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Validation of the HAPPI Kids Continuous Age-Specific Pediatric Reference Intervals
Monsurul Hoq1,2, Susan Matthews3,4, Vicky Karlaftis1
1Murdoch Children's Research Institute, Parkville, Australia.
Insights
This study successfully validated HAPPI Kids continuous reference intervals (RIs) for pediatric biochemistry analytes in a routine laboratory setting. The findings confirm the applicability of these RIs, ensuring accurate patient care and laboratory accreditation.
Area of Science:
- Clinical Biochemistry
- Laboratory Medicine
- Pediatric Diagnostics
Background:
- Appropriate reference intervals (RIs) are crucial for accurate patient care and must align with population demographics and laboratory methods.
- Current Clinical and Laboratory Standard Institute (CLSI) guidelines lack specific recommendations for validating continuous RIs.
Purpose of the Study:
- To validate the recently published HAPPI Kids continuous RIs within a routine laboratory environment.
- To assess the applicability of HAPPI Kids RIs across different laboratory settings and analytical platforms.
Main Methods:
- Compared test results between a primary study laboratory and a routine laboratory using specimens from 77 children.
- Validated HAPPI Kids RIs using 279 pediatric samples on a Siemens ADVIA 1800 or Centaur/XP/XPT analyzer.
- Applied a 90% acceptance criterion for results falling within the established RIs.
Main Results:
- Minimal clinically significant differences were observed between the primary and routine laboratories.
- The HAPPI Kids continuous RIs were validated for 16 of 18 biochemistry analytes after initial analysis.
- The remaining 2 analytes were validated after secondary analysis, confirming the RIs' robustness.
Conclusions:
- The HAPPI Kids RIs are validated for use in routine laboratories, meeting accreditation requirements.
- This study proposes a modified CLSI method for continuous RI validation, benefiting clinical laboratories.
- The validation ensures reliable pediatric biochemistry testing and supports informed clinical decision-making.
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. While guidelines from the Clinical and Laboratory Standard Institute (CLSI) 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 pediatric samples tested on the same analyzer 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 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 of the current CLSI method for validation of continuous RIs that will benefit routine laboratories in general.
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