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Review

Urine-Based Antigen (Protein) Detection Test for the Diagnosis of Visceral Leishmaniasis

1
DetectoGen Inc., Westborough, MA 01581, USA
2
Cummings School of Veterinary Medicine, Tufts University, North Grafton, MA 01536, USA
*
Author to whom correspondence should be addressed.
Microorganisms 2020, 8(11), 1676; https://doi.org/10.3390/microorganisms8111676
Received: 13 October 2020 / Revised: 22 October 2020 / Accepted: 23 October 2020 / Published: 28 October 2020
(This article belongs to the Special Issue Leishmania and Leishmaniasis)
This review describes and appraises a novel protein-based antigen detection test for visceral leishmaniasis (VL). The test detects in patient’s urine six proteins from Leishmania infantum (chagasi) and Leishmania donovani, the etiological agents of VL. The gold standard test for VL is microscopic observation of the parasites in aspirates from spleen, liver, or bone marrow (and lymph node for dogs). Culture of the parasites or detection of their DNA in these aspirates are also commonly used. Serological tests are available but they cannot distinguish patients with active VL from either healthy subjects exposed to the parasites or from subjects who had a successful VL treatment. An antigen detection test based on the agglutination of anti-leishmania carbohydrates antibody coated latex beads has been described. However, the results obtained with this carbohydrate-based test have been conflicting. Using mass spectrometry, we discovered six L. infantum/L. donovani proteins excreted in the urine of VL patients and used them as markers for the development of a robust mAb-based antigen (protein) detection test. The test is assembled in a multiplexed format to simultaneously detect all six markers. Its initial clinical validation showed a sensitivity of 93% and specificity of 100% for VL diagnosis. View Full-Text
Keywords: visceral leishmaniasis; kala-azar; Leishmania donovani; Leishmania infantum; antigenuria; antigen detection test; monoclonal antibody; diagnostic test visceral leishmaniasis; kala-azar; Leishmania donovani; Leishmania infantum; antigenuria; antigen detection test; monoclonal antibody; diagnostic test
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MDPI and ACS Style

Campos-Neto, A.; Abeijon, C. Urine-Based Antigen (Protein) Detection Test for the Diagnosis of Visceral Leishmaniasis. Microorganisms 2020, 8, 1676. https://doi.org/10.3390/microorganisms8111676

AMA Style

Campos-Neto A, Abeijon C. Urine-Based Antigen (Protein) Detection Test for the Diagnosis of Visceral Leishmaniasis. Microorganisms. 2020; 8(11):1676. https://doi.org/10.3390/microorganisms8111676

Chicago/Turabian Style

Campos-Neto, Antonio, and Claudia Abeijon. 2020. "Urine-Based Antigen (Protein) Detection Test for the Diagnosis of Visceral Leishmaniasis" Microorganisms 8, no. 11: 1676. https://doi.org/10.3390/microorganisms8111676

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