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
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) have allowed their application to micronutrient surveys conducted in low-resource countries for ∼2 decades. W...
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| Veröffentlicht in: | The Journal of nutrition 2022-01, Vol.152 (1), p.350-359 |
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| creator | Fischer, Christina M Zhang, Ming Sternberg, Maya R Jefferds, Maria E Whitehead, Ralph D Mei, Zuguo Paudyal, Naveen Joshi, Nira Parajuli, Kedar R Adhikari, Debendra P LaVoie, Donna J Pfeiffer, Christine M |
| description | 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) have allowed their application to micronutrient surveys conducted in low-resource countries for ∼2 decades.
We conducted a comparison between the ELISA and reference-type assays used in the US NHANES.
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 aged 6–59 mo; 100 serum samples from nonpregnant women) for Fer, sTfR, CRP, and AGP. We compared the combined data sets with the ELISA survey results using descriptive analyses.
The Lin's concordance coefficients between the 2 assays were ≥0.89 except for sTfR (Lin's ρ = 0.58). The median relative difference to the reference was as follows: 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 as follows: 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.
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. |
| doi_str_mv | 10.1093/jn/nxab355 |
| format | Article |
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We conducted a comparison between the ELISA and reference-type assays used in the US NHANES.
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 aged 6–59 mo; 100 serum samples from nonpregnant women) for Fer, sTfR, CRP, and AGP. We compared the combined data sets with the ELISA survey results using descriptive analyses.
The Lin's concordance coefficients between the 2 assays were ≥0.89 except for sTfR (Lin's ρ = 0.58). The median relative difference to the reference was as follows: 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 as follows: 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.
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.</description><identifier>ISSN: 0022-3166</identifier><identifier>EISSN: 1541-6100</identifier><identifier>DOI: 10.1093/jn/nxab355</identifier><identifier>PMID: 34605545</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Anemia, Iron-Deficiency - diagnosis ; Anemia, Iron-Deficiency - epidemiology ; Assaying ; Bioassays ; Biomarkers ; C-reactive protein ; C-Reactive Protein - metabolism ; Child ; Comparative analysis ; Enzyme-Linked Immunosorbent Assay ; Female ; Ferritin ; Glycoproteins ; Humans ; Inflammation ; Iron ; iron deficiency ; Micronutrients ; Middle Aged ; Nepal ; Nutrition ; Nutrition Surveys ; Polls & surveys ; Proteins ; Quality assessment ; Quality control ; Receptors, Transferrin ; Reference materials ; soluble transferrin receptor ; Standardization ; Transferrin ; Transferrins ; Young Adult ; α-1-acid glycoprotein</subject><ispartof>The Journal of nutrition, 2022-01, Vol.152 (1), p.350-359</ispartof><rights>2022 American Society for Nutrition.</rights><rights>Published by Oxford University Press on behalf of the American Society for Nutrition 2021. 2021</rights><rights>Published by Oxford University Press on behalf of the American Society for Nutrition 2021.</rights><rights>Copyright American Institute of Nutrition Jan 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-4bdc2c11e4e0a7cf472679f55d6945addcf301bb012dee753a62b7ea1d84dcf23</citedby><cites>FETCH-LOGICAL-c481t-4bdc2c11e4e0a7cf472679f55d6945addcf301bb012dee753a62b7ea1d84dcf23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34605545$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fischer, Christina M</creatorcontrib><creatorcontrib>Zhang, Ming</creatorcontrib><creatorcontrib>Sternberg, Maya R</creatorcontrib><creatorcontrib>Jefferds, Maria E</creatorcontrib><creatorcontrib>Whitehead, Ralph D</creatorcontrib><creatorcontrib>Mei, Zuguo</creatorcontrib><creatorcontrib>Paudyal, Naveen</creatorcontrib><creatorcontrib>Joshi, Nira</creatorcontrib><creatorcontrib>Parajuli, Kedar R</creatorcontrib><creatorcontrib>Adhikari, Debendra P</creatorcontrib><creatorcontrib>LaVoie, Donna J</creatorcontrib><creatorcontrib>Pfeiffer, Christine M</creatorcontrib><title>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</title><title>The Journal of nutrition</title><addtitle>J Nutr</addtitle><description>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) have allowed their application to micronutrient surveys conducted in low-resource countries for ∼2 decades.
