Evaluation of Abbott anti-SARS-CoV-2 CMIA IgG and Euroimmun ELISA IgG/IgA assays in a clinical lab.
Identifieur interne : 000581 ( Main/Exploration ); précédent : 000580; suivant : 000582Evaluation of Abbott anti-SARS-CoV-2 CMIA IgG and Euroimmun ELISA IgG/IgA assays in a clinical lab.
Auteurs : Justin Manalac [États-Unis] ; Jennifer Yee [États-Unis] ; Kyle Calayag [États-Unis] ; Linda Nguyen [États-Unis] ; Payal M. Patel [États-Unis] ; Daniel Zhou [États-Unis] ; Run-Zhang Shi [États-Unis]Source :
- Clinica chimica acta; international journal of clinical chemistry [ 1873-3492 ] ; 2020.
Descripteurs français
- KwdFr :
- MESH :
- immunologie : Betacoronavirus, Immunoglobuline A, Immunoglobuline G.
- méthodes : Test ELISA.
- sang : Immunoglobuline A, Immunoglobuline G.
- Humains, Limite de détection, Mesures de luminescence.
English descriptors
- KwdEn :
- MESH :
- chemical , blood : Immunoglobulin A, Immunoglobulin G.
- immunology : Betacoronavirus, Immunoglobulin A, Immunoglobulin G.
- methods : Enzyme-Linked Immunosorbent Assay.
- Humans, Limit of Detection, Luminescent Measurements, SARS-CoV-2.
Abstract
BACKGROUND
We report our findings of test performance especially specificity of a fully automated Abbott Architect anti-SARS-CoV-2 CMIA IgG and Euroimmun anti-SARS-CoV-2 ELISA IgA/IgG in human plasma.
METHODS
We used positive cohort of 97 samples from Covid-19 patients or healthcare workers, collected at late time points from symptom onsets. We also included another cohort of 215 samples as negative controls, 78 of which had positive serology test results of other infectious diseases or autoimmunity. Assay specificity was assessed by using a total of 847 anonymized samples which were collected before the Covid-19 pandemic from local patient populations seeking clinical care for rheumatoid diseases, thyroid cancer, and therapeutic drug monitoring.
RESULTS
Abbott IgG, Euroimmun IgG/IgA had high precision, demonstrated by both intra- and inter-day CVs of <2%. There was no Abbott or Euroimmun IgG assay cross reactivity in the 78 samples with positive serology of non-SARS-CoV-2 infectious diseases and positive autoimmune antibodies. The Abbott IgG has specificity of 99.6%, while Euroimmun IgG and IgA were as high as 91.5% and 71.5%, respectively.
CONCLUSIONS
Our evaluation confirmed high specificity of the Abbott IgG assay, while it was lower for Euroimmun IgG. Euroimmun IgA has suboptimal specificity which may limit its clinical use. Assay sensitivity was high for both Abbott and Euroimmun IgG assays.
