Validation of a direct agglutination test prototype kit for the diagnosis of visceral leishmaniasis

Oliveira, Edmundo Clarindo; Saliba, Soraya Wilke; Saliba, Juliana Wilke; Rabello, Ana

doi:10.1093/trstmh/trt004

Cited by 16 publications

(18 citation statements)

References 13 publications

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“…DAT-LPC was produced using freeze-dried antigen developed with L. (L.) infantum (MHOM/BR/2002/LPC-RPV) and prepared as described by Harith and others 20 after the improvements recommended by Oliveira and others. 21 First, the 10 + concentrated physiologic solution (9% NaCl plus 1% sodium azide) was diluted 1:10 with type I water, and 5 mL were added into the antigen vial, which was carefully homogenized. Second, the 10 + concentrated diluents solution (9% NaCl, 5 mM N-Acetyl Cystein [NAC], and 1% sodium azide) was diluted 1:10 with physiologic solution (0.9% NaCl).…”

Section: Methodsmentioning

confidence: 99%

Comparison of Parasitological, Serological, and Molecular Tests for Visceral Leishmaniasis in HIV-Infected Patients: A Cross-Sectional Delayed-Type Study

Cota

Sousa²,

Nogueira³

et al. 2013

The American Society of Tropical Medicine and Hygiene

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Abstract. The aim of this study was to evaluate the accuracy of invasive and non-invasive tests for diagnosis of visceral leishmaniasis (VL) in a large series of human immunodeficiency virus (HIV)-infected patients. In this delayedtype cross-sectional study, 113 HIV-infected symptomatic patients were evaluated by an adjudication committee after clinical follow-up to establish the presence or absence of VL as the target condition (reference test). The index tests were recombinant K39 antigen-based immunochromatographic test (rK39), indirect fluorescent antibody test (IFAT), prototype kit of direct agglutination test (DAT-LPC), and real-time polymerase chain reaction (qPCR) in peripheral blood. Compared with parasitological test and adjudication committee diagnosis or latent class model analyses, IFAT and rk39 dipstick test presented the lowest sensitivity. DAT-LPC exhibited good overall performance, and there was no statistical difference between DAT-LPC and qPCR diagnosis accuracy. Real-time PCR emerges as a less invasive alternative to parasitological examination for confirmation of cases not identified by DAT.

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Section: Methodsmentioning

confidence: 99%

Comparison of Parasitological, Serological, and Molecular Tests for Visceral Leishmaniasis in HIV-Infected Patients: A Cross-Sectional Delayed-Type Study

Cota

Sousa²,

Nogueira³

et al. 2013

The American Society of Tropical Medicine and Hygiene

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“…Serological (anti- Leishmania antibody) tests include the enzyme-linked immunosorbent assay (ELISA), indirect fluorescent antibody test (IFAT) and the direct agglutination test (DAT) [3], [4]. However, these antibody detection tests remain positive for several months to years after drug treatment and cure and therefore cannot readily diagnose relapse; such tests can also be positive in asymptomatic individuals living in endemic areas and exposed to L. donovani infection yet with no history of VL or subsequent progression to VL.…”

Section: Introductionmentioning

confidence: 99%

Significantly Lower Anti-Leishmania IgG Responses in Sudanese versus Indian Visceral Leishmaniasis

et al. 2014

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BackgroundVisceral leishmaniasis (VL), a widely distributed systemic disease caused by infection with the Leishmania donovani complex (L. donovani and L. infantum), is almost always fatal if symptomatic and untreated. A rapid point-of-care diagnostic test for anti-Leishmania antibodies, the rK39-immunochromatographic test (rK39-ICT), has high sensitivity and specificity in South Asia but is less sensitive in East Africa. One of the underlying reasons may be continent-specific molecular diversity in the rK39 antigen within the L. donovani complex. However, a second reason may be differences in specific IgG anti-Leishmania levels in patients from different geographical regions, either due to variable antigenicity or immunological response.Methodology/Principal FindingsWe determined IgG titres of Indian and Sudanese VL patients against whole cell lysates of Indian and Sudanese L. donovani strains. Indian VL patients had significantly higher IgG titres against both L. donovani strains compared to Sudanese VL patients (p<0.0001). Mean reciprocal log10 50% end-point titres (1/log10t50) were i) 3.80 and 3.88 for Indian plasma and ii) 2.13 and 2.09 for Sudanese plasma against Indian and Sudanese antigen respectively (p<0.0001). Overall, the Indian VL patients therefore showed a 46.8–61.7 -fold higher mean ELISA titre than the Sudanese VL patients. The higher IgG titres occurred in children (<16 years old) and adults of either sex from India (mean 1/log10t50: 3.60–4.15) versus Sudan (mean 1/log10t50: 1.88–2.54). The greatest difference in IgG responses was between male Indian and Sudanese VL patients of ≥ 16 years old (mean 1/log10t50: 4.15 versus 1.99 = 144-fold (p<0.0001).Conclusions/SignificanceAnti-Leishmania IgG responses among VL patients in Sudan were significantly lower than in India; this may be due to chronic malnutrition with Zn2+ deficiency, or variable antigenicity and capacity to generate IgG responses to Leishmania antigens. Such differential anti-Leishmania IgG levels may contribute to lower sensitivity of the rK39-ICT in East Africa.

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“…The implementation of the DAT-LPC in health care services would be simple because the test requires minimal infrastructure (centrifuges and pipettes), consequently expediting diagnosis. In addition, the DAT-LPC is produced in Brazil 8 . The Brazilian Ministry of Health's decision in 2015 to replace the Kalazar Detect rapid test with the IT LEISH was economically viable and decreased costs, resulting in savings of USD 21,708.72 over three years.…”

Section: Discussionmentioning

confidence: 99%

“…In recent years, a direct agglutination test standardized in the Clinical Research Laboratory (DAT-LPC) of the René Rachou Institute at Oswaldo Cruz Foundation (CPqRR/Fiocruz) has shown high efficiency for the diagnosis of VL in immunocompetent patients (sensitivity of 99% and specificity of 98%) 8 . In immunocompromised patients, the estimated sensitivity of DAT is 89.7% and the specificity is 85.3% 9 .…”

Section: Introductionmentioning

confidence: 99%

Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil

et al. 2017

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Validation of a direct agglutination test prototype kit for the diagnosis of visceral leishmaniasis

Cited by 16 publications

References 13 publications

Comparison of Parasitological, Serological, and Molecular Tests for Visceral Leishmaniasis in HIV-Infected Patients: A Cross-Sectional Delayed-Type Study

Comparison of Parasitological, Serological, and Molecular Tests for Visceral Leishmaniasis in HIV-Infected Patients: A Cross-Sectional Delayed-Type Study

Significantly Lower Anti-Leishmania IgG Responses in Sudanese versus Indian Visceral Leishmaniasis

Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil

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