We conducted a comparison between the ELISA and reference-type assays used in the US NHANES.
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 aged 6–59 mo; 100 serum samples from nonpregnant women) for Fer, sTfR, CRP, and AGP. We compared the combined data sets with the ELISA survey results using descriptive analyses.
The Lin's concordance coefficients between the 2 assays were ≥0.89 except for sTfR (Lin's ρ = 0.58). The median relative difference to the reference was as follows: 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 as follows: 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.
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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anemia, Iron-Deficiency - diagnosis</subject><subject>Anemia, Iron-Deficiency - epidemiology</subject><subject>Assaying</subject><subject>Bioassays</subject><subject>Biomarkers</subject><subject>C-reactive protein</subject><subject>C-Reactive Protein - metabolism</subject><subject>Child</subject><subject>Comparative analysis</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>Ferritin</subject><subject>Glycoproteins</subject><subject>Humans</subject><subject>Inflammation</subject><subject>Iron</subject><subject>iron deficiency</subject><subject>Micronutrients</subject><subject>Middle Aged</subject><subject>Nepal</subject><subject>Nutrition</subject><subject>Nutrition Surveys</subject><subject>Polls & surveys</subject><subject>Proteins</subject><subject>Quality assessment</subject><subject>Quality control</subject><subject>Receptors, Transferrin</subject><subject>Reference materials</subject><subject>soluble transferrin receptor</subject><subject>Standardization</subject><subject>Transferrin</subject><subject>Transferrins</subject><subject>Young Adult</subject><subject>α-1-acid glycoprotein</subject><issn>0022-3166</issn><issn>1541-6100</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kd-KEzEUxoMobl298QEkIN4I4yYzmX83QimrFtoVbNXLkEnO2NSZZEwyXce3883M2u6iIF4l5PzO952TD6GnlLyipM4u9ubCfBdNluf30IzmjCYFJeQ-mhGSpklGi-IMPfJ-TwihrK4eorOMFSTPWT5DP7c7wJ90WGuDV6LBG2HUtZa75HK13Mzx3Hsxedxah5fOGhyreGnaTvS9CDo-rIX7Cs7jhe0H4UDhz9B1-FqHHV502mgpOjw3opt-gMMfoAUHRkKynQa4FY_Om7Hxoh868Ni2OMSRrmCInVe_TeJlrWW0H4PTYALeBBFGH7vcAabH6EErOg9PTuc5-vjmcrt4l6zev10u5qtEsoqGhDVKppJSYEBEKVtWpkVZt3muiprlQinZZoQ2DaGpAijzTBRpU4KgqmKxlmbn6PVRdxibHpSMgzjR8cHpXriJW6H53xWjd_yLPfCqKhirSBR4fhJw9tsIPvC9HV3czvO0SGlVlnVZRurlkYoLe--gvXOghN_EzfeGn-KO8LM_Z7pDb_ONwIsjYMfh_0LsyEH8wYMGx73UN0kp7UAGrqz-V9sv30nK2w</recordid><startdate>20220101</startdate><enddate>20220101</enddate><creator>Fischer, Christina M</creator><creator>Zhang, Ming</creator><creator>Sternberg, Maya R</creator><creator>Jefferds, Maria E</creator><creator>Whitehead, Ralph D</creator><creator>Mei, Zuguo</creator><creator>Paudyal, Naveen</creator><creator>Joshi, Nira</creator><creator>Parajuli, Kedar R</creator><creator>Adhikari, Debendra P</creator><creator>LaVoie, Donna J</creator><creator>Pfeiffer, Christine M</creator><general>Elsevier Inc</general><general>Oxford University Press</general><general>American Institute of Nutrition</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>5PM</scope></search><sort><creationdate>20220101</creationdate><title>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</title><author>Fischer, Christina M ; Zhang, Ming ; Sternberg, Maya R ; Jefferds, Maria E ; Whitehead, Ralph D ; Mei, Zuguo ; Paudyal, Naveen ; Joshi, Nira ; Parajuli, Kedar R ; Adhikari, Debendra P ; LaVoie, Donna J ; Pfeiffer, Christine M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-4bdc2c11e4e0a7cf472679f55d6945addcf301bb012dee753a62b7ea1d84dcf23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anemia, Iron-Deficiency - diagnosis</topic><topic>Anemia, Iron-Deficiency - epidemiology</topic><topic>Assaying</topic><topic>Bioassays</topic><topic>Biomarkers</topic><topic>C-reactive