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A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
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; Murphy, Eileen; Boyle, David S.
Afiliación
  • Brindle E; Center for Studies in Demography and Ecology, University of Washington, Seattle, Washington, United States of America.
  • Lillis L; PATH, Seattle, Washington, United States of America.
  • Barney R; PATH, Seattle, Washington, United States of America.
  • Bansil P; PATH, Seattle, Washington, United States of America.
  • Hess SY; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Wessells KR; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Ouédraogo CT; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Arredondo F; Helen Keller International, Niamey, Niger.
  • Barker MK; Duke University Medical Ctr. Durham, Durham, North Carolina, United States of America.
  • Craft NE; Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.
  • Fischer C; Craft Nutrition Consulting, Elm City, North Carolina, United States of America.
  • Graham JL; Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
  • Havel PJ; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Karakochuk CD; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Zhang M; Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.
  • Mussai EX; Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
  • Mapango C; Faculty of Land and Food Systems, University of British Columbia, Vancouver, British Columbia, Canada.
  • Randolph JM; Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
  • Wander K; Department of Molecular Biosciences, School of Veterinary Medicine and Department of Nutrition, University of California, Davis, California, United States of America.
  • Pfeiffer CM; Binghamton University (SUNY), Binghamton, New York, United States of America.
  • Murphy E; Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
  • Boyle DS; PATH, Seattle, Washington, United States of America.
PLoS One ; 16(11): e0259509, 2021.
Article en En | MEDLINE | ID: mdl-34735520
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ferritinas / Inflamación Tipo de estudio: Clinical_trials Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ferritinas / Inflamación Tipo de estudio: Clinical_trials Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos