Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system.

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Pediatric Reference Intervals

Background:

• Accurate clinical laboratory service relies on validated reference intervals (RIs).
• New analytical systems necessitate verification of established RIs.
• The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) provides RIs for pediatric populations.

Purpose of the Study:

• To verify published CALIPER pediatric RIs for 28 chemistry assays on the Abbott ARCHITECT system using the newer Alinity system.
• To assess the concordance between Abbott ARCHITECT and Alinity analytical systems for pediatric chemistry assays.

Main Methods:

• Analytical validation of 28 chemistry assays on the Alinity system using 100 CALIPER serum samples.
• Comparison of Alinity results against published pediatric RIs and confidence limits from the Abbott ARCHITECT system.
• Verification criteria based on Clinical and Laboratory Standards Institute (CLSI) guidelines (≥90% of results within confidence limits).

Main Results:

• 26 out of 28 assays met the verification criteria.
• Calcium (87%) and magnesium (35%) assays did not meet verification criteria based on ARCHITECT RIs.
• Calcium and magnesium assays were verifiable using Abbott Alinity package insert RIs.

Conclusions:

• CALIPER ARCHITECT RIs were successfully verified on the Alinity system for most assessed chemistry assays.
• Demonstrated concordance between Abbott ARCHITECT and Alinity systems supports the implementation of the Alinity system in pediatric settings.
• Verification of RIs is crucial for accurate interpretation of pediatric laboratory test results.