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首页> 外文期刊>Journal of Breast Cancer >One-step Nucleic Acid Amplification (OSNA): Intraoperative Rapid Molecular Diagnostic Method for the Detection of Sentinel Lymph Node Metastases in Breast Cancer Patients in Korean Cohort
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One-step Nucleic Acid Amplification (OSNA): Intraoperative Rapid Molecular Diagnostic Method for the Detection of Sentinel Lymph Node Metastases in Breast Cancer Patients in Korean Cohort

机译：一步核酸扩增（OSNA）：用于韩国队列中乳腺癌患者前哨淋巴结转移的术中快速分子诊断方法

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Purpose Sentinel lymph node (SLN) biopsy has become a standard procedure in breast cancer patient management. Accurate intraoperative assessment of metastasis of SLNs is essential for appropriate selection to avoid unnecessary axillary dissection. The aim of this study was to evaluate the performance of one-step nucleic acid amplification (OSNA) assay for detection of sentinel lymph node metastasis examination in breast cancer patients. Methods In this study, we compared intraoperative OSNA to histological investigation with multi-level observation in 284 sentinel lymph nodes of 199 patients. Surgically obtained sentinel lymph nodes were sectioned into 2 mm intervals of up to four pieces, half of which were examined with the OSNA assay. The other half of adjacent pieces were histopathologically examined both intraoperatively and postoperatively. The presence/absence of metastases was judged by observing hematoxylin and eosin staining and cytokeratin (AE1/ AE3) immunohistochemically stained multiple slides from one lymph node. Results Among 199 patients included, 36 cases were positive on histological examination and 34 cases were positive on OSNA assay. There were 14 discordant cases. The overall concordance with histology was 93.0% (95% confidence interval [CI], 0.86-0.96), with a sensitivity of 77.8% (95% CI, 0.61-0.90), specificity of 96.3% (95% CI, 0.92-0.99), positive predictive value of 82.4% (95% CI, 0.65-0.93) and negative predictive value of 95.2% (95% CI, 0.91-0.98). The kappa statistic analysis indicated substantial agreement of both methods, with a value of 0.76 (95% CI, 0.64-0.88). The average turnaround time was 39.0 minutes. Conclusion The results of this study indicate that the OSNA assay has equivalent accuracy to histopathology in detecting breast cancer metastasis to lymph nodes when each method is assigned two alternate blocks of four blocks sectioned at 2 mm intervals.
机译：目的前哨淋巴结（SLN）活检已成为乳腺癌患者管理中的标准程序。为适当的选择，以避免不必要的腋窝淋巴结清扫前哨淋巴结转移的准确评估术是必不可少的。这项研究的目的是评估一步法核酸扩增（OSNA）检测在乳腺癌患者前哨淋巴结转移检查中的检测性能。方法在本研究中，我们对199例患者的284个前哨淋巴结进行了术中OSNA与组织学检查及多级观察的比较。将手术获得的前哨淋巴结切成2mm的间隔，最多四片，其中一半用OSNA分析进行检查。术中和术后均进行了病理组织学检查。通过观察苏木精和曙红染色以及细胞角蛋白（AE1 / AE3）免疫组织化学染色来自一个淋巴结的多张载玻片来判断转移的存在与否。结果199例患者中，组织学检查阳性36例，OSNA检测阳性34例。有14起不一致的案件。与组织学的总体一致性为93.0％（95％置信区间[CI]，0.86-0.96），敏感性为77.8％（95％CI，0.61-0.90），特异性为96.3％（95％CI，0.92-0.99）。 ），阳性预测值为82.4％（95％CI，0.65-0.93）和阴性预测值为95.2％（95％CI，0.91-0.98）。 kappa统计分析表明这两种方法基本吻合，数值为0.76（95％CI，0.64-0.88）。平均周转时间为39.0分钟。结论这项研究的结果表明，当每种方法分配两个交替的块，每四个块以2 mm的间隔切片时，OSNA分析在检测乳腺癌转移至淋巴结中具有与组织病理学相同的准确性。

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