Diagnostic potential of 1‐step nucleic acid amplification assay in patients with head and neck squamous cell carcinoma based on CK19 expression in a primary lesion

Abstract

These results suggest that 1-step nucleic acid amplification offers similar diagnostic potential to that of histopathological diagnosis of CLN biopsy in patients with a CK19-positive primary lesion. © 2015 Wiley Periodicals, Inc. Head Neck 38: E239-E245, 2016.

One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma

“…The overall false negative rate after identification of allocation bias was only 1.3% which is consistent with the literature. Goda et al [10], Matsuzuka et al [12] and Suzuki et al [11] found respectively 2.6%, 3.4% and 3.7% of FN. We found a sensitivity and specificity similar to the literature, respectively of 90% and 95.6%.…”

“…Matsuzuka et al [12] found a sensitivity of 82.4% and a specificity of 99.3%. Suzuki et al found a sensitivity and specificity of OSNA assay respectively at 86% and 100% in tumor expressing CK19 protein [11]. The studies of Goda [10], Matsuzuka [12] and Suzuki [11] were undertaken in a population with a variety of neck invasion and sites of HNSCC.…”

“…Suzuki et al found a sensitivity and specificity of OSNA assay respectively at 86% and 100% in tumor expressing CK19 protein [11]. The studies of Goda [10], Matsuzuka [12] and Suzuki [11] were undertaken in a population with a variety of neck invasion and sites of HNSCC. None of these studies targeted a population fully eligible for SLN biopsy.…”

“…To study CK19 protein expression all primary tumors were stained with IHC CK19 (Agilent Dako®, Santa Clara, USA). CK19 tumoral expression was considered as positive if there were more or equal to 1% of the cells stained [11]. Paraffin-embedded tissue was cut at 4 µm, mounted on positively charged slides and dried at 58°C for 60 minutes.…”

“…This technique has been approved for intraoperative SLN analysis in breast cancers [8] and is widely used in SLN analysis of colon cancer in Europe and Japan [9]. Three main studies investigated the feasibility of OSNA assay in HNSCC [10][11][12] whatever the neck LN invasion was. As OSNA assay is a candidate for intra operative SLN analysis in HNSCC the main objective of our study was to compare OSNA assay to standard pathological analysis in cN0 HNSCC patients.…”