Herramientas no invasivas en Venezuela: comparación entre las pruebas inmunoserológicas DAT, rK26 y rK39 en el diagnóstico de leishmaniasis visceral

Terán-Ángel, Guillermo; Rodríguez, Vestalia; Silva, Rosilved; Zerpa, Olga; Schallig, Henk D. F. H.; Ulrich, Marian; Cabrera, Maira

doi:10.7705/biomedica.v30i1.151

Cited by 4 publications

(3 citation statements)

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“…In addition, we considered the recommendations of the WHO for local evaluation of different commercially available tests to determine which showed better diagnostic performance, based on the conditions within each territory [25, 39]. Notably, in Colombia this type of comparison has not yet been performed, although it has been completed in other areas of the world, as well as in the local region (e.g., Brazil and Venezuela) [18, 22, 40–44]. Studies conducted in endemic areas of India and Sudan showed low performance of the tests based on the rK39 antigen, while other antigens (e.g., rKE16) have shown better performance for the detection of anti- Leishmania antibodies [45, 46].…”

Section: Discussionmentioning

confidence: 99%

“…Studies conducted in endemic areas of India and Sudan showed low performance of the tests based on the rK39 antigen, while other antigens (e.g., rKE16) have shown better performance for the detection of anti- Leishmania antibodies [45, 46]. Conversely, studies performed in Brazil and Venezuela have shown > 85% sensitivity and specificity in the rapid tests, which supported their use within the screening scheme for VL [40, 42, 44, 47].…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of four rapid diagnostic tests for canine and human visceral Leishmaniasis in Colombia

et al. 2019

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Background Leishmaniasis caused by different species of Leishmania affect 98 countries worldwide. Visceral Leishmaniasis (VL) is the mortal clinical presentation of the disease that causes the dead to more than 90% of the patients who suffer it. The diagnosis of VL is made by the direct observation of the parasite in bone marrow, spleen and/or liver aspirates that requires complex proceedings. Therefore, serum samples are submitted to Indirect Immunofluorescence to identify the presence of anti- Leishmania antibodies. Despite the variability in the diagnostic performance of the Immunochromatographic Tests (ICTs), there are many evidences that suggest that ICTs can be used for epidemiological screening. However, in Colombia there are not any evidence about the performance of the ICTs for VL diagnosis , both for human and canine serum samples. Therefore, this study evaluated the diagnostic performance of 4 ICTs for VL (2 ICTs in human sera and 2 ICTs in canine sera) in samples from endemic areas of Colombia. Methods We selected a total of 156 human serum samples (82 positive and 74 negative for VL) and 126 canine serum samples (71 positive and 54 negative) diagnosed by in house Indirect Immunofluorescence (IIF). The samples were submitted to the ICTs following the manufacturers’ instructions. Statistical analysis was performed to evaluate the diagnostic performance of each ICT in comparison with the IIF. PCR for HSP70 gene and sanger sequencing was performed in samples with negative results for both ICTs. Results The sensitivity (S) of both ICTs for human samples (Ad-bio Leishmania IgG/IgM Combo Rapid Test and Kalazar Detect™) was 91.5% and specificity (E) were 93.2 and 89.2% respectively, while for the ICTs tested on canine samples (Kalazar Detect™ Rapid Test, Canine and DPP® CVL rapid test) we found S values between 82.9 and 85.7% and E values between 79.6 and 92.6%. We found L. infantum by PCR and sequencing in 2 human samples, and L. braziliensis and L. amazonensis in canine serum samples that were negative by both ICTs. Conclusions We conclude that both tests evaluated on human samples have a similar diagnostic performance, while the Kalazar Detect™ Rapid Test, Canine showed a better diagnostic performance than the DPP® CVL rapid test evaluated on canine samples. Also, we suggest that it is necessary to design tests with antigens of the circulating strains to increase its diagnostic utility.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluation of four rapid diagnostic tests for canine and human visceral Leishmaniasis in Colombia

et al. 2019

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“…The sensitivity of the rK39 RDT has been reported to vary between 37 and 100%, and the specifi city was estimated between 59 and 100% among immunocompetent patients in endemic regions [9][10][11][12][13][14][15][16] . In addition, a meta-analysis of 13 studies reported an overall sensitivity and specifi city of 93.9% and 90.6%, respectively 15 .…”

Section: Introductionmentioning

confidence: 99%

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

Moura

Lopes

Mourão

et al. 2013

Rev. Soc. Bras. Med. Trop.

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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 TM ) 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 Notifi cação (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 confi rmed cases. Estimates for sensitivity and specifi city 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 immunofl uorescence was observed. Conclusions: In summary, the rK39 RDT showed a high specifi city 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.

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Developments in diagnosis and treatment of visceral leishmaniasis during the last decade and future prospects

Ejazi

Ali²

2013

Expert Review of Anti-infective Therapy

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Human visceral leishmaniasis (VL) continues to be a life-threatening neglected tropical disease, with close to 200 million people at risk of infection globally. Epidemics and resurgence of VL are associated with negligence by the policy makers, economic decline and population movements. Control of the disease is hampered by the lack of proficient vaccination, rapid diagnosis in a field setting and severe side effects of current drug therapies. The diagnosis of VL relied largely on invasive techniques of detecting parasites in splenic and bone marrow aspirates. rK39 and PCR, despite problems related to varying sensitivities and specificities and field adaptability, respectively, are considered the best options for VL diagnosis today. No single therapy of VL currently offers satisfactory efficacy along with safety. The field of VL research only recently shifted toward actively identifying new drugs for safe and affordable treatment. Oral miltefosine and safe AmBisome along with better use of amphotericin B have been rapidly implemented in the last decade. A combination therapy will substantially reduce the required dose and duration of drug administration and reduce the chance of the development of resistance. In addition, identification of asymptomatic cases, vector control and treatment of post-kala-azar dermal leishmaniasis would allow new perspectives in VL control and management.

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Herramientas no invasivas en Venezuela: comparación entre las pruebas inmunoserológicas DAT, rK26 y rK39 en el diagnóstico de leishmaniasis visceral

Cited by 4 publications

References 28 publications

Evaluation of four rapid diagnostic tests for canine and human visceral Leishmaniasis in Colombia

Evaluation of four rapid diagnostic tests for canine and human visceral Leishmaniasis in Colombia

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

Developments in diagnosis and treatment of visceral leishmaniasis during the last decade and future prospects

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