STUDY OF PERFORMANCE CHARACTERISTICS OF TSH ON FINECARE™ POCT DEVICE

Abstract

Objective: Thyroid diseases can be diagnosed and monitored by serum thyroid stimulating hormone (TSH) measurement along with serum T3 and T4 (both free and total). However, TSH is used to distinguish between euthyroid and hyperthyroid patients. Hence, analysis sensitivity of the TSH assay plays a very significant role. Aims and objectives – The aim of the study was to perform the precision study, calculate the randomerror and analytical measurement rangeverification, as well as verify the accuracy of TSH estimation on Finecare™ point of care testing (POCT). Methods: The experimental evaluation was done in preliminary and final parts. The preliminary part calculates random errors, systemic errors, and recovery whereas the final evaluation comprises the implementation of the method comparison between chemiluminescence and immunofluorescence assay (CLIA). Results: In the preliminary evaluation, the inter-assay-high-value sample had CV% was 15 whereas the low-value sample has 13, and the intra-assay had a CV% of 5.8. The recovery test shows 22.22% CV. The final evaluation of the new method Immuno Fluorescence Assay and reference method (CLIA) has a correlation of coefficient 0.9937. Conclusion: POCT reduces pre-analytical error by reducing misidentification of the patient, specimen, and sample handling. This reduces the turn-around time. It helps to improve the quality of care, healthy outcomes, and affordability.