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CLSI-based transference and verification of CALIPER pediatric reference intervals for 29 Ortho VITROS 5600 chemistry

Victoria Higgins1, Dorothy Truong2, Amy Woroch3

  • 1Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON M5S 1A8, Canada; CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON M5G 1X8, Canada.

Clinical Biochemistry
|January 9, 2018
PubMed

Insights

The CALIPER project successfully transferred pediatric reference intervals (RIs) for 29 biochemical assays to the Ortho VITROS 5600 system. This expands the availability of accurate RIs for pediatric laboratory testing on this platform.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Pediatric Diagnostics

Background:

  • Accurate pediatric reference intervals (RIs) are crucial for interpreting laboratory results.
  • The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) developed a pediatric RI database.
  • CALIPER RIs were initially established for Abbott ARCHITECT assays.

Purpose of the Study:

  • To transfer and validate pediatric reference intervals (RIs) for 29 biochemical assays to the Ortho VITROS 5600 Chemistry System.
  • To expand the CALIPER pediatric RI database for use with Ortho analytical platforms.

Main Methods:

  • Method comparison analysis using Clinical Laboratory Standards Institute (CLSI) guidelines.
  • Measurement of approximately 200 patient serum samples on both Abbott and Ortho assays.
  • Linear regression analysis to transfer RIs, followed by verification with 84 healthy pediatric samples.

Main Results:

  • Successful transfer and verification of 29 pediatric reference intervals (RIs) for biochemical assays.
  • 90% of results from reference samples fell within the transferred confidence limits.
  • Calcium, CO2, total bilirubin, magnesium, and LDH did not meet criteria for transference or verification.

Conclusions:

  • The CALIPER pediatric RI database is now applicable to laboratories using Ortho VITROS 5600 assays.
  • This study enhances the utility of pediatric RIs for clinical laboratories.
  • Verification of CALIPER RIs on specific platforms and local populations is recommended.
Abstract

Keywords:
Biochemical markersCALIPEROrthoPediatricReference intervals

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