1. A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
- Author
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Eleanor Brindle, Lorraine Lillis, Rebecca Barney, Pooja Bansil, Sonja Y Hess, K Ryan Wessells, Césaire T Ouédraogo, Francisco Arredondo, Mikaela K Barker, Neal E Craft, Christina Fischer, James L Graham, Peter J Havel, Crystal D Karakochuk, Mindy Zhang, Ei-Xia Mussai, Carine Mapango, Jody M Randolph, Katherine Wander, Christine M Pfeiffer, Eileen Murphy, and David S Boyle
- Subjects
Medicine ,Science - Abstract
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
- Published
- 2021
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