Validation of a Novel Diagnostic Kit Using the Semidry Dot-Blot Method to Detect Metastatic Lymph Nodes in Breast Cancer: Distinguishing Macrometastases From Nonmacrometastases

Clin Breast Cancer. 2018 Jun;18(3):e345-e351. doi: 10.1016/j.clbc.2017.07.009. Epub 2017 Jul 15.

Abstract

Background: The semidry dot-blot method is a diagnostic procedure for detecting lymph node (LN) metastases using the presence of cytokeratin (CK) in lavage fluid from sectioned LNs. We evaluated 2 novel kits that use newly developed anti-CK-19 antibodies to diagnose LN metastases in breast cancer.

Patients and methods: We examined 159 LNs dissected that we sliced at 2-mm intervals and washed with phosphate-buffered saline. The suspended cells in the lavage were centrifuged and lysed to extract protein. This extracted protein was used with a low-power and a high-power kit to diagnose LN metastasis. Diagnoses on the basis of the kits were compared with pathological diagnoses.

Results: Of the 159 LNs, 68 were assessed as positive and 91 as negative in permanent section examination. Sensitivity, specificity, and accuracy of the low-power kit for detecting LN metastases was 83.8%, 100%, and 93.1%, respectively. Those of the high-power kit were 92.6%, 92.3%, and 92.5%, respectively. Combining the low- and high-power kit results, those for distinguishing macrometastases were 94.5%, 95.2%, and 95.0%, respectively. Diagnosis was achieved in approximately 20 minutes, at a cost of less than $30 USD.

Conclusion: The kits were accurate, fast, and cost-effective in diagnosing LN metastases without the loss of LN tissue.

Keywords: Breast cancer; Cytokeratin 19; Immunochromatography; Lymph node metastasis; Semi-dry dot-blot.

Publication types

  • Evaluation Study
  • Validation Study

MeSH terms

  • Axilla
  • Breast / pathology
  • Breast / surgery
  • Breast Neoplasms / pathology*
  • Breast Neoplasms / surgery
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Immunoblotting / economics
  • Immunoblotting / methods*
  • Keratin-19 / analysis
  • Lymphatic Metastasis / diagnosis*
  • Lymphatic Metastasis / pathology
  • Middle Aged
  • Neoplasm Micrometastasis / diagnosis*
  • Neoplasm Micrometastasis / pathology
  • Prospective Studies
  • Sensitivity and Specificity
  • Sentinel Lymph Node / pathology*
  • Sentinel Lymph Node Biopsy
  • Time Factors

Substances

  • KRT19 protein, human
  • Keratin-19