Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6134075 | Journal of Virological Methods | 2013 | 6 Pages |
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 (r2Â =Â 0.9931) and Abbott real-time PCR systems (r2Â =Â 0.9894). The lower limit of detection was measured as 9.55Â IU/mL using WHO standards and the dynamic range was linear from 6.68 to 6.68Â ÃÂ 109Â 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 1.92Â log10Â IU/mL, 3.88Â log10Â IU/mL, and 6.84Â log10Â 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.
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Authors
Young Joo Cha, Soo Jin Yoo, Yong-Hak Sohn, Hyun Soo Kim,