Performance Evaluation of Thyroid Function Tests on a Novel Chemiluminescent Microparticle Immunoassay System

Author:

Ahn Sunyoung1,Cho Yonggeun1,Lee Sang-Guk1,Kim Jeong-Ho1

Affiliation:

1. Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

Abstract

Abstract Background The Alinity i system (Abbott), a recently developed automated immunoassay analyzer, has a compact footprint and a throughput of 200 tests per hour. Here, we present the first performance evaluation of thyroid function test (TFT) on the Alinity i system. Methods We performed precision, linearity, comparison, functional sensitivity, carryover, and reference interval verification of 4 hormones (Thyroid Stimulation Hormone; TSH, total T3, free T4, and total T4) using the reagents provided by the manufacturer following the guidelines of the Clinical Laboratory Standards Institute. The performance of Alinity i was compared to that of the Architect i2000 immunoassay analyzer (Abbott, US). Results The within-laboratory coefficients of variation for all the hormones were 1.6–3.6%. Linearity was observed for all the hormones over the entire tested analytical range (R2 ≥ 0.99). The results for all the evaluated hormones using Alinity i system strongly correlated (r ≥ 0.978) with those from Architect i2000. Functional sensitivity was lower than the lower limit of the analytical measurement range. Sample carryover was less than 1.0%. Conclusions TFTs on the Alinity i system showed acceptable performance in terms of precision, linearity, comparison, functional sensitivity, and carryover. Therefore, this system could be a useful laboratory tool for performing TFTs.

Publisher

Oxford University Press (OUP)

Subject

General Medicine

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