Evaluation of the AFIAS-1 thyroid-stimulating hormone point of care test and comparison with laboratory-based devices

Abstract

Objectives Thyroid-stimulating hormone (TSH) is the routine primary screening test to assess thyroid function and rapid measurement of TSH levels is highly desirable especially in emergency situations. In the present study, we compared the analytical performance of a commercially available point-of-care test (AFIAS-1) and five laboratory-based systems. Methods Left over material of 60 patient plasma samples was collected from patient care and used in the respective assay. For statistical analysis of the produced data Bland-Altman and Passing-Bablok regression analysis were applied. Results Good correlation (r=0.982 or higher) was found between all devices. Slopes from regression analysis ranged from 0.972 (95% CI: 0.927–1.013) to 1.276 (95% CI: 1.210–1.315). Among the compared devices, imprecision was high in terms of coefficient of variation (CV=10.3%) for low TSH concentrations and lower (CV=7.3%) for high TSH concentrations. Independent of the method used, we demonstrated a poor standardization of TSH assays, which might impact clinical diagnosis e.g. of hyperthyreosis. Conclusions This study shows that the point-of-care (POC) test AFIAS-1 can serve as an alternative to laboratory-based assays. In addition the data imply that better standardization of TSH measurements is needed.

Performance Evaluation of AFIAS ST2 and Ichroma ST2 Assays in Comparison with Presage ST2 Assay

“…The complexes migrate onto a nitrocellulose membrane and are captured by antibodies on the test line of the strip. More antigens in the sample form more antigen-antibody complexes, leading to stronger fluorescence intensity [ 21 ]. It takes 12 min to obtain sST2 levels using AFIAS ST2, without hands-on time.…”