<?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>S1025-028X2000000300003</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Guía para la estandarización de técnicaGuía técnicas inmunoenzimáticas en ensayos de vacunas]]></article-title>
<article-title xml:lang="en"><![CDATA[Guide for the standardization of enzyme immunoassays for use in vaccine trials]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[Rolando]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[Juan C]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[Xenia]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Estrada]]></surname>
<given-names><![CDATA[Eric]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[Ana M]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Blanco]]></surname>
<given-names><![CDATA[Rosa]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sotolongo]]></surname>
<given-names><![CDATA[Franklin]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
</contrib-group>
<aff id="A01">
<institution><![CDATA[,Instituto Finlay  ]]></institution>
<addr-line><![CDATA[Ciudad de La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2000</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2000</year>
</pub-date>
<volume>9</volume>
<numero>3</numero>
<fpage>13</fpage>
<lpage>18</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2000000300003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2000000300003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2000000300003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Se realizó una revisión sobre la estandarización de técnicas inmunoenzimáticas para ensayos preclínicos y clínicos de vacunas, elaborándose una guía práctica. Se analizan los principios a usar y los pasos a seguir para la optimización de un ensayo, incluyendo la preparación de estándares y controles. Se exponen nuestras experiencias.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[The standardization of enzyme immunoassays, for use in evaluation of pre-clinical and clinical vaccine trials, was reviewed. A practical guide was made. The immunoassay principles and the assay optimization step - including the preparation of standards and controls - are analyzed. Our experience is presented.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Estandarización]]></kwd>
<kwd lng="es"><![CDATA[inmunoensayos enzimáticos]]></kwd>
<kwd lng="es"><![CDATA[ELISA]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="en"><![CDATA[Standardization]]></kwd>
<kwd lng="en"><![CDATA[enzyme immunoassays]]></kwd>
<kwd lng="en"><![CDATA[ELISA]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
</kwd-group>
</article-meta>
</front><body><![CDATA[ <p align="right"><font face="Verdana, Arial, Helvetica, sans-serif" size="2"><b>ARTICULOS ORIGINALES</b></font></p>     <p align="right">&nbsp;</p>     <p align="right"><strong><font size="4" face="Verdana, Arial, Helvetica, sans-serif">Gu&iacute;a para la estandarizaci&oacute;n de t&eacute;cnicaGu&iacute;a t&eacute;cnicas inmunoenzim&aacute;ticas    en ensayos de vacunas    <br> </font></strong></p>     <p align="right">&nbsp;</p>     <p align="right"><strong><font size="3" face="Verdana, Arial, Helvetica, sans-serif">Guide for the standardization of enzyme immunoassays for use in vaccine trials.</font></strong></p>     <p align="right">&nbsp;</p>     <p><strong><font size="2" face="Verdana, Arial, Helvetica, sans-serif">Rolando Ochoa, Juan C. Mart&iacute;nez, Xenia Ferriol, Eric Estrada, Ana M. Garc&iacute;a, Rosa Blanco, Franklin Sotolongo.</font></strong><font size="2" face="Verdana, Arial, Helvetica, sans-serif">    <br> </font></p>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif">Instituto Finlay. Centro de Investigaci&oacute;n-Producci&oacute;n de Vacunas y Sueros. Ciudad de La Habana, Cuba.    ]]></body>
<body><![CDATA[<br> E-mail:<a href="emailto:ochoa@finlay.edu.cu">ochoa@finlay.edu.cu</a></font></p> <hr>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif"><strong>RESUMEN</strong></font></p>     <p align="justify"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">Se realiz&oacute; una revisi&oacute;n sobre la estandarizaci&oacute;n de t&eacute;cnicas inmunoenzim&aacute;ticas para ensayos precl&iacute;nicos y    <br>   cl&iacute;nicos de vacunas, elabor&aacute;ndose una gu&iacute;a pr&aacute;ctica. Se analizan los principios a usar y los pasos a seguir para    <br>   la optimizaci&oacute;n de un ensayo, incluyendo la preparaci&oacute;n de est&aacute;ndares y controles. Se exponen nuestras    <br>   experiencias.    <br>   </font></p>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif"><strong>Palabras claves:</strong> Estandarizaci&oacute;n, inmunoensayos enzim&aacute;ticos, ELISA, vacunas.</font></p> <hr>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif">  <strong>ABSTRACT</strong></font></p>     <p align="justify"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">  The standardization of enzyme immunoassays, for use in evaluation of pre-clinical and clinical vaccine trials, was reviewed. A    practical guide was made. The immunoassay principles and the assay optimization step &ndash; including the preparation of    standards and controls &ndash; are analyzed. Our experience is presented.    ]]></body>
