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.

Alfredo Di Cerbo,Nazario Quagliano,Antonella Napolitano,Alessandro Di Cerbo,Tommaso Iannitti,Federica Pezzuto

doi:10.3390/diagnostics11091590

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.

Highlights

Endocrine and metabolic disorders are a common condition in Europe and worldwide [1,2,3]
Besides iodine deficiency, which is becoming gradually less of a concern due to iodine prophylaxis and food circulation, autoimmune thyroid diseases and thyroid nodules represent the most common thyroid disorders faced by clinical endocrinologists worldwide [1,2,16,17,18,37,38,39]
Subclinical hypothyroidism, defined as a normal FT4 and moderately elevated thyroid stimulating hormone (TSH) levels, affects approximately 5% of women and 3% of men in the United States, and 0.5% of the adult population may be suffering from undiagnosed overt hypo- or hyperthyroidism, characterized by low or high levels of thyroid hormones, respectively [37,38,39,40]

Summary

Introduction

Endocrine and metabolic disorders are a common condition in Europe and worldwide [1,2,3]. They result in a costly use of health resources and a loss of productivity [4,5,6,7]. Iodine deficiency, defined as a daily iodine intake inferior to 50–100 μg, is the most common cause of thyroid disorders and triggers the growth of the thyroid gland, leading to goiter and thyroid nodule formation and, if untreated, hypothyroidism [14]. Iodine deficiency negatively affects quality of life and economic productivity [20]

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Methods

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Discussion

Conclusion