Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2005 Dec;43(12):5973-7.
doi: 10.1128/JCM.43.12.5973-5977.2005.

Diagnostic accuracy of two rK39 antigen-based dipsticks and the formol gel test for rapid diagnosis of visceral leishmaniasis in northeastern Uganda

François Chappuis  1 , Yolanda Mueller, Alexandre Nguimfack, John Bosco Rwakimari, Sophie Couffignal, Marleen Boelaert, Philippe Cavailler, Louis Loutan, Patrice Piola
Affiliations
Comparative Study

Diagnostic accuracy of two rK39 antigen-based dipsticks and the formol gel test for rapid diagnosis of visceral leishmaniasis in northeastern Uganda

François Chappuis et al. J Clin Microbiol. 2005 Dec.

Abstract

The development of an accurate, practical, and affordable diagnostic test is essential to improve the management of visceral leishmaniasis (VL) in remote health centers. We evaluated the Formol Gel test (FGT) and two rK39 antigen-based dipsticks, the DUAL-IT L/M, and the Kalazar Detect for VL diagnosis in Amudat Hospital in Uganda. The DUAL-IT L/M was also evaluated for the diagnosis of malaria. All patients clinically suspect of VL were prospectively included in the study between October 2003 and March 2004. The gold standard used to define a VL case was a positive spleen aspirate or a direct agglutination test titer of >1:12,800 with an appropriate clinical response to antileishmanial therapy. A total of 131 VL and 112 non-VL patients were included in the analysis. The DUAL IT L/M was found to be more sensitive than the Kalazar Detect: 97% (95% confidence interval [95%CI] = 92 to 99%) versus 82% (95%CI = 74 to 87%). The Kalazar Detect and the DUAL IT L/M were highly specific (99% [95%CI = 95 to 100%] and 97% [95%CI = 92 to 99%], respectively). The FGT lacked both sensitivity (66% [95%CI = 57 to 73%]) and specificity (90% [95%CI = 83 to 94%]). The sensitivity of the DUAL IT L/M for malaria was only 57% (95%CI = 37 to 76%). The two rK39 dipsticks can be used for diagnostic confirmation of VL in this region. The DUAL-IT L/M without its malaria diagnostic component (DiaMed-IT LEISH) will be adopted as first-line test for VL in Uganda.

PubMed Disclaimer

Figures

FIG. 1.
FIG. 1.
Diagnostic algorithm of visceral leishmaniasis in Amudat Hospital, Pokot County.
See this image and copyright information in PMC

References

    1. Boelaert, M., S. el Safi, E. Goetghebeur, S. Gomes-Pereira, D. Le Ray, and P. Van der Stuyft. 1999. Latent class analysis permits unbiased estimates of the validity of DAT for the diagnosis of visceral leishmaniasis. Trop. Med. Int. Health. 4:395-401. - PubMed
    1. Boelaert, M., S. El Safi, D. Jacquet, A. de Muynck, P. van der Stuyft, and D. Le Ray. 1999. Operational validation of the direct agglutination test for diagnosis of visceral leishmaniasis. Am. J. Trop. Med. Hyg. 60:129-134. - PubMed
    1. Boelaert, M., S. El Safi, H. Mousa, J. Githure, P. Mbati, V. Gurubacharya, J. Shrestha, D. Jacquet, A. De Muynck, D. Le Ray, and P. Van der Stuyft. 1999. Multi-centre evaluation of repeatability and reproducibility of the direct agglutination test for visceral leishmaniasis. Trop. Med. Int. Health. 4:31-37. - PubMed
    1. Boelaert, M., L. Lynen, P. Desjeux, and P. Van der Stuyft. 1999. Cost-effectiveness of competing diagnostic-therapeutic strategies for visceral leishmaniasis. Bull. W. H. O. 77:667-674. - PMC - PubMed
    1. Boelaert, M., S. Rijal, S. Regmi, R. Singh, B. Karki, D. Jacquet, F. Chappuis, L. Campino, P. Desjeux, D. Le Ray, S. Koirala, and P. Van der Stuyft. 2004. A comparative study of the effectiveness of diagnostic tests for visceral leishmaniasis. Am. J. Trop. Med. Hyg. 70:72-77. - PubMed

Publication types

LinkOut - more resources