Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar
Abstract Background Tuberculosis rapid molecular assays, including GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit®, are highly sensitive and specific. Such performance does not automatically translate in improved disease control and highly depends on their use, local epidemiology and the diagnost...
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| Format: | Article |
| Language: | English |
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BMC
2019-06-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-019-4198-6 |
| _version_ | 1818342282832642048 |
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| author | Niaina Rakotosamimanana Simon Grandjean Lapierre Vaomalala Raharimanga Mamy Serge Raherison Astrid M. Knoblauch Antso Hasina Raherinandrasana Andrianantenaina Rakotoson Julio Rakotonirina Voahangy Rasolofo |
| author_facet | Niaina Rakotosamimanana Simon Grandjean Lapierre Vaomalala Raharimanga Mamy Serge Raherison Astrid M. Knoblauch Antso Hasina Raherinandrasana Andrianantenaina Rakotoson Julio Rakotonirina Voahangy Rasolofo |
| author_sort | Niaina Rakotosamimanana |
| collection | DOAJ |
| description | Abstract Background Tuberculosis rapid molecular assays, including GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit®, are highly sensitive and specific. Such performance does not automatically translate in improved disease control and highly depends on their use, local epidemiology and the diagnostic algorithms they’re implemented within. We evaluate the performance of both assays and assess their impact on additional cases notification when implemented within WHO recommended tuberculosis diagnostic algorithms in Madagascar. Methods Five hundred forty eight presumptive pulmonary tuberculosis patients were prospectively recruited between November 2013 and December 2014 in Antananarivo, Madagascar, a high TB incidence sub-Saharan African urban setting. Both molecular assays were evaluated as first line or add-on testing following negative smear microscopy. Based on locally defined assay performance characteristics we measure the impact of both assays and WHO-recommended diagnostic algorithms on additional tuberculosis case notifications. Results High sensitivity and specificity was confirmed for both GeneXpert MTB/RIF® (86.6% (95% CI 81.1–90.7%) and 97.4% (95% CI 94.9–98.8%)) and Loopamp MTBC Detection Kit® (84.6% (95% CI 78.9–89.0%) and 98.4% (95% CI 96.2–99.4%)). Implementation of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® increased tuberculosis diagnostic algorithms sensitivity from 73.6% (95% CI 67.1–79.3%) up to 88.1% (95% CI 82.8–91.9%). This increase was highest when molecular assays were used as add-on testing following negative smear microscopy. As add-on testing, GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® respectively improved case detection by 23.8 and 21.2% (p < 0.05). Conclusion Including GeneXpert MTB/RIF® or Loopamp MTBC Detection Kit® molecular assays for TB detection on sputum samples from presumptive TB cases can significantly increase case notification in TB diagnostic centers. The TB case detection rate is further increased when those tests are use as second-line follow-on testing following negative smear microscopy results. A country wide scale-up and digital integration of molecular-based TB diagnosis assays shows promises for TB control in Madagascar. |
| first_indexed | 2024-12-13T16:12:13Z |
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| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-13T16:12:13Z |
| publishDate | 2019-06-01 |
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| series | BMC Infectious Diseases |
| spelling | doaj.art-15867f82cb0a402c9cd1f5a7d02804e02022-12-21T23:38:54ZengBMCBMC Infectious Diseases1471-23342019-06-011911810.1186/s12879-019-4198-6Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in MadagascarNiaina Rakotosamimanana0Simon Grandjean Lapierre1Vaomalala Raharimanga2Mamy Serge Raherison3Astrid M. Knoblauch4Antso Hasina Raherinandrasana5Andrianantenaina Rakotoson6Julio Rakotonirina7Voahangy Rasolofo8Mycobacteria Unit, Institut Pasteur de MadagascarMycobacteria Unit, Institut Pasteur de MadagascarEpidemiology Unit, Institut Pasteur de MadagascarMycobacteria Unit, Institut Pasteur de MadagascarMycobacteria Unit, Institut Pasteur de MadagascarCentre hospitalier universitaire de soins et de santé publique d’AnalakelyMycobacteria Unit, Institut Pasteur de MadagascarCentre hospitalier universitaire de soins et de santé publique d’AnalakelyMycobacteria Unit, Institut Pasteur de MadagascarAbstract Background Tuberculosis rapid molecular assays, including GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit®, are highly sensitive and specific. Such performance does not automatically translate in improved disease control and highly depends on their use, local epidemiology and the diagnostic algorithms they’re implemented within. We evaluate the performance of both assays and assess their impact on additional cases notification when implemented within WHO recommended tuberculosis diagnostic algorithms in Madagascar. Methods Five hundred forty eight presumptive pulmonary tuberculosis patients were prospectively recruited between November 2013 and December 2014 in Antananarivo, Madagascar, a high TB incidence sub-Saharan African urban setting. Both molecular assays were evaluated as first line or add-on testing following negative smear microscopy. Based on locally defined assay performance characteristics we measure the impact of both assays and WHO-recommended diagnostic algorithms on additional tuberculosis case notifications. Results High sensitivity and specificity was confirmed for both GeneXpert MTB/RIF® (86.6% (95% CI 81.1–90.7%) and 97.4% (95% CI 94.9–98.8%)) and Loopamp MTBC Detection Kit® (84.6% (95% CI 78.9–89.0%) and 98.4% (95% CI 96.2–99.4%)). Implementation of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® increased tuberculosis diagnostic algorithms sensitivity from 73.6% (95% CI 67.1–79.3%) up to 88.1% (95% CI 82.8–91.9%). This increase was highest when molecular assays were used as add-on testing following negative smear microscopy. As add-on testing, GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® respectively improved case detection by 23.8 and 21.2% (p < 0.05). Conclusion Including GeneXpert MTB/RIF® or Loopamp MTBC Detection Kit® molecular assays for TB detection on sputum samples from presumptive TB cases can significantly increase case notification in TB diagnostic centers. The TB case detection rate is further increased when those tests are use as second-line follow-on testing following negative smear microscopy results. A country wide scale-up and digital integration of molecular-based TB diagnosis assays shows promises for TB control in Madagascar.http://link.springer.com/article/10.1186/s12879-019-4198-6TuberculosisLoop-mediated isothermal amplificationGeneXpertCase detectionMolecular diagnostics |
| spellingShingle | Niaina Rakotosamimanana Simon Grandjean Lapierre Vaomalala Raharimanga Mamy Serge Raherison Astrid M. Knoblauch Antso Hasina Raherinandrasana Andrianantenaina Rakotoson Julio Rakotonirina Voahangy Rasolofo Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar BMC Infectious Diseases Tuberculosis Loop-mediated isothermal amplification GeneXpert Case detection Molecular diagnostics |
| title | Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar |
| title_full | Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar |
| title_fullStr | Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar |
| title_full_unstemmed | Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar |
| title_short | Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar |
| title_sort | performance and impact of genexpert mtb rif r and loopamp mtbc detection kit r assays on tuberculosis case detection in madagascar |
| topic | Tuberculosis Loop-mediated isothermal amplification GeneXpert Case detection Molecular diagnostics |
| url | http://link.springer.com/article/10.1186/s12879-019-4198-6 |
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