Abstract
BackgroundThe 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 FindingsA 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.ConclusionsThe 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.
Highlights
Visceral Leishmaniasis (VL) is a neglected tropical disease for which a simple and quick diagnostic test is available, but not yet widely implemented in rural areas [1]
The rK39 protein used either in a strip test or in an ELISA, and the Direct Aglutination Test (DAT) are the best choices for implementation of rapid, easy and efficient test for serodiagnosis of VL
We present here a systematic review and meta-analysis of studies evaluating serologic assays to diagnose VL to determine the accuracy of rK39 antigen in comparison to the use of other antigen preparations
Summary
Visceral Leishmaniasis (VL) is a neglected tropical disease for which a simple and quick diagnostic test is available, but not yet widely implemented in rural areas [1]. Only a limited number of well conducted trials comparing the different types of tests have been published [2]. The use of crude antigens for the serodiagnosis of tropical diseases is often limited by the difficulty in producing large quantities of the antigen, and can be difficult to make in a standardized manner. Numerous recombinant antigens have become available for use in serodiagnostic testing of leishmaniasis [3]. Sensitivity and specificity of these tests depend upon the region targeted, with a recent study finding a peripheral blood PCR assay having an overall sensitivity of 98.5% [4]. 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
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