Back to basics: validation of automated as compared to manual slide staining in the cytopathology laboratory.

摘要

Regulatory agencies on laboratory accreditation require that a laboratory validate and document an instrument's functionality in its own specific environment, including the capability of the instrument to replace existing processes. Instruments without manufacturer-provided validation protocols must still undergo validation with documentation of the specific method used. This study was performed to validate the Sakura Tissue-Tek DRS 2,000 automated slide stainer.