Development of a protocol for the quantitative determination of HBeAg using the Elecsys (R) HBeAg immunoassay

作者：Wursthorn K^*; Zacher B J; Jaroszewicz J; Darnedde M; Manns M; Wedemeyer H

来源：Journal of Viral Hepatitis, 2011, 18(7): E179-E183.

DOI：10.1111/j.1365-2893.2010.01419.x

• HBeAg
• immunoassay
• protocol
• quantitative

Loss of hepatitis 'e' antigen (HBeAg) in patients with HBeAg-positive chronic hepatitis B is associated with improved long-term clinical outcome and is defined as a goal of antiviral treatment by clinical practice guidelines. Recent studies suggest that baseline levels and on-treatment monitoring of HBeAg levels may identify patients most likely to respond to therapy. The aim of this study was the development of a protocol for the quantitative determination of HBeAg using the Elecsys (R) HBeAg immunoassay. The linear range of the Elecsys (R) HBeAg immunoassay was established using recombinant HBeAg and five different diluents. The assay was validated against the Paul Ehrlich Institute (PEI) international standard serum. Linearity was demonstrated up to a cut-off index (COI) of 1000, independent of the diluent used. Optimal linearity was obtained using the Elecsys (R) Universal Diluent. Using the PEI reference standard, conversion factors were established as 4.50 COI for 1 PEIU/mL corresponding to 0.222 PEIU/mL for a COI of 1. Based on the results from these analyses, a simple algorithm for the quantitative measurement of HBeAg using the Elecsys (R) HBeAg immunoassay was developed. Using a simple algorithm with an initial 1: 40 dilution, the Elecsys (R) HBeAg assay provides robust quantification of serum HBeAg in an easy-to-use and rapid system. The use of a commercially available, standardized diluent improves comparability between laboratories.

• 出版日期2011-7