학술논문
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
Document Type
Article
Author
Brindle, Eleanor; Lillis, Lorraine; Barney, Rebecca; Bansil, Pooja; Hess, Sonja Y.; Wessells, K. Ryan; Ouédraogo, Césaire T.; Arredondo, Francisco; Barker, Mikaela K.; Craft, Neal E.; Fischer, Christina; Graham, James L.; Havel, Peter J.; Karakochuk, Crystal D.; Zhang, Mindy; Mussai, Ei-Xia; Mapango, Carine; Randolph, Jody M.; Wander, Katherine; Pfeiffer, Christine M.
Source
Subject
*DEFICIENCY diseases
*TRANSFERRIN receptors
*BIOMARKERS
*CARRIER proteins
*FERRITIN
*TRANSFERRIN
*MICRONUTRIENTS
*C-reactive protein
*
*
*
*
*
*
*
Language
ISSN
1932-6203
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 <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. [ABSTRACT FROM AUTHOR]