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Completed

NCT Number: NCT04758208

Mindray Pediatric Hematology Reference Intervals Study

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.

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Key information

Conditions

Establish Hematology Reference Intervals

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

About this study

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'

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 0-<19 years

Exclusion criteria

  • History of chronic illness
  • Use of prescription medications within 2 weeks of collection
  • Acute illness within 7 days of collection
  • Pregnancy

Treatment and study plan

Hematology Parameters

Diagnostic Test

Measurement of hematology parameters on BC-6800Plus

Primary outcomes

  1. White Blood Cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  2. Basophil number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  3. Basophil percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  4. Neutrophil number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  5. Neutrophil percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  6. Eosinophil number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  7. Eosinophil percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  8. Lymphocyte number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  9. Lymphocyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  10. Monocyte number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  11. Monocyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  12. Immature Granulocyte number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  13. Immature Granulocyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  14. Reticulocyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  15. Reticulocyte number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  16. Reticulocyte Hemoglobin Expression

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  17. Immature reticulocyte fraction

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  18. Low fluorescent ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  19. Middle fluorescent ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  20. High fluorescent ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  21. Red blood cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  22. Hemoglobin Concentration

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  23. Mean Corpuscular Volume

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  24. Mean Corpuscular Hemoglobin

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  25. Mean Corpuscular Hemoglobin Concentration

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  26. Red Blood Cell Distribution Width - Coefficient of Variation

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  27. Red Blood Cell Distribution Width - Standard Deviation

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  28. Hematocrit

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  29. Nucleated red blood cell (NRBC) number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  30. Nucleated red blood cell percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  31. Platelet count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  32. Mean Platelet Volume

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  33. Platelet Distribution Width

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  34. Plateletcrit

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  35. Immature Platelet Fraction

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  36. Platelet-large cell ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  37. Platelet-large cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

Secondary outcomes

  1. High fluorescent Cell number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  2. High fluorescent Cell percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  3. Optical Red Blood Cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  4. Optical Platelet count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  5. Platelet count - Impedance

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  6. Optical White Blood Cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  7. White blood cell counts - Differential (DIFF)

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  8. Total nucleated cell counts - DIFF

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  9. Immature Eosinophil percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  10. Immature Eosinophil number

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  11. High forward scatter NRBC ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  12. Low forward scatter NRBC ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  13. Neutrophil-to-lymphocyte ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  14. Platelet-to-lymphocyte ratio

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  15. White blood cell count - white cell nucleated basophil channel (WNB)

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  16. Total nucleated cell counts

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  17. Infected Red Blood Cell count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  18. Infected Red Blood Cell permillage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  19. Microcyte count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  20. Microcyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  21. Macrocyte count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  22. Macrocyte percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  23. Mean Reticulocyte Volume

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  24. Red Blood Cell Fragment Count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  25. Red Blood Cell Fragment Percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  26. Platelet Distribution Width Standard Deviation

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  27. Reticulocyte Production Index

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  28. High fluorescent Immature Platelet Fraction

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  29. Immature Platelet Count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  30. DIFF scattergram, mean neutrophil distribution-side scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  31. DIFF scattergram, mean neutrophil distribution-side fluorescent light intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  32. DIFF scattergram, mean neutrophil distribution-forward scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  33. DIFF scattergram, mean lymphocyte distribution-side scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  34. DIFF scattergram, mean lymphocyte distribution-side fluorescent intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  35. DIFF scattergram, mean lymphocyte distribution-forward scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  36. DIFF scattergram, mean monocyte distribution-side scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  37. DIFF scattergram, mean monocyte distribution-side fluorescent light intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  38. DIFF scattergram, mean monocyte distribution-forward scatter intensity

    Time frame: Within 8 hours of sample collection

    Scattergram of laboratory values derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  39. Dimorphic population, smaller distribution RBC count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  40. Dimorphic population, larger distribution RBC count

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  41. Dimorphic population, smaller distribution mean corpuscular volume

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  42. Dimorphic population, larger distribution mean corpuscular volume

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  43. Mean Corpuscular Hemoglobin of Reticulocyte

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  44. Mean Hemoglobin Distribution Width of Red Blood Cell

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  45. Mean Platelet Concentration

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  46. Mean Platelet Matter Content

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  47. Hyperchromic Red Blood Cell percentage (Hyper%)

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

  48. Hypochromic Red Blood Cell percentage

    Time frame: Within 8 hours of sample collection

    Laboratory value derived from the Mindray BC-6800Plus Auto Hematology Analyzer

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • MINDRAY

Registry information

Official study title

Establishment of Pediatric Reference Intervals for Mindray Hematology Parameters for Worldwide Application in Clinical Laboratories

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.