Analytical validation of tests in laboratories of anatomic pathology: a Belgian population-based study

Abstract

Laboratories of anatomic pathology have to validate each analytical test before it is implemented in daily routine. However, evidence-based guidelines regarding validation of analytical tests are limited. A 2016 survey on test validation was performed in all 77 licensed Belgian anatomic pathology laboratories in order to evaluate the implementation and to highlight the current issues of test validation in Belgian anatomic pathology laboratories. Therefore, standard operating procedures for test validation and validation reports were evaluated for the presence of predefined items. Separate validation procedures for CE/IVD-labeled, laboratory-modified and laboratory-developed tests and a description of how each performance characteristic was validated were lacking in 51 (66 %) laboratories. Moreover, only 9 (12 %) laboratories reported to have written procedures for when and how analytical tests need to be revalidated. Better results were observed regarding the description of the performance characteristics, the co-workers involved, recording and archiving of results and raw data, the content of the validation report, ongoing validation, release and implementation into daily routine. Contrary to the evaluation results of the procedures for test validation, better results for the content of the validation reports were obtained. A lack of clear and predefined objective acceptance criteria for each determined performance characteristic was the most common shortcoming observed in validation reports in Belgian anatomic pathology laboratories. In conclusion, there appears to be a need for further development of guidelines for validation and revalidation of analytical tests performed in anatomic pathology laboratories.