<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0120-4157</journal-id>
<journal-title><![CDATA[Biomédica]]></journal-title>
<abbrev-journal-title><![CDATA[Biomed.]]></abbrev-journal-title>
<issn>0120-4157</issn>
<publisher>
<publisher-name><![CDATA[Instituto Nacional de Salud]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0120-41572021000500113</article-id>
<article-id pub-id-type="doi">10.7705/biomedica.5435</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Evaluación del UMELISA CHAGAS® con la incorporación de nuevos péptidos monoméricos y quiméricos representativos de diferentes regiones de Trypanosoma cruzi]]></article-title>
<article-title xml:lang="en"><![CDATA[Evaluation of UMELISA CHAGAS&#8482; with the incorporation of new monomeric and chimeric peptides representative of different regions of Trypanosoma cruzi]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández]]></surname>
<given-names><![CDATA[Idialis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández]]></surname>
<given-names><![CDATA[Milenen]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González]]></surname>
<given-names><![CDATA[Jeny]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gómez]]></surname>
<given-names><![CDATA[Ivonne]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Zulueta]]></surname>
<given-names><![CDATA[Orlando]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramos]]></surname>
<given-names><![CDATA[Grisell]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ortega]]></surname>
<given-names><![CDATA[Darien]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Bequer]]></surname>
<given-names><![CDATA[Dunia Clara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[Giosvany Ernesto]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Inmunoensayo  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>05</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>05</month>
<year>2021</year>
</pub-date>
<volume>41</volume>
<fpage>113</fpage>
<lpage>120</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0120-41572021000500113&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0120-41572021000500113&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0120-41572021000500113&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción. La mayoría de las personas con enfermedad de Chagas desarrolla anticuerpos específicos contra Trypanosoma cruzi. En la infección temprana se producen anticuerpos IgM contra T. cruzi que son reemplazados por IgG durante el curso de la enfermedad. Los primeros síntomas de la enfermedad suelen ser muy leves y atípicos, por lo que a menudo no se detecta en la fase aguda.  Objetivos. Evaluar la sensibilidad y la especificidad clínica y analítica, la precisión y la eficacia del UMELISA CHAGAS® con la incorporación de nuevos péptidos sintéticos en la fase sólida representativos de la proteína SAPA (Shed Acute Phase Antigen) y del antígeno TSA (Trypomastigote Surface Antigen).  Materiales y métodos. Se evaluó un panel de desempeño de título mixto anti-I cruzi y uno de seroconversión de Chagas, así como muestras de suero positivas y negativas provenientes de zonas endémicas de la enfermedad y muestras positivas de otras enfermedades que podían interferir con la prueba. Las pruebas Bioelisa CHAGAS, Chagatest ELISA recombinante v. 4.0, Chagatest HAI y SD BIOLINE CHAGAS Ab Rapid, se emplearon como referencia.  Resultados. Los porcentajes de sensibilidad y especificidad clínica fueron de 97,73 % (IC95% 96,23-99,24) y 99,33 % (IC95% 98,88-99,78), respectivamente. Se obtuvo un 98,96 % de eficacia y una buena precisión.  Conclusiones. Los resultados demuestran que la nueva fase sólida del UMELISA CHAGAS® puede utilizarse para el inmunodiagnóstico, la certificación de sangre y la vigilancia epidemiológica en países endémicos y no endémicos con población de alto riesgo.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction: Most people with Chagas disease develop specific antibodies against Trypanosoma cruzi. In early infection, IgM antibodies against T. cruzi are produced and later replaced for IgG antibodies during the course of the disease. The first symptoms of the infection may be very mild and atypical, which is why the disease is often not detected in the acute phase.  Objectives: To evaluate the clinical and analytical sensitivity, and specificity, accuracy, and efficacy of UMELISA CHAGAS&#8482; with the addition of new synthetic peptides in the solid phase representative of the shed acute phase antigen protein (SAPA) and the trypomastigote surface antigen (TSA).  Materials and methods: We evaluated a mixed anti-I cruzi titer performance panel and a Chagas seroconversion one, as well as positive and negative serum samples from endemic areas of the disease and positive samples for other diseases that may interfere with the assay. The Bioelisa CHAGAS assay, Chaga test recombinant ELISA v.4.0, Chagatest HAI, and SD BIOLINE CHAGAS Ab Rapid were used as reference tests.  Results: The sensitivity of the assay was 97.73% (95% CI: 96,23-99,24) and the clinical specificity, 99.33% (95% CI: 98,88-99,78) while the efficacy and the accuracy were 98.96%.  Conclusions: Our results show that the new solid phase of UMELISA CHAGAS® can be used for immunodiagnostic, blood certification, and epidemiological surveillance in endemic and non-endemic countries with high-risk populations.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Trypanosoma cruzi]]></kwd>
<kwd lng="es"><![CDATA[enfermedad de Chagas/diagnóstico]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos]]></kwd>
<kwd lng="es"><![CDATA[péptidos]]></kwd>
<kwd lng="en"><![CDATA[Trypanosoma cruzi]]></kwd>
<kwd lng="en"><![CDATA[Chagas disease/diagnosis]]></kwd>
<kwd lng="en"><![CDATA[antibodies]]></kwd>
<kwd lng="en"><![CDATA[peptides]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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