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Transference of CALIPER pediatric reference intervals to biochemical assays on the Roche cobas 6000 and the Roche
Victoria Higgins1, Man Khun Chan2, Michelle Nieuwesteeg2
1CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON, Canada.
Insights
Pediatric reference intervals from the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) were successfully transferred to Roche systems. This broadens the CALIPER database for harmonized pediatric laboratory testing.
Area of Science:
- Clinical Chemistry
- Pediatric Laboratory Medicine
- Reference Interval Development
Background:
- The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) established pediatric reference intervals for biochemical markers on the Abbott Architect system.
- Previous work successfully transferred CALIPER intervals to Roche, Beckman, Ortho, and Siemens assays.
Purpose of the Study:
- To expand the CALIPER database by transferring and verifying pediatric reference intervals for 52 biochemical assays on Roche cobas 6000 and Roche Modular P systems.
- To assess the transferability and verification of established pediatric reference intervals across different analytical platforms.
Main Methods:
- Utilized Clinical and Laboratory Standards Institute (CLSI) guidelines (C28-A3 and EP9-A2) for reference interval transference.
- Attempted transference for 16 assays on the Roche cobas 6000 and 36 assays on the Roche Modular P.
- Verified transferable intervals using 100 healthy pediatric samples from the CALIPER cohort.
Main Results:
- High correlation observed between assay systems, with 81% (cobas 6000) and 86% (Modular P) of assays showing transferable intervals from Abbott.
- Bicarbonate and magnesium were not transferable to either Roche system; calcium and prealbumin were not transferable to the Modular P.
- Verified transferability rates were 62% for cobas 6000 and 61% for Modular P.
Conclusions:
- This study successfully extended the CALIPER database to include Roche cobas 6000 and Modular P analytical systems.
- Facilitates wider application of CALIPER pediatric reference intervals in centers using Roche biochemical assays.
- Supports future efforts to develop common reference intervals across multiple platforms for harmonized laboratory test interpretation in pediatric diagnostics.
Objectives:
The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has recently established pediatric age- and sex-specific reference intervals for over 85 biochemical markers on the Abbott Architect system. Previously, CALIPER reference intervals for several biochemical markers were successfully transferred from Abbott assays to Roche, Beckman, Ortho, and Siemens assays. This study further broadens the CALIPER database by performing transference and verification for 52 biochemical assays on the Roche cobas 6000 and the Roche Modular P.
Design And Methods:
Using CLSI C28-A3 and EP9-A2 guidelines, transference of the CALIPER reference intervals was attempted for 16 assays on the Roche cobas 6000 and 36 on the Modular P. Calculated reference intervals were further verified using 100 healthy CALIPER samples.
Results:
Most assays showed strong correlation between assay systems and were transferable from Abbott to the Roche cobas 6000 (81%) and the Modular P (86%). Bicarbonate and magnesium were not transferable on either system and calcium and prealbumin were not transferable to the Modular P. Of the transferable analytes, 62% and 61% were verified on the cobas 6000 and the Modular P, respectively.
Conclusions:
This study extends the utility of the CALIPER database to two additional analytical systems, which facilitates the broad application of CALIPER reference intervals at pediatric centers utilizing Roche biochemical assays. Transference studies across different analytical platforms can later be collectively analyzed in an attempt to develop common reference intervals across all clinical chemistry instruments to harmonize laboratory test interpretation in diagnosis and monitoring of pediatric disease.
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