Comment on “Quality evaluation of microscopy and scanned histological images for diagnostic purposes”: Are scanners better than microscopes?

摘要

There have been animated discussions in the USA, at least in the popular press[1]and online,[2]on whole-slide imaging (WSI) and the Food and Drug Administration's (FDA) view that WSI systems are to be considered class III (highest risk) medical devices with plans to regulate them as such. In order for class III devices (e.g. implantable pacemaker, gynecologic cytology imaging systems) to be approved they require general controls (such as quality system regulation and good manufacturing procedures) and premarket approval.[3]By comparison, microscopes are class I devices. Concerns have been raised that this stance may hamper current efforts to employ WSI for primary diagnosis in USA laboratories in lieu of the optical (conventional) microscope. Several publications have reported that some attributes of digital images may perhaps be better than the "gold standard" tool for microscopic diagnosis in pathology - a microscope – such as portability, archiving, sharing, and performing image analysis.[4]However, what if studies show that digital images acquired from scanners are in fact of better "quality" than those obtained from a microscope. Will this provide reassurance that WSI is suitable for rendering primary diagnoses. We share the thought-provoking findings and our commentary on the recent article published by Redondo and colleagues from Spain who compared the quality of images captured with optical microscopes and scanners.