DEVELOPMENT OF A DOMESTIC ENZYME IMMUNE TEST SYSTEM FOR DETECTION OF ANTI-HEV IGM IN BLOOD SERUM

Background. Though the Republic of Belarus does not belong to countries endemic for viral hepatitis E, numerous studies have proved that hepatitis E virus (HEV) actively circulates among humans and animals. However, the circulation is latent that makes it difficult to diagnose the infection in a timely manner. Objective. To develop and evaluate the quality of a domestic ELISA test system for the detection of anti-HEI IgM. Material and methods. 96-well plates, recombinant proteins ORF2 and ORF3 of the 3rd HEV genotype, conjugate of monoclonal antibodies to human IgM with horseradish peroxidase, solutions for dilution of serums and conjugate containing bovine serum albumin. Results. The recommended concentrations of recombinant polypeptides ORF2 and ORF3 of hepatitis E virus genotype 3 for sorption are 2 and 1 μg/ml, respectively. The optimum dilution of the conjugate is 1:13 000. False positive and false negative results were not detected, sensitivity and specificity being at least 99%. The mean value for coefficient of variation within one plate is 6.4%, within two plates is 11.3%. Conclusions. The characteristics of the developed national test system comply with the recommended standards, thus indicating the possibility of its implementation into clinical laboratory diagnostics.