This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features!
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.

NIH NLM Logo
Log in
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2012 Jan;6(1):e1484.
doi: 10.1371/journal.pntd.0001484. Epub 2012 Jan 31.

Comparative study of rK39 Leishmania antigen for serodiagnosis of visceral leishmaniasis: systematic review with meta-analysis

Affiliations
Meta-Analysis

Comparative study of rK39 Leishmania antigen for serodiagnosis of visceral leishmaniasis: systematic review with meta-analysis

Zuinara Maia et al. PLoS Negl Trop Dis. 2012 Jan.

Abstract

Background: The rK39 recombinant protein is derived from a specific antigen produced by the Leishmania donovani complex, and has been used in the last two decades for the serodiagnosis of visceral leishmaniasis. We present here a systematic review and meta-analysis of studies evaluating serologic assays to diagnose visceral leishmaniasis to determine the accuracy of rK39 antigen in comparison to the use of other antigen preparations.

Methodology/principal findings: A systematic review with meta-analysis of the literature was performed to compare the rK39 strip-test and ELISA formats against serological tests using promastigote antigens derived from whole or soluble parasites for Direct Aglutination Test (DAT), Indirect Immunofluorescence test (IFAT) and ELISA with a promastigote antigen preparation (p-ELISA). Gold standard diagnosis was defined by the demonstration of amastigotes on hematological specimens. A database search was performed on Medline, Lilacs, Scopus, Isi Web of Science, and Cochrane Library. Quality of data was assessed using the QUADAS questionnaire. A search of the electronic databases found 352 papers of which only 14 fulfilled the selection criteria. Three evaluated the rK39 ELISA, while 13 evaluated the rK39 immunochromatographic strip test. The summarized sensitivity for the rK39-ELISA was 92% followed by IFAT 88% and p-ELISA 87%. The summarized specificity for the three diagnostic tests was 81%, 90%, and 77%. Studies comparing the rK39 strip test with DAT found a similar sensitivity of 94%, although the DAT had a slightly higher specificity. The rK39 strip test was more sensitive and specific than the IFAT and p-ELISA. We did not detect any difference in the sensitivity and specificity between strips produced by different manufacturers.

Conclusions: The rK39 protein used either in a strip test or in an ELISA, and the DAT are the best choices for implementation of rapid, easy and efficient test for serodiagnosis of VL.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Algorithm for selection of studies.
Figure 2
Figure 2. ROC plot comparing the performance of the rK39 strip test to serologic techniques utilizing promastigote antigens for diagnosis of Visceral Leishmaniasis.
Figure 3
Figure 3. ROC plot comparing the performance of the rK39-ELISA to the p-ELISA and IFAT for the diagnosis of Visceral Leishmaniasis.
(A) Analysis including all studies that met our selection criteria. (B) Analysis after removal of the outlier study.
Figure 4
Figure 4. ROC plot showing the heterogeneity of strip test by continent.

References

    1. WHO. Leishmaniasis: burden of disease, surveillance e control, epidemics, acess to medicines, information resources. World Health Organization; 2010.
    1. Chappuis F, Sundar S, Hailu A, Ghalib H, Rijal S, et al. Visceral leishmaniasis: what are the needs for diagnosis, treatment and control? Nat Rev Microbiol. 2007;5:873–882. - PubMed
    1. Canavate C, Herrero M, Nieto J, Cruz I, Chicharro C, et al. Evaluation of two rK39 dipstick tests, direct agglutination test, and indirect fluorescent antibody test for diagnosis of visceral leishmaniasis in a new epidemic site in highland Ethiopia. Am J Trop Med Hyg. 2011;84:102–106. - PMC - PubMed
    1. Srivastava P, Mehrotra S, Tiwary P, Chakravarty J, Sundar S. Diagnosis of Indian visceral leishmaniasis by nucleic acid detection using PCR. PLoS One. 2011;6:e19304. - PMC - PubMed
    1. Kalayou S, Tadelle H, Bsrat A, Abebe N, Haileselassie M, et al. Serological evidence of Leishmania donovani infection in apparently healthy dogs using direct agglutination test (DAT) and rk39 dipstick tests in Kafta Humera, north-west Ethiopia. Transbound Emerg Dis. 2011;58:255–262. - PubMed

MeSH terms

Full text links
Public Library of Science full text link Public Library of Science Free PMC article
Cite

AltStyle によって変換されたページ (->オリジナル) /