Back to basics: validation of automated as compared to manual slide staining in the cytopathology laboratory.
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.
Haack
Lori A
LA
Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53792-2472, USA.
Selvaggi
Suzanne M
SM
D001331:Automation; D003581:Cytodiagnosis / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results; D013194:Staining and Labeling / Q000295:instrumentation / Q000379:methods* / Q000592:standards*