Understanding the Basics of Quality Control in the Medical Laboratory – the Impact on Result Interpretation

Vesna Kušec, Nataša Rojnić Putarek, Nevena Krnić, Anita Špehar Uroić, Katja Dumić

Abstract

The aim of this paper was to provide information on the limitations of current analytical methods and the basics in quality control in laboratory endocrinology which affect the results and their interpretation. For the practicing clinical endocrinologist it is important to understand the essentials of the quality of hormone measuring methods and their limitations. Awareness of the quality of methods will allow caution and/or ensure the reliability of result interpretation. A measuring method cannot be performed with equal precision and trueness for the entire measuring range, and may differ between parameters and manufacturers. According to the level of medical decision, the medical laboratory should determine the quality of the method and communicate that information to the clinician. The basic approach to quality control of measurement methods is useful knowledge for doctors working in a hospital setting or private practice. The advantages and limitations are presented of immunoassay-based methods and tandem mass spectrometry (LC-MS/MS) used for measurement in biochemistry laboratory.

Conclusion – Hormone measurement is widely available but the methods may be affected by limitations. Understanding a method’s limitations and options for improvement enables the practicing clinician to interpret the test results rationally.

Keywords

Hormone measurement; Measurement methods; Immunoassay; Quality management; Six sigma

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