Development of a Colloidal Gold Immunochromatographic Strip for Rapid Detection of Cyfra 21-1 in Lymph Node Metastasis of Thyroid Cancer.

Thyroid cancer is the most common endocrine tumor, and the rate of early lymph node metastasis may be as high as 60%. Currently, detection of lymph node metastasis of thyroid cancer during surgery is limited and time-consuming. Elevated levels of Cyfra 21-1, the proteolytic portion of cytokeratin, are associated with the metastasis and progression of thyroid cancer and are an effective biomarker for the prognosis and diagnosis of thyroid cancer. In this study, an immunochromatographic strip test based on colloidal gold nanoparticles was developed to semi-quantitatively detect the levels of Cyfra 21-1 in lymph nodes within 15 min. The standard (calibration) curve equation was Y = 0.003708 × X + 0.1101, and the detection limit was 0.55-1.14 ng mL(-1). The strip did not detect other protein markers of epithelial cells at a concentration of 500 ng mL(-1), including cytokeratin 8, cytokeratin 18, epithelial membrane antigen, and epidermal surface antigen. The ability of the strip to differentiate positive from negative metastasis in 40 lymph node specimens was 100% concordant with that of immunohistochemical staining for Cyfra 21-1. In an assessment of 20 lymph node specimens that had been determined by postoperative histopathology to be positive for lymph node metastasis and 20 specimens that were negative, the sensitivity and specificity of the strip were 100% and 95%, respectively. The sensitivity of the strip remained stable when stored at room temperature for 6 months. Together, these results indicated that although further testing using a larger sample size will be required, this immunochromatographic strip test may be useful for rapid intraoperative detection of thyroid cancer metastasis to lymph nodes.