1. Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients.
- Author
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Kumagai K, Yamamoto N, Miyashiro I, Tomita Y, Katai H, Kushima R, Tsuda H, Kitagawa Y, Takeuchi H, Mukai M, Mano M, Mochizuki H, Kato Y, Matsuura N, and Sano T
- Subjects
- Adenocarcinoma genetics, Adenocarcinoma surgery, Adenocarcinoma, Mucinous genetics, Adenocarcinoma, Mucinous surgery, Adult, Aged, Aged, 80 and over, Carcinoma, Papillary genetics, Carcinoma, Papillary surgery, Carcinoma, Signet Ring Cell genetics, Carcinoma, Signet Ring Cell surgery, Female, Follow-Up Studies, Humans, Lymphatic Metastasis, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Prognosis, Sentinel Lymph Node Biopsy, Stomach Neoplasms genetics, Stomach Neoplasms surgery, Adenocarcinoma secondary, Adenocarcinoma, Mucinous secondary, Biomarkers, Tumor analysis, Carcinoma, Papillary secondary, Carcinoma, Signet Ring Cell secondary, Nucleic Acid Amplification Techniques methods, Stomach Neoplasms pathology
- Abstract
Background: The accurate diagnosis of lymph node (LN) metastasis is important for making treatment decisions for gastric cancer patients. This multicenter study evaluated the clinical performance of the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp.), an automated system that detects cytokeratin 19 (CK19) mRNA, in detecting LN metastases in gastric cancer patients., Methods: LNs retrieved from patients who had undergone gastric cancer surgery at one of the four Japanese hospitals involved in this study were divided into blocks at 2-mm intervals. Alternate blocks were examined with the OSNA assay and the remaining blocks were assessed histologically., Results: A total of 394 LNs from 61 patients were examined. The concordance rate between the OSNA assay and the histological examination was 0.942 (95 % CI, 0.914-0.963). Sensitivity and specificity of the OSNA assay compared to the histological examination were 0.833 (95 % CI, 0.707-0.921) and 0.959 (95 % CI, 0.932-0.977), respectively. Discordant results were observed in 23 LNs (5.8 %), and these were mainly the result of tissue allocation bias and/or low CK19 protein expression., Conclusion: The OSNA assay can detect lymph node metastases in gastric cancer patients as accurately as the histological examination of blocks sectioned at 2-mm intervals. The OSNA assay is a useful tool for the intraoperative diagnosis of LN metastasis in gastric cancer patients.
- Published
- 2014
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