Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Appl Lab Med. 2021 Mar 1;6(2):367-377. doi: 10.1093/jalm/jfaa091.
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.
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).
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%.
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.
Alinity i 系统（雅培）是一种最近开发的自动化免疫分析仪器，具有紧凑的占地面积和每小时 200 个测试的吞吐量。在这里，我们介绍了 Alinity i 系统上甲状腺功能测试（TFT）的首次性能评估。
我们按照临床实验室标准协会的指南，使用制造商提供的试剂，对 4 种激素（促甲状腺激素；TSH、总 T3、游离 T4 和总 T4）进行精密度、线性、比较、功能灵敏度、携带和参考区间验证。将 Alinity i 的性能与 Architect i2000 免疫分析分析仪（雅培，美国）进行了比较。
所有激素的实验室内部变异系数为 1.6-3.6%。所有激素在整个测试分析范围内均表现出线性（R2≥0.99）。使用 Alinity i 系统评估的所有激素的结果与 Architect i2000 的结果高度相关（r≥0.978）。功能灵敏度低于分析测量范围的下限。样品携带小于 1.0%。
Alinity i 系统上的 TFT 在精密度、线性、比较、功能灵敏度和携带方面表现出可接受的性能。因此，该系统可以成为进行 TFT 的有用实验室工具。
