<?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>1812-9528</journal-id>
<journal-title><![CDATA[Memorias del Instituto de Investigaciones en Ciencias de la Salud]]></journal-title>
<abbrev-journal-title><![CDATA[Mem. Inst. Investig. Cienc. Salud]]></abbrev-journal-title>
<issn>1812-9528</issn>
<publisher>
<publisher-name><![CDATA[Instituto de Investigaciones en Ciencias de la Salud]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1812-95282016000300007</article-id>
<article-id pub-id-type="doi">10.18004/mem.iics/1812-9528/2016.014(03)07-013</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Desempeño del Kit ELISA Chagas IICS V.1 para el diagnóstico de la enfermedad de Chagas]]></article-title>
<article-title xml:lang="en"><![CDATA[ELISA Chagas test IICS V.1 evaluation for the diagnosis of Chagas disease]]></article-title>
</title-group>
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<surname><![CDATA[Aria]]></surname>
<given-names><![CDATA[Laura]]></given-names>
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<surname><![CDATA[Acosta]]></surname>
<given-names><![CDATA[María Eugenia]]></given-names>
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<surname><![CDATA[Rojas]]></surname>
<given-names><![CDATA[Alejandra]]></given-names>
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<surname><![CDATA[Infanzón]]></surname>
<given-names><![CDATA[Belén]]></given-names>
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</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Nacional de Asunción Instituto de Investigación en Ciencias de la Salud Departamento de Producción]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Paraguay</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2016</year>
</pub-date>
<volume>14</volume>
<numero>3</numero>
<fpage>7</fpage>
<lpage>13</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_arttext&amp;pid=S1812-95282016000300007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_abstract&amp;pid=S1812-95282016000300007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_pdf&amp;pid=S1812-95282016000300007&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN En Paraguay, el tamizaje serológico para la enfermedad de Chagas en bancos de sangre es necesario, por lo cual es importante un método diagnóstico con alta sensibilidad. El ELISA Chagas test IICS V.1 es un ELISA indirecto sensibilizados con antígeno soluble de epimastigote de T.cruzide la cepa Ypsilon. El objetivo del presente trabajo fue evaluar el desempeño del ELISA Chagas test IICS V.1 en comparación con kits comerciales, ademásanalizar los resultados de la evaluación externa e interna de calidad del kit. En este estudio observacional de prueba diagnóstica se analizaron 56 muestras de suerospositivos y negativos para antígenos de Trypanosoma cruzi, testados por el ELISA BiosChile, obteniéndose una concordancia excelente entre el ELISA Chagas test IICS V.1y los kits comerciales: Chagatest ELISA-Wiener, con Índice kappa: 0,89 IC de 95% (0,76-1) y Test ELISA para Chagas III-Grupo BiosChile con Índice kappa: 0,92 IC 95% (0,82-1).En la evaluación externa de calidad realizada por la Fundação Pró-Sangue/Hemocentro de São Paulo, Brasil en el periodo 2001 al 2012 se analizaron 450 muestras: 372 negativas y 78 positivas para T. cruzi, obteniéndose en dicha evaluación la calificación "A" que indica ausencia de falsos positivos y negativos. Además, en el mismo periodo los valores del control interno se encontraron dentro del rango permitido de ±2DS. Los resultados obtenidos en el estudio demuestran la alta calidad de este test de producción nacional, que sumado al bajo costo del mismo, pueden ser utilizados en trabajos de campo, donde no necesita de instrumentación y las lecturas pueden realizarse a simple vista, constituyendo una herramienta válida y útil para el apoyo al diagnóstico de la enfermedad de Chagas.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT In Paraguay, the serological screening for Chagas disease is mandatory in pregnant women and blood banks, therefore a high sensitivity diagnostic method is required. The aim of this study was to evaluate the ELISA Chagas test IICS V.1 by comparison with commercial kits and to analyze the external and internal quality evaluation results. In this descriptive observational study, 56 seropositive and seronegative to Trypanosoma cruzi samples were analyzed, obtaining an excellent concordance between the ELISA Chagas test IICS V.1 andthese commercial kits: Chagatest ELISA-Wiener, Argentina (kappa index: 0.89) and Test ELISA Chagas III-Grupo Bios, Chile (kappa index: 0.92).In the external quality assessment carried out by the Fundação Pró-Sangue /Blood Center of São Paulo, Brazil in the period 2001 to 2012, 450 samples were analyzed: 372 seronegative and 78 seropositive for T. cruzi. In this evaluation, an "A" score was obtained indicating the absence of false positives and negatives. Additionally, in the same period of time the internal control values were within the accepted range of ± 2SD, with a confidence interval of 95%. The results obtained in the present study demonstrate the high quality of this locally produced test which added to its low cost, making it a valid and useful tool to support the diagnosis of Chagas disease.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Chagas]]></kwd>
<kwd lng="es"><![CDATA[T. cruzi]]></kwd>
<kwd lng="es"><![CDATA[programa de evaluación]]></kwd>
<kwd lng="es"><![CDATA[control interno]]></kwd>
<kwd lng="en"><![CDATA[Chagas]]></kwd>
<kwd lng="en"><![CDATA[T. cruzi]]></kwd>
<kwd lng="en"><![CDATA[evaluation program]]></kwd>
<kwd lng="en"><![CDATA[internal control]]></kwd>
</kwd-group>
</article-meta>
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