The study was carried out to develop approaches to standardization of laboratory diagnostic of hepatitis E. The three stages of standardization are establishment of analytical sensitivity of molecular test for detection of RNA of virus of hepatitis E; establishment of analytical sensitivity in International Units of enzyme-linked immunosorbent assay testing widely applied in Russia for detection of anti-virus of hepatitis E; And development of national reference material - standard anti-virus of hepatitis E IgG validated relatively to International standard. The results of study permitted to develop tools for standardizing of laboratory diagnostic of hepatitis E and epidemiological control of the given function - molecular test for detecting RNA of virus of hepatitis E with sensitivity within range of 1250250 IU/ml, data concerning analytical sensitivity of commercial enzyme-linked immunosorbent assay testing for detecting anti-virus of hepatitis E (0.25 IU/ml) and national standard of anti-virus of hepatitis E with concentration of 5 IU/ml.
Keywords: WHO international standard; enzyme-linked immunosorbent assay; hepatitis E.