title: Evaluation of an enzyme-linked immunosorbent assay for detection and quantification of hepatitis B virus PreS1 envelope antigen in serum samples: comparison with two commercial assays for monitoring hepatitis B virus DNA.
abstract: An in-house sensitive and easy-to-use solid-phase enzyme-linked immunoassay (ELISA) was adapted for the detection and quantification of hepatitis B virus (HBV) PreS1 envelope antigen in serum, and compared with the HBV DNA Hybrid Capturetrade mark system from Murex and the polymerase chain reaction (PCR) Amplicortrade mark HBV Monitor assay from Roche. Twenty-five patients with chronic hepatitis B after liver transplantation were included in this study. The sensitivity of our ELISA was found to be 50 pg of HBsAg/PreS1Ag ml-1. The linearity was between 0.1 and 100 ng ml-1. Intra-assay reproducibility was obtained with a standard deviation of <1%. No correlation between the presence of serum PreS1 antigen and viral DNA detected by direct hybridization (Murex) was observed. In contrast, there was a significant 96% correspondence in the presence of PreS1 antigen and viral DNA detected and quantified by the PCR assay (Roche). In conclusion, the most important and reliable markers for monitoring residual HBV replication in serum were HBV DNA by the PCR assay, and virus envelope PreS1Ag by our in-house ELISA. Thus, PreS1Ag disappearance in serum could be used for evaluating the efficacy of antiviral therapies.
authors.affiliation: Centre Hépato-Biliaire, INSERM E99-41 and UPRES 1596, Hòpital Paul Brousse, Villejuif, France; Roche Diagnostics, Grenoble, France.
authors.forename: D B
authors.initials: DB
authors.lastname: Le Guillou
authors.forename: J C
authors.initials: JC
authors.lastname: Duclos-Vallée
authors.forename: F
authors.initials: F
authors.lastname: Eberle
authors.forename: F
authors.initials: F
authors.lastname: Capel
authors.forename: M A
authors.initials: MA
authors.lastname: Petit
mesh_terms: D004279:DNA, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification* / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000821:virology*; D006801:Humans; D009693:Nucleic Acid Hybridization; D016133:Polymerase Chain Reaction / Q000379:methods; D011498:Protein Precursors / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D011498:Protein Precursors; D011933:Reagent Kits, Diagnostic; C050806:presurface protein 1, hepatitis B surface antigen