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. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by the Israel Innovation Authority [Kmin grant, number 64994], and the Israel Cancer Association [grant number 20230021]. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval for this study was obtained by the Helsinki committee of Soroka University Medical Center (SUMC), approval number 190-17-SOR. All patients provided written informed consent before the FNA procedure was initiated. Patients 18-year-old and older, able to understand and sign the informed consent form, who were evaluated for cervical LN suspected as DTC metastases, were offered to participate. Pregnant women were excluded. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
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