Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients
Identifieur interne : 001545 ( Pmc/Checkpoint ); précédent : 001544; suivant : 001546Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients
Auteurs : Ming Guan ; Hsiao Ying Chen ; Shen Yun Foo ; Yee-Joo Tan ; Phuay-Yee Goh ; Shock Hwa WeeSource :
- Clinical and Diagnostic Laboratory Immunology [ 1071-412X ] ; 2004.
Abstract
An enzyme-linked immunosorbent assay (ELISA) and a rapid immunochromatographic test for detection of immunoglobulin G (IgG) antibodies in severe acute respiratory syndrome (SARS) patients were developed by utilizing the well-characterized recombinant proteins Gst-N and Gst-U274. The ELISA detected IgG antibodies to SARS-CoV in all 74 convalescent-phase samples from SARS patients while weakly cross-reacting to only 1 of the 210 control sera from healthy donors. This finding thus led to a kit sensitivity, specificity, and accuracy of 100, 99.5, and 99.6%, respectively. The test thus provided a positive predictive value (PPV) of 98.7% and a negative predictive value (NPV) of 100%. In addition, the ELISA gave a positive delta of 5.4 and a negative delta of 3.6, indicating an excellent differentiation between positives and negatives. The same recombinant proteins were also applied to a newly developed platform for the development of a 15-min rapid test. The resulting rapid test has an excellent agreement of 99.6%, with a kappa value of 1.00, with the ELISA. Again, this rapid test was able to detect 100% of the samples tested (
Url:
DOI: 10.1128/CDLI.11.2.287-291.2004
PubMed: 15013977
PubMed Central: 371224
Affiliations:
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<series><title level="j">Clinical and Diagnostic Laboratory Immunology</title>
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<front><div type="abstract" xml:lang="en"><p>An enzyme-linked immunosorbent assay (ELISA) and a rapid immunochromatographic test for detection of immunoglobulin G (IgG) antibodies in severe acute respiratory syndrome (SARS) patients were developed by utilizing the well-characterized recombinant proteins Gst-N and Gst-U274. The ELISA detected IgG antibodies to SARS-CoV in all 74 convalescent-phase samples from SARS patients while weakly cross-reacting to only 1 of the 210 control sera from healthy donors. This finding thus led to a kit sensitivity, specificity, and accuracy of 100, 99.5, and 99.6%, respectively. The test thus provided a positive predictive value (PPV) of 98.7% and a negative predictive value (NPV) of 100%. In addition, the ELISA gave a positive delta of 5.4 and a negative delta of 3.6, indicating an excellent differentiation between positives and negatives. The same recombinant proteins were also applied to a newly developed platform for the development of a 15-min rapid test. The resulting rapid test has an excellent agreement of 99.6%, with a kappa value of 1.00, with the ELISA. Again, this rapid test was able to detect 100% of the samples tested (<italic>n</italic>
= 42) while maintaining a specificity of 99.0% (<italic>n</italic>
= 210). The PPV and NPV for the rapid test thus reached 95.3 and 100%, respectively.</p>
</div>
</front>
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<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Clin Diagn Lab Immunol</journal-id>
<journal-id journal-id-type="publisher-id">cdli</journal-id>
<journal-title>Clinical and Diagnostic Laboratory Immunology</journal-title>
<issn pub-type="ppub">1071-412X</issn>
<issn pub-type="epub">1098-6588</issn>
<publisher><publisher-name>American Society for Microbiology</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">15013977</article-id>
<article-id pub-id-type="pmc">371224</article-id>
<article-id pub-id-type="publisher-id">0270</article-id>
<article-id pub-id-type="doi">10.1128/CDLI.11.2.287-291.2004</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Microbial Immunology</subject>
</subj-group>
</article-categories>
<title-group><article-title>Recombinant Protein-Based Enzyme-Linked Immunosorbent Assay and Immunochromatographic Tests for Detection of Immunoglobulin G Antibodies to Severe Acute Respiratory Syndrome (SARS) Coronavirus in SARS Patients</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Guan</surname>
