Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil

Detalhes bibliográficos
Autor(a) principal: Verza, Mirela
Data de Publicação: 2017
Outros Autores: Schmid, Karen Barros, Barcellos, Regina Bones, Linck, Natali, Bello, Graziele Lima, Scapin, Daniel, Sperhacke, Rosa Dea, Nunes Silva, Marcia Susana, Wollheim, Claudia, Celle Rivero, Martha Gabriela [UNIFESP], Kritski, Afranio Lineu, Rezende, Leonides, Jr., Oliveira, Martha Maria, Dalla Costa, Elis Regina, Rosa Rossetti, Maria Lucia
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://dx.doi.org/10.1590/0074-02760160196
https://repositorio.unifesp.br/handle/11600/55167
Resumo: BACKGROUND In high tuberculosis (TB) burden countries, there are few data on the performance of new molecular commercialised assays developed locally. OBJECTIVE To evaluate the performance of a new molecular commercialised assay for TB diagnosis (Detect-TB) in three laboratories. METHODS A total of 302 sputum samples from an equal number of patients with presumptive diagnosis of pulmonary tuberculosis (PTB) were submitted for routine smear microscopy, culture, and Detect-TB assay at three different sites in Brazil (the cities of Caxias do Sul, Sao Paulo and Canoas). FINDINGS Seventy four (24.7%) TB cases were diagnosed (65 bacteriologically confirmed). When compared to smear microscopy/ culture results, the overall sensitivity and specificity of Detect-TB assay was 84.6% (CI 95%
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spelling Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Braziltuberculosisreverse-hybridisation assayIS6110molecular diagnosisDetect-TBBACKGROUND In high tuberculosis (TB) burden countries, there are few data on the performance of new molecular commercialised assays developed locally. OBJECTIVE To evaluate the performance of a new molecular commercialised assay for TB diagnosis (Detect-TB) in three laboratories. METHODS A total of 302 sputum samples from an equal number of patients with presumptive diagnosis of pulmonary tuberculosis (PTB) were submitted for routine smear microscopy, culture, and Detect-TB assay at three different sites in Brazil (the cities of Caxias do Sul, Sao Paulo and Canoas). FINDINGS Seventy four (24.7%) TB cases were diagnosed (65 bacteriologically confirmed). When compared to smear microscopy/ culture results, the overall sensitivity and specificity of Detect-TB assay was 84.6% (CI 95%73.7-91.6) and 93.1% (CI 95%89.195.8), respectively. When compared to bacteriological and clinical diagnostic criteria, the sensitivity and specificity of Detect-TB assay was 74.3% (CI 95%63.3-82.9) and 92.9% (CI 95%88.7-95.6), respectively. Among the three sites - Caxias do Sul, Sao Paulo and Canoas - the sensitivity and specificity were respectively 94.7% and 97.8%71.4% and 93.9%, 82.1% and 88.9%. MAIN CONCLUSIONS These findings suggest that the Detect-TB assay could be applied routinely in reference laboratories across different regions in Brazil.Fundacao Estadual Prod & Pesquisa Saude, Ctr Desenvolvimento Cient & Tecnol, Porto Alegre, RS, BrazilUniv Caxias Do Sul, Lab Pesquisa HIV AIDS, Caxias Do Sul, RS, BrazilUniv Caxias Do Sul, Lab Microbiol Clin, Caxias Do Sul, RS, BrazilUniv Fed Sao Paulo, Lab Especial Microbiol Clin, Sao Paulo, SP, BrazilUniv Fed Rio de Janeiro, Hosp Univ Clementino Fraga Filho, Fac Med, Ctr Pesquisa TB,Lab Genet & Biol Mol, Rio De Janeiro, RJ, BrazilLabtest, Belo Horizonte, MG, BrazilUniv Luterana Brasil, Canoas, RS, BrazilRede Brasileira Pesquisa TB, Rio De Janeiro, RJ, BrazilUniv Fed Sao Paulo, Lab Especial Microbiol Clin, Sao Paulo, SP, BrazilWeb of ScienceCNPq/INCTFINEPLabtestFEPPSCNPq/INCT: 573548/2008-0Fundaco Oswaldo Cruz2020-07-17T14:03:06Z2020-07-17T14:03:06Z2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion94-99application/pdfhttp://dx.doi.org/10.1590/0074-02760160196Memorias Do Instituto Oswaldo Cruz. Rio De Janeiro, Rj, v. 112, n. 2, p. 94-99, 2017.10.1590/0074-02760160196WOS000394155800002.pdf0074-0276https://repositorio.unifesp.br/handle/11600/55167WOS:000394155800002engMemorias Do Instituto Oswaldo CruzRio De Janeiro, Rjinfo:eu-repo/semantics/openAccessVerza, MirelaSchmid, Karen BarrosBarcellos, Regina BonesLinck, NataliBello, Graziele LimaScapin, DanielSperhacke, Rosa DeaNunes Silva, Marcia SusanaWollheim, ClaudiaCelle Rivero, Martha Gabriela [UNIFESP]Kritski, Afranio LineuRezende, Leonides, Jr.Oliveira, Martha MariaDalla Costa, Elis ReginaRosa Rossetti, Maria Luciareponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-08-09T14:46:52Zoai:repositorio.unifesp.br/:11600/55167Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-08-09T14:46:52Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
title Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
spellingShingle Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
Verza, Mirela
tuberculosis
reverse-hybridisation assay
IS6110
molecular diagnosis
Detect-TB
title_short Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
title_full Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
title_fullStr Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
title_full_unstemmed Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
title_sort Performance of a molecular assay to detect Mycobacterium tuberculosis complex DNA in clinical specimens: multicenter study in Brazil
author Verza, Mirela
author_facet Verza, Mirela
Schmid, Karen Barros
Barcellos, Regina Bones
Linck, Natali
Bello, Graziele Lima
Scapin, Daniel
Sperhacke, Rosa Dea
Nunes Silva, Marcia Susana
Wollheim, Claudia
Celle Rivero, Martha Gabriela [UNIFESP]
Kritski, Afranio Lineu
Rezende, Leonides, Jr.
