Togami Shinichi, Tanimoto Akihide, Yanazume Shintaro, Tokunaga Hideki, Nagai Tomoyuki, Watanabe Mika, Yahata Hideaki, Asanoma Kazuo, Yamamoto Hidetaka, Tanaka Tomohito, Ohmichi Masahide, Yamada Takashi, Todo Yukiharu, Yamada Ryutaro, Kato Hidenori, Yamagami Wataru, Masuda Kenta, Kawaida Miho, Niikura Hitoshi, Moriya Takuya, Kobayashi Hiroaki
Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Japan.
Department of Pathology, Kagoshima University Graduate School of Medical and Dental Sciences, Japan.
Gynecol Oncol. 2023 Mar;170:70-76. doi: 10.1016/j.ygyno.2022.12.016. Epub 2023 Jan 11.
This multicenter study aimed to evaluate the accuracy of the one-step nucleic acid amplification (OSNA) assay in diagnosing lymph node metastasis (LNM) in patients with cervical and endometrial cancers.
Surgically removed LNs from patients with cervical and endometrial cancer were sectioned at 2-mm intervals along the short axis direction and alternately examined using the OSNA assay and conventional histopathological examination. Ultrastaging (200-μm LN sections) was performed for metastatic LNs using hematoxylin and eosin staining and immunostaining with an anti-CK19 antibody in cases where the OSNA assay and histopathological examination (performed using 2-mm LN sections) results showed discordance.
A total of 437 LNs from 133 patients were included; 61 patients (14%) showed metastasis by histopathological examination, with a concordance rate of 0.979 (95% confidence interval [CI]: 0.961-0.991) with the OSNA assay. The sensitivity and specificity of the OSNA assay were 0.918 (95% CI: 0.819-0.973) and 0.989 (95% CI: 0.973-0.997), respectively. Discordance between the two methods was observed in nine LNs (2.1%), and allocation bias of metastatic foci was identified as the major cause of discordance.
The OSNA assay showed equally accurate detection of LN metastasis as the histopathological examination. We suggest that the OSNA assay may be a useful tool for the rapid intraoperative diagnosis of LN metastasis in patients with cervical and endometrial cancers.
本多中心研究旨在评估一步核酸扩增（OSNA）检测法诊断宫颈癌和子宫内膜癌患者淋巴结转移（LNM）的准确性。
将手术切除的宫颈癌和子宫内膜癌患者的淋巴结沿短轴方向每隔2毫米切片，并交替使用OSNA检测法和传统组织病理学检查进行检测。对于转移淋巴结，在OSNA检测法和组织病理学检查（使用2毫米淋巴结切片）结果不一致的情况下，采用苏木精-伊红染色和抗CK19抗体免疫染色进行超分期（200微米淋巴结切片）。
共纳入133例患者的437个淋巴结；61例患者（14%）经组织病理学检查显示有转移，与OSNA检测法的一致性率为0.979（95%置信区间[CI]：0.961-0.991）。OSNA检测法的敏感性和特异性分别为0.918（95%CI：0.819-0.973）和0.989（95%CI：0.973-0.997）。在9个淋巴结（2.1%）中观察到两种方法结果不一致，转移灶的分布偏差被确定为不一致的主要原因。
OSNA检测法在检测淋巴结转移方面与组织病理学检查具有同样的准确性。我们认为OSNA检测法可能是一种用于快速术中诊断宫颈癌和子宫内膜癌患者淋巴结转移的有用工具。
