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

Abstract

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.

Nanomaterials: a promising multimodal theranostics platform for thyroid cancer

“…The NPs were stable and could be stored at room temperature for 6 months. 83 Quantum dots (QDs) have a high quantum efficiency and continuous absorption profile. They can be used to excite different emissions at a single wavelength synchronously, and their emission spectrum is tunable with photobleaching resistance and high stability in biological environments.…”

Diagnostic utilities of washout CYFRA 21-1 combined with washout thyroglobulin for metastatic lymph nodes in thyroid cancer: a prospective study

“…It is a useful diagnostic marker not only of thyroid but also stomach and ovarian cancers, laryngeal squamous cell carcinomas, liver metastases of colorectal cancer, and LN metastases of lung cancer 23 – 29 . In thyroid cancer, most prior studies have focused on serum levels of this marker 21 , 22 , 30 , 31 ; few works have assayed CYFRA 21-1 concentrations in metastatic LN washouts 27 , 32 . A previous multidisciplinary study in our institution found that a combination of washout CYFRA 21-1 and Tg levels, and FNAC, afforded high sensitivity of 98.8%, highlighting the diagnostic utility of CYFRA 21-1 27 .…”

A gold-based immunochromatographic strip for the specific detection of tacrolimus in whole blood

“…30 In recent years, the colloidal gold-based immunochromatographic strip (CG-ICS), as a low-cost, high-throughput, timesaving, easy-to-operate and portable biosensor, has been widely applied in areas of food safety, 31 environmental pollution, 32 COVID-19 control 33 and clinical research. 34 The CG-ICS visualizes the specific combination of antigen and antibody through the optical properties of colloidal gold nanoparticles. 35 With no requirements for long incubation, repeated washing and reagent adding or other manual operation steps, the CG-ICS produces semi-quantitative test results visible to the naked eye within 5-10 min, or can achieve quantitative determination though use of a portable strip reader.…”