Brambila E, León-Chávez BA, Lozano-Zarain P

Language: Spanish
References: 18
Page: 155-163
PDF size: 113.90 Kb.

ABSTRACT

The main objective of this work was to plan a quality control system for a glucose kit previously produced in our laboratory. Protocol started defining the quality requirements of the method, assessing the analytical performance, selecting the quality control parameters, and adopting a quality control strategy. According to CLIA‘88 total error allowed to glucose assays was 10%. Glucose method bias and imprecision was 3.9% and 1.13% respectively, achieving an excellent analytical performance of 5.4 sigma. The performance of quality control procedures was assessing by power function graphs, critical-size analytical errors and OPSspec charts. The 1_3s rule with probability for error detection of 90% and probability for false rejections of almost 0% was the most accurate to evaluate the glucose method quality, requiring only 2 control materials. Under 2 months routine conditions, glucose assays showed a stable performance. In conclusion, we developed a specific system of quality control for a glucose method, achieving international quality requirements, but most important, assuring that method results can be used as trustily auxiliary diagnostic tool.

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