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#9500 Leishmania infantum
ELISA kit for the diagnosis of visceral leishmaniasis 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 leishmaniases are clinically distinguished : One of these, visceral leishmaniasis, is caused by Leishmania infantum in the Mediterranean area and in South America and by Leishmania 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 leishmaniasis 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 leishmaniasis.

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 with immunocompetent patients >95% and 
Leishmania-HIV co-infections : 60-85%

Specificity (Swiss blood donors)  >95%

Cross-reactivity occurs with trypanosomiasis 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.

Dilution buffer (TBS-Tween), 50 ml
Washing solution, 50 ml
Enzyme buffer, 50 ml
Stop solution, 25 ml
Negative control serum (canine), 200 µl
Cut-off serum (canine), 200 µl
Positive control serum (canine), 200 µl
Protein A - AP conjugate, 300 µl
Alk. phosphatase substrate, 20 tab.
Multipipette resevoir 25ml, 1x
Frame for ELISA 8-wells holder, 1x
Instructions for use

Ordering information

Leishmania infantum
complete kit (96 assays) No. 9500

 

References

Badaro, R., Reed, S.G., Barral, A., Orge, G., Jones, T.C. (1986) Evaluation of the micro enzyme-linked immunosorbent assay (ELISA) for antibodies in american visceral leishmaniasis : antigen selection for detection of infection specific responses. Am. J. Trop. Med. Hyg. 35: 72-78.

Daleine, G., Deniau, M., Matheron, S., Leport, C., Lebras, J. (1994) Leishmaniose viscérale au cours de l’infection à VIH : avantages du sérodiagnotic par technique ELISA. Pres. Med. 23 : 672-673.

Nassar, N., Gangneux, J.P., Sulahian, A., Derouin, F. (1996) Leishmaniose viscérale au cours du sida : Difficultés du diagnostic sérologique, évaluation d’une nouvelle trousse ELISA. Feuillets de Biologie. 37: 39-42.

Senaldi, G., Xiao-su, H., Hoessli, D.C., Bordier, C. (1996) Serological diagnosis of visceral leishmaniasis by a dot-enzyme immunoassay for the detection of a Leishmania donovani-related circulating antigen. Journal of Immunological Methods. 193: 9-15.

Maia, C., Nunes, M., Cristovao, J., Campino, L. (2010) Experimental canine leishmaniasis: Clinical, parasitological and serological follow-up. Acta Tropica. 116: 193-199.

European directive 98/79/EC registration

Material Safety Data Sheet: Eng - Fra - Deu

Clinical evaluations of the kit (french presentations):
Delaunay, P. et al., Société Française de Parasitologie, Paris 2002: Diaporama
Eiselé, L. et al., Société Française de Parasitologie, Paris 2002: Diaporama
Gharbi, M. et al., Société Française de Parasitologie, Marseille 2003: Poster

 

Bordier Affinity Products SA, Chatanerie 2, Bâtiment Biokema, CH-1023 Crissier, Switzerland
Phone: + 41 21 633 31 67.  Fax: + 41 21 633 31 78. Email: cb(at)bordier.ch

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