在GeneXpert仪器上验证Xpert乳腺癌症STRAT 4测定以评估癌症组织样本中激素受体、Ki67和HER2基因表达状态。

IF 1.3 4区 医学 Q3 ANATOMY & MORPHOLOGY Applied Immunohistochemistry & Molecular Morphology Pub Date : 2023-10-01 Epub Date: 2023-09-14 DOI:10.1097/PAI.0000000000001149
Lina Sewanywa, Martin Hale, Pamela Michelow, Elizabeth Mayne, Tracey Wiggill
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引用次数: 0

摘要

癌症乳腺癌是非洲女性癌症相关死亡的最常见原因,非洲女性癌症患者往往晚期发病。延迟诊断的原因包括诊断途径受限以及国际上对免疫组织化学(IHC)等辅助测试的解释存在争议。细针抽吸(FNAC)是一种有吸引力的替代品,尽管可能会降低灵敏度。Xpert乳腺癌症STRAT4(STRAT4)(CE-IVD*)测定法(Cepheid,Sunnyvale)是半定量逆转录聚合酶链反应测定法,其检测乳腺样品中雌激素受体(ESR1)、孕酮受体(PGR1)、人表皮生长因子受体/Erb-B2受体酪氨酸激酶2(HER2/ERBB2)和增殖标记物的信使RNA(mRNA)表达,MKi67。我们对来自约翰内斯堡学术医院的癌症乳腺癌患者的甲醛固定石蜡包埋(FFPE,n=31)和匹配的FNAC(n=20)样本进行了该测定的性能评估。将IHC和荧光原位杂交分析(对HER2不确定样品进行)与FFPE样品中相应靶基因的mRNA表达进行比较,并将FNAC样品上的mRNA表达与mRNA表达和IHC的FFPE结果进行比较。使用快速裂解(Q)方法(仅对经验证的FFPE-裂解方法进行研究性修改)的FFPE和FNAC样本中IHC/FISH和Xpert乳腺癌症STRAT4之间的一致性显示,FFPE和FN AC样本中ESR1表达的总体百分比一致性分别为90.3%和81.3%,PGR1表达的整体百分比一致性为86.7%和81.3%。对于FFPE和FNAC样本,Ki67表达的一致性最低(使用Ki67阳性率≥20%染色的二元IHC截止值),分别为83.9%和62.5%。这表明STRAT4测定可能是确定FFPE样本中HR和Ki67状态的有用辅助测试,并且在FNAC样本上使用可能是可行的。未来的研究应该扩大样本数量,并建立与当地相关的临界值。
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Validation of the Xpert Breast Cancer STRAT 4 Assay on the GeneXpert instrument to Assess Hormone Receptor, Ki67, and HER2 Gene Expression Status in Breast Cancer Tissue Samples.

Breast cancer is the commonest cause of cancer-related mortality in African females where patients often present later and with advanced disease. Causes for delayed diagnosis include restricted diagnostic access and international controversy on interpretation of ancillary tests like immunohistochemistry (IHC). Fine needle aspirates (FNAC) are an attractive alternative although may have reduced sensitivity. The Xpert Breast Cancer STRAT4 (STRAT4) (CE-IVD*) assay (Cepheid, Sunnyvale) is a semi-quantitative reverse-transcription polymerase chain reaction assay which detects messenger RNA (mRNA) expression in breast samples for estrogen receptor ( ESR1 ), progesterone receptor ( PGR1 ), human epidermal growth factor receptor/Erb-B2 receptor tyrosine kinase 2 (HER2/ ERBB2 ) and the proliferation marker, MKi67 . We assessed the performance of this assay on both formalin-fixed paraffin-embedded (FFPE, n=31) and matched FNAC (n=20) samples from patients presenting with breast cancer to the Johannesburg academic hospitals. IHC and Fluorescent in situ hybridization analysis (performed on HER2-indeterminate samples) was compared with the mRNA expression of the corresponding target genes in FFPE samples, and mRNA expression on FNAC samples was compared with the FFPE results for both mRNA expression and IHC. Concordance between IHC/FISH and Xpert Breast Cancer STRAT4 in FFPE and FNAC samples using the Quick lysis (Q) method (a research-use-only modification of the validated FFPE-lysis method), showed an overall percentage agreement for ESR1 expression of 90.3% and 81.3%, and for PGR1 expression at 86.7% and 81.3% respectively in FFPE and FNAC samples. Concordance was lowest for Ki67 expression, using a binary IHC cutoff for Ki67 positivity at ≥20% staining) at 83.9% and 62.5%, for FFPE and FNAC samples, respectively. This suggests that the STRAT4 assay may be a useful ancillary test in determining HR and Ki67 status in FFPE samples and that use on FNAC samples may be feasible. Future studies should expand the sample numbers and establish locally relevant cutoffs.

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来源期刊
Applied Immunohistochemistry & Molecular Morphology
Applied Immunohistochemistry & Molecular Morphology ANATOMY & MORPHOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.20
自引率
0.00%
发文量
153
期刊介绍: ​Applied Immunohistochemistry & Molecular Morphology covers newly developed identification and detection technologies, and their applications in research and diagnosis for the applied immunohistochemist & molecular Morphologist. Official Journal of the International Society for Immunohistochemisty and Molecular Morphology​.
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