Precision and truthfulness of analytes in clinical biochemistry of the “JD” clinical laboratory, El Carmen 2024

Abstract

This study aimed to analyze the accuracy and precision of clinical biochemistry analytes (glucose, cholesterol, triglycerides, uric acid, urea, and creatinine) at the "JD" clinical laboratory in El Carmen Canton, applying the CLSI EP15-A3 protocol. Twenty-five measurements per control level were performed over five consecutive days, assessing repeatability, intra-laboratory variability, and bias against the manufacturer's reference values. The results showed that glucose, cholesterol, uric acid, and urea met analytical quality standards at all levels. In contrast, the triglyceride analyte presented high bias in the normal control, while creatinine showed critically poor accuracy at the pathological level. These findings lead to the conclusion that, while the laboratory maintains an acceptable overall level of reliability, urgent corrective actions are required for the aforementioned analytes. The study highlights the importance of applying international validation protocols as a tool to ensure clinically safe and reliable results.