<body><![CDATA[<br>   </font></p>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif"><strong>Key words:</strong> Standardization, enzyme immunoassays, ELISA, vaccines.</font></p> <hr>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif">texto completo en pdf</font></p>     <p><font size="2" face="Verdana, Arial, Helvetica, sans-serif"> REFERENCIAS </font></p>     <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">1. Galazka AM. The Immunological Basis for Immunization Series. Module 3. Tetanus. World Health Organization: Geneva, 1996. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">2. Mart&iacute;nez JC, Ochoa R, Cruces A, Fajardo EM, Alvarez E, Ferriol X et al. Validation of an ELISA for the Quantitation of Diphtheria Antitoxin in Human Serum. Biotecnolog&iacute;a Aplicada. 2000;17:183-186. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">3. Ann NQ, Hong HA, Nhon TN, Think ND, Van NT, Hendriks J. Tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the Neonatal Tetanus Program in Vietnam. Dev Biol Stand 1999;101:247-253. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">4. Tijssen P. Outline of the strategies for enzyme immunoassays. In: Burdon RH, van Knippenberg PH, editors. Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays, Amsterdan, London, New York, Tokyo, Elsevier, 1993:9-20. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">5. Mart&iacute;nez JC, Ochoa R, Estrada E, River&oacute;n L, Gonz&aacute;lez M, Ferriol X et al. Validaci&oacute;n de un ELISA para la cuantificaci&oacute;n de inmunoglobulinas s&eacute;ricas humanas anti polisac&aacute;rido capsular de Salmonella typhi. VacciMonitor 1999;8(8):7-10 </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">6. Nerey M, Ochoa R, Mart&iacute;nez JC, Licea T, Ferriol X, Garc&iacute;a AM, et al. Validaci&oacute;n de un ELISA para la cuantificaci&oacute;n de IgG humana anti-polisac&aacute;rido capsular de Neisseria meningitidis serogrupo C. Biotecnolog&iacute;a Aplicada 1999;16:113-115. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">7. Rodr&iacute;guez L, Balmaseda A, Bravo J, Trujillo J, Mart&iacute;nez L, Ochoa R et al. Validaci&oacute;n de un ultramicroELISA de detecci&oacute;n de anticuerpos contra el ant&iacute;geno de superficie de la hepatitis B. Rev Cubana Med Trop 1996;48(1):45-49. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">8. Tijssen P. Non-immunologic molecular recognition systems used in immunoassays. In: Burdon RH, van Knippenberg PH, editors. Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays, Amsterdan, London, New York, Tokyo, Elsevier, 1993:21-37. </font>    <!-- ref --><P  ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">9. Ochoa R, Mart&iacute;nez JC, Ferriol X, Garc&iacute;a AM, Estrada E, Blanco R, et al. Principios y procedimientos para la validaci&oacute;n de inmunoensayos cuantitativos empleados para evaluar la inmunogenicidad de vacunas. VacciMonitor 1999;8(10):9-13. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">10. Ochoa R, Mart&iacute;nez JC, Estrada E, Garc&iacute;a AM. Ferriol X, Blanco R et al. Validaci&oacute;n de inmunoensayos cualitativos usados para evaluar la inmunogenicidad de vacunas. VacciMonitor 2000;9(1):17-20. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">11. Chaloner-Larsson G, Anderson R, Egan A. A WHO guide to good manufacturing practice (GMP) requirements. Part 2: Validation. Validation of analytical assays. WHO Geneva, 1997:65-95. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">12. Plikaytis B D, Carlone G M, Turner S H, Gheesling L L, Holder P F. Program ELISA user's manual. Centers for Disease Control and Prevention, Atlanta, 1993. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">13. Ochoa R. A new format ELISA for the detection of HBsAg. Biotecnolog&iacute;a Aplicada 1998;15:250-253. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">14. Tijssen P. The immobilization of immunoreactants on solid phases. In: Burdon RH, van Knippenberg PH, editors. Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays, Amsterdan, London, New York, Tokyo, Elsevier, 1993:297-328. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">15. Labsystems. Studies on Immobilization of Biological Materials. Enhanced Adsorption to Modified Polystyrene. Labsystems Research Centre, Finland, 1992. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">16. Esser P. Blocking Agent and Detergent in ELISA. Nunc Bulletin 1991 June 9:1-4. </font>    <!-- ref --><P ALIGN="JUSTIFY"><font size="2" face="Verdana, Arial, Helvetica, sans-serif">17. Tijssen P. Kinetics and nature of antibody-antigen interactions. In: Burdon RH, van Knippenberg PH, editors. Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays, Amsterdan, London, New York, Tokyo, Elsevier, 1993:123-149. </font>    <p>&nbsp; </p>      ]]></body><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Galazka]]></surname>
