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CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche
Mathew P Estey1, Ashley H Cohen, David A Colantonio
1CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Canada.
Insights
The CALIPER program expanded pediatric reference intervals to five major clinical chemistry platforms. This increases the global applicability of these essential biochemical markers for children and adolescents.
Area of Science:
- Clinical Chemistry
- Pediatric Reference Intervals
- Biochemical Markers
Background:
- The CALIPER program previously established pediatric reference intervals for 40 biochemical markers.
- The initial database was limited to Abbott ARCHITECT assays.
Purpose of the Study:
- To expand the CALIPER pediatric reference interval database to include assays from other major manufacturers.
- To enhance the widespread clinical application of CALIPER reference intervals.
Main Methods:
- Reference intervals were statistically transferred to Beckman Coulter, Ortho Vitros, Roche Cobas, and Siemens Vista platforms.
- Validation involved 100 reference specimens from healthy children and adolescents.
- External quality assessment (EQA) was conducted for all participating testing centers.
Main Results:
- Transferred pediatric reference intervals generally aligned with previous findings.
- Significant assay-specific differences in reference limits were observed for numerous analytes.
- EQA results reflected the similarities and differences in reference limits across manufacturers.
Conclusions:
- The study successfully extended the CALIPER reference interval database to five major analytical platforms.
- This expansion facilitates the global use of CALIPER pediatric reference intervals in clinical settings.
Objectives:
The CALIPER program recently established a comprehensive database of age- and sex-stratified pediatric reference intervals for 40 biochemical markers. However, this database was only directly applicable for Abbott ARCHITECT assays. We therefore sought to expand the scope of this database to biochemical assays from other major manufacturers, allowing for a much wider application of the CALIPER database.
Design And Methods:
Based on CLSI C28-A3 and EP9-A2 guidelines, CALIPER reference intervals were transferred (using specific statistical criteria) to assays performed on four other commonly used clinical chemistry platforms including Beckman Coulter DxC800, Ortho Vitros 5600, Roche Cobas 6000, and Siemens Vista 1500. The resulting reference intervals were subjected to a thorough validation using 100 reference specimens (healthy community children and adolescents) from the CALIPER bio-bank, and all testing centers participated in an external quality assessment (EQA) evaluation.
Results:
In general, the transferred pediatric reference intervals were similar to those established in our previous study. However, assay-specific differences in reference limits were observed for many analytes, and in some instances were considerable. The results of the EQA evaluation generally mimicked the similarities and differences in reference limits among the five manufacturers' assays. In addition, the majority of transferred reference intervals were validated through the analysis of CALIPER reference samples.
Conclusions:
This study greatly extends the utility of the CALIPER reference interval database which is now directly applicable for assays performed on five major analytical platforms in clinical use, and should permit the worldwide application of CALIPER pediatric reference intervals.
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