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Evaluation of fully automated assays for the detection of Rubella IgM and IgG antibodies by the Elecsys(®) immunoassay system.
van Helden, Josef; Grangeot-Keros, Liliane; Vauloup-Fellous, Christelle; Vleminckx, Renaud; Masset, Frédéric; Revello, Maria-Grazia.
Afiliación
  • van Helden J; Medizinisches Versorgungszentrum, Dr. Stein & Kollegen, Laboratoriumsmedizin, Mikrobiologie, Infektionsepidemiologie, Virologie, Transfusionsmedizin und Humangenetik, Mönchengladbach, Germany. Electronic address: jvhelden@labor-stein.de.
  • Grangeot-Keros L; Hôpital Antoine-Béclère Service de Microbiologie-Immunologie Biologique, Clamart, France.
  • Vauloup-Fellous C; Hôpital Antoine-Béclère Service de Microbiologie-Immunologie Biologique, Clamart, France.
  • Vleminckx R; LABM BIOPATH Cité de l'Europe Ouest, Coquelles, France.
  • Masset F; LABM BIOPATH Cité de l'Europe Ouest, Coquelles, France.
  • Revello MG; Fondazione IRCCS, Policlinico San Matteo, Struttura Complessa di Ostetricia e Ginecologia, Pavia, Italy.
J Virol Methods ; 199: 108-15, 2014 Apr.
Article en En | MEDLINE | ID: mdl-24487099
Screening for acute rubella infection in pregnancy is an important element of antenatal care. This study compared the sensitivity, specificity and reproducibility of two new, fully automated Elecsys(®) Rubella IgM and IgG immunoassays designed for the Elecsys 2010, Modular Analytics E170, COBAS e-411 and COBAS e-601 and e602 analytical platforms, with current assays using serum from patients with primary rubella infections, vaccinated patients, patients with potentially cross-reacting infections and on routine samples in clinical laboratories in France, Germany and Italy. Both assays showed good within-run and within-laboratory precision. A sensitivity of 79.8-96.0% was demonstrated for Elecsys IgM in primary, early acute infection, consistent with existing assays. In samples obtained from routine antenatal screening, the Elecsys Rubella IgM assay revealed high specificity (98.7-99.0%). A significantly (p<0.0001) lower reactivity was demonstrated in samples from previously infected patients where acute rubella infection was excluded, and the incidence of false positives in patients with potentially cross-reacting infections was lower with Elecsys Rubella IgM compared with other. The Elecsys Rubella IgG assay exhibited a relative sensitivity of 99.9-100.0% and specificity of 97.4-100.0% in samples from routine antenatal screening. The Elecsys Rubella IgM and IgG assays allow convenient, rapid and reliable determination of anti-rubella antibodies. Sensitivity, specificity and reproducibility were comparable with existing assay systems. Assay results were available in approximately half the time required for currently employed methods and the assays are compatible with widely used analytical platforms.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Rubéola (Sarampión Alemán) / Virus de la Rubéola / Inmunoglobulina G / Inmunoglobulina M / Técnicas de Laboratorio Clínico / Automatización de Laboratorios / Anticuerpos Antivirales Tipo de estudio: Diagnostic_studies / Evaluation_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Europa Idioma: En Revista: J Virol Methods Año: 2014 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Rubéola (Sarampión Alemán) / Virus de la Rubéola / Inmunoglobulina G / Inmunoglobulina M / Técnicas de Laboratorio Clínico / Automatización de Laboratorios / Anticuerpos Antivirales Tipo de estudio: Diagnostic_studies / Evaluation_studies Límite: Female / Humans / Pregnancy País/Región como asunto: Europa Idioma: En Revista: J Virol Methods Año: 2014 Tipo del documento: Article Pais de publicación: Países Bajos