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.

Study of Performance Characteristics of TSH on Finecare™ Poct Device

“…Hence, the POCT is an important milestone for the rapid estimation of TSH levels. However, TSH assays should be standardized, quality control study should be implicated and repeatability and accuracy should be ensured [9]. Many methodologies have been utilized for the measurement of TSH levels since the 1950s.…”

“…However, they face a different type of interference that causes erroneous clinical decisions. CLIA has higher sensitivity, low background signal, and automatic and faster sample processing time, the only disadvantage is the high cost of instrumentation [9]. In standard protocol for lab analysis, the test is requested, and the specimen is obtained, processed, and analyzed after which therapy is prescribed by the clinician.…”

Diagnostic criteria and scoring systems for thyroid storm: An evaluation of their utility – comparative review

“…Researchers explore next-generation sequencing to identify genetic variants linked to thyroid disorders, potentially enhancing personalized risk assessment and diagnosis. [16] Metabolomics, which studies small molecules in biological fluids, is being leveraged to investigate metabolic profiles associated with thyroid storm. Identifying unique metabolic signatures holds promise for gaining insights into the condition and its diagnosis.…”

High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow Immunoassay (LFIA)

“…Endocrine and metabolic disorders are common worldwide [1][2][3]. Among these, thyroid dysfunction remains a major problem [1].…”

“…Among these, thyroid dysfunction remains a major problem [1]. The measurement of thyroid-stimulating hormone (TSH) levels represents the first-line assay for assessing thyroid function [2]. TSH is the most significant test for understanding any relevant thyroid problems [3]; along with triiodothyronine (T3) and thyroxine (T4) testing, primary or secondary thyroid disease can be diagnosed [4].…”