protein</topic><topic>C-Reactive Protein - metabolism</topic><topic>Child</topic><topic>Comparative analysis</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Female</topic><topic>Ferritin</topic><topic>Glycoproteins</topic><topic>Humans</topic><topic>Inflammation</topic><topic>Iron</topic><topic>iron deficiency</topic><topic>Micronutrients</topic><topic>Middle Aged</topic><topic>Nepal</topic><topic>Nutrition</topic><topic>Nutrition Surveys</topic><topic>Polls & surveys</topic><topic>Proteins</topic><topic>Quality assessment</topic><topic>Quality control</topic><topic>Receptors, Transferrin</topic><topic>Reference materials</topic><topic>soluble transferrin receptor</topic><topic>Standardization</topic><topic>Transferrin</topic><topic>Transferrins</topic><topic>Young Adult</topic><topic>α-1-acid glycoprotein</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fischer, Christina M</creatorcontrib><creatorcontrib>Zhang, Ming</creatorcontrib><creatorcontrib>Sternberg, Maya R</creatorcontrib><creatorcontrib>Jefferds, Maria E</creatorcontrib><creatorcontrib>Whitehead, Ralph D</creatorcontrib><creatorcontrib>Mei, Zuguo</creatorcontrib><creatorcontrib>Paudyal, Naveen</creatorcontrib><creatorcontrib>Joshi, Nira</creatorcontrib><creatorcontrib>Parajuli, Kedar R</creatorcontrib><creatorcontrib>Adhikari, Debendra P</creatorcontrib><creatorcontrib>LaVoie, Donna J</creatorcontrib><creatorcontrib>Pfeiffer, Christine M</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of nutrition</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fischer, Christina M</au><au>Zhang, Ming</au><au>Sternberg, Maya R</au><au>Jefferds, Maria E</au><au>Whitehead, Ralph D</au><au>Mei, Zuguo</au><au>Paudyal, Naveen</au><au>Joshi, Nira</au><au>Parajuli, Kedar R</au><au>Adhikari, Debendra P</au><au>LaVoie, Donna J</au><au>Pfeiffer, Christine M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The Journal of nutrition</jtitle><addtitle>J Nutr</addtitle><date>2022-01-01</date><risdate>2022</risdate><volume>152</volume><issue>1</issue><spage>350</spage><epage>359</epage><pages>350-359</pages><issn>0022-3166</issn><eissn>1541-6100</eissn><abstract>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) have allowed their application to micronutrient surveys conducted in low-resource countries for ∼2 decades.
We conducted a comparison between the ELISA and reference-type assays used in the US NHANES.
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 aged 6–59 mo; 100 serum samples from nonpregnant women) for Fer, sTfR, CRP, and AGP. We compared the combined data sets with the ELISA survey results using descriptive analyses.
The Lin's concordance coefficients between the 2 assays were ≥0.89 except for sTfR (Lin's ρ = 0.58). The median relative difference to the reference was as follows: 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 as follows: 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.
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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34605545</pmid><doi>10.1093/jn/nxab355</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Anemia, Iron-Deficiency - diagnosis Anemia, Iron-Deficiency - epidemiology Assaying Bioassays Biomarkers C-reactive protein C-Reactive Protein - metabolism Child Comparative analysis Enzyme-Linked Immunosorbent Assay Female Ferritin Glycoproteins Humans Inflammation Iron iron deficiency Micronutrients Middle Aged Nepal Nutrition Nutrition Surveys Polls & surveys Proteins Quality assessment Quality control Receptors, Transferrin Reference materials soluble transferrin receptor Standardization Transferrin Transferrins Young Adult α-1-acid glycoprotein |
| title | 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 |
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