Immunochromatographic rK39 strip test in the serodiagnosis of visceral leishmaniasis in Tunisia.

The performance of the rK39 strip test in the diagnosis of Tunisian visceral leishmaniasis (VL) was evaluated and compared with that of immunofluorescent antibody test (IFAT). A total of 929 sera, including 574 from VL patients, 54 from cutaneous leishmaniasis (CL) patients, 42 from patients with other protozoan diseases, 152 from patients with non-parasitic diseases and 107 from healthy controls, were used in the study. The sensitivity and specificity of the rK39 strip test were 87.1 and 94.4%, respectively. Sixteen CL sera showed positive results, suggesting that the rK39 strip test is not restricted to Leishmania donovani complex detection. IFAT was comparatively more sensitive (98.9%) but slightly less specific (90.7%). Despite cross-reactivity shown by CL sera, the rK39 strip test can be recommended for the routine diagnosis of VL in Tunisia, as VL and CL are distinct clinical entities.