<?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>2007-8447</journal-id>
<journal-title><![CDATA[Revista biomédica]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. biomédica]]></abbrev-journal-title>
<issn>2007-8447</issn>
<publisher>
<publisher-name><![CDATA[Universidad Autónoma de Yucatán, Centro de Investigaciones Regionales Dr. Hideyo Noguchi Naturaleza]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2007-84472017000300111</article-id>
<article-id pub-id-type="doi">10.32776/revbiomed.v28i3.549</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Validación de un inmunoensayo tipo ELISA para la cuantificación de los niveles séricos de antígeno de superficie en pacientes con infección crónica por Virus de la Hepatitis B.]]></article-title>
<article-title xml:lang="en"><![CDATA[Validation of an ELISA for quantitation of serum levels of surface antigen in patients with chronic hepatitis B.]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Pelier]]></surname>
<given-names><![CDATA[Cira V.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Chang-Monteagudo]]></surname>
<given-names><![CDATA[Arturo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Zúñiga-Rosales]]></surname>
<given-names><![CDATA[Yaíma]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Torres-Rives]]></surname>
<given-names><![CDATA[Bárbara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez-Tellez]]></surname>
<given-names><![CDATA[Goytibell]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rosa-Hernández]]></surname>
<given-names><![CDATA[Deyanira la]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez-Perera]]></surname>
<given-names><![CDATA[Adonay]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Genética Médica  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<aff id="Af2">
<institution><![CDATA[,Instituto de Hematología e Inmunología  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2017</year>
</pub-date>
<volume>28</volume>
<numero>3</numero>
<fpage>111</fpage>
<lpage>123</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S2007-84472017000300111&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S2007-84472017000300111&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S2007-84472017000300111&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Introducción Durante la etapa aguda de la infección por el Virus de la Hepatitis B (VHB) y el período inicial de una infección crónica, el DNA está en forma episomal (libre o extracromosomal) y se replica en el hepatocito produciendo, entre otros, viriones infectivos, DNA polimerasa y antígeno de superficie del virus (HBsAg).  Objetivo Validar un inmunoensayo tipo ELISA para cuantificar los niveles de HBsAg en pacientes con hepatitis B crónica.  Método Se realizó un estudio experimental de desarrollo tecnológico. Se llevó a cabo la normalización y validación de un inmunoensayo enzimático heterogéneo de doble anticuerpo para la cuantificación de HBsAg en sueros de seres humanos. 115 muestras de pacientes con hepatitis B crónica con resultados de carga viral se correlacionaron con las concentraciones de HBsAg.  Resultados y discusión El método presentó coeficientes de variación intra e interensayo de 9,8 y 13,2% respectivamente. El rango de trabajo se estimó entre 0.15 y 60 ng/mL. El porcentaje de recuperación estuvo entre el 90 y 110% y el ajuste lineal de la curva estándar presentó un coeficiente de determinación superior a 0,99. La correlación alcanzada entre los niveles de DNA y la concentración de HBsAg fue de 62.5%.  Conclusiones La evaluación del ELISA para la cuantificación de HBsAg desarrollado en el laboratorio mostró que cumple los parámetros de validación para su uso clínico.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Introduction During the acute phase of infection with Hepatitis B Virus (HBV) and the initial period of chronic infection, DNA is episomally (free or extrachromosomal) and replicates in hepatocytes producing among other virions, DNA polymerase and virus surface antigen (HBsAg).  Objective Validate an ELISA to quantify HBsAg levels in patients with chronic hepatitis B.  Method An experimental study of technological developmentwas conducted. The normalization and validation of heterogeneous double antibody enzyme linked inmunoassay for quantitation of HBsAg in human sera was carried out. 115 serum samples from patients with chronic hepatitis B with viral load results were correlated with its HBsAg concentrations.  Results and discussion The developed method presented variation coefficients intra and interassay of 9.8 and 13.2% respectively. The working range was estimated between 0.15 and 60 ng/mL. The recovery rate was between 90 and 110% and the linear fit of the standard curve presented a determination coefficient greater than 0, 99. The correlation between the DNA levels and HBsAg concentration was 62.5%.  Conclusions The assessment of the ELISA for quantitation of HBsAg developed in the laboratory showed that it achieved validation parameters for its clinical use.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[VH]]></kwd>
<kwd lng="es"><![CDATA[HBsAg]]></kwd>
<kwd lng="es"><![CDATA[ELISA]]></kwd>
<kwd lng="es"><![CDATA[inmunoensayo]]></kwd>
<kwd lng="es"><![CDATA[normalización]]></kwd>
<kwd lng="es"><![CDATA[optimización]]></kwd>
<kwd lng="es"><![CDATA[validación]]></kwd>
<kwd lng="en"><![CDATA[HBV]]></kwd>
<kwd lng="en"><![CDATA[HBsAg]]></kwd>
<kwd lng="en"><![CDATA[ELISA]]></kwd>
<kwd lng="en"><![CDATA[immunoassay]]></kwd>
<kwd lng="en"><![CDATA[standardization]]></kwd>
<kwd lng="en"><![CDATA[optimization]]></kwd>
<kwd lng="en"><![CDATA[validation]]></kwd>
</kwd-group>
</article-meta>
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