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

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.