<?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>0123-9392</journal-id>
<journal-title><![CDATA[Infectio]]></journal-title>
<abbrev-journal-title><![CDATA[Infect.]]></abbrev-journal-title>
<issn>0123-9392</issn>
<publisher>
<publisher-name><![CDATA[Asociación Colombiana de Infectología.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0123-93922020000500005</article-id>
<article-id pub-id-type="doi">10.22354/in.v24i3.868</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Consenso de grupo Ad-hoc sobre recomendaciones para la evaluación y controles de calidad para el diagnóstico molecular y serológico de la infección humana por SARS CoV-2]]></article-title>
<article-title xml:lang="en"><![CDATA[Ad-hoc group consensus recommendations on the evaluation and quality control of molecular and serological diagnostics tests for SARS CoV-2 human infection]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gomez Marin]]></surname>
<given-names><![CDATA[Jorge E.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castellanos]]></surname>
<given-names><![CDATA[Jaime]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodriguez-Morales]]></surname>
<given-names><![CDATA[Alfonso J.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cardona-Ospina]]></surname>
<given-names><![CDATA[Jaime A.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Forero Duarte]]></surname>
<given-names><![CDATA[Jorge Eduardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mattar]]></surname>
<given-names><![CDATA[Salim]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Esparza]]></surname>
<given-names><![CDATA[Germán]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad del Quindío Centro de Investigaciones Biomédicas ]]></institution>
<addr-line><![CDATA[Armenia Quindío]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad El Bosque Laboratorio de Virología ]]></institution>
<addr-line><![CDATA[Bogotá ]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidad Tecnológica de Pereira Facultad de Ciencias de la Salud Grupo de Investigación Infección e Inmunidad]]></institution>
<addr-line><![CDATA[Pereira Risaralda]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Instituto para la Investigación en Ciencias Biomédicas Risaralda Pereira]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af5">
<institution><![CDATA[,Universidad de Antioquia Escuela de Microbiología ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af6">
<institution><![CDATA[,Universidad de Cordoba Instituto de Investigaciones Biologicas del Tropico ]]></institution>
<addr-line><![CDATA[Monteria ]]></addr-line>
<country>Colombia</country>
</aff>
<aff id="Af7">
<institution><![CDATA[,PROASECAL SAS Programa de aseguramiento de Calidad ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<volume>24</volume>
<numero>3</numero>
<fpage>5</fpage>
<lpage>10</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0123-93922020000500005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0123-93922020000500005&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0123-93922020000500005&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Se formulan recomendaciones de un grupo de consenso de expertos sobre los criterios para evaluar el desempeño diagnóstico (tamaño y selección de muestras para sensibilidad y especificidad analíticas, criterios para establecer límites de detección, criterios para establecer el estándar de oro para las serologías) que deberían ser tenidos en cuenta al evaluar y validar las pruebas diagnósticas para SARS CoV-2. Con el propósito de asegurar la calidad de las pruebas serológicas a utilizar en el país, se recomienda la participación en un programa de control de calidad externo, que garantice la idoneidad y desempeño en la realización de las pruebas diagnósticas serológicas y moleculares durante esta pandemia, ya que su uso tiene profundas implicaciones para las medidas de intervención clínicas individuales y de seguimiento y control en salud pública.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract We formulate recommendations from a consensus working group on the criteria to evaluate the diagnostic performance (size and criteria of selection of samples to determine sensitivity, analytical specificity, criteria for limit of detection, criteria for gold standard to evaluate serological assays) that should be taken into account during the evaluation and validation/verification of diagnostic tests for SARS CoV-2 infection. A national external quality control program should be established to guarantee the suitability and performance of these diagnostic serological and molecular tests during this pandemic, that will have deep implications for decisions on clinical and public health.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Pruebas diagnósticas]]></kwd>
<kwd lng="es"><![CDATA[SARS CoV-2, COVID 19, control calidad laboratorio]]></kwd>
<kwd lng="en"><![CDATA[laboratory diagnosis]]></kwd>
<kwd lng="en"><![CDATA[SARS CoV-2]]></kwd>
<kwd lng="en"><![CDATA[COVID 19]]></kwd>
<kwd lng="en"><![CDATA[laboratory quality control]]></kwd>
</kwd-group>
</article-meta>
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