A Multisite Performance Study Comparing the Reading of Immunohistochemical Slides on a Computer Monitor With Conventional Manual Microscopy for Estrogen and Progesterone Receptor Analysis

Abstract

A multisite study was conducted to assess the performance of the Aperio digital pathology system (Aperio Technologies, Vista, CA) for reading estrogen receptor (ER) and progesterone receptor (PR) slides on a computer monitor. A total of 520 formalin-fixed breast tissue specimens were assayed at 3 clinical sites for ER and PR (260 each). Percentage and average staining intensity of positive nuclei were assessed. At each site, 3 pathologists performed a blinded reading of the glass slides using their microscopes initially and later using digital images on a computer monitor. Comparable percentages of agreements were obtained for manual microscopy (MM) and manual digital slide reading (MDR) (ER, percentage of positive nuclei with cutoffs: MM, 91.3%-99.0%/MDR, 91.3%-100.0%; PR, percentage of positive nuclei with cutoffs: MM, 83.8%-99.0%/MDR, 76.3%-100.0%). Reading ER and PR slides on a computer monitor using the Aperio digital pathology system is equivalent to reading the slides with a conventional light microscope.

Whole slide imaging for human epidermal growth factor receptor 2 immunohistochemistry interpretation: Accuracy, Precision, and reproducibility studies for digital manual and paired glass slide manual interpretation

“…[24] There is also considerable importance given to reproducibility of results to insure that this expensive therapy is given to those patients who are most likely to benefit from its use. Although multiple prior studies of immunohistochemical stains in general,[52526] and more specifically HER2 studies have shown substantial agreement between glass slide and digital interpretations,[679111227] studies of automated image analysis algorithms on HER2 interpretation comparing different scanning devices and different image analysis algorithms have suggested that there may be differences between the instruments and hence that verification of each individual system's performance should be accomplished prior to clinical use. [10] Individual laboratories that use these FDA cleared devices do not have to repeat the studies presented herein, but do have to perform verification procedures to insure that the device/system is performing at its expected level.…”

Validation of Whole-Slide Imaging for Histolopathogical Diagnosis: Current State

“…These diagnostic algorithms facilitate quantification of IHC positivity resulting in a more objective evaluation, which is extremely useful in the evaluation of some biological markers. Algorithms for the evaluation of IHC stains are variably used depending on the subspecialties and are particularly useful in cases of breast cancer [26,27,28,29]. …”

“…A major advantage of digitization in breast pathology is the possibility to use image analysis to improve the accuracy and reproducibility of HER-2, estrogen and progesterone receptors, and Ki67 scoring, which have a crucial role in the planning of treatment strategies [27,28,29,49]. Moreover, the evaluation may be improved with the use of automatic quantification algorithms (fig.…”

Les lames virtuelles en recherche expérimentale et en recherche clinique

“…La microscopie digitale permet la normalisation de la numérisation et l'affichage des images microscopiques sur un écran d'ordinateur. La microscopie digitale améliore la précision, la fiabilité et la reproductibilité de la quantification immunohistochimique en mettant en évidence les erreurs possibles d'interprétation en microscopie manuelle [2]. Les images numériques ont aussi l'avantage de faciliter le stockage, la récupéra-tion et le partage entre pathologistes, ce qui améliore la consultation des données.…”