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Doctoral Thesis
DOI
https://doi.org/10.11606/T.6.2020.tde-15042020-121755
Document
Author
Full name
Jansen Pacheco Nunes
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 1998
Supervisor
Committee
Nitrini, Sandra Maria Ottati de Oliveira (President)
Alchorne, Mauricio Motta de Avelar
Barata, José Maria Soares
Ferreira, Luiz Alberto Peregrino
Santos Junior, Manuel Fernando Queiroz dos
Title in Portuguese
Contribuição para garantia da qualidade na sorologia da sífilis
Keywords in Portuguese
Doenças Sexualmente Transmissíveis
Laboratórios de Saúde Pública
Sífilis
Testes Sorológicos
Abstract in Portuguese
Com o objetivo de traçar um perfil atual do comportamento dos kits utilizados no Brasil para a sorologia da sífilis, foram estudados 13 (treze) conjuntos ( 09 nacionais e 04 importados) e avaliados segundo sua performance na reação de V.D.R.L., frente a um conjunto de soros conhecido e composto de 41 soros, sendo 21 soros positivos e 20 negativos, nas mesmas condições de experimento e respeitando as particulares de cada fabricante. Foi verificado se os kits produziam a mesma resposta frente a um mesmo soro, se existia um nível de variação de resultados de um mesmo soro quando testado com kits diferentes e a reprodutibilidade de resultados entre lotes diferentes de um mesmo fabricante sorteado aleatoriamente. Baseados em dados estatísticos constatou-se que os kits diferem quanto aos resultados de classificação e nível de variação de um mesmo soro, ou seja , apresentam resultados diferentes e variados quando analisam um único soro. A análise inter-lote de um mesmo fabricante constatou-se que os kits, apesar das variações, não diferem estatisticamente quanto a classificação dos resultados, dentro das condições estabelecidas no conjunto de soros estudado.
Title in English
Not available
Keywords in English
Not available
Abstract in English
Aimiing at designing an updated outline of the behavior of the kits for syphilis serology used in Brazil, 13 (thirteen) sets (09 national and 04 imported) were studied and assessed according to their perfomance in the V.D.R.L. reaction against a set made up of 41 serums, 21 positive and 20 negative. This was achieved in the same experiment conditions, respecting each manufacturer's particularities. It was surveyed if the kits produced the same response against a particular serum, if there was a variation level of results of a particular serum when tested with different kits, and the reproducibility of results between different lots from the same manufacturer, selected at random. Based in statistic data, it was ascertained that the kits differ concerning classification results and variation level of a particular serum, that is, they present different and varied results when analyzing an only serum, the analysis between lots of a unique manufacturer certified that the kits, in spite of the variations, do not differ statistically regarding the results classification within the conditions determined in the studied serums.
 
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DR_385_Nunes_1998.pdf (5.86 Mbytes)
Publishing Date
2020-04-15
 
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