The diagnostic value of one step nucleic acid amplification (OSNA) in differentiating lymph node metastasis of tumors: A systematic review and meta-analysis

The aim of this study was clarify the diagnostic accuracy of one step nucleic acid amplification (OSNA) for differentiating metastatic lymph nodes from non-metastatic ones in patients with tumors (not including breast cancer). A systematic literature search for original diagnostic studies was performed in PubMed. Findings were pooled by using combined effect models and hierarchic summary receiver operating characteristic curve models. Meta-regression analysis and threshold effect evaluating were performed to explore the sources of heterogeneity affected classification accuracy. 19 studies (803 positive and 4594 negative lymph nodes) were analyzed, including 4 different tumor types (head and neck cancers, gastrointestinal cancers, lung cancer and gynecological malignancies). In the studies of head and neck cancers the pooled sensitivity, specificity and area under the curve (AUC) of the OSNA method were 0.85(0.79–0.89), 0.96(0.92–0.98) and 0.91 (0.88–0.93), respectively. Similarly, the corresponding values in the studies of gastrointestinal cancers were 0.90(0.85–0.94), 0.96(0.94–0.98) and 0.97 (0.96–0.99), respectively. Because of limited number of studies, the other two tumor types were inestimable in the subsequent meta-analyses. Pooled data suggest that the OSNA assay has a high diagnostic accuracy for the detection of lymph node metastases. For wide spread implementation, additional studies on other different types of tumors are warranted. •The OSNA assay is useful to distinguish metastatic lymph nodes from non-metastatic ones in several tumor types.•250 copies/μl appeared to be an optimal cutoff value that distinguished between positive and negative lymph nodes.•CK-19 was selected as a useful mRNA marker for the OSNA assay.