Quantitative assessment of hepatitis B virus DNA in chronic hepatitis B: comparison of two solution hybridization assays

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Abstract
We compared two solution hybridization assays, the AffiProbe assay (Orion Corporation) and the Abbott HBV‐DNA assay (Abbott), for quantitative measurement of hepatitis B virus (HBV) DNA in serum samples obtained from chronic hepatitis B surface antigen (HBsAg) carriers. Forty transversally collected (group 1) and 83 serially collected (group 2) serum samples from chronic hepatitis B patients were tested with both assays. The serial serum samples were obtained from 6 patients who underwent α‐interferon therapy with different outcomes (nonresponse, hepatitis B e antigen [HBeAg] seroconversion, HBeAg and HBsAg seroconversion). In group 1 a good correlation (r = 0.91; P < 0.001) was found between the HBV‐DNA results of the two assays. Two samples (5%) were HBV‐DNA positive according to the Abbott but negative according to the AffiProbe assay; for all other samples the HBV‐DNA status corresponded. In group 2 the assays gave colinear HBV‐DNA results during follow‐up of 5 of the 6 patients (correlation for the total group: r = 0.90; P < 0.001). Nevertheless, in both groups the AffiProbe assay yielded about 5–10 times higher HBV‐DNA levels than the Abbott HBV‐DNA assay (P < 0.001). These discordant results were most probably due to standardization differences of the positive control samples of the two test systems. This observation underlines the need for international standardization of HBV‐DNA and uniform reference panels.