<given-names><![CDATA[AM]]></given-names>
</name>
</person-group>
<source><![CDATA[The Immunological Basis for Immunization Series: Module 3. Tetanus]]></source>
<year>1996</year>
<publisher-loc><![CDATA[Geneva ]]></publisher-loc>
<publisher-name><![CDATA[World Health Organization]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Cruces]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Fajardo]]></surname>
<given-names><![CDATA[EM]]></given-names>
</name>
<name>
<surname><![CDATA[Alvarez]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Validation of an ELISA for the Quantitation of Diphtheria Antitoxin in Human Serum]]></article-title>
<source><![CDATA[Biotecnología Aplicada]]></source>
<year>2000</year>
<volume>17</volume>
<page-range>183-186</page-range></nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ann]]></surname>
<given-names><![CDATA[NQ]]></given-names>
</name>
<name>
<surname><![CDATA[Hong]]></surname>
<given-names><![CDATA[HA]]></given-names>
</name>
<name>
<surname><![CDATA[Nhon]]></surname>
<given-names><![CDATA[TN]]></given-names>
</name>
<name>
<surname><![CDATA[Think]]></surname>
<given-names><![CDATA[ND]]></given-names>
</name>
<name>
<surname><![CDATA[Van]]></surname>
<given-names><![CDATA[NT]]></given-names>
</name>
<name>
<surname><![CDATA[Hendriks]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the Neonatal Tetanus Program in Vietnam]]></article-title>
<source><![CDATA[Dev Biol Stand]]></source>
<year>1999</year>
<volume>101</volume>
<page-range>247-253</page-range></nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tijssen]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Outline of the strategies for enzyme immunoassays]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Burdon]]></surname>
<given-names><![CDATA[RH]]></given-names>
</name>
<name>
<surname><![CDATA[van Knippenberg]]></surname>
<given-names><![CDATA[PH]]></given-names>
</name>
</person-group>
<source><![CDATA[Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays]]></source>
<year>1993</year>
<page-range>9-20</page-range><publisher-loc><![CDATA[Amsterdan ]]></publisher-loc>
<publisher-name><![CDATA[Elsevier]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Estrada]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Riverón]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[González]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Validación de un ELISA para la cuantificación de inmunoglobulinas séricas humanas anti polisacárido capsular de Salmonella typhi]]></article-title>
<source><![CDATA[VacciMonitor]]></source>
<year>1999</year>
<volume>8</volume>
<numero>8</numero>
<issue>8</issue>
<page-range>7-10</page-range></nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Nerey]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Licea]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[AM]]></given-names>
</name>
</person-group>
<article-title xml:lang="es"><![CDATA[Validación de un ELISA para la cuantificación de IgG humana anti-polisacárido capsular de Neisseria meningitidis serogrupo C]]></article-title>
<source><![CDATA[Biotecnología Aplicada]]></source>
<year>1999</year>
<volume>16</volume>
<page-range>113-115</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Rodríguez]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Balmaseda]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Bravo]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Trujillo]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang="es"><![CDATA[Validación de un ultramicroELISA de detección de anticuerpos contra el antígeno de superficie de la hepatitis B]]></article-title>
<source><![CDATA[Rev Cubana Med Trop]]></source>
<year>1996</year>
<volume>48</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>45-49</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tijssen]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Non-immunologic molecular recognition systems used in immunoassays]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Burdon]]></surname>
<given-names><![CDATA[RH]]></given-names>
</name>
<name>
<surname><![CDATA[van Knippenberg]]></surname>
<given-names><![CDATA[PH]]></given-names>
</name>
</person-group>
<source><![CDATA[Laboratory techniques in biochemistry and molecular biology: Practice and theory of enzyme immunoassays]]></source>
<year>1993</year>
<page-range>21-37</page-range><publisher-loc><![CDATA[Amsterdan ]]></publisher-loc>
