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Leishmania PCR test for primates

primate assay data sheet

Leishmania donovani complex

Test code:
X0032 - Ultrasensitive qualitative detection but not differentiation of Leishmania donovani and Leishmania infantum ("Leishmania donovani complex") by real time PCR


Leishmaniasis is a vector-borne disease whereby an obligate intracellular protozoan of the genus Leishmania is transmitted through a sandfly bite. Approximately 21 of 30 known species of Leishmania can infect human. These include the L. donovani complex with 2 species (L. donovani and L. infantum [also known as L. chagasi in the New World]); the L. mexicana complex with 3 main species (L. mexicana, L. amazonensis, and L. venezuelensis); L. tropica; L. major; L. aethiopica; and the subgenus Viannia with 4 main species (L. (V.) braziliensis, L. (V.) guyanensis, L. (V.) panamensis, and L. (V.) peruviana). These different Leishmania species are morphologically indistinguishable, and can only be distinguished by biochemical or molecular methods.

Among these species, L. donovani causes the most severe form of the disease in humans. It is responsible for visceral leishmaniasis or “kala-azar”, when it infects spleen, liver and bone marrow. The parasite is prevalent throughout tropical and temperate regions including Africa (mostly in Sudan), China, India, Nepal, southern Europe, southern Russia and South America.

Similar to other Leishmania species, the development of L. donovani requires two different hosts to complete its life cycle: human is the definitive host and sandfly is the intermediate host. Some 70 animal species can be natural reservoir hosts of Leishmania parasites. Of these reservoir species, dogs are of particular concern to epidemiologists because their cohabitation with humans can facilitate transmission of the disease. Symptomatic leishmaniasis disease can occur in canines, rodents and some other animal species (World Health Organization, 2014).

Incubation period is generally 3 to 6 months after infection, and in some cases may be over a year, though in India leishmaniasis incubation can be as short as 10 days. Infected individuals may develop recurring high fever, enlargement of spleen and liver, and dark skin pigmentation. Morphological changes around the facial and abdominal regions are especially prominent. Skin becomes coarse and hard. Warty eruptions are common in African infections. In advanced stages, infected patients become emaciated and anemic. The mortality rate is high in regions with poor medical facilities.

Diagnosis of L. donovani complex infection can be conducted by either parasitological or serological methods. Parasitological identification relies on skillful microscopic examination of stained splenic aspirate smears obtained through invasive procedures; the sensitivity and specificity of serological methods are poor. However, molecular detection by polymerase chain reaction is rapid, highly specific and sensitive, and can be performed directly on a small blood sample, thus avoiding invasive procedures to obtain specimens for diagnosis (Abbasi et al., 2013).


  • Help confirm the disease causing agent
  • Shorten the time required to confirm a clinical diagnosis of Leishmania infection.
  • Help ensure that primate facilities are free of this parasite
  • Early prevention of spread of this parasite
  • Minimize personnel exposure to this parasite
  • Safety monitoring of biological products and vaccines that derive from susceptible animals

Abbasi, I., Aramin, S., Hailu, A., Shiferaw, W., Kassahun, A., Belay, S., Jaffe, C. and Warburg, A. (2013) Evaluation of PCR procedures for detecting and quantifying Leishmania donovani DNA in large numbers of dried human blood samples from a visceral leishmaniasis focus in Northern Ethiopia. BMC Infect. Dis. 13:153.

World Health Organization, Leishmaniasis Fact Sheet N375, January 2014

Specimen requirement: 0.2 ml EDTA whole blood, or 0.2 ml tissue or bone marrow, or 0.2 ml cell culture.

Contact Zoologix if advice is needed to determine an appropriate specimen type for a specific diagnostic application. For specimen types not listed here, please contact Zoologix to confirm specimen acceptability and shipping instructions.

For all specimen types, if there will be a delay in shipping, or during very warm weather, refrigerate specimens until shipped and ship with a cold pack unless more stringent shipping requirements are specified. Frozen specimens should be shipped so as to remain frozen in transit. See shipping instructions for more information.

Turnaround time: 2 business days

Methodology: Qualitative real time PCR

Normal range: Nondetected

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