Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis
Abstract Background Parasitological investigation of bone marrow, splenic or lymph node aspirations is the gold standard for the diagnosis of visceral leishmaniasis (VL). However, this invasive test requires skilled clinical and laboratory staff and adequate facilities, and sensitivity varies depend...
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | https://doi.org/10.1186/s12879-023-08772-1 |
| _version_ | 1797630399389630464 |
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| author | Tamalee Roberts Suzanne H. Keddie Sayaphet Rattanavong Santiago Rayment Gomez John Bradley Ruth H. Keogh Oliver Bärenbold Jane Falconer Petra F. Mens Heidi Hopkins Elizabeth A. Ashley |
| author_facet | Tamalee Roberts Suzanne H. Keddie Sayaphet Rattanavong Santiago Rayment Gomez John Bradley Ruth H. Keogh Oliver Bärenbold Jane Falconer Petra F. Mens Heidi Hopkins Elizabeth A. Ashley |
| author_sort | Tamalee Roberts |
| collection | DOAJ |
| description | Abstract Background Parasitological investigation of bone marrow, splenic or lymph node aspirations is the gold standard for the diagnosis of visceral leishmaniasis (VL). However, this invasive test requires skilled clinical and laboratory staff and adequate facilities, and sensitivity varies depending on the tissue used. The direct agglutination test (DAT) is a serological test that does not need specialised staff, with just minimal training required. While previous meta-analysis has shown DAT to have high sensitivity and specificity when using parasitology as the reference test for diagnosis, meta-analysis of DAT compared to other diagnostic techniques, such as PCR and ELISA, that are increasingly used in clinical and research settings, has not been done. Methods We conducted a systematic review to determine the diagnostic performance of DAT compared to all available tests for the laboratory diagnosis of human VL. We searched electronic databases including Medline, Embase, Global Health, Scopus, WoS Science Citation Index, Wiley Cochrane Central Register of Controlled Trials, Africa-Wide Information, LILACS and WHO Global Index. Three independent reviewers screened reports and extracted data from eligible studies. A meta-analysis estimated the diagnostic sensitivity and specificity of DAT. Results Of 987 titles screened, 358 were selected for full data extraction and 78 were included in the analysis, reporting on 32,822 participants from 19 countries. Studies included were conducted between 1987–2020. Meta-analysis of studies using serum and DAT compared to any other test showed pooled sensitivity of 95% (95%CrI 90–98%) and pooled specificity of 95% (95%CrI 88–98%). Results were similar for freeze-dried DAT and liquid DAT when analysed separately. Sensitivity was lower for HIV-positive patients (90%, CrI 59–98%) and specificity was lower for symptomatic patients (70%, CrI 43–89%). When comparing different geographical regions, the lowest median sensitivity (89%, CrI 67–97%) was in Western Asia (five studies). Conclusions This systematic review and meta-analysis demonstrates high estimated pooled sensitivity and specificity of DAT for diagnosis of VL, although sensitivity and specificity were lower for different patient groups and geographical locations. This review highlights the lack of standardisation of DAT methods and preparations, and the lack of data from some important geographical locations. Future well-reported studies could provide better evidence to inform test implementation for different patient populations and use cases. PROSPERO registration CRD42021240830 |
| first_indexed | 2024-03-11T11:07:41Z |
| format | Article |
| id | doaj.art-a3c14f743780452aac22a0c964230f8a |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-03-11T11:07:41Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-a3c14f743780452aac22a0c964230f8a2023-11-12T12:07:47ZengBMCBMC Infectious Diseases1471-23342023-11-0123111110.1186/s12879-023-08772-1Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysisTamalee Roberts0Suzanne H. Keddie1Sayaphet Rattanavong2Santiago Rayment Gomez3John Bradley4Ruth H. Keogh5Oliver Bärenbold6Jane Falconer7Petra F. Mens8Heidi Hopkins9Elizabeth A. Ashley10Lao- Oxford-Mahosot Hospital- Wellcome Trust Research Unit, Mahosot HospitalLondon School of Hygiene & Tropical MedicineLao- Oxford-Mahosot Hospital- Wellcome Trust Research Unit, Mahosot HospitalDepartment of