title: Evaluation of a new recombinant K39 rapid diagnostic test for Sudanese visceral leishmaniasis.
abstract: A new rK39 rapid diagnostic dipstick test (DiaMed-IT-Leish) was compared with aspiration and a direct agglutination test (DAT) for diagnosis of visceral leishmaniasis (VL) in 201 parasitologically confirmed cases, 133 endemic controls, and in 356 clinical suspects in disease-endemic and -epidemic areas in Sudan. The sensitivity of the rK39 test in parasitologically confirmed VL cases was 90%, whereas the specificity in disease-endemic controls was 99%. The sensitivity of the DAT was 98%. In clinically suspected cases, the sensitivity of the rK39 test was 81% and the specificity was 97%. When compared with the diagnostic protocol based on the DAT and aspiration used by Médecins sans Frontières in epidemic situations, the positive predictive value was 98%, and the negative predictive value was 71%. This rK39 rapid diagnostic test is suitable for screening as well as diagnosis of VL. Further diagnostic work-up of dipstick-negative patients with clinically suspected VL is important. The ease and convenience of the dipstick test will allow decentralization and improved access to care in disease-endemic areas in Sudan.
authors.affiliation: Médecins sans Frontières-Holland, Amsterdam, The Netherlands. koert.ritmeijer@amsterdam.msf.org
authors.forename: Koert
authors.initials: K
authors.lastname: Ritmeijer
authors.forename: Yoseph
authors.initials: Y
authors.lastname: Melaku
authors.forename: Marius
authors.initials: M
authors.lastname: Mueller
authors.forename: Sammy
authors.initials: S
authors.lastname: Kipngetich
authors.forename: Caroline
authors.initials: C
authors.lastname: O'keeffe
authors.forename: Robert N
authors.initials: RN
authors.lastname: Davidson
mesh_terms: D000953:Antigens, Protozoan / Q000097:blood*; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000097:blood / Q000175:diagnosis*; D011237:Predictive Value of Tests; D015800:Protozoan Proteins / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012680:Sensitivity and Specificity; D013397:Sudan; D013997:Time Factors
chemical_list: D000953:Antigens, Protozoan; D015800:Protozoan Proteins; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; C079253:K39 antigen, Leishmania