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
. 2023 Dec 29;123(1):77.
doi: 10.1007/s00436-023-08103-y.

The use of recombinant K39, KMP11, and crude antigen-based indirect ELISA as a serological diagnostic tool and a measure of exposure for cutaneous leishmaniasis in Sri Lanka

Charani Karunathilake  1 , Narmadha Alles  1 , Rajika Dewasurendra  1 , Isurika Weerasinghe  1 , Nipuni Chandrasiri  1 , Sachee Bhanu Piyasiri  1 , Nilakshi Samaranayake  1 , Hermali Silva  1 , Nuwani Manamperi  2 , Nadira Karunaweera  3
Affiliations

The use of recombinant K39, KMP11, and crude antigen-based indirect ELISA as a serological diagnostic tool and a measure of exposure for cutaneous leishmaniasis in Sri Lanka

Charani Karunathilake et al. Parasitol Res. .

Abstract

Cutaneous leishmaniasis (CL) in Sri Lanka is caused by Leishmania donovani, a parasite widely known to cause visceral leishmaniasis. Despite the fact that CL is not generally believed to elicit serological immune responses, recent studies show the presence of antibody responses against this atypical form of CL. This study assesses the potential of using recombinant K39 (rK39), KMP11, and crude parasite antigen-based indirect ELISAs as serological diagnostic tools and measures of exposure for CL in Sri Lanka. The study used serum samples from confirmed CL patients (n = 266) and apparently healthy individuals from endemic settings (n = 411). Serum samples from individuals residing in non-endemic areas were used as negative controls. In-house indirect ELISAs were optimized and validated for recombinant antigens. Previously validated crude parasite extract-based indirect ELISA was performed for comparison. The statistical analyses were performed using SPSS v26.0. The rK39 (sensitivity = 71.2%, specificity = 64%) and KMP11 (sensitivity = 79.2%, specificity = 71.4%) based indirect ELISA were shown to be less suitable for the diagnosis of CL, while crude parasite extract-based indirect ELISA (sensitivity = 82.4%, specificity = 85.7%) might be a better method of diagnosis. All 03 ELISAs seemed to be good methods as measures of exposure since correlations were observed between the seropositivity of all 03 ELISAs (rK39: p = 0.037, KMP11: p = 0.007, CrudeAg: p = 0.000) with provincial case incidences. The findings will be important in identifying the disease hotspots in order to design the control measures for CL induced by L. donovani in Sri Lanka.

Keywords: Asymptomatic; Laboratory diagnosis; Leishmania donovani; Sero-prevalence.

PubMed Disclaimer

Conflict of interest statement

Competing interests The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Distribution of optical density of samples from CL patients (CL), healthy individuals from endemic settings (EC), healthy individuals from non-endemic settings (NEC)
Fig. 2
Fig. 2
Distribution of percentages of seropositive apparently healthy individuals in different (a) age categories and (b) provinces
Fig. 3
Fig. 3
A Percentage of seropositive individuals for (a) all tested antigens, (b) rK39, (c) KMP11, (d) crude antigen and number of cases reported from each province in 2018. B Correlation of percentage seropositivity of (e) rK39, (f) KMP11, (g) crude antigen and case incidence from each province in 2018
Fig. 3
Fig. 3
A Percentage of seropositive individuals for (a) all tested antigens, (b) rK39, (c) KMP11, (d) crude antigen and number of cases reported from each province in 2018. B Correlation of percentage seropositivity of (e) rK39, (f) KMP11, (g) crude antigen and case incidence from each province in 2018
Fig. 4
Fig. 4
Percentage of seropositive CL patients according to (a) the lesion duration and (b) the treatment duration
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Athukorale DN, Seneviratne JKK, Ihalamulla RL, Premaratne UN (1992) Locally acquired cutaneous leishmaniasis in Sri Lanka. J Trop Med Hyg 95(6):432–433 - PubMed
    1. Basu R, Bhaumik S, Basu JM, Naskar K, De T, Roy S (2005) Kinetoplastid membrane protein-11 DNA vaccination induces complete protection against both pentavalent antimonial-sensitive and -resistant strains of Leishmania donovani that correlates with inducible nitric oxide synthase activity and IL-4 generation: evidence for mixed Th1- and Th2-like responses in visceral leishmaniasis. J Immunol 174(11):7160–7171. 10.4049/JIMMUNOL.174.11.7160 - DOI - PubMed
    1. Carrillo E, Moreno J (2019) Editorial: Biomarkers in leishmaniasis. Front Cell Infect Microbiol 9(November):1–4. 10.3389/fcimb.2019.00388 - DOI - PMC - PubMed
    1. Castellani A (1904) “Leishmania Donovani” in Ceylon. Seventy-Second Annual Meeting of the British Medical Association, BMJ2 629–78. 10.1136/bmj.2.2281.629 - DOI
    1. CDC (2020) Leishmaniasis. https://www.cdc.gov/parasites/leishmaniasis/index.html. Accessed 21 February 2023

MeSH terms

Substances

LinkOut - more resources