title: Performance evaluation of ExiStation HBV diagnostic system for hepatitis B virus DNA quantitation.
abstract: The performance of a recently developed real-time PCR system, the ExiStation HBV diagnostic system, for quantitation of hepatitis B virus (HBV) in human blood was evaluated. The detection limit, reproducibility, cross-reactivity, and interference were evaluated as measures of analytical performance. For the comparison study, 100 HBV-positive blood samples and 100 HBV-negative samples from Korean Blood Bank Serum were used, and the results of the ExiStation HBV system showed good correlation with those obtained using the Cobas TaqMan (r2=0.9931) and Abbott real-time PCR systems (r2=0.9894). The lower limit of detection was measured as 9.55 IU/mL using WHO standards and the dynamic range was linear from 6.68 to 6.68×10(9) IU/mL using cloned plasmids. The within-run coefficient of variation (CV) was 9.4%, 2.1%, and 1.1%, and the total CV was 11.8%, 3.6%, and 1.7% at a concentration of 1.92 log10 IU/mL, 3.88 log10 IU/mL, and 6.84 log10 IU/mL, respectively. No cross-reactivity or interference was detected. The ExiStation HBV diagnostic system showed satisfactory analytical sensitivity, excellent reproducibility, no cross-reactivity, no interference, and high agreement with the Cobas TaqMan and Abbott real-time PCR systems, and is therefore a useful tool for the detection and monitoring of HBV infection.
authors.affiliation: Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
authors.forename: Young Joo
authors.initials: YJ
authors.lastname: Cha
authors.forename: Soo Jin
authors.initials: SJ
authors.lastname: Yoo
authors.forename: Yong-Hak
authors.initials: YH
authors.lastname: Sohn
authors.forename: Hyun Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D001769:Blood / Q000821:virology; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D004279:DNA, Viral
keywords: Hepatitis B virus; Quantitation; Real-time PCR
references.citation: J Virol Methods. 1995 Feb;51(2-3):277-88
references.pmid: 7738148
references.citation: J Clin Microbiol. 2010 Oct;48(10):3641-7
references.pmid: 20720031
references.citation: J Clin Microbiol. 2011 Sep;49(9):3215-21
references.pmid: 21795507
references.citation: J Clin Microbiol. 1994 Aug;32(8):1939-44
references.pmid: 7527426
references.citation: J Clin Microbiol. 1994 Oct;32(10):2581-3
references.pmid: 7814504
references.citation: J Clin Microbiol. 2011 Aug;49(8):2854-8
references.pmid: 21697326
references.citation: J Clin Microbiol. 2002 Apr;40(4):1567-8
references.pmid: 11923400
references.citation: J Hepatol. 2009 Feb;50(2):227-42
references.pmid: 19054588
references.citation: Rinsho Byori. 1998 Feb;46(2):151-7
references.pmid: 9528339
references.citation: J Clin Microbiol. 1999 May;37(5):1489-97
references.pmid: 10203511