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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 : 000646 ( Ncbi/Curation ); précédent : 000645; suivant : 000647

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

Auteurs : Ming Guan ; Hsiao Ying Chen ; Shen Yun Foo ; Yee-Joo Tan ; Phuay-Yee Goh ; Shock Hwa Wee

Source :

RBID : PMC:371224

Descripteurs français

English descriptors

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 (n = 42) while maintaining a specificity of 99.0% (n = 210). The PPV and NPV for the rapid test thus reached 95.3 and 100%, respectively.


Url:
DOI: 10.1128/CDLI.11.2.287-291.2004
PubMed: 15013977
PubMed Central: 371224

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PMC:371224

Le document en format XML

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<term>Enzyme-Linked Immunosorbent Assay (methods)</term>
<term>Humans</term>
<term>Immunoglobulin G (analysis)</term>
<term>Immunoglobulin G (immunology)</term>
<term>Predictive Value of Tests</term>
<term>Recombinant Proteins (immunology)</term>
<term>SARS Virus (immunology)</term>
<term>SARS Virus (isolation & purification)</term>
<term>Sensitivity and Specificity</term>
<term>Severe Acute Respiratory Syndrome (diagnosis)</term>
<term>Severe Acute Respiratory Syndrome (immunology)</term>
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<term>Immunoglobuline G (analyse)</term>
<term>Immunoglobuline G (immunologie)</term>
<term>Protéines recombinantes (immunologie)</term>
<term>Sensibilité et spécificité</term>
<term>Syndrome respiratoire aigu sévère (diagnostic)</term>
<term>Syndrome respiratoire aigu sévère (immunologie)</term>
<term>Test ELISA ()</term>
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<term>Immunoglobulin G</term>
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<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>
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