A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
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DOI：
10.1371/journal.pone.0259509
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Boyle DS
中科院分区：
文献类型：
--
作者：
Brindle E;Lillis L;Barney R;Bansil P;Hess SY;Wessells KR;Ouédraogo CT;Arredondo F;Barker MK;Craft NE;Fischer C;Graham JL;Havel PJ;Karakochuk CD;Zhang M;Mussai EX;Mapango C;Randolph JM;Wander K;Pfeiffer CM;Murphy E;Boyle DS
缺乏跨实验室的比较数据往往是吸收和采用新技术的障碍。此外，由于缺乏统一，不同免疫测定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中进行的验证实验和测定结果的跨实验室比较，以评估Q-plex™ 7-plex人微量营养素阵列（7-plex）的性能特征，这是一种使用血浆或血清同时定量与微量营养素（MN）缺乏、炎症和疟疾抗原血症相关的七种生物标志物的免疫测定法; α-1-酸性糖蛋白、C-反应蛋白、铁蛋白、富组氨酸蛋白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检测（在10个试验平板上分别制备n = 20个实验），以评估精密度和线性。7个独立实验室使用相同的7重检测试剂盒检测了从尼日尔一组孕妇中采集的76份相同肝素血浆样本，以评估实验室间结果的差异。在分析验证实验中，试验内和试验间的变异系数分别为<6%和<15%，试验线性为96%至99%，但铁蛋白除外，其在某些试验中具有边际性能。实验室间比较显示，实验室间76份血浆标本的所有分析物结果总体一致，所有分析物的Lin一致性相关系数平均值≥0.8。排除不符合常规质量控制（QC）标准的平板，除sTfR外，所有分析物的试验间变异均可接受，其平均试验间变异系数≥ 20%。这项初步的跨实验室研究表明，7重检测方案可以由具有一定免疫测定方法经验的用户实施，但熟悉多重方案并不重要。
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.
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影响因子：
3.8
作者：
Arndt MB;Cantera JL;Mercer LD;Kalnoky M;White HN;Bizilj G;Boyle DS;de Hostos EL;Choy RKM
通讯作者：
Choy RKM
影响因子：
168.9
作者：
BEADLE, C;LONG, GW;HOFFMAN, SL
通讯作者：
HOFFMAN, SL
影响因子：
2.9
作者：
Salvante, Katrina G.;Brindle, Eleanor;Nepomnaschy, Pablo A.
通讯作者：
Nepomnaschy, Pablo A.
影响因子：
5.9
作者：
Silubonde, Takana Mary;Baumgartner, Jeannine;Norris, Shane
通讯作者：
Norris, Shane
影响因子：
2.2
作者：
Brindle, Eleanor;Fujita, Masako;O'Connor, Kathleen A.
通讯作者：
O'Connor, Kathleen A.