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KMID : 0390320130230020085
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Chungbuk Medical Journal
2013 Volume.23 No. 2 p.85 ~ p.91
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Evaluation of Abbott Real-time HBV-DNA Quantification Kit for Hepatitis B Viral Load
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Son Bo-Ra
Shin Kyeong-Seob
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Abstract
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Purpose: The quantification of hepatitis B viral load is essential to monitor antiviral therapy in patients with chronic hepatitis B (CHB). The aim of this study is to evaluate the performance of Abbott real-time HBV quantification kit (Abbott Laboratories, USA).
Materials and Methods: The performance including precision, linearity, detection sensitivity, cross-reactivity, and carry-over, was evaluated. A comparison study of Abbott HBV kit with COBAS TaqMan™ HBV quantification kit (Roche Molecular Systems, Inc., NJ., USA) was also performed by using the samples of 43 patients diagnosed with CHB.
Results: Within-run and between-run coefficients of variation were 0.60-1.45% and 1.65-2.20%, respectively. Linearity were maintained from 2.01 to 8.54 log IU/mL and detection sensitivity was verified to be 15 IU/mL. It showed a good correlation with the COBAS TaqMan™ HBV (r2=0.9625). The HBV-DNA in plasma preparation tube showed higher results than the results in serum separation tube. None of hepatitis C virus showed cross-activity and interference. None of high HBV-DNA concentration showed carry-over.
Conclusions: The performance of Abbott real-time HBV quantification kit was excellent. Therefore, this kit is useful to monitor antiviral therapy in Korean patients with CHB.
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KEYWORD
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HBV-DNA quantification, Antiviral agents, Evaluation of performance
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