Background: One-step nucleic acid amplification (OSNA) assay is a molecular diagnostic method for intraoperative detection of lymph node metastasis by amplifying cytokeratin 19 mRNA. We aim to further evaluate the performance of OSNA assay for the intraoperative diagnosis of sentinel lymph node metastasis in breast cancer. Methods: PubMed, Cochrane Library, Web of Science databases were searched to retrieve related literature published up until December 2017. This meta-analysis was performed using a random-effects model. Risks of bias and quality assessments of included studies were evaluated and subgroup analysis was performed. Results: Nineteen studies were included in this meta-analysis. For overall metastasis, the pooled sensitivity, specificity and area under the summary receiver-operating characteristic curve (AUC) were 0.90, 0.96 and 0.98, respectively. For macrometastasis, the pooled sensitivity, specificity and AUC were 0.85, 0.98 and 0.94, respectively. Conclusion: OSNA assay is an accurate molecular diagnosis for intraoperative detection of sentinel lymph node macrometastasis in breast cancer. (C) 2018 Elsevier Ltd. All rights reserved.