DOI: 10.1016/j.cca.2020.09.002
PubMed: 32910980
PubMed Central: PMC7476889
Affiliations:
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Patel</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care</wicri:regionArea><wicri:noRegion>Stanford Health Care</wicri:noRegion></affiliation></author><author><name sortKey="Zhou, Daniel" sort="Zhou, Daniel" uniqKey="Zhou D" first="Daniel" last="Zhou">Daniel Zhou</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care</wicri:regionArea><wicri:noRegion>Stanford Health Care</wicri:noRegion></affiliation></author><author><name sortKey="Shi, Run Zhang" sort="Shi, Run Zhang" uniqKey="Shi R" first="Run-Zhang" last="Shi">Run-Zhang Shi</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States; Department of Pathology, Stanford University School of Medicine, United States. Electronic address: rzshi@stanford.edu.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States; Department of Pathology, Stanford University School of Medicine</wicri:regionArea><wicri:noRegion>Stanford University School of Medicine</wicri:noRegion></affiliation></author></analytic><series><title level="j">Clinica chimica acta; international journal of clinical chemistry</title><idno type="eISSN">1873-3492</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Betacoronavirus (immunology)</term><term>Enzyme-Linked Immunosorbent Assay (methods)</term><term>Humans (MeSH)</term><term>Immunoglobulin A (blood)</term><term>Immunoglobulin A (immunology)</term><term>Immunoglobulin G (blood)</term><term>Immunoglobulin G (immunology)</term><term>Limit of Detection (MeSH)</term><term>Luminescent Measurements (MeSH)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Betacoronavirus (immunologie)</term><term>Humains (MeSH)</term><term>Immunoglobuline A (immunologie)</term><term>Immunoglobuline A (sang)</term><term>Immunoglobuline G (immunologie)</term><term>Immunoglobuline G (sang)</term><term>Limite de détection (MeSH)</term><term>Mesures de luminescence (MeSH)</term><term>Test ELISA (méthodes)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Immunoglobulin A</term><term>Immunoglobulin G</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Betacoronavirus</term><term>Immunoglobuline A</term><term>Immunoglobuline G</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Betacoronavirus</term><term>Immunoglobulin A</term><term>Immunoglobulin G</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Enzyme-Linked Immunosorbent Assay</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Test ELISA</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Immunoglobuline A</term><term>Immunoglobuline G</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Limit of Detection</term><term>Luminescent Measurements</term><term>SARS-CoV-2</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Humains</term><term>Limite de détection</term><term>Mesures de luminescence</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>We report our findings of test performance especially specificity of a fully automated Abbott Architect anti-SARS-CoV-2 CMIA IgG and Euroimmun anti-SARS-CoV-2 ELISA IgA/IgG in human plasma.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We used positive cohort of 97 samples from Covid-19 patients or healthcare workers, collected at late time points from symptom onsets. We also included another cohort of 215 samples as negative controls, 78 of which had positive serology test results of other infectious diseases or autoimmunity. Assay specificity was assessed by using a total of 847 anonymized samples which were collected before the Covid-19 pandemic from local patient populations seeking clinical care for rheumatoid diseases, thyroid cancer, and therapeutic drug monitoring.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Abbott IgG, Euroimmun IgG/IgA had high precision, demonstrated by both intra- and inter-day CVs of <2%. There was no Abbott or Euroimmun IgG assay cross reactivity in the 78 samples with positive serology of non-SARS-CoV-2 infectious diseases and positive autoimmune antibodies. The Abbott IgG has specificity of 99.6%, while Euroimmun IgG and IgA were as high as 91.5% and 71.5%, respectively.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Our evaluation confirmed high specificity of the Abbott IgG assay, while it was lower for Euroimmun IgG. Euroimmun IgA has suboptimal specificity which may limit its clinical use. Assay sensitivity was high for both Abbott and Euroimmun IgG assays.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32910980</PMID><DateCompleted><Year>2020</Year><Month>10</Month><Day>28</Day></DateCompleted><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-3492</ISSN><JournalIssue CitedMedium="Internet"><Volume>510</Volume><PubDate><Year>2020</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Clinica chimica acta; international journal of clinical chemistry</Title><ISOAbbreviation>Clin Chim Acta</ISOAbbreviation></Journal><ArticleTitle>Evaluation of Abbott anti-SARS-CoV-2 CMIA IgG and Euroimmun ELISA IgG/IgA assays in a clinical lab.