Infectious Disease Epidemiology, Faculty of Medicine, London Centre for Neglected Tropical Disease Research, St Marys Campus, Imperial College LondonLondon School of Hygiene & Tropical MedicineLondon School of Hygiene & Tropical MedicineLondon School of Hygiene & Tropical MedicineLondon School of Hygiene & Tropical MedicineDepartment of Medical Microbiology, Experimental Parasitology Unit, Amsterdam University Medical Centers, Academic Medical Center at the University of AmsterdamLondon School of Hygiene & Tropical MedicineLao- Oxford-Mahosot Hospital- Wellcome Trust Research Unit, Mahosot HospitalAbstract Background Parasitological investigation of bone marrow, splenic or lymph node aspirations is the gold standard for the diagnosis of visceral leishmaniasis (VL). However, this invasive test requires skilled clinical and laboratory staff and adequate facilities, and sensitivity varies depending on the tissue used. The direct agglutination test (DAT) is a serological test that does not need specialised staff, with just minimal training required. While previous meta-analysis has shown DAT to have high sensitivity and specificity when using parasitology as the reference test for diagnosis, meta-analysis of DAT compared to other diagnostic techniques, such as PCR and ELISA, that are increasingly used in clinical and research settings, has not been done. Methods We conducted a systematic review to determine the diagnostic performance of DAT compared to all available tests for the laboratory diagnosis of human VL. We searched electronic databases including Medline, Embase, Global Health, Scopus, WoS Science Citation Index, Wiley Cochrane Central Register of Controlled Trials, Africa-Wide Information, LILACS and WHO Global Index. Three independent reviewers screened reports and extracted data from eligible studies. A meta-analysis estimated the diagnostic sensitivity and specificity of DAT. Results Of 987 titles screened, 358 were selected for full data extraction and 78 were included in the analysis, reporting on 32,822 participants from 19 countries. Studies included were conducted between 1987–2020. Meta-analysis of studies using serum and DAT compared to any other test showed pooled sensitivity of 95% (95%CrI 90–98%) and pooled specificity of 95% (95%CrI 88–98%). Results were similar for freeze-dried DAT and liquid DAT when analysed separately. Sensitivity was lower for HIV-positive patients (90%, CrI 59–98%) and specificity was lower for symptomatic patients (70%, CrI 43–89%). When comparing different geographical regions, the lowest median sensitivity (89%, CrI 67–97%) was in Western Asia (five studies). Conclusions This systematic review and meta-analysis demonstrates high estimated pooled sensitivity and specificity of DAT for diagnosis of VL, although sensitivity and specificity were lower for different patient groups and geographical locations. This review highlights the lack of standardisation of DAT methods and preparations, and the lack of data from some important geographical locations. Future well-reported studies could provide better evidence to inform test implementation for different patient populations and use cases. PROSPERO registration CRD42021240830https://doi.org/10.1186/s12879-023-08772-1Visceral leishmaniasisDirect agglutination testDiagnosisLeishmaniaMeta-analysis |
| spellingShingle | Tamalee Roberts Suzanne H. Keddie Sayaphet Rattanavong Santiago Rayment Gomez John Bradley Ruth H. Keogh Oliver Bärenbold Jane Falconer Petra F. Mens Heidi Hopkins Elizabeth A. Ashley Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis BMC Infectious Diseases Visceral leishmaniasis Direct agglutination test Diagnosis Leishmania Meta-analysis |
| title | Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis |
| title_full | Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis |
| title_fullStr | Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis |
| title_full_unstemmed | Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis |
| title_short | Accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis: a systematic review and meta-analysis |
| title_sort | accuracy of the direct agglutination test for diagnosis of visceral leishmaniasis a systematic review and meta analysis |
| topic | Visceral leishmaniasis Direct agglutination test Diagnosis Leishmania Meta-analysis |
| url | https://doi.org/10.1186/s12879-023-08772-1 |
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