Commutability between stabilized materials and fresh human serum to improve laboratory performance

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Diagnostic Accuracy

Background:

• Despite technological advances, commutability of laboratory materials is a persistent quality issue.
• Non-commutable controls and calibrators can significantly affect patient status assessments.
• Carrier-bound reagent techniques present unique challenges for quality control.

Purpose of the Study:

• To assess commutability between stabilized materials and clinical specimens for five serum analytes.
• To identify specific problems with non-commutable calibrators and controls in a clinical laboratory setting.
• To minimize the impact of non-commutability on daily laboratory practice and patient care.

Main Methods:

• Evaluated commutability of 27 stabilized materials (controls and calibrators) against clinical specimens.
• Utilized both carrier-bound reagent chemistry and conventional wet methods for analysis.
• Investigated materials for five key serum quantities.

Main Results:

• Major difficulties were encountered in selecting appropriate accuracy controls for carrier-bound reagent techniques.
• Finding materials commutable for multiple analytes simultaneously proved challenging.
• Apparent incongruencies in daily quality surveillance were explained by non-commutable materials.

Conclusions:

• Non-commutability of calibrators and controls negatively impacts laboratory performance.
• Suggestions for reducing non-commutability issues include improved value assignment for multicalibrators.
• A collaborative effort among manufacturers, external quality assessment schemes, and laboratories is crucial to address commutability challenges.