Performance evaluation of ExiStation HBV diagnostic system for hepatitis B virus DNA quantitation
- Authors
- Cha, Young Joo; Yoo, Soo Jin; Sohn, Yong-Hak; Kim, Hyun Soo
- Issue Date
- Nov-2013
- Publisher
- ELSEVIER SCIENCE BV
- Keywords
- Hepatitis B virus; Real-time PCR; Quantitation
- Citation
- JOURNAL OF VIROLOGICAL METHODS, v.193, no.2, pp 492 - 497
- Pages
- 6
- Journal Title
- JOURNAL OF VIROLOGICAL METHODS
- Volume
- 193
- Number
- 2
- Start Page
- 492
- End Page
- 497
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/14155
- DOI
- 10.1016/j.jviromet.2013.07.027
- ISSN
- 0166-0934
1879-0984
- 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 (r(2) = 0.9931) and Abbott real-time PCR systems (r(2) = 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 x 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 log(10) IU/mL, 3.88 log(10) IU/mL, and 6.84 log(10) 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. (C) 2013 Elsevier B.V. All rights reserved.
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