<?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>S1812-95282023000100006</article-id>
<article-id pub-id-type="doi">10.18004/mem.iics/1812-9528/2023.e21122306</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Evaluación de un prototipo de ensayo de aglutinación látex-estreptavidina-tp17 para detección de anticuerpos anti-Treponema pallidum]]></article-title>
<article-title xml:lang="en"><![CDATA[Evaluation of a latex-streptavidin-tp17 agglutination assay prototype for detection of anti-Treponema pallidum antibodies]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sanabria]]></surname>
<given-names><![CDATA[Arianna]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González]]></surname>
<given-names><![CDATA[Cecilia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Guillén]]></surname>
<given-names><![CDATA[Ivalena de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Aria-Zaya]]></surname>
<given-names><![CDATA[Laura]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rojas]]></surname>
<given-names><![CDATA[Alejandra]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Bernal]]></surname>
<given-names><![CDATA[Cynthia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hetter]]></surname>
<given-names><![CDATA[María Eugenia Acosta-de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,aff1  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Paraguay</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Nacional de Asunción Facultad de Ciencias Químicas ]]></institution>
<addr-line><![CDATA[San Lorenzo ]]></addr-line>
<country>Paraguay</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<volume>21</volume>
<numero>1</numero>
<fpage>6</fpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_arttext&amp;pid=S1812-95282023000100006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_abstract&amp;pid=S1812-95282023000100006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.iics.una.py/scielo.php?script=sci_pdf&amp;pid=S1812-95282023000100006&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN La sífilis es una infección bacteriana causada por Treponema pallidum. El diagnóstico se basa en las características clínicas y en pruebas laboratoriales serológicas indirectas. El objetivo fue evaluar un prototipo de ensayo de aglutinación de látex-estreptavidina-Tp17 para detección de anticuerpos anti-T. pallidum. Se estandarizaron las condiciones óptimas de un prototipo de ensayo de aglutinación basado en la unión estreptavidina-biotina sobre soporte de látex con la proteína recombinante Tp17. Se analizó la concordancia del ensayo con otras pruebas comerciales para determinar su utilidad como alternativa en el diagnóstico de sífilis. Se lograron obtener las condiciones óptimas de preparación del reactivo y se demostró la estabilidad del mismo hasta los 90 días conservado a 4ºC. En cuanto a la concordancia entre el prototipo y otras pruebas comerciales, se analizaron 56 muestras con la prueba de VDRL y se obtuvo un índice kappa de 0,48 IC95% (0,24-0,73) indicando una fuerza de concordancia moderada. Por otro lado, 44 muestras fueron previamente evaluadas por quimioluminiscencia (CLIA), siendo el índice kappa calculado 0,81 IC95% (0,55-1) representando una fuerza de concordancia casi perfecta entre los métodos. Adicionalmente&lt; se determinaron la sensibilidad y la especificidad teniendo como referencia a la prueba de CLIA debido a la similitud en la utilización del antígeno Tp17 en ambos métodos, brindando un resultado de 94,87% y 100% respectivamente. Estos resultados plantean obtener una evaluación de la performance orientada a una posible aplicación en la población general.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Syphilis is a bacterial infection caused by Treponema pallidum. Diagnosis is based on clinical features and indirect serological laboratory tests. The objective was to evaluate a latex-streptavidin-Tp17 agglutination assay prototype for the detection of anti-T. pallidum antibodies. The optimal conditions of a agglutination assay prototype based on streptavidin-coated polystyrene latex particles and a biotinylated Tp17 were standardized. The concordance of the assay with other commercial tests was analyzed to determine its usefulness as an alternative in the diagnosis of syphilis. The optimal conditions for the reagents preparation were obtained and the reagent stability was demonstrated for up to 90 days stored at 4ºC. Regarding the concordance between the prototype and other commercial tests, 56 samples were analyzed with the VDRL test and a kappa index of 0.48 CI95% (0.24-0.73) was obtained, indicating a moderate agreement. Also, 44 samples, previously evaluated by chemiluminescence (CLIA), were evaluated with the assay, and a kappa index of 0.81 CI95% (0.55-1) was obtained demonstrating an almost perfect strength of agreement. Additionally, sensitivity and specificity were determined using the CLIA method as reference due to the similarity in the use of the Tp17 antigen in both methods, and 94.87% and 100% were obtained respectively. These results suggest further evaluation of the assay performance oriented to a possible application in the general population.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Aglutinación]]></kwd>
<kwd lng="es"><![CDATA[concordancia]]></kwd>
<kwd lng="es"><![CDATA[proteína recombinante]]></kwd>
<kwd lng="es"><![CDATA[sífilis]]></kwd>
<kwd lng="en"><![CDATA[Agglutination]]></kwd>
<kwd lng="en"><![CDATA[concordance]]></kwd>
<kwd lng="en"><![CDATA[recombinant protein]]></kwd>
<kwd lng="en"><![CDATA[syphilis]]></kwd>
</kwd-group>
</article-meta>
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