Diagnostic accuracy of one-step nucleic acid amplification for detection of sentinel lymph node metastasis in breast cancer: A meta-analysis

Abstract

The one-step nucleic acid amplification (OSNA) assay has been widely studied for intraoperative diagnosis of sentinel lymph node (SLN) metastasis in breast cancer. However, its diagnostic performance remains inconclusive. The aim of this study was to evaluate the accuracy of OSNA in detecting SLN metastasis in breast cancer. We systematically searched PubMed, Embase, and the Cochrane Library for relevant studies published up to July 2025. All data were analyzed using Stata 16 and RevMan 5.3. Subgroup analysis was performed using a fixed -effects model. A total of 20 eligible studies were included in this analysis, comprising 8917 SLNs from 4645 patients. The sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the summary receiver operating characteristic curve (AUC) of OSNA for detecting SLN metastasis were 0.88 (95 % CI:0.84–0.91), 0.95 (95 % CI:0.94–0.96), 18.0 (95 % CI:14.6–22.1), 0.13(95 % CI:0.10–0.17),141 (95 % CI:97–205), and 0.97 (95 % CI:0.96–0.98), respectively. The overall sensitivity, specificity, PLR, NLR, DOR and AUC for frozen section (FS) were 0.82 (95 % CI: 0.56–0.94), 0.99 (95 % CI: 0.98–1.00), 127.0 (95 % CI: 37.1–435.4), 0.18 (95 % CI: 0.06–0.51), 708 (95 % CI: 198–2541), and 0.99 (95 % CI:0.98–1.00), respectively. There was no statistically significant difference in the AUC between OSNA and FS (p = 0.85, z = 0.19). The OSNA assay is a highly accurate intraoperative tool for detecting SLN metastasis in breast cancer, demonstrating high sensitivity and overall diagnostic performance comparable to FS.