Evaluation of the one-step nucleic acid amplification assay for detecting lymph node metastasis in patients with cervical and endometrial cancer: A multicenter prospective study

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 histo-pathological examination. Ultrastaging (200-mu m LN sections) was performed for metastatic LNs using hematox-ylin 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 histopa-thological 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 ex-amination. We suggest that the OSNA assay may be a useful tool for the rapid intraoperative diagnosis of LN me-tastasis in patients with cervical and endometrial cancers. (c) 2023 Elsevier Inc. All rights reserved.