Recombinant K39 immunochromatographic test for diagnosis of human leishmaniasis
Rosa Monno1, Giorgia Giannelli, Caterina Rizzo
1Department of Internal Medicine & Public Health, Unit of Hygiene, School of Medicine, University of Bari, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy. r.monno@igiene-seconda.uniba.it
Insights
A new recombinant K39 immunochromatographic test (ICT) offers a rapid, 100% accurate method for diagnosing visceral leishmaniasis (VL). This cost-effective test is highly sensitive and specific, even in co-infected patients.
Area of Science:
- Tropical medicine
- Immunology
- Diagnostic assays
Background:
- Visceral leishmaniasis (VL) diagnosis can be challenging, especially in low endemicity areas.
- Current diagnostic methods like immunofluorescent antibody assay (IFA) have limitations.
- Need for rapid, accurate, and cost-effective diagnostic tools for VL.
Purpose of the Study:
- To evaluate a new recombinant K39 immunochromatographic test (ICT) for diagnosing visceral leishmaniasis (VL).
- To compare the performance of ICT against the established immunofluorescent antibody assay (IFA).
- To assess the sensitivity, specificity, and cost-effectiveness of ICT in a Southern Italian population.
Main Methods:
- A cohort of 264 individuals was tested, including confirmed VL patients, suspected cases, healthy controls, and patients with other diseases.
- Sera were analyzed using both the recombinant K39 immunochromatographic test (ICT) and the immunofluorescent antibody assay (IFA).
- Performance metrics including sensitivity and specificity were calculated for the ICT.
Main Results:
- The ICT demonstrated 100% sensitivity and 100% specificity in diagnosing VL.
- All 19 VL patients tested positive with ICT, while all other individuals tested negative.
- The ICT performed effectively in diagnosing VL even in patients co-infected with HIV.
Conclusions:
- The recombinant K39 ICT is a highly sensitive, specific, and rapid diagnostic tool for visceral leishmaniasis.
- ICT is a non-invasive, cost-effective alternative to IFA, particularly in low endemicity settings.
- The test's high performance and affordability support its use in VL diagnosis and control efforts.
Abstract:
A new recombinant K39 immunochromatographic test (ICT) was compared with the immunofluorescent antibody assay (IFA) for the rapid serological diagnosis of visceral leishmaniasis (VL) in Apulia, Southern Italy. A total of 264 individuals were tested, including 19 patients with VL (three of which were HIV positive), 67 individuals with suspected VL, 40 healthy controls and 138 patients with other diseases. The ICT was positive in all 19 patients with VL and negative in sera from the remaining individuals. Both the sensitivity and specificity of ICT was 100%. The ICT also worked well in HIV-Leishmania co-infected patients. Antibodies to Leishmania detected by the IFA and ICT remained at detectable levels for up to 12-24 months. A positive reaction by the ICT was detectable at a serum dilution of up to 1:20,480, indicating that a strong immunoresponse is mounted against the recombinant K39 antigen. In conclusion, the ICT is highly sensitive, specific, rapid, noninvasive and cost effective (euro8.43 for ICT and euro12 for IFA) in the diagnosis of VL in areas of low VL endemicity.
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