The immunodiagnostic tests for
cystic echinococcosis (CE) are mostly serological tests based on ELISA that use
hydatid cyst antigens for primary screening because of its simple preparation and availability. The challenge to develop new serological methods (as compared to those based on the
hydatid cyst fluid
antigens) to meet the gold standard remains. Appropriate sources of antigenic material are necessary for application to improve the efficacy of immunodiagnostic tests at a population level. In the current study, a fusion
protein containing the coding sequence of
antigen B2t and two sequences of EPC1
antigen with some modifications was reconstructed. Using bioinformatics tools, these sequences were joined together by applying the sequence of a rigid α-helix-forming linker to obtain an appropriate structure of a fusion
protein. Synthetic
recombinant fusion protein was expressed using pET28a as a vector and evaluated by indirect ELISA test for sera from patients with hepatic CE and other
parasitic infections. The sensitivity of the fusion
protein was lower (88.46%) than the available ELISA kit (96.15%). However, the differences in sensitivity were not statistically significant as compared to the recombinant fusion
peptide with the commercial kit (p = 0.269). The specificity of the
recombinant fusion protein (95.45%) was not significantly lower than the commercial kit (96.59%; p = 1.000). Moreover, surprisingly there was no difference in the cross-reactivity values of performance between the recombinant-ELISA and commercial kit. The positive and negative predictive values of the recombinant
antigen were achieved as 92% and 93.33%, respectively, while for the commercial kit, they were obtained as 94.33% and 97.70%, respectively. In conclusion, as an early evaluation of these
antigens the performance of our
recombinant fusion protein in ELISA is relatively promising. Although, it seemed that this
peptide with specific antigenic
epitopes might be more appropriate for the serological evaluation of CE by use of bioinformatics tools, our findings showed that cross-reactions and a negative reaction could occur in clinical performance. This fusion
protein may have utility for diagnosis in humans, but further evaluation is needed using the WHO ultrasound classification for CE.