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Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain.
PLoS Negl Trop Dis. 2018 03; 12(3):e0006277.PN

Abstract

BACKGROUND

Visceral leishmaniasis (VL), the most severe form of leishmaniasis, is endemic in Europe with Mediterranean countries reporting endemic status alongside a worrying northward spread. Serological diagnosis, including immunochromatographic test based on the recombinant antigen rK39 (rK39-ICT) and a direct agglutination test (DAT) based on the whole parasite antigen, have been validated in regions with high VL burden, such as eastern Africa and the Indian subcontinent. To date, no studies using a large set of patients have performed an assessment of both methods within Europe.

METHODOLOGY/PRINCIPAL FINDINGS

We selected a range of clinical serum samples from patients with confirmed VL (including HIV co-infection), Chagas disease, malaria, other parasitic infections and negative samples (n = 743; years 2009-2015) to test the performance of rK39-ICT rapid test (Kalazar Detect Rapid Test; InBios International, Inc., USA) and DAT (ITM-DAT/VLG; Institute of Tropical Medicine Antwerp, Belgium). An in-house immunofluorescence antibody test (IFAT), was included for comparison. Estimated sensitivities for rK39-ICT and DAT in HIV-negative VL patients were 83.1% [75.1-91.2] and 84.2% [76.3-92.1], respectively. Sensitivity was reduced to 67.3% [52.7-82.0] for rK39 and increased to 91.3% [82.1-100.0] for DAT in HIV/VL co-infected patients. The in-house IFAT was more sensitive in HIV-negative VL patients, 84.2% [76.3-92.1] than in HIV/VL patients, 79.4% [73.3-96.2]. DAT gave 32 false positives in sera from HIV-negative VL suspects, compared to 0 and 2 for rK39 and IFAT, respectively, but correctly detected more HIV/VL patients (42/46) than rK39 (31/46) and IFAT (39/46).

CONCLUSIONS/SIGNIFICANCE

Though rK39-ICT and DAT exhibited acceptable sensitivity and specificity a combination with other tests is required for highly sensitive diagnosis of VL cases in Spain. Important variation in the performance of the tests were seen in patients co-infected with HIV or with other parasitic infections. This study can help inform the choice of serological test to be used when screening or diagnosing VL in a European Mediterranean setting.

Authors+Show Affiliations

European Public Health Microbiology Training Program (EUPHEM), European Centre for Disease Control and Prevention, Stockholm, Sweden. WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.WHO Collaborating Centre for Leishmaniasis, National Centre for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

29494596

Citation

Bangert, Mathieu, et al. "Validation of rK39 Immunochromatographic Test and Direct Agglutination Test for the Diagnosis of Mediterranean Visceral Leishmaniasis in Spain." PLoS Neglected Tropical Diseases, vol. 12, no. 3, 2018, pp. e0006277.
Bangert M, Flores-Chávez MD, Llanes-Acevedo IP, et al. Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain. PLoS Negl Trop Dis. 2018;12(3):e0006277.
Bangert, M., Flores-Chávez, M. D., Llanes-Acevedo, I. P., Arcones, C., Chicharro, C., García, E., Ortega, S., Nieto, J., & Cruz, I. (2018). Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain. PLoS Neglected Tropical Diseases, 12(3), e0006277. https://doi.org/10.1371/journal.pntd.0006277
Bangert M, et al. Validation of rK39 Immunochromatographic Test and Direct Agglutination Test for the Diagnosis of Mediterranean Visceral Leishmaniasis in Spain. PLoS Negl Trop Dis. 2018;12(3):e0006277. PubMed PMID: 29494596.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain. AU - Bangert,Mathieu, AU - Flores-Chávez,María D, AU - Llanes-Acevedo,Ivonne P, AU - Arcones,Carolina, AU - Chicharro,Carmen, AU - García,Emilia, AU - Ortega,Sheila, AU - Nieto,Javier, AU - Cruz,Israel, Y1 - 2018/03/01/ PY - 2017/10/04/received PY - 2018/01/28/accepted PY - 2018/03/13/revised PY - 2018/3/2/pubmed PY - 2018/6/19/medline PY - 2018/3/2/entrez SP - e0006277 EP - e0006277 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 12 IS - 3 N2 - BACKGROUND: Visceral leishmaniasis (VL), the most severe form of leishmaniasis, is endemic in Europe with Mediterranean countries reporting endemic status alongside a worrying northward spread. Serological diagnosis, including immunochromatographic test based on the recombinant antigen rK39 (rK39-ICT) and a direct agglutination test (DAT) based on the whole parasite antigen, have been validated in regions with high VL burden, such as eastern Africa and the Indian subcontinent. To date, no studies using a large set of patients have performed an assessment of both methods within Europe. METHODOLOGY/PRINCIPAL FINDINGS: We selected a range of clinical serum samples from patients with confirmed VL (including HIV co-infection), Chagas disease, malaria, other parasitic infections and negative samples (n = 743; years 2009-2015) to test the performance of rK39-ICT rapid test (Kalazar Detect Rapid Test; InBios International, Inc., USA) and DAT (ITM-DAT/VLG; Institute of Tropical Medicine Antwerp, Belgium). An in-house immunofluorescence antibody test (IFAT), was included for comparison. Estimated sensitivities for rK39-ICT and DAT in HIV-negative VL patients were 83.1% [75.1-91.2] and 84.2% [76.3-92.1], respectively. Sensitivity was reduced to 67.3% [52.7-82.0] for rK39 and increased to 91.3% [82.1-100.0] for DAT in HIV/VL co-infected patients. The in-house IFAT was more sensitive in HIV-negative VL patients, 84.2% [76.3-92.1] than in HIV/VL patients, 79.4% [73.3-96.2]. DAT gave 32 false positives in sera from HIV-negative VL suspects, compared to 0 and 2 for rK39 and IFAT, respectively, but correctly detected more HIV/VL patients (42/46) than rK39 (31/46) and IFAT (39/46). CONCLUSIONS/SIGNIFICANCE: Though rK39-ICT and DAT exhibited acceptable sensitivity and specificity a combination with other tests is required for highly sensitive diagnosis of VL cases in Spain. Important variation in the performance of the tests were seen in patients co-infected with HIV or with other parasitic infections. This study can help inform the choice of serological test to be used when screening or diagnosing VL in a European Mediterranean setting. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/29494596/Validation_of_rK39_immunochromatographic_test_and_direct_agglutination_test_for_the_diagnosis_of_Mediterranean_visceral_leishmaniasis_in_Spain_ L2 - http://dx.plos.org/10.1371/journal.pntd.0006277 DB - PRIME DP - Unbound Medicine ER -