Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal

Detalhes bibliográficos
Autor(a) principal: Cardoso, Fernanda Alves de Brito e
Data de Publicação: 2010
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Institucional da UFG
Texto Completo: http://repositorio.bc.ufg.br/tede/handle/tede/4808
Resumo: The introduction of the nucleic acid amplification tests (NAATs) was a major breakthrough in the screening for the sexually transmitted diseases (STD) caused by Chlamydia trachomatis and Neisseria gonorrhoeae because they are highly sensitive and they can be used with noninvasive specimens, such as urine. The use of urine has made it far easier to test asymptomatic individuals and has also made it possible to perform epidemiological studies in places other than clinical settings. Many studies have shown also that vaginal swab can be used for detection of both infections, however, just the NAAT Aptima Combo 2 has been cleared by Food and Drug Administration for this specimen use. In Brazil, the most widely used NAAT for the diagnosis of chlamydia and neisseria is the kit Amplicor CT/NG (Roche) and, up to date, there isn’t any study which evaluates the use of vaginal swabs. Objectives: To evaluate the performance of the kit AMPLICOR CT/NG (Roche) in the diagnosis of C. trachomatis and N. gonorrhoeae using urine, endocervical and vaginal swabs and to analyze the agreement of results between the different biological specimens. Methods: The target population was sexually active adolescents and young women between 15 and 24 years from Inhumas, Goias. Socio-demographic and sexual behavior were obtained through a face-to-face interview. The diagnosis was performed by PCR using the AMPLICOR CT/NG (Roche) assay in urine, vaginal swab (VS) and endocervical swab (ES) specimens. For the performance evaluation were calculated the sensitivity, specificity, positive predictive value and negative predictive value. The kappa coefficient was calculated to assess agreement between the samples. It was considered a true-positive result when at least two of three biological samples from the same patient were positive for chlamydia and/or gonococcus. Results:Among the 428 participants the mean age was 19,4 years. The three biological specimens were collected from 309 adolescents (72.2%). Among these, the prevalence rates were 8.7% (IC95% 5,8-12,4) for C. trachomatis and 2.3% (IC95% 0,9-4,6) for N. gonorrhoeae.For chlamydia the sensitivities observed with the different samples were above 80% and specificities exceeding 97% with positive predictive values (PPV) between 78.8% and 84.6% and negative predictive values (VPNs) >98%. For the gonococcus the sensitivities were 42.8% for urine, 71.4% for ES and 100% for VS with specificities >96% for the three samples. The two types of swab showed low PPVs for gonococcus (≈40%) and urine showed PPV of 100%. VPNs were >98%. The agreement of results between specimens was around 94% for the detection of both infections. However, the values of kappa (κ) coefficient ranged from 0.68 to 0.73 for chlamydia, which means substantial agreement between samples. For gonococcal infection, the agreement was slight or fair with κ coefficients ranging from 0.13 to 0.33. Conclusions:The performances of the specimens and the κ values suggest that the vaginal swab appears to be equivalent to urine and endocervical swab for detection of chlamydia and may be suitable for screening studies. The three samples showed different performance in the detection of gonococcus and did not present good agreement of results, suggesting that they are not equivalent in the diagnosis of this infection with the PCR kit used.
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spelling Alves, Maria de Fátima Costahttp://lattes.cnpq.br/1412047788155346Turchi, Marília Dalvahttp://lattes.cnpq.br/3769826743537934Alves , Maria de Fátima CostaTurchi, Marília DalvaAlves, Rosane Ribeiro Figueiredohttp://lattes.cnpq.br/5670068419954169Cardoso, Fernanda Alves de Brito e2015-10-28T14:25:41Z2010-12-14CARDOSO, F. A. B. Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal. 2010. 