<?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>1025-028X</journal-id>
<journal-title><![CDATA[Vaccimonitor]]></journal-title>
<abbrev-journal-title><![CDATA[Vaccimonitor]]></abbrev-journal-title>
<issn>1025-028X</issn>
<publisher>
<publisher-name><![CDATA[Finlay Ediciones]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1025-028X2021000300105</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Validación de pruebas rápidas de COVID-19. Isla de la Juventud, Cuba]]></article-title>
<article-title xml:lang="en"><![CDATA[COVID-19 rapid test validation. Isla de la Juventud, Cuba]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González-Fiallo]]></surname>
<given-names><![CDATA[Sayli]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mena-Rodríguez]]></surname>
<given-names><![CDATA[Idorka]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Doeste-Hernández]]></surname>
<given-names><![CDATA[Victor Manuel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castro-Batista]]></surname>
<given-names><![CDATA[Percy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Espinosa-Reyes]]></surname>
<given-names><![CDATA[Soni]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Dirección Municipal de Salud Pública  ]]></institution>
<addr-line><![CDATA[Isla de la Juventud ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<volume>30</volume>
<numero>3</numero>
<fpage>105</fpage>
<lpage>114</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2021000300105&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2021000300105&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2021000300105&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Contar con métodos diagnósticos que reúnan ciertos atributos es vital para guiar las decisiones sanitarias, el contexto actual lo amerita. Con el objetivo de validar la capacidad de dos pruebas rápidas para detectar anticuerpos debido a la infección por SARS-CoV-2 en la Isla de la Juventud, Cuba, de abril a mayo de 2020, se realizó un estudio descriptivo de corte transversal de evaluación de pruebas rápidas: Wondfo (SARS-CoV-2 antibody test) y Lungene covid-19 IgG/IgM rapid test, en comparación con la prueba de reacción en cadena de la polimerasa en tiempo real. Se construyeron dos muestras homogéneas de 250 cada una, determinándose indicadores de validación. Se obtuvieron valores de sensibilidad de 6,6% y 8,3% respectivamente para cada prueba, mientras que la especificidad resultó superior para Wondfo (95%). Los valores predictivos positivos resultaron muy bajos, los negativos adecuados, superior en Lungene con el 94,8%. Los valores de razón de verosimilitud fueron clasificados como inútiles. En diferentes escenarios en cuanto a casos sintomáticos, se alcanzó sensibilidad del 50% en intervalo de 1 a 7 días para Wondfo. El área bajo la curva ROC para Wondfo fue 0,50 (IC95%=0,46-0,55) y para Lungene 0,46 (IC95%=0,38-0,55). El índice kappa para Wondfo fue de 0,025 y 0,010 para Lungene. Las pruebas rápidas exploradas mostraron muy baja sensibilidad, valor predictivo positivo y razón de verosimilitud inadecuada. La validez global de las pruebas no demostró un buen desempeño diagnóstico, marcado por el valor del área bajo la curva ROC.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Having diagnostic methods that meet certain attributes is vital to guide health decisions, the current context warrants it. In order to validate the capacity of two rapid tests to detect antibodies due to SARS-CoV-2 infection in Isla de la Juventud, Cuba, from April to May 2020, a descriptive cross-sectional evaluation study was carried out. Rapid tests: Wondfo (SARS-CoV-2 antibody test) and Lungene covid-19 IgG/IgM, were compared to the real-time polymerase chain reaction test. Two homogeneous samples of 250 each were constructed, determining validation indicators. Sensitivity values of 6.6% and 8.3% respectively were obtained for each test, while the specificity was higher for Wondfo (95%). The positive predictive values were very low, the negative ones were adequate, higher in Lungene with 94.8%. Likelihood ratio values were classified as useless. In different scenarios in terms of symptomatic cases, sensitivity of 50% was reached in an interval of 1 to 7 days for Wondfo. The area under the ROC curve for Wondfo was 0.50 (95% CI = 0.46-0.55) and 0.46 for Lungene (95%CI = 0.38-0.55). The kappa index for Wondfo was 0.025 and 0.010 for Lungene. The rapid tests explored showed very low sensitivity, positive predictive value, and inadequate likelihood ratio. The global validity of the tests did not demonstrate a good diagnostic performance, marked by the value of the area under the ROC curve. The degree of agreement was poor.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[COVID-19]]></kwd>
<kwd lng="es"><![CDATA[ELISA]]></kwd>
<kwd lng="es"><![CDATA[estudio de validación]]></kwd>
<kwd lng="en"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="en"><![CDATA[COVID 19]]></kwd>
<kwd lng="en"><![CDATA[ELISA]]></kwd>
<kwd lng="en"><![CDATA[validation study]]></kwd>
</kwd-group>
</article-meta>
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