Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting
Introduction Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect™) for the detection of VL in an endemic, large urban are...
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Sociedade Brasileira de Medicina Tropical (SBMT)
2013-09-01
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| Series: | Revista da Sociedade Brasileira de Medicina Tropical |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000500589&lng=en&tlng=en |
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| author | Alexandre Sampaio Moura Helen Maria Ramos de Oliveira Lopes Maria Vitoria Assumpcao Mourao Maria Helena Franco Morais |
| author_facet | Alexandre Sampaio Moura Helen Maria Ramos de Oliveira Lopes Maria Vitoria Assumpcao Mourao Maria Helena Franco Morais |
| author_sort | Alexandre Sampaio Moura |
| collection | DOAJ |
| description | Introduction Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect™) for the detection of VL in an endemic, large urban area. Methods Data were collected from a registry of rK39 RDT performed at 11 emergency care units in Belo Horizonte, Brazil, and from a national database of reportable communicable diseases of the Sistema de Informação de Agravos de Notificação (SINAN). Results The rapid rK39 test was performed in 476 patients, with 114 (23.9%) positive results. The analysis of rK39 RDT performance was based on 381 (80%) cases reported to the SINAN database, of which 145 (38.1%) were confirmed cases. Estimates for sensitivity and specificity were 72.4% (95% CI: 64.6-79%) and 99.6% (95%CI: 97.6-99.9%), respectively. Positive and negative predictive values were estimated at 99.1% (95%CI: 94.9-99.8%) and 85.5% (95%CI: 80.8-89.1%), respectively. In addition, close agreement between the rK39 RDT and indirect immunofluorescence was observed. Conclusions In summary, the rK39 RDT showed a high specificity but only moderate sensitivity. In endemic areas for VL, treatment may be considered in cases with clinical manifestations and a positive rK39 RDT, but those with a negative test should be subjected to further investigation. |
| first_indexed | 2024-04-12T11:16:26Z |
| format | Article |
| id | doaj.art-1723e1a2580444a8b7c0c9ece1306e9a |
| institution | Directory Open Access Journal |
| issn | 1678-9849 |
| language | English |
| last_indexed | 2024-04-12T11:16:26Z |
| publishDate | 2013-09-01 |
| publisher | Sociedade Brasileira de Medicina Tropical (SBMT) |
| record_format | Article |
| series | Revista da Sociedade Brasileira de Medicina Tropical |
| spelling | doaj.art-1723e1a2580444a8b7c0c9ece1306e9a2022-12-22T03:35:29ZengSociedade Brasileira de Medicina Tropical (SBMT)Revista da Sociedade Brasileira de Medicina Tropical1678-98492013-09-0146558959310.1590/0037-8682-0145-2013S0037-86822013000500589Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban settingAlexandre Sampaio MouraHelen Maria Ramos de Oliveira LopesMaria Vitoria Assumpcao MouraoMaria Helena Franco MoraisIntroduction Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect™) for the detection of VL in an endemic, large urban area. Methods Data were collected from a registry of rK39 RDT performed at 11 emergency care units in Belo Horizonte, Brazil, and from a national database of reportable communicable diseases of the Sistema de Informação de Agravos de Notificação (SINAN). Results The rapid rK39 test was performed in 476 patients, with 114 (23.9%) positive results. The analysis of rK39 RDT performance was based on 381 (80%) cases reported to the SINAN database, of which 145 (38.1%) were confirmed cases. Estimates for sensitivity and specificity were 72.4% (95% CI: 64.6-79%) and 99.6% (95%CI: 97.6-99.9%), respectively. Positive and negative predictive values were estimated at 99.1% (95%CI: 94.9-99.8%) and 85.5% (95%CI: 80.8-89.1%), respectively. In addition, close agreement between the rK39 RDT and indirect immunofluorescence was observed. Conclusions In summary, the rK39 RDT showed a high specificity but only moderate sensitivity. In endemic areas for VL, treatment may be considered in cases with clinical manifestations and a positive rK39 RDT, but those with a negative test should be subjected to further investigation.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000500589&lng=en&tlng=enVisceral leishmaniasisSerologic testSensitivity and specificity |
| spellingShingle | Alexandre Sampaio Moura Helen Maria Ramos de Oliveira Lopes Maria Vitoria Assumpcao Mourao Maria Helena Franco Morais Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting Revista da Sociedade Brasileira de Medicina Tropical Visceral leishmaniasis Serologic test Sensitivity and specificity |
| title | Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| title_full | Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| title_fullStr | Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| title_full_unstemmed | Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| title_short | Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| title_sort | performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting |
| topic | Visceral leishmaniasis Serologic test Sensitivity and specificity |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000500589&lng=en&tlng=en |
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