Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units.
BACKGROUND:Determine TB-LAM Ag (LAM) is a point of care test developed to diagnose tuberculosis (TB). The aim of this study was to evaluate the diagnostic performance of LAM in people living with HIV using Brazilian public health network algorithm for TB diagnosis. METHODS AND FINDINGS:A cross-secti...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2019-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0221038 |
| _version_ | 1818403364170366976 |
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| author | Aline Benjamin Solange Cesar Cavalcante Leda Fátima Jamal Denise Arakaki-Sanchez Josué Nazareno de Lima Jose Henrique Pilotto Francisco Ivanildo de Oliveira Junior Tâmara Newman Lobato Souza Maria Cristina Lourenço Maeve Brito de Mello Pedro Emmanuel Alvarenga Americano do Brasil Draurio Barreira Valeria Rolla |
| author_facet | Aline Benjamin Solange Cesar Cavalcante Leda Fátima Jamal Denise Arakaki-Sanchez Josué Nazareno de Lima Jose Henrique Pilotto Francisco Ivanildo de Oliveira Junior Tâmara Newman Lobato Souza Maria Cristina Lourenço Maeve Brito de Mello Pedro Emmanuel Alvarenga Americano do Brasil Draurio Barreira Valeria Rolla |
| author_sort | Aline Benjamin |
| collection | DOAJ |
| description | BACKGROUND:Determine TB-LAM Ag (LAM) is a point of care test developed to diagnose tuberculosis (TB). The aim of this study was to evaluate the diagnostic performance of LAM in people living with HIV using Brazilian public health network algorithm for TB diagnosis. METHODS AND FINDINGS:A cross-sectional study design was used to enroll 199 adult patients in two sites in Rio de Janeiro and two in São Paulo. The study enrolled HIV-infected patients with CD4 counts ≤200 cells/mm3 (in the Alere PIMA CD4 assay at study screening), patients coughing for at least 2 weeks or presenting a chest radiography suggestive of TB. LAM, in conjunction with sputum smear microscopy or Xpert MTB/RIF (Xpert) as compared to Mycobacterium tuberculosis culture, which was used as a reference standard. TB prevalence was 24.6%. Overall accuracy of LAM was 79.9% (73.8%-84.9%), positive and negative predictive values were 62.2% (46.1%-75.9%) and 84% (77.5%-88.8%), respectively. The overall LAM sensitivity was 46.9% (33.7%-60.6%) and specificity was 90.7% (84.9%-94.4%). The best performance of LAM was observed among patients with CD4 counts ≤50 cells/mm3 (sensitivity = 70.4% and specificity = 85.9%). When 2 respiratory smears were used in conjunction with LAM, sensitivity increased 22%, as compared to just 2 smears. Furthermore, LAM when used in conjunction with two respiratory smears, was as sensitive as compared to a single one. However, no improvement in TB diagnosis occurred when LAM was used with Xpert as compared to Xpert alone. Among 14 LAM false positive tests, Non-Tuberculosis Mycobacteria were isolated in three cases. CONCLUSION:LAM is a point of care test that increased TB diagnosis in immunosuppressed HIV-infected patients when used in conjunction with smear microscopy, but not when used with Xpert in Brazilian public health network sites. Use of LAM test should be considered in settings where immunosuppressed HIV patients need rapid TB diagnosis. |
| first_indexed | 2024-12-14T08:23:05Z |
| format | Article |
| id | doaj.art-183b22545d7645599f7802afc74ad7ee |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-14T08:23:05Z |
| publishDate | 2019-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-183b22545d7645599f7802afc74ad7ee2022-12-21T23:09:43ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01149e022103810.1371/journal.pone.0221038Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units.Aline BenjaminSolange Cesar CavalcanteLeda Fátima JamalDenise Arakaki-SanchezJosué Nazareno de LimaJose Henrique PilottoFrancisco Ivanildo de Oliveira JuniorTâmara Newman Lobato SouzaMaria Cristina LourençoMaeve Brito de MelloPedro Emmanuel Alvarenga Americano do BrasilDraurio BarreiraValeria RollaBACKGROUND:Determine TB-LAM Ag (LAM) is a point of care test developed to diagnose tuberculosis (TB). The aim of this study was to evaluate the diagnostic performance of LAM in people living with HIV using Brazilian public health network algorithm for TB diagnosis. METHODS AND FINDINGS:A cross-sectional study design was used to enroll 199 adult patients in two sites in Rio de Janeiro and two in São Paulo. The study enrolled HIV-infected patients with CD4 counts ≤200 cells/mm3 (in the Alere PIMA CD4 assay at study screening), patients coughing for at least 2 weeks or presenting a chest radiography suggestive of TB. LAM, in conjunction with sputum smear microscopy or Xpert MTB/RIF (Xpert) as compared to Mycobacterium tuberculosis culture, which was used as a reference standard. TB prevalence was 24.6%. Overall accuracy of LAM was 79.9% (73.8%-84.9%), positive and negative predictive values were 62.2% (46.1%-75.9%) and 84% (77.5%-88.8%), respectively. The overall LAM sensitivity was 46.9% (33.7%-60.6%) and specificity was 90.7% (84.9%-94.4%). The best performance of LAM was observed among patients with CD4 counts ≤50 cells/mm3 (sensitivity = 70.4% and specificity = 85.9%). When 2 respiratory smears were used in conjunction with LAM, sensitivity increased 22%, as compared to just 2 smears. Furthermore, LAM when used in conjunction with two respiratory smears, was as sensitive as compared to a single one. However, no improvement in TB diagnosis occurred when LAM was used with Xpert as compared to Xpert alone. Among 14 LAM false positive tests, Non-Tuberculosis Mycobacteria were isolated in three cases. CONCLUSION:LAM is a point of care test that increased TB diagnosis in immunosuppressed HIV-infected patients when used in conjunction with smear microscopy, but not when used with Xpert in Brazilian public health network sites. Use of LAM test should be considered in settings where immunosuppressed HIV patients need rapid TB diagnosis.https://doi.org/10.1371/journal.pone.0221038 |
| spellingShingle | Aline Benjamin Solange Cesar Cavalcante Leda Fátima Jamal Denise Arakaki-Sanchez Josué Nazareno de Lima Jose Henrique Pilotto Francisco Ivanildo de Oliveira Junior Tâmara Newman Lobato Souza Maria Cristina Lourenço Maeve Brito de Mello Pedro Emmanuel Alvarenga Americano do Brasil Draurio Barreira Valeria Rolla Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. PLoS ONE |
| title | Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. |
| title_full | Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. |
| title_fullStr | Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. |
| title_full_unstemmed | Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. |
| title_short | Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. |
| title_sort | accuracy of determine tb lam ag to detect tb in hiv infected patients associated with diagnostic methods used in brazilian public health units |
| url | https://doi.org/10.1371/journal.pone.0221038 |
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