Mindray Pediatric Hematology Reference Intervals Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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)
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This study is regulated by 'Canada: Health Canada'
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This study has been reviewed and approved by 'Canada: Ethics Review Committee'
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy CALIPER Participants 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. |
Diagnostic Test: Hematology Parameters
Measurement of hematology parameters on BC-6800Plus
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Outcome Measures
Primary Outcome Measures
- White Blood Cell count [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
- 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
- Neutrophil percentage [Within 8 hours of sample collection]
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
- 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
- Lymphocyte 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
- Monocyte percentage [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
- Immature Granulocyte 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
- 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
- Immature reticulocyte fraction [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
- Middle fluorescent ratio [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
- Red blood cell count [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
- Mean Corpuscular Volume [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
- Mean Corpuscular Hemoglobin Concentration [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
- 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
- Nucleated red blood cell (NRBC) number [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 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
- Platelet Distribution Width [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
- Immature Platelet Fraction [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
- Platelet-large cell count [Within 8 hours of sample collection]
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
Secondary Outcome Measures
- High fluorescent Cell number [Within 8 hours of sample collection]
Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer
- High fluorescent Cell percentage [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
- 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
- Optical White 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
- Total nucleated cell counts - DIFF [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
- Immature Eosinophil number [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
- Low forward scatter NRBC ratio [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
- Platelet-to-lymphocyte ratio [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
- Total nucleated cell counts [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
- Infected Red Blood Cell permillage [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
- Macrocyte count [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
- 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
- Red Blood Cell Fragment 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
- Reticulocyte Production Index [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
- Immature Platelet Count [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 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 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 lymphocyte 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 fluorescent 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
- 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
- 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 RBC count [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
- Dimorphic population, smaller distribution mean corpuscular volume [Within 8 hours of sample collection]
Laboratory value 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
- Mean Corpuscular Hemoglobin of Reticulocyte [Within 8 hours of sample collection]
Laboratory value 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
- Mean Platelet Concentration [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
- Hyperchromic Red Blood Cell percentage (Hyper%) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 0-<19 years
Exclusion Criteria:
-
History of chronic illness
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Use of prescription medications within 2 weeks of collection
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Acute illness within 7 days of collection
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hospital for Sick Children | Toronto | Ontario | Canada | M5G1X8 |
Sponsors and Collaborators
- The Hospital for Sick Children
- MINDRAY
Investigators
- Principal Investigator: Khosrow Khosrow, PhD, The Hospital for Sick Children
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB1000069402