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Clinical and Diagnostic Laboratory Immunology, September 1998, p. 717-720, Vol. 5, No. 5
1071-412X/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

rK39 Enzyme-Linked Immunosorbent Assay for Diagnosis of Leishmania donovani Infection

E. E. Zijlstra,1 N. S. Daifalla,1,dagger P. A. Kager,2 E. A. G. Khalil,1 A. M. El-Hassan,1 S. G. Reed,3 and H. W. Ghalib1,*

Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan1; Department of Infectious Disease, Tropical Medicine and AIDS, Academic Medical Centre, Amsterdam, The Netherlands2; and Corixa Corporation, Seattle, Washington3

Received 7 November 1997/Returned for modification 22 April 1998/Accepted 10 June 1998

The rK39 enzyme-linked immunosorbent assay (ELISA) was compared with the direct agglutination test (DAT) for Leishmania donovani infection in the Sudan. rK39 ELISA proved more sensitive than DAT in diagnosis of kala-azar (93 and 80%, respectively); both tests may remain positive up to 24 months after treatment. For patients with post-kala-azar dermal leishmaniasis and individuals with subclinical infection, rK39 ELISA performed as well as DAT but could detect infection 6 months earlier in ~40% of patients. Conversion in DAT and rK39 ELISA also occurred in leishmanin skin test (LST)-positive individuals, suggesting active parasite replication (rK39 is an amastigote antigen) in these presumably immune individuals. In contrast to DAT, rK39 ELISA also detected infection in randomly selected LST-positive individuals (in four of six) and endemicity (LST-negative) controls (in one of five). rK39 ELISA appears more sensitive than DAT and may prove an important tool in epidemiological studies.

* Corresponding author. Present address: College of Medicine, King Saud University, P.O. Box 641, Abha, Saudi Arabia. Phone: 966-7-2292564. Fax: 966-7-2240565.

dagger Present address: Infectious Disease Research Institute, Seattle, Wash.

Clinical and Diagnostic Laboratory Immunology, September 1998, p. 717-720, Vol. 5, No. 5
1071-412X/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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