Cazzaniga Giorgio, Mascadri Francesco, Marletta Stefano, Caputo Alessandro, Guidi Gabriele, Gambaro Giovanni, Eccher Albino, Dei Tos Angelo Paolo, Pagni Fabio, L'Imperio Vincenzo
Department of Medicine and Surgery, Pathology, IRCCS Fondazione San Gerardo dei Tintori, University of Milano-Bicocca, Monza, Italy.
Division of Pathology, Humanitas Cancer Center, Catania, Italy.
J Clin Pathol. 2024 Nov 21. doi: 10.1136/jcp-2024-209418.
The digital transformation of the pathology laboratory is being continuously sustained by the introduction of innovative technologies promoting whole slide image (WSI)-based primary diagnosis. Here, we proposed a real-life benchmark of a pathology-dedicated medical monitor for the primary diagnosis of renal biopsies, evaluating the concordance between the 'traditional' microscope and commercial monitors using WSI from different scanners.
The College of American Pathologists WSI validation guidelines were used on 60 consecutive renal biopsies from three scanners (Aperio, 3DHISTECH and Hamamatsu) using pathology-dedicated medical grade (MG), professional grade (PG) and consumer-off-the-shelf (COTS) monitors, comparing results with the microscope diagnosis after a 2-week washout period.
MG monitor was faster (1090 vs 1159 vs 1181 min, delta of 6-8%, p<0.01), with slightly better performances on the detection of concurrent diseases compared with COTS (κ=1 vs 0.96, 95% CI=0.87 to 1), but equal concordance to the commercial monitors on main diagnosis (κ1). Minor discrepancies were noted on specific scores/classifications, with MG and PG monitors closer to the reference report (r=0.98, 95% CI=0.83 to 1 vs 0.98, 95% CI=0.83 to 1 vs 0.91, 95% CI=0.76 to 1, κ=0.93, 95% CI=077 to 1 vs 0.93, 95% CI=0.77 to 1 vs 0.86, 95% CI=0.64 to 1, κ=1 vs 0.50, 95% CI=0 to 1 vs 0.50, 95% CI=0 to 1, for IgA, antineutrophilic cytoplasmic antibody and lupus nephritis, respectively). Streamlined Pipeline for Amyloid detection through congo red fluorescence Digital Analysis detected amyloidosis on both monitors (4 of 30, 13% cases), allowing detection of minimal interstitial deposits with slight overestimation of the Amyloid Score (average 6 vs 7).
The digital transformation needs careful assessment of the hardware component to support a smart and safe diagnostic process. Choosing the display for WSI is critical in the process and requires adequate planning.
通过引入促进基于全切片图像（WSI）的初步诊断的创新技术，病理学实验室的数字化转型正在持续推进。在此，我们提出了一种用于肾活检初步诊断的病理学专用医用显示器的实际基准，使用来自不同扫描仪的WSI评估“传统”显微镜与商用显示器之间的一致性。
根据美国病理学家学会的WSI验证指南，使用病理学专用的医疗级（MG）、专业级（PG）和消费级现成（COTS）显示器，对来自三台扫描仪（Aperio、3DHISTECH和滨松）的60例连续肾活检进行分析，在2周的洗脱期后将结果与显微镜诊断进行比较。
MG显示器速度更快（1090分钟对1159分钟对1181分钟，差值为6 - 8%，p<0.01），与COTS相比，在并发疾病检测方面表现略好（κ = 1对0.96，95%置信区间 = 0.87至1），但在主要诊断方面与商用显示器的一致性相同（κ1）。在特定评分/分类上存在一些细微差异，MG和PG显示器更接近参考报告（IgA、抗中性粒细胞胞浆抗体和狼疮性肾炎的r分别为0.98，95%置信区间 = 0.83至1对0.98，95%置信区间 = 0.83至1对0.91，95%置信区间 = 0.76至1；κ分别为0.93，95%置信区间 = 0.77至1对0.93，95%置信区间 = 0.77至1对0.86，95%置信区间 = 0.64至1；κ分别为1对0.50，95%置信区间 = 0至1对0.50，95%置信区间 = 0至1）。通过刚果红荧光数字分析的简化淀粉样蛋白检测流程在两台显示器上均检测到淀粉样变性（30例中有4例，占13%），能够检测到最小的间质沉积物，但淀粉样蛋白评分略有高估（平均为6对7）。
数字化转型需要对硬件组件进行仔细评估，以支持智能且安全的诊断过程。在这个过程中，为WSI选择显示器至关重要，需要进行充分规划。
