<?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>0864-0300</journal-id>
<journal-title><![CDATA[Revista Cubana de Investigaciones Biomédicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Cubana Invest Bioméd]]></abbrev-journal-title>
<issn>0864-0300</issn>
<publisher>
<publisher-name><![CDATA[ECIMED]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0864-03002023000100018</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Control de la calidad y ensayos de rendimiento de CromoCen® SALM según la norma ISO 11133:2014/Amd.1:2018]]></article-title>
<article-title xml:lang="en"><![CDATA[Quality control and performance testing of CromoCen® SALM according to ISO 11133: 2014 / Amd.1: 2018]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alfonso Valdés]]></surname>
<given-names><![CDATA[Ivonne]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Zhurbenko]]></surname>
<given-names><![CDATA[Raisa]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lobaina Rodríguez]]></surname>
<given-names><![CDATA[Tamara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez Martínez]]></surname>
<given-names><![CDATA[Claudio]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Biopreparados (BioCen)  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Cuba</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>42</volume>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0864-03002023000100018&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0864-03002023000100018&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0864-03002023000100018&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción: En Cuba, se desarrolló un medio de cultivo cromogénico y fluorogénico, para la detección, aislamiento y diferenciación de Salmonella de otras bacterias Gram negativas. El método que emplea el medio fue validado y su uso se adoptó en una norma cubana. El aseguramiento de la calidad y el control del rendimiento de los medios garantizan la confiabilidad de los resultados analíticos. La norma ISO 11133 establece criterios mínimos y métodos para evaluarlos.  Objetivo:  Evaluar los criterios de control de la calidad y de rendimiento de CromoCen® SALM, establecidos en la ISO 11133:2014/Amd.1:2018, para demostrar su fiabilidad para el análisis microbiológico de los alimentos de consumo humano.  Métodos:  Se evaluaron los indicadores de calidad físico-químicos de tres lotes y se definió un conjunto de ellos que caracteriza la calidad del medio antes y después de terminado, así como la consistencia entre lotes. Para el ensayo de rendimiento se seleccionaron 10 cepas de diferentes géneros. Se determinó la relación de productividad, el factor de selectividad y la electividad de CromoCen® SALM, según la ISO 11133.  Resultados:  La evaluación físico-química mostró una consistencia entre lotes en color, homogeneidad, apariencia del polvo y del medio preparado. Los valores de contenido de humedad y pH se encontraron dentro de los valores establecidos para este producto. La relación de productividad de CromoCen® SALM con respecto al agar triptona soya, fue superior al 50%, mientras que el factor de selectividad resultó de 4. Se demostró que en el medio de cultivo se puede diferenciar un grupo representativo de géneros microbianos de Salmonella.  Conclusiones:  CromoCen® SALM cumple con los requisitos de calidad establecidos para este tipo de productos, según la ISO 11133 vigente. La correcta formulación de los lotes, así como el cumplimiento de los requisitos de calidad aseguran el funcionamiento adecuado para lo que fue diseñado.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  In Cuba, a new chromogenic and fluorogenic culture medium was developed for the detection, isolation and differentiation of Salmonella from other Gram negative bacteria. The method and medium were validated and their use was adopted as a Cuban standard. Quality assurance and control of media is essential and mandatory to ensure the reliability of the results of the analysis in which they are used. ISO 11133 establishes minimum criteria and methods to evaluate them.  Objective:  To evaluate the quality and performance criteria of CromoCen® SALM, as recommended in ISO 11133:2014/Amd.1:2018 to demonstrate its reliability for the microbiological analysis of food for human consumption.  Methods:  The physical-chemical quality indicators of three batches were evaluated and a group of them was defined to characterize its quality before and after finishing, as well to evaluate the consistency between batches. For the performance test, 12 strains of different genera were selected. The productivity ratio, the selectivity factor and the electivity of CromoCen® SALM were determined.  Results:  The physico-chemical evaluation showed a consistency between batches in color, homogeneity, appearance of the powder and of the prepared medium. The moisture content and pH values ranged within the established values for this product. The productivity ratio of CromoCen® SALM with respect to tryptone soy agar was greater than 50%, while the selectivity factor was 4. It was shown that in the culture medium a representative group of Salmonella microbial genera can be differentiated.  Conclusions:  CromoCen® SALM meets the quality requirements established for this type of products, according to the current ISO 11133 standard. The correct formulation of the batches, as well as the fulfillment of the quality requirements ensure the proper functionality and match the design purpose.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[control de la calidad]]></kwd>
<kwd lng="es"><![CDATA[Salmonella]]></kwd>
<kwd lng="es"><![CDATA[medios de cultivo]]></kwd>
<kwd lng="es"><![CDATA[ISO 11133]]></kwd>
<kwd lng="en"><![CDATA[quality control]]></kwd>
<kwd lng="en"><![CDATA[Salmonella]]></kwd>
<kwd lng="en"><![CDATA[culture media]]></kwd>
<kwd lng="en"><![CDATA[ISO 11133]]></kwd>
</kwd-group>
</article-meta>
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