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The aim of the study was to compare the prognostic significance of lymph node status of patients with lung cancer analyzed by three different methods: hematoxylin and eosin (H&amp;E), immunohistochemistry of cytokeratin 19 (IHC CK19), and One-Step Nucleic Acid Amplification (OSNA). The clinical relevance of the results was evaluated based on relation to prognosis; the disease-free interval (DFI) and overall survival (OS) were analyzed. During radical surgical treatment, a total of 1426 lymph nodes were obtained from 100 patients, creating 472 groups of nodes (4-5 groups per patient) and examined by H&amp;E, IHC CK19 and OSNA. The median follow-up was 44 months. Concordant results on the lymph node status of the H&amp;E, IHC CK19 and OSNA examinations were reported in 78% of patients. We recorded shorter OS in patients with positive results provided by both OSNA and H&amp;E. The study demonstrated a higher percentage of detected micrometastases in lymph nodes by the OSNA method. However, the higher sensitivity of the OSNA, with the cut-off value 250 copies of mRNA of CK19/µL, resulted in a lower association of OSNA positivity with progress of the disease compared to H&amp;E. Increasing the cut-off to 615 copies resulted in an increase in concordance between the OSNA and H&amp;E, which means that the higher cut-off is more relevant in the case of lung tumors.

Prognostic Significance of Lymph Node Examination by the OSNA Method in Lung Cancer Patients—Comparison with the Standard Histopathological Procedure