在发展中国家，使用 Xpert Breast Cancer STRAT4 进行组织处理中的生物标志物评估。
Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue Processed in a Developing Country.
机构信息
Windhoek Central Hospital, Windhoek, Namibia.
Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
出版信息
Am J Clin Pathol. 2021 Oct 13;156(5):766-776. doi: 10.1093/ajcp/aqab016.
OBJECTIVES
Breast cancer immunohistochemistry (IHC) biomarker testing is limited in low-resource settings, and an alternative solution is needed. A point-of-care mRNA STRAT4 breast cancer assay for ESR1, PGR, ERBB2, and MKi67, for use on the GeneXpert platform, has been recently validated on tissues from internationally accredited laboratories, showing excellent concordance with IHC.
METHODS
We evaluated STRAT4/IHC ESR1/estrogen receptor (ER), ERBB2/human epidermal growth factor receptor 2 (HER2) concordance rates of 150 breast cancer tissues processed in Rwanda, with undocumented cold ischemic and fixation time.
RESULTS
Assay fail/indeterminate rate was 2.6% for ESR1 and ERBB2. STRAT4 agreement with ER IHC was 92.5% to 93.3% and 97.8% for HER2, for standard (1x) and concentrated (4x) reagent-conserving protocols, respectively. Eleven of 12 discordant ER/ESR1 cases were ESR1- negative/IHC-positive. These had low expression of ER by IHC in mostly very small tumor areas tested (7/12; <25 mm2). In two of three discordant HER2 cases, the STRAT4-ERBB2 result correlated with the subsequent fluorescence in situ hybridization (FISH) result. STRAT4-ERBB2 results in 9 of 10 HER2-IHC equivocal cases were concordant with FISH.
CONCLUSIONS
The STRAT4 assay is an alternative for providing quality-controlled breast cancer biomarker data in laboratories unable to provide quality and/or cost-efficient IHC services.
目的
在资源有限的环境下，乳腺癌免疫组织化学（IHC）生物标志物检测受到限制，因此需要寻找替代方案。一种即时检测（POC）mRNA STRAT4 乳腺癌检测试剂盒，用于 ESR1、PGR、ERBB2 和 MKi67 的检测，可在 GeneXpert 平台上使用，最近已在经过国际认证的实验室的组织上得到验证，其与 IHC 的一致性表现出色。
方法
我们评估了 STRAT4/IHC ESR1/雌激素受体（ER）、ERBB2/人表皮生长因子受体 2（HER2）在未经记录的冷缺血和固定时间处理的 150 份卢旺达乳腺癌组织中的一致性率。
结果
ESR1 和 ERBB2 的检测失败/不确定率为 2.6%。STRAT4 与 ER IHC 的一致性分别为 92.5%至 93.3%和 97.8%，适用于标准（1x）和浓缩（4x）试剂节约协议。12 例 ER/ESR1 不一致的病例中，有 11 例为 ESR1 阴性/IHC 阳性。这些病例的 ER 表达通过 IHC 检测主要在很小的肿瘤区域呈弱阳性（7/12；<25mm2）。在 3 例 HER2 不一致的病例中，STRAT4-ERBB2 结果与随后的荧光原位杂交（FISH）结果相关。在 10 例 HER2-IHC 不确定的病例中，有 9 例 STRAT4-ERBB2 结果与 FISH 结果一致。
结论
在无法提供高质量和/或具有成本效益的 IHC 服务的实验室中，STRAT4 检测试剂盒是提供质量控制的乳腺癌生物标志物数据的替代方案。
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