<?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>S0375-07602021000300002</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Evaluación del desempeño clínico del ensayo SUMASIGNAL VHC para la detección del ARN del virus de la hepatitis C]]></article-title>
<article-title xml:lang="en"><![CDATA[Evaluation of the clinical performance of the SUMASIGNAL HCV assay for detection of hepatitis C virus RNA]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Montalvo Villalba]]></surname>
<given-names><![CDATA[María Caridad]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-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[López Hernández]]></surname>
<given-names><![CDATA[Dayesi]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Bello Corredor]]></surname>
<given-names><![CDATA[Marité]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez Montesino]]></surname>
<given-names><![CDATA[Yenisleidys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Marrero Sánchez]]></surname>
<given-names><![CDATA[Bárbara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González González]]></surname>
<given-names><![CDATA[Yaime Josefina]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Armas Cayarga]]></surname>
<given-names><![CDATA[Anny]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto de Medicina Tropical &#8220;Pedro Kourí&#8221; (IPK)  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<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>12</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<volume>73</volume>
<numero>3</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0375-07602021000300002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0375-07602021000300002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0375-07602021000300002&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción:  La detección y cuantificación del genoma del virus de la hepatitis C (ARN-VHC), mediante la transcripción inversa-PCR en tiempo real (RT-qPCR), es vital para el diagnóstico y seguimiento del tratamiento antiviral de los pacientes con hepatitis C. Objetivo: Evaluar los indicadores de desempeño clínico como la especificidad, sensibilidad y reproducibilidad del ensayo SUMASIGNAL VHC, comercializado por el Centro de Inmunoensayo (Cuba), tomando como técnica de referencia la prueba Artus® HCV RG RT-qPCR.  Métodos : Se empleó un panel conformado por 70 muestras de suero: 46 ARN-VHC positivas, 12 ARN-VHC negativas y 12 positivas a marcadores moleculares de otros virus. El coeficiente de correlación de Pearson (r) y la prueba de Bland-Altman, se utilizaron para comparar las cargas virales del VHC, obtenidas por las técnicas SUMASIGNAL VHC y la de referencia; las que fueron expresadas en logaritmo en base 10 (log10) UI/mL. Los valores de p&lt; 0,05 se consideraron estadísticamente significativos.  Resultados:  La sensibilidad y especificidad clínica del SUMASIGNAL VHC fue 100 %; mientras que no se detectó reactividad cruzada con los otros virus evaluados. Se demostró que el ensayo en cuestión, tuvo una correlación buena (r= 0,89) y fuerte concordancia (media= -0,01 Log10 UI/mL) con la prueba de referencia (p&lt; 0,0001). La reproducibilidad de la cuantificación del ARN-VHC en dos momentos diferentes, con la prueba SUMASIGNAL VHC mostró una correlación excelente (r= 0,97; p&lt; 0,0001).  Conclusiones:  El ensayo SUMASIGNAL VHC proporciona datos válidos, reproducibles y técnicamente confiables para realizar el diagnóstico específico del VHC, incluso constituye una herramienta útil para monitorear la carga viral de este agente en el Sistema Nacional de Salud Cubano.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  Detection and quantification of the hepatitis C virus genome (HCV RNA) by real time reverse transcription PCR (RT-qPCR) are vital for the diagnosis and antiviral treatment follow-up of hepatitis C patients.  Objective:  Evaluate the clinical performance of the SUMASIGNAL HCV assay for quantification of HCV viral load.  Methods:  A panel was formed with 70 serum samples: 46 HCV RNA positive, 12 HCV RNA negative and 12 positive for molecular markers of other viruses. Pearson's correlation coefficient (r) and the Bland-Altman plot were used to compare the HCV viral loads obtained by SUMASIGNAL HCV techniques with reference values, which were expressed as base 10 logarithm (log10) UI/ml. Values of p &lt;0.05 were considered statistically significant.  Results:  The clinical sensitivity and specificity of SUMASIGNAL HVC were 100%, and no cross-reactivity was detected with the other viruses evaluated. The study assay exhibited a good correlation (r= 0.89) and strong concordance (mean= -0.01 Log10 UI/ml) with the reference test (p&lt; 0.0001). Reproducibility of the HCV RNA quantification with the SUMASIGNAL HCV test at two different moments displayed an excellent correlation (r= 0.97; p&lt; 0.0001).  Conclusions:  The SUMASIGNAL HVC assay provides valid, reproducible and technically reliable data for specific HCV diagnosis. It is also a useful tool to monitor the viral load of this agent in the Cuban National Health System.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[virus de la hepatitis C]]></kwd>
<kwd lng="es"><![CDATA[carga viral]]></kwd>
<kwd lng="es"><![CDATA[reacción en cadena de la polimerasa en tiempo real; evaluación del desempeño]]></kwd>
<kwd lng="en"><![CDATA[hepatitis C virus]]></kwd>
<kwd lng="en"><![CDATA[viral load]]></kwd>
<kwd lng="en"><![CDATA[real time polymerase chain reaction]]></kwd>
<kwd lng="en"><![CDATA[performance evaluation]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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