Evaluation and validation of an enzyme-linked immunosorbent assay and an immunochromatographic test for serological diagnosis of severe acute respiratory syndrome.
Identifieur interne : 002D19 ( PubMed/Checkpoint ); précédent : 002D18; suivant : 002D20Evaluation and validation of an enzyme-linked immunosorbent assay and an immunochromatographic test for serological diagnosis of severe acute respiratory syndrome.
Auteurs : Ming Guan [Singapour] ; Kwok Hung Chan ; J S Malik Peiris ; See Wai Kwan ; Siu Yan Lam ; Chiu Mei Pang ; Ka Wing Chu ; Kit Man Chan ; Hsiao Ying Chen ; Ewe Beng Phuah ; Caiqin Jane WongSource :
- Clinical and diagnostic laboratory immunology [ 1071-412X ] ; 2004.
Descripteurs français
- KwdFr :
- Anticorps antiviraux (sang), Chromatographie (), Facteurs temps, Humains, Immunoglobuline G (sang), Normes de référence, Protéines recombinantes (immunologie), Sensibilité et spécificité, Syndrome respiratoire aigu sévère (diagnostic), Syndrome respiratoire aigu sévère (sang), Technique d'immunofluorescence, Test ELISA (), Tests sérologiques (normes), Virus du SRAS (immunologie).
- MESH :
- diagnostic : Syndrome respiratoire aigu sévère.
- immunologie : Protéines recombinantes, Virus du SRAS.
- normes : Tests sérologiques.
- sang : Anticorps antiviraux, Immunoglobuline G, Syndrome respiratoire aigu sévère.
- Chromatographie, Facteurs temps, Humains, Normes de référence, Sensibilité et spécificité, Technique d'immunofluorescence, Test ELISA.
English descriptors
- KwdEn :
- Antibodies, Viral (blood), Chromatography (methods), Enzyme-Linked Immunosorbent Assay (methods), Fluorescent Antibody Technique, Humans, Immunoglobulin G (blood), Recombinant Proteins (immunology), Reference Standards, SARS Virus (immunology), Sensitivity and Specificity, Serologic Tests (standards), Severe Acute Respiratory Syndrome (blood), Severe Acute Respiratory Syndrome (diagnosis), Time Factors.
- MESH :
- chemical , blood : Antibodies, Viral, Immunoglobulin G.
- chemical , immunology : Recombinant Proteins.
- blood : Severe Acute Respiratory Syndrome.
- diagnosis : Severe Acute Respiratory Syndrome.
- immunology : SARS Virus.
- methods : Chromatography, Enzyme-Linked Immunosorbent Assay.
- standards : Serologic Tests.
- Fluorescent Antibody Technique, Humans, Reference Standards, Sensitivity and Specificity, Time Factors.
Abstract
A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the "gold standard", both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immunochromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r = 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.
DOI: 10.1128/CDLI.11.4.699-703.2004
PubMed: 15242944
Affiliations:
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first="Ming" last="Guan">Ming Guan</name><affiliation wicri:level="1"><nlm:affiliation>Genelabs Diagnostics Pte Ltd., Singapore, Republic of Singapore. guanming@mail.genelabs.com.sg</nlm:affiliation><country wicri:rule="url">Singapour</country></affiliation></author><author><name sortKey="Chan, Kwok Hung" sort="Chan, Kwok Hung" uniqKey="Chan K" first="Kwok Hung" last="Chan">Kwok Hung Chan</name></author><author><name sortKey="Peiris, J S Malik" sort="Peiris, J S Malik" uniqKey="Peiris J" first="J S Malik" last="Peiris">J S Malik Peiris</name></author><author><name sortKey="Kwan, See Wai" sort="Kwan, See Wai" uniqKey="Kwan S" first="See Wai" last="Kwan">See Wai Kwan</name></author><author><name sortKey="Lam, Siu Yan" sort="Lam, Siu Yan" uniqKey="Lam S" first="Siu Yan" last="Lam">Siu Yan Lam</name></author><author><name sortKey="Pang, Chiu Mei" sort="Pang, Chiu Mei" uniqKey="Pang C" first="Chiu Mei" last="Pang">Chiu Mei Pang</name></author><author><name sortKey="Chu, Ka Wing" sort="Chu, 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type="abstract" xml:lang="en">A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the "gold standard", both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immunochromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r = 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">15242944</PMID><DateCompleted><Year>2005</Year><Month>01</Month><Day>13</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">1071-412X</ISSN><JournalIssue CitedMedium="Print"><Volume>11</Volume><Issue>4</Issue><PubDate><Year>2004</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Clinical and diagnostic laboratory immunology</Title><ISOAbbreviation>Clin. Diagn. Lab. Immunol.</ISOAbbreviation></Journal><ArticleTitle>Evaluation and validation of an enzyme-linked immunosorbent assay and an immunochromatographic test for serological diagnosis of severe acute respiratory syndrome.