</ArticleTitle><Pagination><MedlinePgn>687-690</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0009-8981(20)30434-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cca.2020.09.002</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">We report our findings of test performance especially specificity of a fully automated Abbott Architect anti-SARS-CoV-2 CMIA IgG and Euroimmun anti-SARS-CoV-2 ELISA IgA/IgG in human plasma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We used positive cohort of 97 samples from Covid-19 patients or healthcare workers, collected at late time points from symptom onsets. We also included another cohort of 215 samples as negative controls, 78 of which had positive serology test results of other infectious diseases or autoimmunity. Assay specificity was assessed by using a total of 847 anonymized samples which were collected before the Covid-19 pandemic from local patient populations seeking clinical care for rheumatoid diseases, thyroid cancer, and therapeutic drug monitoring.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Abbott IgG, Euroimmun IgG/IgA had high precision, demonstrated by both intra- and inter-day CVs of <2%. There was no Abbott or Euroimmun IgG assay cross reactivity in the 78 samples with positive serology of non-SARS-CoV-2 infectious diseases and positive autoimmune antibodies. The Abbott IgG has specificity of 99.6%, while Euroimmun IgG and IgA were as high as 91.5% and 71.5%, respectively.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Our evaluation confirmed high specificity of the Abbott IgG assay, while it was lower for Euroimmun IgG. Euroimmun IgA has suboptimal specificity which may limit its clinical use. Assay sensitivity was high for both Abbott and Euroimmun IgG assays.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier B.V. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Manalac</LastName><ForeName>Justin</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yee</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calayag</LastName><ForeName>Kyle</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Pathology, Stanford University School of Medicine, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nguyen</LastName><ForeName>Linda</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Payal M</ForeName><Initials>PM</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhou</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shi</LastName><ForeName>Run-Zhang</ForeName><Initials>RZ</Initials><AffiliationInfo><Affiliation>Clinical Chemistry and Immunology Section of Clinical Laboratories, Stanford Health Care, United States; Department of Pathology, Stanford University School of Medicine, United States. Electronic address: rzshi@stanford.edu.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D023362">Evaluation Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>09</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Clin Chim Acta</MedlineTA><NlmUniqueID>1302422</NlmUniqueID><ISSNLinking>0009-8981</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007070">Immunoglobulin A</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007074">Immunoglobulin G</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004797" MajorTopicYN="N">Enzyme-Linked Immunosorbent Assay</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007070" MajorTopicYN="N">Immunoglobulin A</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007074" MajorTopicYN="N">Immunoglobulin G</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057230" MajorTopicYN="N">Limit of Detection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008163" MajorTopicYN="Y">Luminescent Measurements</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Architect</Keyword><Keyword MajorTopicYN="N">Euroimmun</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2</Keyword><Keyword MajorTopicYN="N">Serology</Keyword><Keyword MajorTopicYN="N">Specificity</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>07</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>09</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>09</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>9</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>10</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>9</Month><Day>10</Day><Hour>20</Hour><Minute>11</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32910980</ArticleId><ArticleId IdType="pii">S0009-8981(20)30434-4</ArticleId><ArticleId IdType="doi">10.1016/j.cca.2020.09.002</ArticleId><ArticleId IdType="pmc">PMC7476889</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Clin Microbiol. 2020 Jul 23;58(8):</Citation><ArticleIdList><ArticleId IdType="pubmed">32381641</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Chem. 2020 Aug 1;66(8):1055-1062</Citation><ArticleIdList><ArticleId IdType="pubmed">32402061</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Virol. 2020 Aug;129:104512</Citation><ArticleIdList><ArticleId IdType="pubmed">32563180</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Manalac, Justin" sort="Manalac, Justin" uniqKey="Manalac J" first="Justin" last="Manalac">Justin Manalac</name></noRegion><name sortKey="Calayag, Kyle" sort="Calayag, Kyle" uniqKey="Calayag K" first="Kyle" last="Calayag">Kyle Calayag</name><name sortKey="Nguyen, Linda" sort="Nguyen, Linda" uniqKey="Nguyen L" first="Linda" last="Nguyen">Linda Nguyen</name><name sortKey="Patel, Payal M" sort="Patel, Payal M" uniqKey="Patel P" first="Payal M" last="Patel">Payal M. Patel</name><name sortKey="Shi, Run Zhang" sort="Shi, Run Zhang" uniqKey="Shi R" first="Run-Zhang" last="Shi">Run-Zhang Shi</name><name sortKey="Yee, Jennifer" sort="Yee, Jennifer" uniqKey="Yee J" first="Jennifer" last="Yee">Jennifer Yee</name><name sortKey="Zhou, Daniel" sort="Zhou, Daniel" uniqKey="Zhou D" first="Daniel" last="Zhou">Daniel Zhou</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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