Analytical performance evaluation of sensitive and old generation reagent in routine practical use: estradiol...

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Performance Evaluation

Background:

• Accurate measurement of Estradiol (E2) is crucial in medical diagnostics.
• Total Error (TE) and sigma analysis are established metrics for assessing laboratory test quality.
• Evaluating reagent performance is vital for reliable patient results.

Purpose of the Study:

• To assess the analytical performance of Beckman Coulter Access Estradiol (E2) and Sensitive E2 reagents.
• Compare the Total Error (TE), sigma analysis, and measurement uncertainty of the two E2 reagents.
• Determine the suitability of the sensitive E2 reagent for clinical laboratory use.

Main Methods:

• Utilized quality control data from December 2017 to December 2019.
• Employed Total Error (TE) and sigma analysis for performance evaluation.
• Calculated measurement uncertainty using ISO/TS 20914 guidelines and CLIA-2019 for TEa limits.

Main Results:

• Sensitive E2 reagent showed significantly lower median TE (11.16%) compared to the old reagent (27.46%).
• Process sigma results improved from below 3 sigma with the old reagent to above 3 sigma for 11 months with the new reagent.
• Measurement uncertainty was higher for the old reagent and at lower concentration levels for both reagents.

Conclusions:

• The sensitive E2 reagent offers superior analytical performance over the old reagent regarding TE, process sigma, and measurement uncertainty.
• Both autoanalyzers showed improved performance with the sensitive E2 reagent.
• Further optimization of the sensitive E2 reagent is recommended for improved accuracy at low E2 concentrations.