<publisher-name><![CDATA[London, New York, Tokyo, Elsevier]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[AM]]></given-names>
</name>
<name>
<surname><![CDATA[Estrada]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Blanco]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang="es"><![CDATA[Principios y procedimientos para la validación de inmunoensayos cuantitativos empleados para evaluar la inmunogenicidad de vacunas]]></article-title>
<source><![CDATA[VacciMonitor]]></source>
<year>1999</year>
<volume>8</volume>
<numero>10</numero>
<issue>10</issue>
<page-range>9-13</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Martínez]]></surname>
<given-names><![CDATA[JC]]></given-names>
</name>
<name>
<surname><![CDATA[Estrada]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[AM]]></given-names>
</name>
<name>
<surname><![CDATA[Ferriol]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
<name>
<surname><![CDATA[Blanco]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang="es"><![CDATA[Validación de inmunoensayos cualitativos usados para evaluar la inmunogenicidad de vacunas]]></article-title>
<source><![CDATA[VacciMonitor]]></source>
<year>2000</year>
<volume>9</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>17-20</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Chaloner-Larsson]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Anderson]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Egan]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<source><![CDATA[A WHO guide to good manufacturing practice (GMP) requirements: Validation. Validation of analytical assays]]></source>
<year>1997</year>
<page-range>65-95</page-range><publisher-loc><![CDATA[Geneva ]]></publisher-loc>
<publisher-name><![CDATA[WHO]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Plikaytis]]></surname>
<given-names><![CDATA[BD]]></given-names>
</name>
<name>
<surname><![CDATA[Carlone]]></surname>
<given-names><![CDATA[G M]]></given-names>
</name>
<name>
<surname><![CDATA[Turner]]></surname>
<given-names><![CDATA[S H]]></given-names>
</name>
<name>
<surname><![CDATA[Gheesling]]></surname>
<given-names><![CDATA[L L]]></given-names>
</name>
<name>
<surname><![CDATA[Holder]]></surname>
<given-names><![CDATA[P F]]></given-names>
</name>
</person-group>
<source><![CDATA[Program ELISA user's manual]]></source>
<year>1993</year>
<publisher-loc><![CDATA[Atlanta ]]></publisher-loc>
<publisher-name><![CDATA[Centers for Disease Control and Prevention]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ochoa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[A new format ELISA for the detection of HBsAg]]></article-title>
<source><![CDATA[Biotecnología Aplicada]]></source>
<year>1998</year>
<volume>15</volume>
<page-range>250-253</page-range></nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tijssen]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[The immobilization of immunoreactants on solid phases]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Burdon]]></surname>
<given-names><![CDATA[RH]]></given-names>
</name>
<name>
<surname><![CDATA[van Knippenberg]]></surname>
<given-names><![CDATA[PH]]></given-names>
</name>
</person-group>
<source><![CDATA[Laboratory techniques in biochemistry and molecular biology: Practice and theory of enzyme immunoassays]]></source>
<year>1993</year>
<page-range>297-328</page-range><publisher-loc><![CDATA[Amsterdan ]]></publisher-loc>
<publisher-name><![CDATA[London, New York, Tokyo, Elsevier]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="book">
<collab>Labsystems</collab>
<source><![CDATA[Studies on Immobilization of Biological Materials. Enhanced Adsorption to Modified Polystyrene]]></source>
<year>1992</year>
<publisher-name><![CDATA[Labsystems Research Centre]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Esser]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Blocking Agent and Detergent in ELISA]]></article-title>
<source><![CDATA[Nunc Bulletin]]></source>
<year>1991</year>
<month> J</month>
<day>un</day>
<page-range>1-4</page-range></nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tijssen]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<article-title xml:lang="en"><![CDATA[Kinetics and nature of antibody-antigen interactions]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Burdon]]></surname>
<given-names><![CDATA[RH]]></given-names>
</name>
<name>
<surname><![CDATA[Knippenberg]]></surname>
<given-names><![CDATA[PH]]></given-names>
</name>
</person-group>
<source><![CDATA[Laboratory techniques in biochemistry and molecular biology. Practice and theory of enzyme immunoassays]]></source>
<year>1993</year>
<page-range>123-149</page-range><publisher-loc><![CDATA[Amsterdan ]]></publisher-loc>
<publisher-name><![CDATA[London, New York, Tokyo, Elsevier,]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
