Department of Laboratory Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Konkuk University Medical Center, Seoul, Korea.
J Clin Lab Anal. 2021 Mar;35(3):e23671. doi: 10.1002/jcla.23671. Epub 2020 Dec 7.
Although a diagnosis of infectious diseases is essential for timely treatment, the performance of diagnostic tests has been hardly evaluated due to variable results that are influenced by multiple factors in different conditions. In the present study, the performance of the Alinity i system, which is a newly developed immunoassay to diagnose infectious diseases, was evaluated.
We evaluated the precision, linearity, correlation, and carryover of 16 analytes (HAV Ab IgG, HBsAg, HBeAg, anti-HBc, anti-HBe, anti-HBs, anti-HCV, HIV Ag/Ab, EBV VCA IgM, EBV VCA IgG, EBV EBNA IgG, CMV IgM, CMV IgG, Toxoplasma IgG, Rubella IgG, and Syphilis TP) of Alinity i by comparison with ARCHITECT i2000 system following the rationale of the Clinical and Laboratory Standards Institute (CLSI).
For quantitative tests, the coefficients of variation (CV) % of repeatability and intermediate precision were between 0% and 4.18%. The coefficients of the linearity (r ) over a widely tested analytical range were ≥ 0.990 and the correlation between Alinity i and the ARCHITECT i2000 system was strong (r ≥ 0.994). For qualitative tests, the agreement between Alinity i and the ARCHITECT i2000 system was excellent (kappa coefficient 1) with 100% sensitivity and specificity. Carryover rates for all analytes were less than 1.0% (-0.11% ~ 0.21%).
The Alinity i system showed good analytical performance and favorable comparability with the ARCHITECT i2000 It could be suitable as a routine immunoassay analyzer for screening and diagnosis of infectious disease.
尽管传染病的诊断对于及时治疗至关重要，但由于在不同条件下受多种因素影响，诊断测试的结果存在很大差异，因此其性能几乎未得到评估。本研究评估了一种新开发的用于诊断传染病的免疫测定法——Alinity i 系统的性能。
我们通过比较与临床和实验室标准协会（CLSI）原理一致的 ARCHITECT i2000 系统，评估了 Alinity i 系统 16 种分析物（HAV Ab IgG、HBsAg、HBeAg、抗-HBc、抗-HBe、抗-HBs、抗-HCV、HIV Ag/Ab、EBV VCA IgM、EBV VCA IgG、EBV EBNA IgG、CMV IgM、CMV IgG、Toxoplasma IgG、风疹 IgG 和梅毒 TP）的精密度、线性、相关性和携带污染。
对于定量检测，重复性和中间精密度的变异系数（CV）%在 0%至 4.18%之间。在广泛测试的分析范围内，线性系数（r）≥0.990，Alinity i 与 ARCHITECT i2000 系统之间的相关性很强（r≥0.994）。对于定性检测，Alinity i 与 ARCHITECT i2000 系统之间具有极好的一致性（kappa 系数 1），具有 100%的灵敏度和特异性。所有分析物的携带污染率均小于 1.0%（-0.11%至 0.21%）。
Alinity i 系统表现出良好的分析性能，与 ARCHITECT i2000 系统具有良好的可比性。它可以作为一种常规免疫分析仪器，用于传染病的筛查和诊断。
