An introduction to Whole Slide Imaging

Whole slide imaging (WSI) has advanced to a point where it could replace the glass slide as the primary means of pathology evaluation. In general, a virtual slide is made using a computer system that scans the entire microscopic slide at specific magnification and stores all image data in an electronic file system. The Food and Drug Administration (FDA) recently authorized the useof the WSI Philips IntelliSite Pathology Solution (PIPS) in lieu of a light microscope after satisfying a list of testing requirements and undergoing clinical concordance studies. While PIPS was intended for clinical surgical pathology specimens and not a non-clinical setting, it is reasonable to assume that regulatory guidelines for WSI within a non-clinical GLP environment should follow equally rigorous bench and software testing as that set out for clinical use. Therefore, within a GLP environment, all hard- and software used in the digital pathology work flow will need to be validated and its use should be controlled by standard operating procedures (SOP).