Automation of fluorescent in situ hybridization (FISH) leading to cost savings and consistent high-quality results.

IF 2 4区医学 Q2 PATHOLOGY

Journal of Clinical Pathology Pub Date : 2025-09-17 DOI:10.1136/jcp-2025-210119

Grace J Kwon, Aaron Blackley, Kathryn Perkinson, Rex C Bentley, Elizabeth N Pavlisko, Diana M Cardona

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引用次数: 0

Abstract

Aims: Despite continually improving guidelines, human epidermal growth factor receptor 2 (HER2) testing for breast and gastro-oesophageal carcinoma continues to be a technical challenge in clinical laboratories. Manual HER2 fluorescence in situ hybridisation (FISH) testing is labour-intensive and prone to inter-run and interoperator variability. We aimed to adopt and validate a Leica BOND-III automated staining platform for HER2 FISH testing.

Methods: We recently validated the Leica BOND-III automated staining platform for HER2 FISH testing and compared it to our previous manual FISH (Agilent HER2 IQFISH pharmDx) methodology using 77 breast cancer cases and 8 gastric cancer cases.

Results: Using the automated Leica BOND-III automated staining platform, we achieved 0.95 sensitivity and 0.97 specificity in HER2 FISH testing for breast cancer cases and 1.0 sensitivity and specificity for gastric carcinoma cases. There was a 98% concordance rate between results of automated testing versus our previous manual method. The automated staining platform decreased technical hands-on time significantly while also reducing overall supply costs for the laboratory.

Conclusions: We were able to implement and validate the automated Leica BOND-III staining platform seamlessly into a complex laboratory for HER2 FISH testing that has overall significantly decreased hands-on time by technologists and supply costs. Automated Leica BOND-III HER2 FISH staining results were highly concordant with our previous manual FISH method in both breast cancer and gastric cancer cases.

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自动化荧光原位杂交（FISH）导致成本节约和一致的高质量结果。

目的：尽管指南不断改进，但乳腺癌和胃食管癌的人表皮生长因子受体2 （HER2）检测仍然是临床实验室的技术挑战。人工HER2荧光原位杂交（FISH）检测是一项劳动密集型的工作，而且容易出现运行间和操作人员之间的差异。我们的目标是采用并验证Leica BOND-III自动染色平台用于HER2 FISH检测。方法：我们最近验证了用于HER2 FISH检测的徕卡BOND-III自动染色平台，并将其与我们之前的手动FISH（安捷伦HER2 IQFISH pharmDx）方法进行了比较，使用了77例乳腺癌病例和8例胃癌病例。结果：采用徕卡BOND-III自动染色平台，乳腺癌HER2 FISH检测灵敏度为0.95，特异性为0.97；胃癌HER2 FISH检测灵敏度和特异性为1.0。与我们以前的手工方法相比，自动化测试的结果有98%的一致性。自动化染色平台大大减少了技术操作时间，同时也降低了实验室的总体供应成本。结论：我们能够将自动化的Leica BOND-III染色平台无缝地应用于HER2 FISH测试的复杂实验室，从而大大减少了技术人员的动手时间和供应成本。在乳腺癌和胃癌病例中，自动徕卡BOND-III HER2 FISH染色结果与我们之前的手工FISH方法高度一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Pathology 医学-病理学

CiteScore

7.80

自引率

2.90%

发文量

113

审稿时长

3-8 weeks

期刊介绍： Journal of Clinical Pathology is a leading international journal covering all aspects of pathology. Diagnostic and research areas covered include histopathology, virology, haematology, microbiology, cytopathology, chemical pathology, molecular pathology, forensic pathology, dermatopathology, neuropathology and immunopathology. Each issue contains Reviews, Original articles, Short reports, Correspondence and more.