title: The novel one-step nucleic acid amplification (OSNA) assay for the diagnosis of lymph node metastasis in patients with non-small cell lung cancer (NSCLC): Results of a multicenter prospective study.
abstract: The precise and rapid diagnosis of the presence or absence of lymph node (LN) metastasis is essential for deciding upon an appropriate therapeutic strategy for patients with non-small cell lung cancer (NSCLC). We conducted a prospective multicenter clinical trial in Japan to evaluate a rapid, automated and objective assay system, the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp), which targets cytokeratin 19 mRNA, to detect LN metastasis of NSCLC.
  
  
  
  A total of 410 Lymph nodes (LNs) from 111 patients with clinical stage IB to IIIA NSCLC who underwent lung resection with LN dissection were included in this study. The LNs were divided into 4 blocks and examined by either the OSNA assay or a 3-level histological examination. The results of each method were compared and further analyses were performed for discordant cases. The primary endpoint was a concordance rate of more than 85% between the two methods.
  
  
  
  The concordance rate between the two methods was 92.7% (95% CI, 89.7-95.0%), with a sensitivity of 79.7% (95% CI, 67.2-89.0%). Discordant results were observed in 30 LNs (5.8%), and were mainly due to a tissue allocation bias and/or contamination by CK19-expressing alveolar cells in LNs.
  
  
  
  The OSNA assay gave a diagnosis that was as accurate as a 3-level histological examination, which is more detailed than a histological examination in routine clinical practice. The OSNA assay might be useful in intraoperative decision-making in personalized lung cancer surgery based on the LN status.
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Electronic address: kznakaga@ncc.go.jp.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Nakagawa
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; Division of General Thoracic Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Asamura
authors.affiliation: Division of Pathology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan; Department of Pathology and Laboratory Medicine, Kansai Medical University, 2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Tsuta
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors.forename: Kanji
authors.initials: K
authors.lastname: Nagai
authors.affiliation: Division of Thoracic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan; Department of Thoracic Surgery, Fukuyama City Hospital, 5-23-1 Zaocho, Fukuyama, Hiroshima 721-8511, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Yamada
authors.affiliation: Division of Pathology, Research Center for Innovative Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors.forename: Genichiro
authors.initials: G
authors.lastname: Ishii
authors.affiliation: Department of Thoracic Surgery, Kinki University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mitsudomi
authors.affiliation: Department of Pathology, Kinki University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Ito
authors.affiliation: Department of General Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Higashiyama
authors.affiliation: Department of Pathology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Tomita
authors.affiliation: Department of General Thoracic Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Inoue
authors.affiliation: Department of Pathology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Morii
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.
authors.forename: Nariaki
authors.initials: N
authors.lastname: Matsuura
authors.affiliation: Department of General Thoracic Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.
authors.forename: Meinoshin
authors.initials: M
authors.lastname: Okumura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics / Q000473:pathology* / Q000556:secondary* / Q000601:surgery; D000066491:Clinical Decision-Making; D005260:Female; D006652:Histological Techniques / Q000379:methods; D006801:Humans; D007432:Intraoperative Period; D007564:Japan / Q000453:epidemiology; D053539:Keratin-19 / Q000235:genetics; D008175:Lung Neoplasms / Q000473:pathology; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000235:genetics / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011446:Prospective Studies; D012333:RNA, Messenger / Q000235:genetics
chemical_list: D053539:Keratin-19; D012333:RNA, Messenger
keywords: Histological examination; LN status; Lymph node metastasis; Non-small cell lung cancer (NSCLC); One-step nucleic acid amplification (OSNA)