Center for Studies in Demography and Ecology, University of Washington, Seattle, Washington, United States of America.
PATH, Seattle, Washington, United States of America.
PLoS One. 2021 Nov 4;16(11):e0259509. doi: 10.1371/journal.pone.0259509. eCollection 2021.
A lack of comparative data across laboratories is often a barrier to the uptake and adoption of new technologies. Furthermore, data generated by different immunoassay methods may be incomparable due to a lack of harmonization. In this multicenter study, we describe validation experiments conducted in a single lab and cross-lab comparisons of assay results to assess the performance characteristics of the Q-plex™ 7-plex Human Micronutrient Array (7-plex), an immunoassay that simultaneously quantifies seven biomarkers associated with micronutrient (MN) deficiencies, inflammation and malarial antigenemia using plasma or serum; alpha-1-acid glycoprotein, C-reactive protein, ferritin, histidine-rich protein 2, retinol binding protein 4, soluble transferrin receptor, and thyroglobulin. Validations included repeated testing (n = 20 separately prepared experiments on 10 assay plates) in a single lab to assess precision and linearity. Seven independent laboratories tested 76 identical heparin plasma samples collected from a cohort of pregnant women in Niger using the same 7-plex assay to assess differences in results across laboratories. In the analytical validation experiments, intra- and inter-assay coefficients of variation were acceptable at <6% and <15% respectively and assay linearity was 96% to 99% with the exception of ferritin, which had marginal performance in some tests. Cross-laboratory comparisons showed generally good agreement between laboratories in all analyte results for the panel of 76 plasma specimens, with Lin's concordance correlation coefficient values averaging ≥0.8 for all analytes. Excluding plates that would fail routine quality control (QC) standards, the inter-assay variation was acceptable for all analytes except sTfR, which had an average inter-assay coefficient of variation of ≥20%. This initial cross-laboratory study demonstrates that the 7-plex test protocol can be implemented by users with some experience in immunoassay methods, but familiarity with the multiplexed protocol was not essential.
实验室之间缺乏比较数据通常是新技术采用的障碍。此外，由于缺乏协调，不同免疫分析方法产生的数据可能无法比较。在这项多中心研究中，我们描述了在单个实验室进行的验证实验以及在实验室间比较测定结果，以评估 Q-plex™ 7 重人微量营养素阵列（7 重）的性能特征，该免疫分析方法同时定量七种与微量营养素（MN）缺乏、炎症和疟原抗原血症相关的生物标志物，使用血浆或血清；α-1-酸性糖蛋白、C 反应蛋白、铁蛋白、组氨酸丰富蛋白 2、视黄醇结合蛋白 4、可溶性转铁蛋白受体和甲状腺球蛋白。验证包括在单个实验室中进行重复测试（20 个单独的实验，每个实验在 10 个测定板上进行），以评估精密度和线性度。七个独立实验室使用相同的 7 重分析方法测试了来自尼日尔孕妇队列的 76 个相同肝素血浆样本，以评估实验室之间结果的差异。在分析验证实验中，内和间测定的变异系数分别可接受<6%和<15%，并且除了铁蛋白外，测定的线性度为 96%至 99%，铁蛋白在某些测试中表现不佳。实验室间比较显示，在 76 个血浆标本的面板中，所有分析物的结果在所有实验室之间通常具有良好的一致性，所有分析物的 Lin 一致性相关系数值平均≥0.8。排除不符合常规质量控制（QC）标准的板，除 sTfR 外，所有分析物的测定内变异性均可接受，sTfR 的平均测定内变异系数≥20%。这项初步的实验室间研究表明，7 重测试方案可以由具有免疫分析方法经验的用户实施，但对多重协议的熟悉并不是必需的。
