Analytical Performance of Adams A1c HA-8180V: Model for Quality Targets Versus Biological Variation and Sigma Metrics

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Analytical Performance Evaluation

Background:

• Hemoglobin A1c (HbA1c) is crucial for diagnosing type 2 diabetes (T2D) and prediabetes, and for monitoring glycemic control.
• Accurate HbA1c measurements are essential for effective clinical decision-making.
• This study assessed the analytical performance of the ADAMS A1C HA-8180V analyzer in a clinical laboratory setting.

Purpose of the Study:

• To evaluate the analytical performance of the ADAMS A1C HA-8180V analyzer.
• To determine the accuracy and precision of HbA1c measurements using this automated analyzer.
• To assess if the analyzer meets established quality standards for T2D diagnosis and management.

Main Methods:

• A retrospective study analyzed internal quality control (IQC) and external quality assessment (EQA) data from April 2023 to April 2024.
• Imprecision and accuracy were calculated using IQC and EQA results.
• Performance was assessed against three models: biological variation (BV), Sigma metrics (SM), and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Model for Quality Targets (MQT).

Main Results:

• Internal quality control showed coefficients of variation (CVs) of 0.82% and 0.92%, significantly below the recommended 3.4%.
• External quality assessment revealed a mean relative bias of 1.47%.
• All performance models (BV, SM, MQT) indicated that the analyzer's results met or exceeded IFCC criteria, with most exceeding 5 sigma and all exceeding 2 sigma.

Conclusions:

• The ADAMS A1C HA-8180V analyzer demonstrates robust analytical performance.
• The laboratory's HbA1c testing meets IFCC standards for routine diagnostics and patient monitoring.
• The analyzer is suitable for reliable T2D diagnosis and management.