Evaluation of a new assay for HBV DNA quantitation in patients with chronic hepatitis B |
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| Affiliation: | 1. Institute of Hygiene, KF-University Graz, Universitaetsplatz 4, A-8010 Graz, Austria;2. Roche Molecular Systems, Branchburg, NJ, USA;3. Department of Pediatrics, KF-University, Graz, Austria;1. Hubei Key Lab of Novel Reactor & Green Chemical Technology, Key Laboratory for Green Chemical Process of Ministry of Education, School of Chemical Engineering and Pharmacy, Wuhan Institute of Technology, Wuhan 430205, China;2. College of Chemical Engineering, Beijing University of Chemical Technology, Beijing 100029, China;3. Sinopec Shanghai Research Institute of Petrochemical Technology, Shanghai 201208, China;1. Process Systems Engineering, Max Planck Institute for Dynamics of Complex Technical Systems, Sandtorstr. 1, D-39106 Magdeburg, Germany;2. Process Systems Engineering, Otto-von-Guericke University Magdeburg, Universitätsplatz 2, D-39106 Magdeburg, Germany;1. Institute of Biochemistry and Biophysics, University of Tehran, Mailbox 13145-1384, Tehran, Iran;2. Center of Excellence in Biothermodynamics, University of Tehran, Mailbox 13145-1384, Tehran, Iran;3. Department of Molecular and Cell Biology, Faculty of Basic Sciences, University of Mazandaran, Mailbox 47416-95447, Babolsar, Iran;4. Biopolymers, Interactions and Associations, UR 1268, Institut National de la Recherche Agronomique, Nantes, France |
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| Abstract: | Background: The Amplicor™ HBV Monitor Test for quantitative determination of serum hepatitis B virus (HBV) DNA has recently been introduced. This assay is based on PCR and a non-radioactive hybridization and detection system on microwell plates.Objective: The performance of the Amplicor™ HBV Monitor Test was evaluated in a routine diagnostic laboratory. The Amplicor™ HBV Monoitor assay was compared to the Digene Hybrid Capture™ System HBV DNA assay for the quantitation of HBV in patient sera.Study design: Sensitivity and reproducibility were determined with 10-fold dilution series of two Eurohep HBV reference plasma specimens. Furthermore, 196 sera from 14 children with chronic HBV infection and interferon therapy were tested with both assays.Results: The detection limit was found to be 103 copies/ml with the Amplicor™ PCR assay compared to 106 to 107 copies/ml with the Digene™ hybridization assay. Both assays were quasi-linear over the measurable ranges. The new PCR assay proved to be very reliable. With the Amplicor™ PCR assay, 26.2% of the HBV DNA-positive clinical samples were found between 103 and 107 copies/ml and all of them tested below the detection limit with the hybridization assay.Conclusion: The Amplicor™ HBV Monitor Test shows excellent sensitivity and provides a valuable tool for the detection of HBV DNA in serum. It can be used for recognizing those patients who might benefit from antiviral therapy, for evaluation of the efficacy of anti-HBV therapy, and for validation of blood products. |
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