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比较 2 种用于免疫组化检测恶性黑色素瘤、肺癌、胃肠道癌、甲状腺癌和神经胶质瘤中 BRAF V600E 突变的单克隆抗体。

Comparison of 2 monoclonal antibodies for immunohistochemical detection of BRAF V600E mutation in malignant melanoma, pulmonary carcinoma, gastrointestinal carcinoma, thyroid carcinoma, and gliomas.

机构信息

Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114.

出版信息

Hum Pathol. 2013 Nov;44(11):2563-70. doi: 10.1016/j.humpath.2013.06.018. Epub 2013 Sep 24.

Abstract

BRAF mutation is seen in a variety of human neoplasms including cutaneous malignant melanoma, papillary thyroid carcinoma, colorectal carcinoma, non-small cell lung carcinoma, pleomorphic xanthoastrocytoma, and others. Currently, there are 2 commercially available monoclonal antibodies for the detection of BRAF V600E mutation; however, a full and practical comparison of their performance in various tumor types on an automated staining platform has not been done. We investigated their sensitivity and specificity in detecting the BRAF V600E mutation in a series of 152 tumors including 31 malignant melanomas, 25 lung carcinomas, 32 gastrointestinal carcinomas, 23 thyroid carcinomas, 35 gliomas, and 6 other malignancies. In this series, the concordance rate between immunohistochemistry (IHC) and mutational analyses was 97% (148/152) for VE1 and 88% (131/149) for anti-B-Raf. The sensitivity and specificity were 98% (60/61) and 97% (88/91) for monoclonal VE1 and 95% (58/61) and 83% (73/88) for anti-B-Raf, respectively. There were 4 cases with discordant IHC and mutational results for monoclonal VE1 in contrast to 18 cases for anti-B-Raf. Our studies showed that IHC with monoclonal VE1 has a better performance compared with anti-B-Raf in an automated staining platform and confirmed that clone VE1 provides excellent sensitivity and specificity for detecting the BRAF V600E mutation in a variety of tumor types in a clinical setting.

摘要

BRAF 突变可见于多种人类肿瘤,包括皮肤恶性黑色素瘤、甲状腺乳头状癌、结直肠癌、非小细胞肺癌、多形性黄色星形细胞瘤等。目前,有 2 种商业化的用于检测 BRAF V600E 突变的单克隆抗体;然而,尚未在自动化染色平台上对其在各种肿瘤类型中的性能进行全面和实际的比较。我们在包括 31 例恶性黑色素瘤、25 例肺癌、32 例胃肠道癌、23 例甲状腺癌、35 例胶质瘤和 6 例其他恶性肿瘤在内的 152 例肿瘤系列中研究了它们在检测 BRAF V600E 突变中的敏感性和特异性。在该系列中,免疫组化(IHC)和突变分析之间的一致性率为 VE1 为 97%(148/152),抗-B-Raf 为 88%(131/149)。单克隆 VE1 的敏感性和特异性分别为 98%(60/61)和 97%(88/91),抗-B-Raf 分别为 95%(58/61)和 83%(73/88)。与抗-B-Raf 相比,单克隆 VE1 有 4 例 IHC 与突变结果不一致,而抗-B-Raf 有 18 例。我们的研究表明,在自动化染色平台上,单克隆 VE1 的 IHC 比抗-B-Raf 具有更好的性能,并证实克隆 VE1 在临床环境中检测多种肿瘤类型的 BRAF V600E 突变具有出色的敏感性和特异性。

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