Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan

Mukhtar, Maowia M.; Abdoun, Asim; Ahmed, Abdallah E.; Ghalib, H. W.; Reed, Steven G.; Boelaert, Marleen; Menten, Joris; Khair, Musa Mohammed; Howard, Randall F.

doi:10.1093/trstmh/trv060

Cited by 38 publications

(34 citation statements)

References 19 publications

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“…In fact, cumulative evidence point to a low specificity (Sp) of several serological assays that hamper the detection of Leishmania infection in dogs (Gomes et al 2008;Morales-Yuste et al 2012;Arruda et al 2016;Elshafie et al 2016;Fraga et al 2016). Moreover, detection of L. infantum vectors across central European countries like Switzerland, Germany and Hungary (Naucke et al 2008;Ready, 2010), in conjunction with global warming, might open new areas to endemicity, through the adaptation of the vectors to new latitudes (Geisweid et al 2013;Millan et al 2014). In fact, disease is advancing northwards, with reports of infected animals in traditionally non-endemic areas (Saari et al 2000;Dujardin et al 2008;Ready, 2010;Miro et al 2012;Carvalho et al 2015;Maia and Cardoso, 2015).…”

Section: Introductionmentioning

confidence: 99%

The use ofEscherichia colitotal antigens as a complementary approach to address seropositivity toLeishmaniaantigens in canine leishmaniosis

et al. 2017

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S U M M A R YCanine leishmaniosis (CanL) is a major veterinary concern and a public health issue. Serological data are essential for disease management. Several antigens used in serological assays have specificity related problems preventing relevant seropositivity values establishment. Herein we report significant seropositivity level disparity in a study cohort with 384 dogs from eight countries, for antigens traditionally used in CanL -soluble promastigote Leishmania antigens (SPLA) and K39 recombinant protein (rK39): 43·8 and 2·9% for SPLA and rK39, respectively. To better understand the reasons for this disparity, CanL-associated serological response was characterized using, for complement serological evaluation, a ubiquitous antigen -soluble Escherichia coli antigens (SECAs). Using cohorts of CanL dogs and dogs without clinical evidences of CanL from non-endemic regions of Portugal, the serological response of CanL animals followed specific trend of seropositivity rK39 > SPLA > SECA absent in non-diseased animals. Using receiver operating characteristic curve analysis, these characteristic trends were converted in ratios, SPLA/SECA, rK39/SECA and rK39/ SPLA, that presented high predictive for discriminating the CanL cohort that was potentiated when applied in a scoring system involving positivity to four out of five predictors (rK39, SPLA, SPLA/SECA, rK39/SECA and rK39/ SPLA). In fact, this approach discriminated CanL with similar sensitivity/specificity as reference antigens, diminishing seropositivity in European cohort to 1·8%. Ultimately, non-related antigens like SECA and seropositivity ratios between antigens enable different perspectives into serological data focusing on the search of characteristic serological signatures and not simple absolute serology values contributing to comprehensive serological status characterization.

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Section: Introductionmentioning

confidence: 99%

The use ofEscherichia colitotal antigens as a complementary approach to address seropositivity toLeishmaniaantigens in canine leishmaniosis

et al. 2017

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“…In the general population, the sensitivity and speci city of recombinant K28 antigen (99.6% and 95-100%, respectively) is similar to rK39 ELISA for the diagnosis of VL [45]. rK28 antigen can be used in rapid tests with good performance, showing high speci city (near 100%) and sensitivity (92%) for the diagnosis of visceral leishmaniasis [46]. However, it has not been used in studies including people from Latin America, and there are few studies discriminating its performance in PLWH.…”

Section: Discussionmentioning

confidence: 99%

Frequency of Leishmania spp. infection among HIV-infected patients living in an urban area in Brazil: a cross-sectional study

Cunha

CELESTE

KESPER

et al. 2020

Preprint

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Background: There is little information about the frequency of Leishmania infection in asymptomatic people living with HIV (PLWH) and about the performance of laboratory diagnostic methods in coinfected patients in Latin America. The main objective of this study is to evaluate the frequency of Leishmania spp. infection in HIV-infected patients living in an urban area in Brazil. Methods: To detect Leishmania infection, diagnostic tests were performed to detect anti-Leishmania antibodies (ELISA using Leptomonas seymouri antigens; ELISA using rK39 antigens; ELISA using rK28 antigens; indirect fluorescent-antibody test (IFAT); direct agglutination test (DAT)) and Leishmania DNA (polymerase chain reaction (PCR) with the target genes kDNA and ITS-1). Results: The frequency of at least one positive test was 15%. For ELISA using Leptomonas antigens and IFAT, there was an association between CD4+ T lymphocyte counts and test positivity, with a higher positivity of these tests in more immunosuppressed patients (CD4+ T cell count < 200/mm3). Conclusions: According to our data, there was a high prevalence of Leishmania spp. infections in this population living with HIV. Although there is the possibility of cross-reaction, some tests that are considered highly specific for the diagnosis of Leishmania infection were positive. There was also an association between the positivity of some tests studied and lower values of CD4+ T lymphocytes.

