Last data update: Apr 18, 2025. (Total: 49119 publications since 2009)
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Query Trace: Fischer CM[original query] |
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The VitMin Lab Sandwich-ELISA Assays for iron and inflammation markers compared well with clinical analyzer reference-type assays in subsamples of the Nepal National Micronutrient Status Survey
Fischer CM , Zhang M , Sternberg MR , Jefferds ME , Whitehead RD , Mei Z , Paudyal N , Joshi N , Parajuli KR , Adhikari DP , LaVoie DJ , Pfeiffer CM . J Nutr 2021 152 (1) 350-359 BACKGROUND: The low cost and small specimen volume of the VitMin Lab ELISA assays for serum ferritin (Fer), soluble transferrin receptor (sTfR), C-reactive protein (CRP), and α-1-acid glycoprotein (AGP) allowed their application to micronutrient surveys conducted in low-resource countries for ∼2 decades. OBJECTIVE: We conducted a comparison between the ELISA and reference-type assays used in the US National Health and Nutrition Examination Survey. METHODS: Using the Roche clinical analyzer as a reference, we measured random subsets of the 2016 Nepal National Micronutrient Status Survey (200 serum samples from children 6-59 mo; 100 serum samples from non-pregnant women) for Fer, sTfR, CRP, and AGP. We compared the combined data sets to the ELISA survey results using descriptive analyses. RESULTS: The Lin's concordance coefficients between the 2 assays were ≥ 0.89 except for sTfR (Lin's rho = 0.58). The median relative difference to the reference was: Fer -8.5%, sTfR 71.2%, CRP -19.5%, and AGP -8.2%. The percentage of VitMin samples agreeing within ± 30% of the reference was: Fer 88.5%, sTfR 1.70%, CRP 74.9%, and AGP 92.9%. The prevalence of abnormal results was comparable between the 2 assays for Fer, CRP, and AGP, and for sTfR after adjusting to the Roche assay. Continued biannual performance (2007-2019) of the VitMin assays in CDC's external quality assessment program (6 samples/y) demonstrated generally acceptable performance. CONCLUSION: Using samples from the Nepal survey, the VitMin ELISA assays produced mostly comparable results to the Roche reference-type assays for Fer, CRP, and AGP. The lack of sTfR assay standardization to a common reference material explains the large systematic difference observed for sTfR, which could be corrected by an adjustment equation pending further validation. This snapshot comparison together with the long-term external quality assessment links the survey data generated by the VitMin Lab to the Roche assays used in NHANES. |
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