Development of a Multi-Epitope Recombinant Protein for the Diagnosis of Human Visceral Leishmaniasis

Abstract background: iran is one of the endemic areas of mediterranean visceral leish-maniasis, a disease caused by leishmania infantum. in this work, we examined whether proteína quimérica 10 (pq10) recombinant protein is suitable for immu-nological diagnosis of human visceral leishmaniasis. methods: the study was carried out in tarbiat modares university during 2016-2018. the coding sequence of pq10 recombinant protein was sub-cloned in pet28 expression vector and was commercially synthesized by generay bio-technology, china. sequencing with proper primers was done, the expression, op-timization of expression and protein purification were performed, and the purified recombinant protein was confirmed by western blot. the efficacy of pq10 for se-rodiagnosis was evaluated with 50 positive and 50 negative serum samples, which confirmed by the direct agglutination test and collected from individuals living in the visceral leishmaniasis endemic areas of iran. elisa was performed with the pq10 recombinant protein. results: the 95% ci sensitivity of elisa that was evaluated with sera from natu-rally infected individuals was 84%. the 95% ci specificity value of the elisa de-termined with sera from healthy individuals (50 serum samples) and from individu-als with other infectious diseases was 82%. the 95% ci positive predictive value (ppv) and negative predictive value (npv) were exterminated 82.35% and 83.67%, respectively. conclusion: we have used a recombinant synthetic protein to improve serodiag-nosis of human visceral leishmaniasis. pq10 could be useful for diagnosis of asymptomatic cases, as well as in the early phase of infections.