</ArticleTitle><Pagination><MedlinePgn>699-703</MedlinePgn></Pagination><Abstract><AbstractText>A newly developed severe acute respiratory syndrome (SARS)-specific enzyme-linked immunosorbent assay (ELISA) was further validated to confirm cutoff values and evaluate its diagnostic performance with clinical samples. In parallel, an immunochromatographic test was also evaluated. A total of 227 clinical serum specimens collected from SARS patients were used in the study, together with 385 samples from healthy donors. By use of an immunofluorescent (IF) test as the "gold standard", both the ELISA and the immunochromatographic test were able to detect immunoglobulin G antibodies to SARS not only from late-convalescent-stage samples (>21 days from the onset of clinical symptoms), as previously established, but also from early-acute-phase samples (1 to 10 days from onset). The ELISA, using an optical density (OD) of 0.25 as its cutoff value, produced the best sensitivity while maintaining high specificity. It detected SARS-specific antibodies in 58, 70, 75, and 95%, respectively, of the four groups of samples collected from patients 1 to 10 days, 11 to 20 days, 21 to 30 days, and more than 30 days after the onset of clinical symptoms. Similarly, the immunochromatographic test detected SARS-specific antibodies in 55, 68, 81, and 79% of the four groups, respectively. The overall specificities for the ELISA and the rapid test were 99.5 and 97.7%, respectively. Although the positive correlation observed between the ELISA OD values and the IF titers was moderate (r = 0.6915; P < 0.001), the detection rates of both the ELISA and the rapid test were found well in agreement with the IF titers.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Guan</LastName><ForeName>Ming</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Genelabs Diagnostics Pte Ltd., Singapore, Republic of Singapore. guanming@mail.genelabs.com.sg</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chan</LastName><ForeName>Kwok Hung</ForeName><Initials>KH</Initials></Author><Author ValidYN="Y"><LastName>Peiris</LastName><ForeName>J S Malik</ForeName><Initials>JS</Initials></Author><Author ValidYN="Y"><LastName>Kwan</LastName><ForeName>See Wai</ForeName><Initials>SW</Initials></Author><Author ValidYN="Y"><LastName>Lam</LastName><ForeName>Siu Yan</ForeName><Initials>SY</Initials></Author><Author ValidYN="Y"><LastName>Pang</LastName><ForeName>Chiu Mei</ForeName><Initials>CM</Initials></Author><Author ValidYN="Y"><LastName>Chu</LastName><ForeName>Ka Wing</ForeName><Initials>KW</Initials></Author><Author ValidYN="Y"><LastName>Chan</LastName><ForeName>Kit Man</ForeName><Initials>KM</Initials></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Hsiao Ying</ForeName><Initials>HY</Initials></Author><Author ValidYN="Y"><LastName>Phuah</LastName><ForeName>Ewe Beng</ForeName><Initials>EB</Initials></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Caiqin Jane</ForeName><Initials>CJ</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D023361">Validation Study</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Diagn Lab Immunol</MedlineTA><NlmUniqueID>9421292</NlmUniqueID><ISSNLinking>1071-412X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007074">Immunoglobulin G</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002845" MajorTopicYN="N">Chromatography</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004797" MajorTopicYN="N">Enzyme-Linked Immunosorbent Assay</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005455" MajorTopicYN="N">Fluorescent Antibody Technique</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007074" MajorTopicYN="N">Immunoglobulin G</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011994" MajorTopicYN="N">Recombinant Proteins</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012015" MajorTopicYN="N">Reference Standards</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D045473" MajorTopicYN="N">SARS Virus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012680" MajorTopicYN="N">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012698" MajorTopicYN="N">Serologic Tests</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D045169" MajorTopicYN="N">Severe Acute Respiratory Syndrome</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>7</Month><Day>10</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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last="Chen">Hsiao Ying Chen</name><name sortKey="Chu, Ka Wing" sort="Chu, Ka Wing" uniqKey="Chu K" first="Ka Wing" last="Chu">Ka Wing Chu</name><name sortKey="Kwan, See Wai" sort="Kwan, See Wai" uniqKey="Kwan S" first="See Wai" last="Kwan">See Wai Kwan</name><name sortKey="Lam, Siu Yan" sort="Lam, Siu Yan" uniqKey="Lam S" first="Siu Yan" last="Lam">Siu Yan Lam</name><name sortKey="Pang, Chiu Mei" sort="Pang, Chiu Mei" uniqKey="Pang C" first="Chiu Mei" last="Pang">Chiu Mei Pang</name><name sortKey="Peiris, J S Malik" sort="Peiris, J S Malik" uniqKey="Peiris J" first="J S Malik" last="Peiris">J S Malik Peiris</name><name sortKey="Phuah, Ewe Beng" sort="Phuah, Ewe Beng" uniqKey="Phuah E" first="Ewe Beng" last="Phuah">Ewe Beng Phuah</name><name sortKey="Wong, Caiqin Jane" sort="Wong, Caiqin Jane" uniqKey="Wong C" first="Caiqin Jane" last="Wong">Caiqin Jane Wong</name></noCountry><country name="Singapour"><noRegion><name sortKey="Guan, Ming" sort="Guan, Ming" uniqKey="Guan M" first="Ming" 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