophil percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Neutrophil number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Granulocyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
High fluorescent ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Hemoglobin Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red Blood Cell Distribution Width - Standard Deviation Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hematocrit Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Platelet Fraction Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet-large cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Platelet Volume Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Basophil number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Granulocyte number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Monocyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature reticulocyte fraction Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red blood cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Lymphocyte number 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 Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Nucleated red blood cell percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet Distribution Width Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
White Blood Cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Neutrophil percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte Hemoglobin Expression Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Hemoglobin Concentration Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Nucleated red blood cell (NRBC) number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Lymphocyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Monocyte number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Low fluorescent ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Plateletcrit Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
- Secondary Outcome Measures
Name Time Method High fluorescent Cell percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Eosinophil percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
High forward scatter NRBC ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet-to-lymphocyte ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
High fluorescent Cell number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Optical Red Blood Cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
White blood cell counts - Differential (DIFF) Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Eosinophil number Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Microcyte count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Microcyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet Distribution Width Standard Deviation Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Immature Platelet Count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Optical Platelet count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Platelet count - Impedance Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Neutrophil-to-lymphocyte ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Infected Red Blood Cell permillage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Macrocyte percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Infected Red Blood Cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Reticulocyte Volume Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red Blood Cell Fragment Count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
High fluorescent Immature Platelet Fraction Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Dimorphic population, larger distribution RBC count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Optical White Blood Cell count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Total nucleated cell counts - DIFF Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Low forward scatter NRBC ratio Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Reticulocyte Production Index Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean neutrophil distribution-side scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean lymphocyte distribution-side scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Hemoglobin Distribution Width of Red Blood Cell Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Total nucleated cell counts Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
White blood cell count - white cell nucleated basophil channel (WNB) Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Macrocyte count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Red Blood Cell Fragment Percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean lymphocyte distribution-side fluorescent intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean monocyte distribution-forward scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Dimorphic population, smaller distribution mean corpuscular volume Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Corpuscular Hemoglobin of Reticulocyte Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Platelet Concentration Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean neutrophil distribution-side fluorescent light intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean lymphocyte distribution-forward scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Dimorphic population, smaller distribution RBC count Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Mean Platelet Matter Content Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hypochromic Red Blood Cell percentage Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Hyperchromic Red Blood Cell percentage (Hyper%) Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean neutrophil distribution-forward scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean monocyte distribution-side scatter intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
DIFF scattergram, mean monocyte distribution-side fluorescent light intensity Within 8 hours of sample collection Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Dimorphic population, larger distribution mean corpuscular volume Within 8 hours of sample collection Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada