title: Assessment of suitability of the one step nucleic acid amplification (OSNA) assay as an intraoperative procedure for detection of metastasis in sentinel lymph nodes of breast cancer.
abstract: OBJECTIVE
  We aimed to assess the one step nucleic acid amplification (OSNA) assay as an intraoperative method in comparison with frozen sections (FS) for detection of metastasis in sentinel lymph nodes (SLNs) of breast cancer.
  
  
  METHODS
  100 SLNs from patients with breast carcinoma were enrolled within a 3-month period. Alternate 2 mm node slices were subjected to routine FS, and later to permanent histology, and the rest for automated molecular detection of CK19 mRNA using OSNA. FS and OSNA findings were compared with permanent histology results. Difference in turnaround time was also noted.
  
  
  RESULTS
  With permanent histology as gold standard, OSNA was discrepant in 8 of 98 (3 false negative, 5 false positive) included SLNs whereas FS had 2 false negative cases. FS had higher sensitivity (89%, p=<0.001), specificity (100%, p=0.001) and concordance rate (98%) than OSNA (83%, 94% and 92%, respectively). FS showed almost perfect agreement (κ=0.929) whereas OSNA showed substantial agreement (κ=0.740) when compared with permanent histology. OSNA turnaround time was twice longer (mean of 47.7 min) than FS.
  
  
  CONCLUSIONS
  Automation of SLN assessment using OSNA is a potentially useful intraoperative diagnostic tool with acceptable accuracy. Discordant findings in this study may be due to sampling allocation. Since OSNA is more time-consuming, its practical advantage over routine FS requires further study in view of current technical workflow considerations.
authors.affiliation: Department of Pathology, Singapore General Hospital, Singapore, Singapore.
authors.forename: Ana Richelia
authors.initials: AR
authors.lastname: Jara-Lazaro
authors.affiliation: Department of Pathology, Singapore General Hospital, Singapore, Singapore.
authors.forename: Ilyana Huda Mohamed
authors.initials: IH
authors.lastname: Hussain
authors.affiliation: Department of Pathology, Singapore General Hospital, Singapore, Singapore.
authors.forename: Aye Aye
authors.initials: AA
authors.lastname: Thike
authors.affiliation: Department of General Surgery, Singapore General Hospital, Singapore, Singapore.
authors.forename: Chow Yin
authors.initials: CY
authors.lastname: Wong
authors.affiliation: Department of Surgical Oncology, National Cancer Center, Singapore, Singapore.
authors.forename: Gay Hui
authors.initials: GH
authors.lastname: Ho
authors.affiliation: Department of Surgical Oncology, National Cancer Center, Singapore, Singapore.
authors.forename: Wei Sean
authors.initials: WS
authors.lastname: Yong
authors.affiliation: Department of Surgical Oncology, National Cancer Center, Singapore, Singapore.
authors.forename: Kong Wee
authors.initials: KW
authors.lastname: Ong
authors.affiliation: Department of Surgical Oncology, National Cancer Center, Singapore, Singapore.
authors.forename: Preetha
authors.initials: P
authors.lastname: Madhukumar
authors.affiliation: Department of General Surgery, Singapore General Hospital, Singapore, Singapore.
authors.forename: Benita Kiat Tee
authors.initials: BK
authors.lastname: Tan
authors.affiliation: Department of General Surgery, Singapore General Hospital, Singapore, Singapore.
authors.forename: Chung Lie
authors.initials: CL
authors.lastname: Oey
authors.affiliation: Department of Pathology, Singapore General Hospital, Singapore, Singapore.
authors.forename: Jacqueline Siok Gek
authors.initials: JS
authors.lastname: Hwang
authors.affiliation: Department of Pathology, Singapore General Hospital, Singapore, Singapore.
authors.forename: Puay Hoon
authors.initials: PH
authors.lastname: Tan
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000473:pathology*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D053539:Keratin-19 / Q000032:analysis; D008207:Lymphatic Metastasis / Q000175:diagnosis*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy; D013997:Time Factors
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19
keywords: BREAST CANCER; MOLECULAR PATHOLOGY; SENTINEL NODE