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Milestones

  1. Development of a study design
  2. Research Ethics Board (REB) approvals
  3. Consent forms, questionnaires, specimen collection and handling protocols designed, standardized and harmonized among all study centres
  4. Pre-analytical, analytical, and post-analytical steps designed and harmonized
  5. Implementation of a promotion and recruitment plan: initiation of major promotional campaigns and development of promotional tools (posters, banners, brochures, postcards, storybook)
  6. Establishment of the CALIPER volunteer team: volunteers assist with all aspects of the project, including behind-the-scenes administrative tasks, promotion and recruitment in the community, front-line work with children and families, and lab work such as sample processing
  7. Development of the CALIPER websites
  8. Completion and publication of several pilot studies on the Abbott Architect ci8200, Roche Cobas 6000, and Ortho Vitros Fusion 5.1 platforms using data from outpatient clinic samples
    • Small pilot studies were also initiated in collaboration with diagnostic industry partners who provided reagents and instruments to analyze paediatric samples (obtained from outpatient clinics with relatively healthy children) on specific clinical instruments.

      These pilot studies allowed for determination of preliminary reference intervals for some laboratory tests, and helped the research team gain valuable practical experience with all aspects of sample collection, testing, statistical analysis, and determination of age- and gender-specific reference intervals.
  9. Completion of analyte stability study – analyte stability was examined in serum samples from children of different age groups after the samples were stored for up to 13 months at -80°C. Most analytes showed stability within the analytical variation of the assays
  10. Completion of fasting and diurnal variation study – analyte levels with and without fasting and at different times of the day were measured and compared. More analytes are relatively stable throughout the day regardless of fasting state or food intake.
  11. Publication of the CALIPER database of pediatric reference intervals for chemistry and immunoassay biomarkers, endocrine and fertility hormones, vitamins, cancer biomarkers and a growing number of other specialty assays. The reference intervals are partitioned by age and sex where necessary.
  12. Although the paediatric reference interval database was initially based on biomarker measurements on the Abbott Architect analytical platform, transference studies have been performed to transfer the reference intervals to other commonly used analytical platforms including Beckman, Siemens, Ortho and Roche. Further transference and full studies are under way to continue to expand the CALIPER database.
  13. Development of the CALIPER reference app for iPhone and Android, now available through iTunes and Google Play.
  14. The CALIPER principal investigator has been awarded a seven-year CIHR Foundation Grant (2016-2023) to continue CALIPER initiatives.
  15. Development of an external quality assurance/harmonization program in collaboration with CEQAL
  16. Through a series of collaborations and transference studies, CALIPER has been assisting several other paediatric hospitals in Canada, USA, and internationally to implement routine use of CALIPER Reference Intervals in their clinical practice.
  17. The CALIPER database is now accessed by thousands of scientists and laboratory specialists from 68 countries worldwide.
  18. CALIPER was awarded the 2015 Innovations Award by the Canadian Society of Clinical Chemists in recognition of its major contributions to paediatric laboratory medicine.