title: Quantitative assessment of hepatitis B virus DNA in chronic hepatitis B: comparison of two solution hybridization assays.
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 alpha-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.
authors.affiliation: Department of Internal Medicine II, University Hospital Dijkzigt, The Netherlands.
authors.forename: H L
authors.initials: HL
authors.lastname: Janssen
authors.forename: Y A
authors.initials: YA
authors.lastname: Schoenmaker-Weber
authors.forename: H
authors.initials: H
authors.lastname: Kruining
authors.forename: S W
authors.initials: SW
authors.lastname: Schalm
authors.forename: R A
authors.initials: RA
authors.lastname: Heijtink
mesh_terms: D002908:Chronic Disease; D004279:DNA, Viral / Q000097:blood / Q000235:genetics*; D006509:Hepatitis B / Q000382:microbiology*; D006515:Hepatitis B virus / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*
chemical_list: D004279:DNA, Viral