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比较 HercepTest mAb pharmDx（Dako Omnis，GE001）和 Ventana PATHWAY Anti-HER-2/neu（4B5）两种免疫组化试剂检测 HER2 表位的敏感性，使用 IHC 校准品。

Comparing the Sensitivity of HER2 Epitope Detection of HercepTest mAb pharmDx (Dako Omnis, GE001) and Ventana PATHWAY Anti-HER-2/neu (4B5) Using IHC Calibrators.

机构信息

Agilent Technologies, Glostrup, Denmark.

Formely Agilent Technologies, Barcelona, Spain.

出版信息

Appl Immunohistochem Mol Morphol. 2024;32(10):469-475. doi: 10.1097/PAI.0000000000001230. Epub 2024 Oct 24.

DOI:10.1097/PAI.0000000000001230
PMID:39444059
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11537468/
Abstract

Accurate assessment of HER2 expression levels is paramount for determining eligibility for targeted therapies. HER2 immunohistochemistry provides a semiquantitative measurement of HER2 protein overexpression. Historically, little focus has been on the lower end of the HER2 expression range. The advent of novel therapeutic molecules that require fewer membrane epitopes to be effective has prompted a reevaluation of the current immunohistochemistry testing protocols, with special emphasis on the detection limit. Here, we have used Boston Cell Standards technology to determine the sensitivity of 2 commercially available HER2 immunohistochemistry assays, including a lower limit of detection.

摘要

准确评估 HER2 表达水平对于确定靶向治疗的适应证至关重要。HER2 免疫组化提供了 HER2 蛋白过表达的半定量测量。从历史上看，人们对 HER2 表达范围的低端关注较少。需要较少膜表位才能有效的新型治疗分子的出现促使人们重新评估当前的免疫组化检测方案，特别强调检测限。在这里，我们使用波士顿细胞标准技术来确定两种市售的 HER2 免疫组化检测方法的敏感性，包括检测下限。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/46bc72ddda0d/pai-32-469-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/e9c776839a85/pai-32-469-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/3128bb954734/pai-32-469-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/10607f3d9793/pai-32-469-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/3a3d36691f3f/pai-32-469-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/46bc72ddda0d/pai-32-469-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/e9c776839a85/pai-32-469-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/3128bb954734/pai-32-469-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/10607f3d9793/pai-32-469-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/3a3d36691f3f/pai-32-469-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ca/11537468/46bc72ddda0d/pai-32-469-g005.jpg

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Nat Med. 2023 Aug;29(8):2110-2120. doi: 10.1038/s41591-023-02478-2. Epub 2023 Jul 24.
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ESMO expert consensus statements (ECS) on the definition, diagnosis, and management of HER2-low breast cancer.
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