Evaluation of six commercial kits for the serological diagnosis of Mediterranean visceral leishmaniasis

Lévêque, Maude F.; Battery, Emilie; Delaunay, Pascal; Lmimouni, B.; Karim, Abdul; L’Ollivier, Coralie; Bastien, Patrick; Mary, Charles; Pomarès, Christelle; Fillaux, Judith; Lachaud, Laurence

doi:10.1371/journal.pntd.0008139

Cited by 20 publications

(19 citation statements)

References 22 publications

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“…The performance of rK39-ICT has been evaluated in highly endemic country settings with variable results in different geographic locations [11,14]. In addition, recent evidence from the Mediterranean region indicates 83% sensitivity of rK39-ICT in immunocompetent Spanish patients [15] as well as 85-90% sensitivity in VL samples obtained from France, Morocco, and Tunisia [16].…”

Section: Discussionmentioning

confidence: 99%

Serodiagnosis of Visceral Leishmaniasis in Northeastern Italy: Evaluation of Seven Serological Tests

et al. 2020

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This study compares the performance of seven assays, including two ELISA (Leishmania ELISA IgG + IgM, Vircell Microbiologists; Leishmania infantum IgG ELISA, NovaTec), three rK39-based immunochromatographic tests (rK39-ICTs) (Leishmania Dipstick Rapydtest, Apacor; On Site Leishmania IgG/IgM Combo Rapid Test, CTK Biotech; LEISHMANIA Strip quick Test, Cypress Diagnostic), one indirect immunofluorescent antibody test (IFAT) (Leishmania-Spot IF, BioMérieux), and one western blot (WB) (Leishmania WESTERN BLOT IgG, LDBio Diagnostics) for serodiagnosis of visceral leishmaniasis (VL). Serum samples from 27 VL patients living in northeastern Italy were analyzed, as well as the serum samples from 50 individuals in whom VL diagnosis was excluded. The WB and the IFAT had 96% sensitivity, followed by the ELISA (63% and 74%, respectively). The rK39-ICT exhibited the worst performance among the serological tests, with sensitivities ranging from 52% to 70%. By combining selected ELISA/ICT, the sensitivity of VL detection reached 89%. IFAT and WB outperformed ELISA and rK39-ICT by possessing optimal sensitivity, but their high cost and complexity of execution would not allow their employment as screening tests. In conclusion, the combination of easy-to-perform tests, such as ICT and ELISA, could improve sensitivity in the serodiagnosis of Mediterranean VL.

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Section: Discussionmentioning

confidence: 99%

Serodiagnosis of Visceral Leishmaniasis in Northeastern Italy: Evaluation of Seven Serological Tests

et al. 2020

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“…The serostatus for Leishmania in the index patient and the graft donor was also retrospectively analysed by testing sera that were collected immediately before the transplant with the Leishmania Western Blot IgG (LDBio Diagnostics ® , Lyon, France), a sensitive method to detect specific IgG in individuals with VL or asymptomatic Leishmani a infection [ 9 , 10 ]. The test revealed the presence of anti-leishmanial IgG in the patients’ serum immediately before the transplant, while the donor’s serum tested negative.…”

Section: Case Presentationmentioning

confidence: 99%

Updated diagnosis and graft involvement for visceral leishmaniasis in kidney transplant recipients: a case report and literature review

et al. 2022

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Purpose Visceral leishmaniasis (VL) has become a rising concern to transplantation teams, being associated with graft dysfunction and reduced survival of renal transplant recipients. Here, we describe a case of VL occurring in a kidney transplant (KT) recipient in Italy, a country in which Leishmania infantum is endemic and we reviewed the literature on the clinical course and diagnosis of VL in KT recipients residing or travelling to southern Europe. Results The VL case was diagnosed 18 months after transplant and 28 days after the onset of symptoms by quantitative PCR (qPCR) on peripheral blood. A graft biopsy showed renal involvement, and PCR performed on graft tissue displayed the presence of Leishmania DNA. The retrospective confirmation of Leishmania-positive serology in a serum sample collected before transplantation, as well as the absence of anti-Leishmania IgG in the graft donor strongly suggest that reactivation of a latent parasitic infection caused VL in the current case. Conclusion VL is often underdiagnosed in transplant recipients, despite the presence of latent Leishmania infection being reported in endemic countries. This case report, as well as the literature review on leishmaniasis in KT recipients, underline the importance of rapid VL diagnosis to promptly undergo treatment. Serology is scarcely sensitive in immunocompromised patients, thus molecular tests in peripheral blood should be implemented and standardized for both VL identification and follow-up.

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“…Moreover, several studies reported variations in sensitivity depending on the geographical region concerned. Sensitivity was lower in East Africa (36% to 87%), Brazil (61% to 92%), and the Mediterranean basin (52% to 91%), than in the Indian subcontinent (92% to 100%) [ 5 , 6 , 20 , 32 , 34 , 50 , 64 ]. For CL and ML diagnosis, serological tests are not commonly used because of their low sensitivity and variable specificity [ 81 ].…”

Section: Introductionmentioning

confidence: 99%

A systematic review of peptide-based serological tests for the diagnosis of leishmaniasis

et al. 2023

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Serological methods should meet the needs of leishmaniasis diagnosis due to their high sensitivity and specificity, economical and adaptable rapid diagnostic test format, and ease of use. Currently, the performances of serological diagnostic tests, despite improvements with recombinant proteins, vary greatly depending on the clinical form of leishmaniasis and the endemic area. Peptide-based serological tests are promising as they could compensate for antigenic variability and improve performance, independently of Leishmania species and subspecies circulating in the endemic areas. The objective of this systematic review was to inventory all studies published from 2002 to 2022 that evaluate synthetic peptides for serological diagnosis of human leishmaniases and also to highlight the performance (e.g., sensitivity and specificity) of each peptide reported in these studies. All clinical forms of leishmaniasis, visceral and tegumentary, and all Leishmania species responsible for these diseases were considered. Following PRISMA statement recommendations, 1,405 studies were identified but only 22 articles met the selection criteria and were included in this systematic review. These original research articles described 77 different peptides, of which several have promising performance for visceral or tegumentary leishmaniasis diagnosis. This review highlights the importance of and growing interest in synthetic peptides used for serological diagnosis of leishmaniases, and their performances compared to some widely used tests with recombinant proteins.

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Evaluation of six commercial kits for the serological diagnosis of Mediterranean visceral leishmaniasis

Cited by 20 publications

References 22 publications

Serodiagnosis of Visceral Leishmaniasis in Northeastern Italy: Evaluation of Seven Serological Tests

Serodiagnosis of Visceral Leishmaniasis in Northeastern Italy: Evaluation of Seven Serological Tests

Updated diagnosis and graft involvement for visceral leishmaniasis in kidney transplant recipients: a case report and literature review

A systematic review of peptide-based serological tests for the diagnosis of leishmaniasis

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