Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy

Abstract

Endocrine and metabolic disorders are a common condition in Europe and worldwide, and, among these, thyroid dysfunction still remains a problem. The measurement of thyroid stimulating hormone (TSH) levels represents the first-line assay for the assessment of thyroid function. In the present study, we compared serum concentrations of TSH, measured using a commercially available point-of-care test (POCT) method (FastPack® IP) and an established “conventional” laboratory-based method (Beckmann Access 2) in a cohort of patients from Foggia in Southern Italy. A strong correlation (r = 0.994) was found between both methods and was also confirmed by receiver operating characteristic (ROC) curve analysis (0.82). The within-run coefficient of variation (CV) using FastPack® ranged from 4.03% and 8.57% at the TSH concentrations of 39.49 and 0.70 mIU/L, respectively. The between-run CV was 10.34% and 6.33% at the TSH concentrations of 0.87 and 26.55 mIU/L, respectively. The ratios of within- to between-assay CV were 0.83 and 1.06 at the TSH levels of 0.70 and 52.59 mIU/mL, respectively. In this study, we showed that serum TSH levels can be measured in a few minutes and at low-cost in terms of materials and equipment required. We observed that this approach is user-friendly, accurate, reproducible, and suitable for use in the clinic, while also meeting the criteria for effectiveness, impact, efficiency, and sustainability.