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“…However, the parasite commonly isolated in VL, HIV/Hepatitis co-or triple-infection [58]. In some remote areas, a non-specific test of formal gel still used [15] and countercurrent immune-electrophoresis, complement fixation of indirect haemagglutination test. Further still, leishmanin/Montenegro test is an epidemiological tool that measures cell-mediated immunity [5] new technique of monoclonal antibodies, nucleic acid hybridization, and PCR, on most occasions CL reveals positivity between 2-3 months after the disappearance of lesion and finally remains positive in the host lifetime [24] in contrast, MCL test can be done with smears, biopsy, and culture…”

Section: Diagnosis Deduction Foot-notementioning

confidence: 99%

“…Clinically, the disease is characterized by signs including fever, weight loss, fatigue, anemia, and enlargement of liver and spleen, lymph node, mucosa of the small intestine and the respiratory tract [15,16]. Regardless of these signs and symptoms, there is also a sudden onset of fever associated with the disease manifestation [16,17].…”

Section: Introductionmentioning

confidence: 99%

Visceral Leishmaniasis: Evaluation of Diagnostic Tools, Therapeutic Regimens, and Associated Risk Factors in Areas with Frequent Outbreaks in South Sudan and Sudan: Case Reports and Review of Literature

Amanya¹,

Peng²

2018

J Trop Dis

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Introduction: Visceral leishmaniasis of genus Leishmania donovani is a known cause of Kala-azar, with an agent of Phlebotomus species. Other species of public health importance include Phlebotomus-martini that engulfed South Sudan bordering counties with Kenya whereas Phlebotomus-orientalis dominates northern parts of South Sudan and Sudan. It exhibits rare behavioral characteristics of outer door bites. Among Eastern African countries, South Sudan is a highly endemic area where more than 1/3 of the population is at risks of infections. This review aimed to evaluate the current diagnosis, treatment and risk factors associated with epidemics and mortality due to Visceral Leishmaniasis in Sudan and South Sudan. Methodology and Objective:Literatures published in SCI Journals, pub med, and science direct, Google, WHO reports, MSF, and CDC websites were searched starting from 1945 to 2018. Visceral leishmaniasis/VL diagnostic tools, treatment regimens, and associated risk factors were the keywords used during browsing. Details referred to Given Figures in the methodology section.Findings: Several risk factors contributed to the frequency of VL outbreaks. Chronic wars, malnutrition and settlement in areas infested by the sand fly, co-infections with either HIV or Hepatitis an emerging public health concern. Government efforts to control and eliminates the vectors of VL are lacking with negligible resources allocation. Acacia trees are proved to harbor sand fly as resting and hiding places. K39/K26 or rk39/rk28 dipstick is a field base diagnostic tool commonly used. Treatments with liposomal AmporicinB, sodium stibogluconate plus paromomycin are recommended for use in South Sudan. This review also revealed that areas formerly free from Kala-azar had experience recurrent epidemic.Conclusion: VL in South Sudan remains highly isolated from clinical diagnosis, treatment, and control strategies. Routine data for surveillance is also an absence. National guidelines and protocols for treatment, and vector control remain at standstill. The level of resistance of visceral Leishmania parasites to the available anti-leishmanial drugs required more researches. There is a close relationship between frequent VL outbreaks and internal conflicts, poor malnutrition, poverty and displacement to high transmission zones, individuals who are new in sand fly infested areas are at greater risks, including children, elderly and pregnant women.

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Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan

Abstract: An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.

Cited by 38 publications

References 19 publications

The use ofEscherichia colitotal antigens as a complementary approach to address seropositivity toLeishmaniaantigens in canine leishmaniosis

The use ofEscherichia colitotal antigens as a complementary approach to address seropositivity toLeishmaniaantigens in canine leishmaniosis

Frequency of Leishmania spp. infection among HIV-infected patients living in an urban area in Brazil: a cross-sectional study

Visceral Leishmaniasis: Evaluation of Diagnostic Tools, Therapeutic Regimens, and Associated Risk Factors in Areas with Frequent Outbreaks in South Sudan and Sudan: Case Reports and Review of Literature

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