Point Of Care Thyroglobulin Lateral Flow Immunoassay for Rapid Detection of Differentiated Thyroid Carcinoma Metastasis to Cervical Lymph Nodes

Read the full article See related articles

Listed in

This article is not in any list yet, why not save it to one of your lists.
Log in to save this article

Abstract

Metastatic cervical lymph nodes (LN) are detected in 20-30% of patients with differentiated thyroid cancer (DTC). Current guidelines recommend that once a cervical LN is suspected to be DTC metastasis during a neck ultrasound (US) procedure, it should be investigated via a fine needle aspiration (FNA) biopsy for cytological evaluation and saline washout of the needle for thyroglobulin (Tg) measurement (FNA-Tg). Since Tg is a protein produced exclusively by thyroid follicular cells, a positive FNA-Tg result establishes the diagnosis of metastatic DTC irrespective of cytology. The conventional, immunoassay-based, FNA-Tg washout requires a laboratory and skilled personnel. We developed a semi-quantitative, lateral flow-based method which was shown to detect at the point-of-care (POC), within 10 minutes, positive Tg samples in needle washouts of a suspicious LN at the site of FNA biopsy. In the pre-clinical phase, the POC-Tg limit of detection was determined to be at a concentration equal to 5 ng/mL, after a 1 mL dilution with normal saline. Our prototype was optimized by evaluating different components: types of membranes, pads, antibodies, and gold conjugates. We evaluated our POC-Tg kits on thirty clinical samples: 16 were found positive while the other 14 were seen as negative. All the negative and positive results were further validated by the attending clinical labs, resulting in 100% compatibility compared to the standard procedure. The proof-of-value of our POC-Tg test lies in its ability to significantly reduce the time to results, thus enhancing clinical decision-making, and saving time and valuable resources.

Article activity feed