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OSNA:一种基于细胞角蛋白19(CK19)mRNA浓度的快速分子检测方法,用于评估肺癌患者的超声支气管镜引导下经支气管针吸活检(EBUS-TBNA)样本

OSNA: A Fast Molecular Test Based on CK19 mRNA Concentration for Assessment of EBUS-TBNA Samples in Lung Cancer Patients.

作者信息

Oezkan Filiz, Khan Amir Maqbul, Hager Thomas, Freitag Lutz, Christoph Daniel, Darwiche Kaid

机构信息

Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Hospital, University Duisburg-Essen, Essen, Germany.

Division of Interventional Pulmonary, Baylor Scott and White Hospital, Waxahachie, TX.

出版信息

Clin Lung Cancer. 2016 May;17(3):198-204. doi: 10.1016/j.cllc.2015.09.001. Epub 2015 Sep 21.

Abstract

BACKGROUND

Lung cancer is the major cause of cancer death worldwide. Mediastinal lymph node staging is important for pretreatment lung cancer management. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a well established method for mediastinal lymph node staging. Although EBUS-TBNA samples are much smaller than surgical lymph node biopsies, histopathological evaluation and molecular testing can successfully be performed. One step nucleic acid amplification (OSNA), which measures cytokeratin 19 (CK19) mRNA concentration, is a target marker that is gaining importance in quick detection of lymph node metastases in breast cancer and other cancers. Recent publications suggest accurate and rapid detection of lung cancer metastases in surgically removed lymph nodes. In this study we aimed to investigate if CK19 mRNA detection via OSNA is feasible to accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.

MATERIALS AND METHODS

A total of 102 EBUS-TBNA samples of 55 patients were collected. EBUS-TBNA was performed in lymph nodes exceeding 5 mm. OSNA was performed using a ready to use amplification kit (Lynoamp; Sysmex, Kobe, Japan) in the RD-100 I, an automated real-time detection system (Sysmex).

RESULTS

Histopathological analysis confirmed malignancy in 90 cases and excluded malignancy in 12 cases. Overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 78.9%, 58.3%, 93.4%, 26.9%, and 76.5%, respectively.

CONCLUSIONS

One step nucleic acid amplification is feasible for EBUS-TBNA lymph node samples of lung cancer patients, but CK19 mRNA is an inaccurate marker, which is unlikely to be useful as an adjuvant test for EBUS-TBNA. Further studies are required to define the optimal sample size and sampling method.

摘要

背景

肺癌是全球癌症死亡的主要原因。纵隔淋巴结分期对于肺癌的术前治疗管理至关重要。支气管内超声引导下经支气管针吸活检术(EBUS-TBNA)是一种成熟的纵隔淋巴结分期方法。尽管EBUS-TBNA获取的样本比手术切除的淋巴结活检样本小得多,但组织病理学评估和分子检测仍可成功进行。一步核酸扩增(OSNA)可测量细胞角蛋白19(CK19)mRNA浓度,是一种在乳腺癌和其他癌症的淋巴结转移快速检测中日益重要的靶标标志物。最近的出版物表明,在手术切除的淋巴结中可准确快速地检测到肺癌转移。在本研究中,我们旨在调查通过OSNA检测CK19 mRNA是否可行,以使用EBUS-TBNA样本准确检测肺癌患者的淋巴结转移。

材料与方法

共收集了55例患者的102份EBUS-TBNA样本。对直径超过5毫米的淋巴结进行EBUS-TBNA。使用现成的扩增试剂盒(Lynoamp;日本神户Sysmex公司)在RD-100 I自动实时检测系统(Sysmex)中进行OSNA。

结果

组织病理学分析证实90例为恶性,12例排除恶性。总体敏感性、特异性、阳性预测值、阴性预测值和准确性分别为78.9%、58.3%、93.4%、26.9%和76.5%。

结论

一步核酸扩增对于肺癌患者的EBUS-TBNA淋巴结样本是可行的,但CK19 mRNA是一个不准确的标志物,不太可能用作EBUS-TBNA的辅助检测。需要进一步研究来确定最佳样本量和采样方法。

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