CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter DxC biochemical
Petra A T Araújo1, Dylan Thomas1, Tara Sadeghieh1
1CALIPER Program, Paediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Insights
Pediatric reference intervals from the CALIPER database were successfully transferred to Beckman Coulter DxC800 assays for most biochemical markers. This allows broader use of these vital pediatric reference intervals in clinical settings.
Area of Science:
- Clinical Chemistry
- Pediatric Laboratory Medicine
- Biochemical Assays
Background:
- The CALIPER program provides extensive pediatric reference intervals for biochemical markers, primarily using Abbott ARCHITECT assays.
- Broader clinical application necessitates evaluating assay transference to other platforms, such as Beckman Coulter.
Purpose of the Study:
- To assess the transferability of CALIPER pediatric reference intervals to 36 Beckman Coulter Synchron Unicel DxC800 assays.
- To validate the transferred reference intervals using established clinical laboratory guidelines (CLSI C28-A3/EP9-A3).
Main Methods:
- Compared 36 biochemical assays using 200 pediatric serum specimens on Abbott ARCHITECT ci8200 and Beckman Coulter DxC800 platforms.
- Evaluated assay correlation using R(2) values, regression analysis, standardized residuals, Bland-Altman, and quantile-quantile plots.
- Verified transferred reference intervals by analyzing samples from 100 healthy children on the Beckman Coulter system.
Main Results:
- Reference intervals for 31 out of 36 biochemical assays were transferable to Beckman Coulter DxC800 assays.
- Newly calculated intervals were verified for 28 out of 31 transferable assays.
- Eighteen assays showed excellent correlation (R(2)≥0.95), and 13 showed strong correlation (0.77≤R2≤0.94).
Conclusions:
- Successful transference of numerous biochemical markers from the CALIPER database to Beckman Coulter DxC800 assays was achieved.
- This transference facilitates wider utilization of CALIPER pediatric reference intervals at institutions using Beckman Coulter DxC assays.
Background:
The CALIPER program has established a comprehensive database of age- and sex-stratified pediatric reference intervals for over 85 common biochemical markers, largely using the Abbott ARCHITECT assays. To allow a broader application of the CALIPER database, we examined transference to 36 Beckman Coulter Synchron Unicel DxC800 assays, based on the CLSI C28-A3/EP9-A3 guidelines.
Methods:
Patient sample comparisons were performed for 36 biochemical assays using 200 serum specimens obtained from pediatric patients on the Abbott ARCHITECT ci8200 and the Beckman Coulter DxC800. For each analyte, R(2) values were calculated to assess the quality of correlation between the platforms. Statistical criteria used to assess transferability included a) regression analysis to create the equation of the line of best fit, b) standardized residual, c) Bland-Altman, and d) quantile-quantile plots. Transferred reference intervals were further verified by analyzing serum samples from 100 healthy children from the CALIPER cohort on the Beckman Coulter system.
Results:
The reference intervals for most of the assessed analytes were transferable to Beckman Coulter assays (31 out of 36 studied) and the newly calculated reference intervals were verified through analysis of CALIPER reference samples (28 out of 31). Eighteen assays demonstrated excellent correlation (R(2)≥0.95), and 13 assays showed strong correlation (0.77≤R2≤0.94).
Conclusion:
The current study allowed successful transference of a large number of biochemical markers from the CALIPER database to assays on the Beckman Coulter DxC800 platform. Transference should facilitate broader application of CALIPER reference intervals at pediatric centers using DxC biochemical assays.
