A Rapid Intraoperative Parathyroid Hormone Assay Based on the Immune Colloidal Gold Technique for Parathyroid Identification in Thyroid Surgery

Objective A novel immunochromatographic test strip method was developed to detect tissue parathyroid hormone (PTH) using the immune colloidal gold technique (ICGT). The accuracy and application value of this method for intraoperative parathyroid identification were evaluated. Methods Serum samples were collected to measure PTH by both ICGT and electrochemiluminescence immunoassay (ECLIA). Patients who underwent unilateral and total thyroidectomy were enrolled to evaluate the feasibility and clinical efficacy of rapid intraoperative identification of parathyroid glands via PTH determination using ICGT. Two sample preparation methods, fine needle aspiration (FNA) and tissue block homogenate (TBH), were used for PTH-ICGT analysis. Results Bablok analysis showed a linear relationship between the serum PTH measurements obtained by ICGT and ECLIA. Non-parathyroid tissues had much lower PTH concentrations (14.8 +/- 2.1 pg/ml, n = 97) detected by ICGT, compared to the parathyroid gland tissues (955.3 +/- 16.1 pg/ml, n = 79; P < 0.0001), With biopsy results as the standard, ICGT showed higher diagnosis rates as compared with direct visual inspection, for identifying both parathyroid glands (97.4 vs. 78.2%) and non-parathyroid tissues (100 vs. 68.9%). The cut-off values for parathyroid identification by FNA and TBH methods were 63.99 and 136.30 pg/ml, respectively. The detection time was 2 min by TBH method for in vitro tissue detection and 6 min by FNA method for in situ tissue detection, both of which were faster than traditional intraoperative cryopathological examination (usually >30 min). Intraoperative application of ICGT method was associated with higher postoperative serum calcium and blood PTH levels at 1 and 3 months as well as a lower incidence of postoperative transient hypocalcemia, as compared with direct visual inspection. Conclusion PTH-ICGT assay shows high potential as a rapid, novel alternative for intraoperative parathyroid identification.

Automated summary

A novel immunochromatographic test strip method was developed for rapid intraoperative identification of parathyroid glands based on tissue PTH detection using the immune colloidal gold technique. The method showed high accuracy and efficiency compared to traditional inspection methods, with faster detection times and improved diagnostic rates for both parathyroid and non-parathyroid tissues. The use of PTH-ICGT assay also resulted in better postoperative outcomes compared to direct visual inspection, with higher serum calcium and blood PTH levels at 1 and 3 months post-surgery and lower incidence of transient hypocalcemia.