96 f. Dissertação (Mestrado em Medicina Tropical e Saúde Publica) - Universidade Federal de Goiás, Goiânia, 2010.http://repositorio.bc.ufg.br/tede/handle/tede/4808ark:/38995/00130000022n3The introduction of the nucleic acid amplification tests (NAATs) was a major breakthrough in the screening for the sexually transmitted diseases (STD) caused by Chlamydia trachomatis and Neisseria gonorrhoeae because they are highly sensitive and they can be used with noninvasive specimens, such as urine. The use of urine has made it far easier to test asymptomatic individuals and has also made it possible to perform epidemiological studies in places other than clinical settings. Many studies have shown also that vaginal swab can be used for detection of both infections, however, just the NAAT Aptima Combo 2 has been cleared by Food and Drug Administration for this specimen use. In Brazil, the most widely used NAAT for the diagnosis of chlamydia and neisseria is the kit Amplicor CT/NG (Roche) and, up to date, there isn’t any study which evaluates the use of vaginal swabs. Objectives: To evaluate the performance of the kit AMPLICOR CT/NG (Roche) in the diagnosis of C. trachomatis and N. gonorrhoeae using urine, endocervical and vaginal swabs and to analyze the agreement of results between the different biological specimens. Methods: The target population was sexually active adolescents and young women between 15 and 24 years from Inhumas, Goias. Socio-demographic and sexual behavior were obtained through a face-to-face interview. The diagnosis was performed by PCR using the AMPLICOR CT/NG (Roche) assay in urine, vaginal swab (VS) and endocervical swab (ES) specimens. For the performance evaluation were calculated the sensitivity, specificity, positive predictive value and negative predictive value. The kappa coefficient was calculated to assess agreement between the samples. It was considered a true-positive result when at least two of three biological samples from the same patient were positive for chlamydia and/or gonococcus. Results:Among the 428 participants the mean age was 19,4 years. The three biological specimens were collected from 309 adolescents (72.2%). Among these, the prevalence rates were 8.7% (IC95% 5,8-12,4) for C. trachomatis and 2.3% (IC95% 0,9-4,6) for N. gonorrhoeae.For chlamydia the sensitivities observed with the different samples were above 80% and specificities exceeding 97% with positive predictive values (PPV) between 78.8% and 84.6% and negative predictive values (VPNs) >98%. For the gonococcus the sensitivities were 42.8% for urine, 71.4% for ES and 100% for VS with specificities >96% for the three samples. The two types of swab showed low PPVs for gonococcus (≈40%) and urine showed PPV of 100%. VPNs were >98%. The agreement of results between specimens was around 94% for the detection of both infections. However, the values of kappa (κ) coefficient ranged from 0.68 to 0.73 for chlamydia, which means substantial agreement between samples. For gonococcal infection, the agreement was slight or fair with κ coefficients ranging from 0.13 to 0.33. Conclusions:The performances of the specimens and the κ values suggest that the vaginal swab appears to be equivalent to urine and endocervical swab for detection of chlamydia and may be suitable for screening studies. The three samples showed different performance in the detection of gonococcus and did not present good agreement of results, suggesting that they are not equivalent in the diagnosis of this infection with the PCR kit used.A introdução dos testes de amplificação de ácidos nucléicos (NAATs) foi um grande avanço no rastreamento das doenças sexualmente transmissíveis (DST) causadas por Chlamydia trachomatis e Neisseria gonorrhoeae, pois apresentam alta sensibilidade e permitem a utilização de amostras de coleta não invasiva, como a urina. O uso da urina facilitou o diagnóstico em indivíduos assintomáticos e possibilitou a realização de estudos epidemiológicos em locais fora do ambiente clínico. Vários estudos mostram que o swab vaginal também pode ser utilizado na detecção de ambas as infecções, porém a Food and Drug Administration restringe o seu uso apenas pelo NAAT Aptima Combo 2. No Brasil, o NAAT mais utilizado no diagnóstico de clamídia e neisseria é o kit Amplicor CT/NG (Roche) e, até o momento, nenhum estudo avaliou a utilização do swab vaginal. Objetivos:Avaliar o desempenho do kit AMPLICOR CT\NG (Roche) no diagnóstico de C. trachomatis e N. gonorrhoeae empregando urina, swabs endocervical e vaginal e analisar a concordância de resultados entre as diferentes amostras biológicas. Métodos: A população alvo foi constituída de adolescentes e jovens sexualmente ativas, com idade entre 15 e 24 anos, residentes em Inhumas, Goiás. Os dados sócio-demográficos e de comportamento sexual foram obtidos através de entrevista. O diagnóstico foi realizado empregando o kit Amplicor CT/NG (Roche) em amostras de urina, swab endocervical (SE) e swab vaginal (SV). Para avaliação do desempenho foram calculadas a sensibilidade, especificidade, valor preditivo positivo e negativo dos testes. O coeficiente kappa foi calculado para avaliar a concordância entre as amostras. Considerou-se um resultado como verdadeiro-positivo quando pelo menos duas das três amostras biológicas da mesma paciente fossem positivas para clamídia e/ou gonococo. Resultados: Entre as 