Leishmania infantum
ELISA kit for the diagnosis of visceral leishmaniosis in humans and dogs

Parasitology and clinical relevance

The parasites of the genus Leishmania are intracellular protists transmitted by an insect vector. Traditionally three forms of leishmanioses are clinically distinguished : One of these, visceral leishmaniosis, is caused by Leishmania infantum in the Mediterranean area and in South America and by L. donovani in Eastern Africa and in Southern Asia. This infection affects millions of individuals and is frequently lethal if left untreated. Recently a growing number of patients developed visceral leishmaniosis during a co-infection with HIV. Epidemiologically, the domestic dog is very sensitive to infection by L. infantum and is an important reservoir host for the transmission of the human disease. The culture of the parasite from biopsies or a direct detection of amastigotes in tissue smears are definitve proof for the presence of the parasite. However, as the antibody titers are usually elevated in the absence of HIV co-infection, serology is conveniently used as a less invasive procedure for the diagnosis and the follow-up during treatment of visceral leishmaniosis.

Test-Kit

96 determinations of IgG antibodies using standard methodologies

Wells sensitized with soluble antigens from cultured Leishmania infantum promastigotes

8-wells polystyrene breakable strips : useful and economic format for laboratories with a small workload

CE registration:  H-CH/CA01/IVD/01756

Sensitivity and specificity

Sensitivity    Immunocompetent patients > 95%
Leishmania-HIV co-infections : 60 - 85 %

Specificity    (Swiss blood donors)  > 95%

Cross-reactivity occurs with trypanosomiases and to some extent with leprosy and tuberculosis

The conjugate used in this kit (protein A) allows the detection of antibodies in the serum of humans and dogs

Contents

96 wells coated with Leishmania infantum promastigote soluble antigens

TBS-Tween,  50 ml
Washing solution,  50 ml
Enzyme buffer,  50 ml
Stop solution,  25 ml
Negative control serum (canine),  200
ml
Cut-off serum (canine),  200
ml
Positive control serum (canine),  200
ml
Protein A-AP conjugate,  300
ml
Alk. Phosphatase substrate,  20 tablets
Multipipette reservoir
Frame for ELISA 8-wells holder
Detailed protocol

Ordering information

Leishmania infantum
(96 assays) No. 9500

 

References

Alvar J. (1994) Parasitol. Today 10, 160-163

Kar K. (1995) Crit. Rev. Microbiol. 21, 123-152

Senaldi G. & al. (1996) J. Immunol. Methods 193, 9-15

European directive 98/79/EC registration: Click here.   Material Safety Data Sheet: Click here.
Technical sheet and instructions for article N° 9500, PDF format, 23 Ko: Click here.

Clinical evaluation of the kit (posters in french available, PDF format):
Delaunay, P. et al., Société Française de Parasitologie, Paris 2002: Click here.
Eiselé, L. et al., Société Française de Parasitologie, Paris 2002: Click here.
Gharbi, M. et al., Société Française de Parasitologie, Marseille 2003: Click here.

Conditions and distributors Home page
Click here to read long-term quality control reports

 

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