Calibration - an under-appreciated component in the analytical process of the medical laboratories.

Calibration of an analytical measurement procedure is an important basis for the reliability of patient results. Many publications and as well as procedures on how to estimate quality control and interpret those results have been become available over the years. In this publication we are focusing on the critical part of the calibration as there are no clear communication or guidelines on how to perform it.

Time to address quality control processes applied to antibody testing for infectious diseases.

As testing for infectious diseases moves from manual, biological testing such as complement fixation to high throughput automated autoanalyzer, the methods for controlling these assays have also changed to reflect those used in clinical chemistry. However, there are many differences between infectious disease serology and clinical chemistry testing, and these differences have not been considered when applying traditional quality control methods to serology. Infectious disease serology, which is highly regulated, detects antibodies of varying classes and to multiple and different antigens that change according to the organisms' genotype/serotype and stage of disease.