428 participantes a média de idade foi de 19,4 anos. Os três espécimes biológicos foram coletados de 309 adolescentes (72,2%). Entre estas, as prevalências foram de 8,7% (IC95% 5,8-12,4)para C. trachomatis e de 2,3% (IC95% 0,9-4,6) para N. gonorrhoeae. Para clamídia as sensibilidades observadas com as diferentes amostras foram superiores a 80% e as especificidades superiores a 97%, com valores preditivos positivos (VPPs) entre 78,8% e 84,6% e valores preditivos negativos (VPNs) >98%. Para o gonococo as sensibilidades foram de 42,8% na urina, 71,4% no SE e de 100% no SV com especificidades >96% nas três amostras. Os dois tipos de swab apresentaram baixos VPPs para o gonococo (≈ 40%) e a urina apresentou VPP de 100%. Os VPNs foram >98%. A concordância de resultados da PCR empregando as diferentes amostras foi de cerca de 94% para ambas as infecções. Entretanto, os valores do coeficiente kappa (κ) variaram de 0,68 a 0,73 para clamídia, o que significa concordância substancial entre as amostras. Para a infecção gonocócica, a concordância foi fraca ou razoável com valores de κ variando de 0,13 a 0,33. Conclusões: Os desempenhos das amostras e os valores do κ sugerem que o swab vaginal parece ser equivalente à urina e ao swab endocervical na detecção da clamídia podendo ser recomendado para estudos de triagem. As três amostras diferiram quanto ao desempenho na detecção da infecção gonocócica e não apresentaram boa concordância de resultados sugerindo que não são equivalentes no diagnóstico desta infecção com o kit de PCR utilizado.Submitted by Cláudia Bueno (claudiamoura18@gmail.com) on 2015-10-27T17:20:50Z No. of bitstreams: 2 Dissertação - Fernanda Alves de Brito e Cardoso - 2010.pdf: 3862835 bytes, checksum: bac9d567036b30752cd19dc0042891c0 (MD5) license_rdf: 23148 bytes, checksum: 9da0b6dfac957114c6a7714714b86306 (MD5)Approved for entry into archive by Luciana Ferreira (lucgeral@gmail.com) on 2015-10-28T14:25:41Z (GMT) No. of bitstreams: 2 Dissertação - Fernanda Alves de Brito e Cardoso - 2010.pdf: 3862835 bytes, checksum: bac9d567036b30752cd19dc0042891c0 (MD5) license_rdf: 23148 bytes, checksum: 9da0b6dfac957114c6a7714714b86306 (MD5)Made available in DSpace on 2015-10-28T14:25:41Z (GMT). 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dc.title.por.fl_str_mv Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
dc.title.alternative.eng.fl_str_mv Molecular diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infections: evaluation of vaginal swab performance
title Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
spellingShingle Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
Cardoso, Fernanda Alves de Brito e
C. trachomatis
N. gonorrhoeae
PCR
Desempenho
Urina
Swab endocervical
Swab vaginal
C. trachomatis
N. gonorrhoeae
Prevalence
Urine
Endocervical swab
Vaginal swab
Performance
IMUNOLOGIA::IMUNOLOGIA APLICADA
title_short Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
title_full Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
title_fullStr Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
title_full_unstemmed Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
title_sort Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal
author Cardoso, Fernanda Alves de Brito e
author_facet Cardoso, Fernanda Alves de Brito e
author_role author
dc.contributor.advisor1.fl_str_mv Alves, Maria de Fátima Costa
dc.contributor.advisor1Lattes.fl_str_mv http://lattes.cnpq.br/1412047788155346
dc.contributor.advisor-co1.fl_str_mv Turchi, Marília Dalva
dc.contributor.advisor-co1Lattes.fl_str_mv http://lattes.cnpq.br/3769826743537934
dc.contributor.referee1.fl_str_mv Alves , Maria de Fátima Costa
dc.contributor.referee2.fl_str_mv Turchi, Marília Dalva
dc.contributor.referee3.fl_str_mv Alves, Rosane Ribeiro Figueiredo
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/5670068419954169
dc.contributor.author.fl_str_mv Cardoso, Fernanda Alves de Brito e
contributor_str_mv Alves, Maria de Fátima Costa
Turchi, Marília Dalva
Alves , Maria de Fátima Costa
Turchi, Marília Dalva
Alves, Rosane Ribeiro Figueiredo
dc.subject.por.fl_str_mv C. trachomatis
N. gonorrhoeae
PCR
Desempenho
Urina
Swab endocervical
Swab vaginal
topic C. trachomatis
N. gonorrhoeae
PCR
Desempenho
Urina
Swab endocervical
Swab vaginal
C. trachomatis
N. gonorrhoeae
Prevalence
Urine
Endocervical swab
Vaginal swab
Performance
IMUNOLOGIA::IMUNOLOGIA APLICADA
dc.subject.eng.fl_str_mv C. trachomatis
N. gonorrhoeae
Prevalence
Urine
Endocervical swab
Vaginal swab
Performance
dc.subject.cnpq.fl_str_mv IMUNOLOGIA::IMUNOLOGIA APLICADA
