Verifying measurements on Siemens Atellica® instruments using clinically acceptable analytical performance...

Area of Science:

• Clinical Chemistry and Laboratory Medicine
• Analytical Performance Verification
• Diagnostic Test Evaluation

Background:

• Clinical chemistry analyser measurements require verification for clinical utility.
• Clinically Acceptable Analytical Performance Specifications (CAAPS) guide performance standards.
• Intra-individual biological variation (CV) is a key component of performance evaluation.

Purpose of the Study:

• To verify the performance of Siemens Atellica® Solution chemistry analysers.
• To compare measured analytical variation (CV) against established CAAPS for six measurands.
• To assess the clinical applicability of analyser measurements based on performance verification.

Main Methods:

• Estimated analytical variation (CV) for six measurands: B-HbA1c, U-Alb, P-Na, P-AmylP, P-LDL-C, and P-Crea.
• Calculated experimental CV using single-instrument imprecision, parallel instrument variation, and bias estimation.
• Compared experimental CV with pre-defined CAAPS for each measurand.

Main Results:

• Three of six measurands met their respective CAAPS.
• Specific CVs reported: B-HbA1c (1.4%), U-Alb (10.9%), P-Na (1.2%), P-AmylP (8.2%), P-LDL-C (4.9%), P-Crea (4.2%).
• P-Na measurements suggest a need for assay improvement, particularly for emergency patient samples.

Conclusions:

• Analytical variation (CV) must be considered when establishing diagnostic targets for laboratory tests.
• The study highlights the necessity of rigorous performance verification for clinical chemistry analysers.
• CAAPS provide crucial benchmarks for assessing the clinical suitability of diagnostic measurements.