Oliveira, Martha Maria
Dalla Costa, Elis Regina
Rosa Rossetti, Maria Lucia
author_role author
author2 Schmid, Karen Barros
Barcellos, Regina Bones
Linck, Natali
Bello, Graziele Lima
Scapin, Daniel
Sperhacke, Rosa Dea
Nunes Silva, Marcia Susana
Wollheim, Claudia
Celle Rivero, Martha Gabriela [UNIFESP]
Kritski, Afranio Lineu
Rezende, Leonides, Jr.
Oliveira, Martha Maria
Dalla Costa, Elis Regina
Rosa Rossetti, Maria Lucia
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Verza, Mirela
Schmid, Karen Barros
Barcellos, Regina Bones
Linck, Natali
Bello, Graziele Lima
Scapin, Daniel
Sperhacke, Rosa Dea
Nunes Silva, Marcia Susana
Wollheim, Claudia
Celle Rivero, Martha Gabriela [UNIFESP]
Kritski, Afranio Lineu
Rezende, Leonides, Jr.
Oliveira, Martha Maria
Dalla Costa, Elis Regina
Rosa Rossetti, Maria Lucia
dc.subject.por.fl_str_mv tuberculosis
reverse-hybridisation assay
IS6110
molecular diagnosis
Detect-TB
topic tuberculosis
reverse-hybridisation assay
IS6110
molecular diagnosis
Detect-TB
description BACKGROUND In high tuberculosis (TB) burden countries, there are few data on the performance of new molecular commercialised assays developed locally. OBJECTIVE To evaluate the performance of a new molecular commercialised assay for TB diagnosis (Detect-TB) in three laboratories. METHODS A total of 302 sputum samples from an equal number of patients with presumptive diagnosis of pulmonary tuberculosis (PTB) were submitted for routine smear microscopy, culture, and Detect-TB assay at three different sites in Brazil (the cities of Caxias do Sul, Sao Paulo and Canoas). FINDINGS Seventy four (24.7%) TB cases were diagnosed (65 bacteriologically confirmed). When compared to smear microscopy/ culture results, the overall sensitivity and specificity of Detect-TB assay was 84.6% (CI 95%
publishDate 2017
dc.date.none.fl_str_mv 2017
2020-07-17T14:03:06Z
2020-07-17T14:03:06Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1590/0074-02760160196
Memorias Do Instituto Oswaldo Cruz. Rio De Janeiro, Rj, v. 112, n. 2, p. 94-99, 2017.
10.1590/0074-02760160196
WOS000394155800002.pdf
0074-0276
https://repositorio.unifesp.br/handle/11600/55167
WOS:000394155800002
url http://dx.doi.org/10.1590/0074-02760160196
https://repositorio.unifesp.br/handle/11600/55167
identifier_str_mv Memorias Do Instituto Oswaldo Cruz. Rio De Janeiro, Rj, v. 112, n. 2, p. 94-99, 2017.
10.1590/0074-02760160196
WOS000394155800002.pdf
0074-0276
WOS:000394155800002
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Memorias Do Instituto Oswaldo Cruz
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 94-99
application/pdf
dc.coverage.none.fl_str_mv Rio De Janeiro, Rj
dc.publisher.none.fl_str_mv Fundaco Oswaldo Cruz
publisher.none.fl_str_mv Fundaco Oswaldo Cruz
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
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