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

ABSTRACT

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. Although the tests report a numerical value (usually signal to cut-off), they are not measuring an amount of antibodies, but the intensity of binding within the test system. All serology assays experience lot-to-lot variation, making the use of quality control methods used in clinical chemistry inappropriate. In many jurisdictions, the use of the manufacturer-provided kit controls is mandatory to validate the test run. Use of third-party controls, which are highly recommended by ISO 15189 and the World Health Organization, must be manufactured in a manner whereby they have minimal lot-to-lot variation and at a level where they detect exceptional variation. This paper outlines the differences between clinical chemistry and infectious disease serology and offers a range of recommendations when addressing the quality control of infectious disease serology.