Development and evaluation of Leishmania infantum rK26 ELISA for serodiagnosis of visceral leishmaniasis in Iran

• Published in: Parasitology 2008-08, Vol.135 (9), p.1035-1041
• Main Authors: FARAJNIA, S., DARBANI, B., BABAEI, H., ALIMOHAMMADIAN, M. H., MAHBOUDI, F., GAVGANI, A. M.
• Format: Article
• Language: English
• Subjects: Agglutination Tests; Animals; Biological and medical sciences; Child; Child, Preschool; Enzyme-Linked Immunosorbent Assay; Fundamental and applied biological sciences. Psychology; General aspects; General aspects and techniques. Study of several systematic groups. Models; Humans; Infectious diseases; Invertebrates; Iran; K26; Leishmania infantum; Leishmania infantum - immunology; Leishmaniasis, Visceral - diagnosis; Parasites; recombinant antigens; serodiagnosis; Vector-borne diseases
• ISSN: 0031-1820; 1469-8161
• DOI: 10.1017/S003118200800454X

The purpose of this study was to prepare recombinant K26 antigen from Leishmania infantum and evaluate its performance by enzyme-linked immunosorbent assay (ELISA) test for serodiagnosis of visceral leishmaniasis (VL) in endemic regions of Iran. The results were compared with those obtained by direct agglutination test (DAT) and whole cell ELISA using crude parasite antigen. Of 93 sera from patients with confirmed VL, 90 sera were positive with rK26 ELISA (sensitivity=96·8%), whereas 85 sera were positive with DAT (sensitivity=91·4%) and 89 sera were positive with whole cell ELISA (sensitivity=95·7%). Of 130 subjects who either had other infectious diseases (n=30) or were healthy (n=100), rK26 ELISA were negative in all cases (specificity=100%), whereas DAT were negative in 116 cases (specificity=89·2%) and whole cell ELISA was negative in 114 cases (specificity=87·7%). The results of this study indicate that the rK26 ELISA is more sensitive and specific than conventional methods and could be used for reliable diagnosis of VL caused by Leishmania infantum.