<given-names>Ming</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
<xref ref-type="corresp" rid="cor1">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Chen</surname>
<given-names>Hsiao Ying</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yun Foo</surname>
<given-names>Shen</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Tan</surname>
<given-names>Yee-Joo</given-names>
</name>
<xref ref-type="aff" rid="aff1">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Goh</surname>
<given-names>Phuay-Yee</given-names>
</name>
<xref ref-type="aff" rid="aff1">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wee</surname>
<given-names>Shock Hwa</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
</contrib-group>
<aff id="aff1">Genelabs Diagnostics Pte, Ltd.,<label>1</label>
Collaborative Anti-Viral Research Group, Institute of Molecular and Cell Biology, Singapore, Republic of Singapore<label>2</label>
</aff>
<author-notes><fn id="cor1"><label>*</label>
<p>Corresponding author. Mailing address: Genelabs Diagnostics Pte Ltd., 85 Science Park Dr. 04-01, Singapore Science Park, Singapore 118259, Republic of Singapore. Phone: (65) 67750008. Fax: (65) 67754536. E-mail: <email>guanming@mail.genelabs.com.sg</email>
.</p>
</fn>
</author-notes>
<pub-date pub-type="ppub"><month>3</month>
<year>2004</year>
</pub-date>
<volume>11</volume>
<issue>2</issue>
<fpage>287</fpage>
<lpage>291</lpage>
<history><date date-type="received"><day>10</day>
<month>11</month>
<year>2003</year>
</date>
<date date-type="rev-recd"><day>11</day>
<month>12</month>
<year>2003</year>
</date>
<date date-type="accepted"><day>29</day>
<month>12</month>
<year>2003</year>
</date>
</history>
<copyright-statement>Copyright © 2004, American Society for Microbiology</copyright-statement>
<copyright-year>2004</copyright-year>
<abstract><p>An enzyme-linked immunosorbent assay (ELISA) and a rapid immunochromatographic test for detection of immunoglobulin G (IgG) antibodies in severe acute respiratory syndrome (SARS) patients were developed by utilizing the well-characterized recombinant proteins Gst-N and Gst-U274. The ELISA detected IgG antibodies to SARS-CoV in all 74 convalescent-phase samples from SARS patients while weakly cross-reacting to only 1 of the 210 control sera from healthy donors. This finding thus led to a kit sensitivity, specificity, and accuracy of 100, 99.5, and 99.6%, respectively. The test thus provided a positive predictive value (PPV) of 98.7% and a negative predictive value (NPV) of 100%. In addition, the ELISA gave a positive delta of 5.4 and a negative delta of 3.6, indicating an excellent differentiation between positives and negatives. The same recombinant proteins were also applied to a newly developed platform for the development of a 15-min rapid test. The resulting rapid test has an excellent agreement of 99.6%, with a kappa value of 1.00, with the ELISA. Again, this rapid test was able to detect 100% of the samples tested (<italic>n</italic>
= 42) while maintaining a specificity of 99.0% (<italic>n</italic>
= 210). The PPV and NPV for the rapid test thus reached 95.3 and 100%, respectively.</p>
</abstract>
</article-meta>
</front>
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<affiliations><list></list>
<tree><noCountry><name sortKey="Chen, Hsiao Ying" sort="Chen, Hsiao Ying" uniqKey="Chen H" first="Hsiao Ying" last="Chen">Hsiao Ying Chen</name>
<name sortKey="Goh, Phuay Yee" sort="Goh, Phuay Yee" uniqKey="Goh P" first="Phuay-Yee" last="Goh">Phuay-Yee Goh</name>
<name sortKey="Guan, Ming" sort="Guan, Ming" uniqKey="Guan M" first="Ming" last="Guan">Ming Guan</name>
<name sortKey="Tan, Yee Joo" sort="Tan, Yee Joo" uniqKey="Tan Y" first="Yee-Joo" last="Tan">Yee-Joo Tan</name>
<name sortKey="Wee, Shock Hwa" sort="Wee, Shock Hwa" uniqKey="Wee S" first="Shock Hwa" last="Wee">Shock Hwa Wee</name>
<name sortKey="Yun Foo, Shen" sort="Yun Foo, Shen" uniqKey="Yun Foo S" first="Shen" last="Yun Foo">Shen Yun Foo</name>
</noCountry>
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