A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.
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 i...
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oai:doaj.org-article:1bb28664d89c4683983102703b24e7f82021-12-02T20:04:19ZA multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia.1932-620310.1371/journal.pone.0259509https://doaj.org/article/1bb28664d89c4683983102703b24e7f82021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0259509https://doaj.org/toc/1932-6203A 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.Eleanor BrindleLorraine LillisRebecca BarneyPooja BansilSonja Y HessK Ryan WessellsCésaire T OuédraogoFrancisco ArredondoMikaela K BarkerNeal E CraftChristina FischerJames L GrahamPeter J HavelCrystal D KarakochukMindy ZhangEi-Xia MussaiCarine MapangoJody M RandolphKatherine WanderChristine M PfeifferEileen MurphyDavid S BoylePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 11, p e0259509 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Medicine R Science Q |
| spellingShingle |
Medicine R Science Q 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 David S Boyle A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| description |
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. |
| format |
article |
| author |
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 David S Boyle |
| author_facet |
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 David S Boyle |
| author_sort |
Eleanor Brindle |
| title |
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| title_short |
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| title_full |
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| title_fullStr |
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| title_full_unstemmed |
A multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| title_sort |
multicenter analytical performance evaluation of a multiplexed immunoarray for the simultaneous measurement of biomarkers of micronutrient deficiency, inflammation and malarial antigenemia. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2021 |
| url |
https://doaj.org/article/1bb28664d89c4683983102703b24e7f8 |
| work_keys_str_mv |
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