<?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>0375-0760</journal-id>
<journal-title><![CDATA[Revista Cubana de Medicina Tropical]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Cubana Med Trop]]></abbrev-journal-title>
<issn>0375-0760</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Información de Ciencias Médicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0375-07602022000100003</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Evaluación de ensayos ultramicroanalíticos para la detección de anticuerpos contra el SARS-CoV-2]]></article-title>
<article-title xml:lang="en"><![CDATA[Evaluation of ultramicroanalytic assays to detect antibodies against SARS-CoV-2]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodriguez Lay]]></surname>
<given-names><![CDATA[Licel de los Ángeles]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Tejero]]></surname>
<given-names><![CDATA[Yahisel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pelegrino]]></surname>
<given-names><![CDATA[José L.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Morales Verdecia]]></surname>
<given-names><![CDATA[Darling Danay]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Montalvo]]></surname>
<given-names><![CDATA[Maria Caridad]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Valdés]]></surname>
<given-names><![CDATA[Odalys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Resik]]></surname>
<given-names><![CDATA[Sonia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Guzmán]]></surname>
<given-names><![CDATA[María G.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto de Medicina Tropical Pedro Kourí (IPK)  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<volume>74</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0375-07602022000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0375-07602022000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0375-07602022000100003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción:  En el presente trabajo se muestran los resultados de la validación de los ensayos serológicos in vitro para la detección de anticuerpos IgM, IgG y anticuerpos totales contra el SARS-CoV-2 UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 y UMELISA SARS-CoV-2 IgG desarrollados por el Centro de Inmunoensayo (CIE).  Métodos:  Se utilizaron paneles de muestras de suero de individuos negativos y de casos confirmados de COVID-19 para determinar el desempeño analítico de cada ensayo.  Resultados:  La especificidad clínica de los ensayos UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 y UMELISA SARS-CoV-2 IgG fue del 100 % en todos los ensayos y la especificidad analítica fue de 100 % para los dos primeros ensayos y del 93,1 % para el último. La sensibilidad clínica fue de 64,3, 80,8 y 97,5 %, respectivamente. El valor predictivo positivo fue de 100 % en todos los ensayos, en tanto que el negativo osciló entre 83,3 y 95,2 %. La concordancia fluctuó entre 92,4 y 96,9 % y el índice kappa de todos los ensayos fue muy bueno. La sensibilidad de los ensayos se incrementó a 82,76, 96,5 y 100 %, respectivamente, en las muestras de suero colectadas con más de 14 días de iniciado el cuadro clínico.  Conclusiones:  Los ensayos demostraron una elevada sensibilidad y especificidad, lo que permite contar con herramientas basadas en una tecnología desarrollada en Cuba que posibilita la realización de estudios serológicos, vigilancia epidemiológica y de otro tipo, incluyendo los relacionados con vacunas en una plataforma con amplia distribución nacional.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction: This paper shows the results obtained in the validation of in vitro serological assays to detect IgM, IgG antibodies, and total antibodies against SARS-CoV-2 UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 and UMELISA SARS-CoV-2 IgG developed by the Immunoassay Center.  Methods: Panels of serum samples from negative and COVID-19 confirmed patients were used to determine the analytical performance of each assay.  Results: UMELISA SARS-CoV-2 IgM, UMELISA ANTI-SARS-CoV-2 and UMELISA SARS-CoV-2 IgG assays demonstrated 100% clinical specificity for all assays; and 100% analytical specificity for the first two assays, and 93.1% for the last one. Clinical sensitivity was 64.3%, 80.8% and 97.5%, respectively. The positive predictive value was 100% in all assays, while the negative predictive value ranged from 83.3% to 95.2%. Concordance varied from 92.4% to 96.9%, and kappa index in every assay was very good. Assays sensitivity increased to 82.7%, 96.5% and 100 %, respectively for serum samples collected more than 14 days after onset of the symptoms.  Conclusions: The assays demonstrated high sensitivity and specificity, which allows us to have Cuban technology-based tools for serological, epidemiological surveillance, and other types of studies, including those related to vaccines on a platform with wide national distribution.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[COVID-19]]></kwd>
<kwd lng="es"><![CDATA[UMELISA]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos IgM anti-SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos IgG anti-SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos totales anti-SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[respuesta inmune humoral]]></kwd>
<kwd lng="en"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="en"><![CDATA[COVID-19]]></kwd>
<kwd lng="en"><![CDATA[UMELISA]]></kwd>
<kwd lng="en"><![CDATA[IgM anti-SARS-CoV-2 antibodies]]></kwd>
<kwd lng="en"><![CDATA[IgG anti-SARS-CoV-2 antibodies]]></kwd>
<kwd lng="en"><![CDATA[anti-SARS-CoV-2 total antibodies]]></kwd>
<kwd lng="en"><![CDATA[humoral immune response]]></kwd>
</kwd-group>
</article-meta>
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