TY - JOUR
T1 - Evaluation of the one-step nucleic acid amplification assay for detecting lymph node metastasis in patients with cervical and endometrial cancer
T2 - A multicenter prospective study
AU - Togami, Shinichi
AU - Tanimoto, Akihide
AU - Yanazume, Shintaro
AU - Tokunaga, Hideki
AU - Nagai, Tomoyuki
AU - Watanabe, Mika
AU - Yahata, Hideaki
AU - Asanoma, Kazuo
AU - Yamamoto, Hidetaka
AU - Tanaka, Tomohito
AU - Ohmichi, Masahide
AU - Yamada, Takashi
AU - Todo, Yukiharu
AU - Yamada, Ryutaro
AU - Kato, Hidenori
AU - Yamagami, Wataru
AU - Masuda, Kenta
AU - Kawaida, Miho
AU - Niikura, Hitoshi
AU - Moriya, Takuya
AU - Kobayashi, Hiroaki
N1 - Funding Information:
Sysmex Corporation (Kobe, Japan) provided research funding for this multicenter prospective study. Sysmex had no role in the data interpretation or preparation of the report.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/3
Y1 - 2023/3
N2 - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
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U2 - 10.1016/j.ygyno.2022.12.016
DO - 10.1016/j.ygyno.2022.12.016
M3 - Article
C2 - 36638744
AN - SCOPUS:85146346017
SN - 0090-8258
VL - 170
SP - 70
EP - 76
JO - Gynecologic Oncology
JF - Gynecologic Oncology
ER -
