Elsevier

Human Pathology

Volume 45, Issue 8, August 2014, Pages 1713-1721
Human Pathology

Original contribution
Whole slide imaging diagnostic concordance with light microscopy for breast needle biopsies,☆☆,

https://doi.org/10.1016/j.humpath.2014.04.007Get rights and content

Summary

This study investigated the diagnostic accuracy of whole slide imaging (WSI) in breast needle biopsy diagnosis in comparison with standard light microscopy (LM). The study examined the effects of image capture magnification and computer monitor quality on diagnostic concordance of WSI and LM. Four pathologists rendered diagnoses using WSI to examine 85 breast biopsies (92 parts; 786 slides) consisting of benign and malignant cases. Each WSI case was evaluated using images captured at either ×20 or ×40 magnifications and viewed using a Digital Imaging and Communication in Medicine (DICOM) grade, color-calibrated monitor or a standard, desktop liquid-crystal display (LCD) monitor. For each combination, the WSI result was compared with the original, LM diagnosis. The overall concordance rate observed between WSI and LM was 97.1% (95% confidence intervals [CI]: 94.3%-98.5%). After a washout period, all cases were reviewed a second time by each pathologist after using LM, and the second LM diagnosis was compared with the WSI diagnosis rendered by the same pathologist. Intraobserver concordance between WSI and LM was 95.4% (95% CI: 92.2%-97.4%). The second LM diagnoses were also compared with the original LM diagnoses, and the observed interobserver LM concordance rate was 97.3% (95% CI: 93.1%-99.0%). The study data demonstrated that breast needle biopsy diagnoses rendered by WSI were equivalent to diagnoses rendered by LM. No diagnostic differences were detected between the underlying viewing system parameters of monitor quality and image capture resolution. The results of this study demonstrated that WSI can be effectively used in subspecialty diagnostic cases where a minimum amount of tissue is available.

Introduction

The US Food and Drug Administration has determined that whole slide imaging (WSI) instruments will be regulated as class III medical devices [1], [2]. The validation parameters used by commercial entities to obtain clearance are under consideration. This study investigated the diagnostic concordance rates of breast needle biopsy diagnosis when WSI was used as the primary diagnostic device in comparison with light microscopy (LM). Second, preliminary data were collected to determine whether the image capture resolution and viewing monitor characteristics used in this study affected diagnostic concordance rates between WSI and LM.

Although the diagnostic accuracy of traditional telepathology systems is well established [3], [4], [5], WSI represents the evolution of telepathology for remote histopathology diagnostics [6]. Evidence supporting the equivalence of WSI to LM as a primary diagnostic tool is mounting, and multiple studies supporting WSI for general surgical pathology usage have been published [7], [8], [9]. WSI has been evaluated for specialty surgical pathology applications including prostate [10], gastrointestinal [11], [12], and dermatopathology specimens [13], [14], [15]. The studies, in general, followed the College of American Pathologists (CAP) recommendations for validation of specific WSI uses [16]. WSI has been demonstrated to assist rapid diagnostic consultation in women’s health clinics [17], but there are limited data supporting the use of WSI for primary diagnosis of breast needle biopsies. This study investigated the use of WSI for primary diagnostic interpretation of breast tissue obtained by needle biopsy. Two factors have been identified that could impact the overall accuracy of WSI including the scanning image magnification and the use of monitors of variable levels of quality. A previous WSI validation study by Campbell et al [7] noted that when slides were imaged at a magnification of ×20, interpretation of intranuclear detail was difficult, and microorganism detection was challenging.

There is a paucity of research investigating the optimal image capture resolution or monitor viewing characteristics used for pathologist interpretation of WSI. Although researchers agree that glass slide quality [18], spatial resolution of images [19], camera optical lens quality [20], and color standardization [21] are important factors affecting WSI, no definitive specifications have been established to determine guidelines and parameters for WSI use for primary diagnosis. For WSI to be adopted and used for primary diagnoses, the issues of image quality and optimal system performance in terms of their impact on diagnostic accuracy must be addressed.

The American College of Radiology (ACR) has published documentation and research supporting their guidelines for image management and viewing of images for diagnostic purposes [22]. The consideration and pathway established by the ACR for validation of digital imaging technologies were used to design a multistep study to determine diagnostic accuracy of WSI and investigate the effect of image resolution and monitor characteristics on diagnostic concordance and accuracy of diagnoses rendered by WSI [23].

Section snippets

Materials and methods

A computer review of the anatomical pathology laboratory information system was used to identify 85 breast needle biopsy cases (ie, stereotactic, needle core, and vacuum-assisted needle core) originally interpreted and reported by a single, board-certified pathologist who serves as the senior breast subspecialty expert for the department [24]. Seventy-eight cases consisted of one part, and 7 cases consisted of 2 parts comprising a total of 786 hematoxylin and eosin slides [25]. Based on the

Results

Complete concordance between WSI and the original LM diagnoses was reached in 113 (31%) diagnoses. Discordant opinions were reported from 12 (3%) diagnoses involving 9 cases. The remaining 243 (66%) of the diagnoses were scored as concordant with clinically insignificant differences. When the 2 concordant categories were grouped together, overall concordance rates were 97.1% (95% CI: 94.3%-98.5%) as shown in Table 2. No significant difference between concordance rates by pathologist was noted.

Discussion

The application of digital imaging to the practice of radiology required a complete evaluation of the technology including hardware, software, and operator capability. Many similarities exist for digital pathology including the impact of computer monitor quality and image production on the accuracy of diagnose and viewing monitor quality on diagnostic accuracy of WSI, LM diagnoses were compared with WSI diagnoses rendered using different image capture resolutions and different monitor quality

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    Competing interests: At the time the work described in this manuscript was performed, Ventana Medical Systems (Tucson, AZ) was a research collaborator with the Department of Pathology and Microbiology.

    ☆☆

    Funding/Support: No monetary assistance was provided by Ventana to the department or any project participant.

    Elements of the data used in this manuscript were included as part of the principal author’s doctoral thesis.

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