description The introduction of the nucleic acid amplification tests (NAATs) was a major breakthrough in the screening for the sexually transmitted diseases (STD) caused by Chlamydia trachomatis and Neisseria gonorrhoeae because they are highly sensitive and they can be used with noninvasive specimens, such as urine. The use of urine has made it far easier to test asymptomatic individuals and has also made it possible to perform epidemiological studies in places other than clinical settings. Many studies have shown also that vaginal swab can be used for detection of both infections, however, just the NAAT Aptima Combo 2 has been cleared by Food and Drug Administration for this specimen use. In Brazil, the most widely used NAAT for the diagnosis of chlamydia and neisseria is the kit Amplicor CT/NG (Roche) and, up to date, there isn’t any study which evaluates the use of vaginal swabs. Objectives: To evaluate the performance of the kit AMPLICOR CT/NG (Roche) in the diagnosis of C. trachomatis and N. gonorrhoeae using urine, endocervical and vaginal swabs and to analyze the agreement of results between the different biological specimens. Methods: The target population was sexually active adolescents and young women between 15 and 24 years from Inhumas, Goias. Socio-demographic and sexual behavior were obtained through a face-to-face interview. The diagnosis was performed by PCR using the AMPLICOR CT/NG (Roche) assay in urine, vaginal swab (VS) and endocervical swab (ES) specimens. For the performance evaluation were calculated the sensitivity, specificity, positive predictive value and negative predictive value. The kappa coefficient was calculated to assess agreement between the samples. It was considered a true-positive result when at least two of three biological samples from the same patient were positive for chlamydia and/or gonococcus. Results:Among the 428 participants the mean age was 19,4 years. The three biological specimens were collected from 309 adolescents (72.2%). Among these, the prevalence rates were 8.7% (IC95% 5,8-12,4) for C. trachomatis and 2.3% (IC95% 0,9-4,6) for N. gonorrhoeae.For chlamydia the sensitivities observed with the different samples were above 80% and specificities exceeding 97% with positive predictive values (PPV) between 78.8% and 84.6% and negative predictive values (VPNs) >98%. For the gonococcus the sensitivities were 42.8% for urine, 71.4% for ES and 100% for VS with specificities >96% for the three samples. The two types of swab showed low PPVs for gonococcus (≈40%) and urine showed PPV of 100%. VPNs were >98%. The agreement of results between specimens was around 94% for the detection of both infections. However, the values of kappa (κ) coefficient ranged from 0.68 to 0.73 for chlamydia, which means substantial agreement between samples. For gonococcal infection, the agreement was slight or fair with κ coefficients ranging from 0.13 to 0.33. Conclusions:The performances of the specimens and the κ values suggest that the vaginal swab appears to be equivalent to urine and endocervical swab for detection of chlamydia and may be suitable for screening studies. The three samples showed different performance in the detection of gonococcus and did not present good agreement of results, suggesting that they are not equivalent in the diagnosis of this infection with the PCR kit used.
publishDate 2010
dc.date.issued.fl_str_mv 2010-12-14
dc.date.accessioned.fl_str_mv 2015-10-28T14:25:41Z
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dc.identifier.citation.fl_str_mv CARDOSO, F. A. B. Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal. 2010. 96 f. Dissertação (Mestrado em Medicina Tropical e Saúde Publica) - Universidade Federal de Goiás, Goiânia, 2010.
dc.identifier.uri.fl_str_mv http://repositorio.bc.ufg.br/tede/handle/tede/4808
dc.identifier.dark.fl_str_mv ark:/38995/00130000022n3
identifier_str_mv CARDOSO, F. A. B. Diagnóstico molecular das infecções por Chlamydia trachomatis e Neisseria gonorrhoeae: avaliação do desempenho do swab vaginal. 2010. 96 f. Dissertação (Mestrado em Medicina Tropical e Saúde Publica) - Universidade Federal de Goiás, Goiânia, 2010.
ark:/38995/00130000022n3
url http://repositorio.bc.ufg.br/tede/handle/tede/4808
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dc.rights.driver.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
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rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
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dc.publisher.none.fl_str_mv Universidade Federal de Goiás
dc.publisher.program.fl_str_mv Programa de Pós-graduação em Medicina Tropical e Saúde Publica (IPTSP)
dc.publisher.initials.fl_str_mv UFG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv Instituto de Patologia Tropical e Saúde Pública - IPTSP (RG)
publisher.none.fl_str_mv Universidade Federal de Goiás
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