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Development of nation-wide reference intervals using an indirect method and harmonized assays.

James K Fleming1, Alex Katayev2, Candace M Moorer2

  • 1Laboratory Corporation of America,® Holdings (retired), USA.

Clinical Biochemistry
|October 9, 2021
PubMed
Summary

This study presents the largest collection of reference intervals (RIs) calculated using an indirect method with big data. These robust RIs cover diverse populations and age groups, improving pediatric and geriatric test result interpretation.

Keywords:
Big DataComputerizationData MiningHarmonizationIndirect MethodReference Intervals

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Area of Science:

  • Clinical Laboratory Science
  • Biostatistics
  • Medical Diagnostics

Background:

  • Traditional reference interval (RI) determination relies on direct sampling or biochemical screening.
  • Indirect calculation methods using patient data are gaining prominence, endorsed by the IFCC.
  • Accurate RIs are crucial for interpreting laboratory test results.

Purpose of the Study:

  • To establish a comprehensive dataset of age and gender-specific reference intervals (RIs) using an indirect calculation method.
  • To leverage big data for more robust and inclusive RI determination.
  • To facilitate accurate interpretation of laboratory tests across all age groups.

Main Methods:

  • Utilized a large database of 72 million patient test results from Laboratory Corporation of America.
  • Employed a modified indirect calculation method (Hoffmann) for RI determination.
  • Ensured representation of diverse US populations across various age demographics (neonatal to geriatric).

Main Results:

  • Generated reference intervals for 266 analytes across approximately 2,700 age categories.
  • The dataset represents a nationwide, unbiased sample regarding age, gender, race, and geography.
  • This large-scale indirect calculation provides statistically powerful results.

Conclusions:

  • This work represents the largest collection of indirectly calculated RIs to date.
  • The derived RIs are robust and suitable for clinical chemistry, endocrinology, coagulation, and hematology.
  • This method enhances the determination of pediatric and geriatric RIs, overcoming limitations of traditional approaches.