Validation of the HAPPI Kids Continuous Age-Specific Pediatric Reference Intervals.

HAPPI Kids study team, Monsurul Hoq, Sue Matthews, Vicky Karlaftis, Janet Burgess, Susan Donath, John Carlin, Vera Ignjatovic, Paul Monagle

Research output: Contribution to journalArticle

Abstract

Abstract
Introduction
To facilitate best possible patient care, reference intervals (RIs) adopted by a laboratory must be appropriate for the population demographics and where applicable, the analytical principle and/or the analytical instrument used. Whilst guidelines from the Clinical and Laboratory Standard Institute recommend a validation process for discrete RIs, there are no current recommendations for the validation process for continuous RIs. This study aimed to validate recently published, HAPPI Kids continuous RIs, in a routine laboratory.

Methods
Initially, the difference in test results between the primary study laboratory that contributed to previous RIs development and a routine laboratory was assessed using specimens from 77 children tested in both laboratories using the Siemens ADVIA 1800 or Centaur/XP/XPT. Later, validation of the HAPPI Kids RIs was undertaken using 279 paediatric samples tested on the same analyser type in the routine laboratory. The previously published RIs were validated if more than 90% of results in the routine laboratory were within the RIs.

Results
There was minimal evidence of clinically significant differences in test results between the primary and routine laboratories. The continuous RIs were validated after initial analysis for 16 of the 18 biochemistry analytes tested, and after secondary analysis for the remaining 2 analytes.

Conclusion
This study validates the HAPPKI Kids RIs in a routine laboratory, satisfying the laboratory accreditation requirements for evaluation, implementation and sourcing of RIs. In addition, this study presents a modification of the current CLSI method for validation of continuous RIs that will benefit routine laboratories in general.

Impact statement
According to the Clinical Laboratory and Science Institute (CLSI), previously published reference intervals (RIs) need to be validated prior to use. However, there is currently no specific guideline for the validation process when it comes to continuous RIs. Addressing this gap, our study validates, the recently published HAPPI Kids RIs, in a routine laboratory, satisfying the laboratory accreditation requirements for evaluation, implementation and sourcing of RIs. In addition, this study presents a modification to the current CLSI method for validation of continuous RIs that will benefit routine laboratories in general.
Original languageEnglish
Article numberjfaa045
Number of pages8
JournalThe Journal of Applied Laboratory Medicine
Early online date19 Apr 2020
DOIs
Publication statusE-pub ahead of print - 19 Apr 2020

Keywords

  • paediatric
  • reference intervals
  • Validation
  • HAPPIKids

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  • Cite this

    HAPPI Kids study team, Hoq, M., Matthews, S., Karlaftis, V., Burgess, J., Donath, S., Carlin, J., Ignjatovic, V., & Monagle, P. (2020). Validation of the HAPPI Kids Continuous Age-Specific Pediatric Reference Intervals. The Journal of Applied Laboratory Medicine, [jfaa045]. https://doi.org/10.1093/jalm/jfaa045