Wegscheider Anne-Sophie, Gorniak Joanna, Rollinson Sara, Gough Leanne, Dhaliwal Navdeep, Guardiola Agustin, Gasior Anna, Helmer Denise, Pounce Zoe, Niendorf Axel
MVZ Prof. Dr. Med. A. Niendorf Pathologie Hamburg-West GmbH, Institute for Histology, Cytology and Molecular Diagnostics, Lornsenstr. 4, 22767 Hamburg, Germany.
APIS Assay Technologies Ltd., Second Floor, Citylabs 1.0, Nelson Street, Manchester M13 9NQ, UK.
Diagnostics (Basel). 2024 Jan 23;14(3):241. doi: 10.3390/diagnostics14030241.
An accurate status determination of breast cancer biomarkers (ER, PR, HER2, Ki67) is crucial for guiding patient management. The "gold standard" for assessing these biomarkers in FFPE tissue is IHC, which faces challenges in standardization and exhibits substantial variability. In this study, we compare the concordance of a new commercial RT-qPCR kit with IHC in determining BC biomarker status.
The performance was evaluated using 634 FFPE specimens, which underwent histological analysis in accordance with standard of care methods. HER2 2+ tumors were referred to ISH testing. An immunoreactive score of ≥2/12 was considered positive for ER/PR and 20% staining was used as a cut-off for Ki67 high/low score. RT-qPCR and results calling were performed according to the manufacturer's instructions.
High concordance with IHC was seen for all markers (93.2% for ER, 87.1% for PR, 93.9% for HER2, 77.9% for Ki67 and 80.1% for proliferative signature (assessed against Ki67 IHC)).
By assessing the concordance with the results obtained through IHC, we sought to demonstrate the reliability and utility of the kit for precise BC subtyping. Our findings suggest that the kit provides a highly precise and accurate quantitative assessment of BC biomarkers.
准确确定乳腺癌生物标志物（雌激素受体、孕激素受体、人表皮生长因子受体2、Ki67）的状态对于指导患者管理至关重要。在福尔马林固定石蜡包埋（FFPE）组织中评估这些生物标志物的“金标准”是免疫组化（IHC），其在标准化方面面临挑战且存在很大变异性。在本研究中，我们比较了一种新的商业逆转录定量聚合酶链反应（RT-qPCR）试剂盒与免疫组化在确定乳腺癌生物标志物状态方面的一致性。
使用634个FFPE标本评估其性能，这些标本按照标准护理方法进行组织学分析。HER2 2+肿瘤需进行原位杂交（ISH）检测。雌激素受体/孕激素受体免疫反应评分≥2/12被视为阳性，Ki67高/低评分的截断值为20%染色。根据制造商的说明进行RT-qPCR和结果判定。
所有标志物与免疫组化的一致性都很高（雌激素受体为93.2%，孕激素受体为87.1%，人表皮生长因子受体2为93.9%，Ki67为77.9%，增殖特征为80.1%（根据Ki67免疫组化评估））。
通过评估与免疫组化结果的一致性，我们试图证明该试剂盒在精确的乳腺癌亚型分类方面的可靠性和实用性。我们的研究结果表明，该试剂盒对乳腺癌生物标志物提供了高度精确和准确的定量评估。
