Performance Characteristics and Comparison of Abbott and artus Real-Time Systems for Hepatitis B Virus DNA Quantification

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http://jcm.asm.org/cgi/content/abstract/49/9/3215

Journal of Clinical Microbiology, September 2011,p. 3215-3221, Vol. 49, No. 9

0095-1137/11/$12.00+0 doi:10.1128/JCM.00915-11

Copyright © 2011, American Society for Microbiology. .

Performance Characteristics and Comparison of Abbott and artus Real-Time Systems

for Hepatitis B Virus DNA Quantification

Ashrafali M. Ismail1, Jayashree Sivakumar1, Raghavendran Anantharam1, Sujitha

Dayalan1, Prasanna 2, Gnanadurai J. Fletcher1, Manu Gnanamony1 and Priya

Abraham1*

Departments of Clinical Virology,1

Biostatistics, Christian Medical College, Vellore, India 6320042

Received 4 May 2011/ Returned for modification 1 July 2011/ Accepted 19 July

2011

Virological monitoring of hepatitis B virus (HBV) DNA is critical to the

management of HBV infection. With several HBV DNA quantification assays

available, it is important to use the most efficient testing system for

virological monitoring. In this study, we evaluated the performance

characteristics and comparability of three HBV DNA quantification systems:

Abbott HBV real-time PCR (Abbott PCR), artus HBV real-time PCR with QIAamp DNA

blood kit purification (artus-DB), and artus HBV real-time PCR with the QIAamp

DSP virus kit purification (artus-DSP). The lower limits of detection of these

systems were established against the WHO international standards for HBV DNA and

were found to be 1.43, 82, and 9 IU/ml, respectively. The intra-assay and

interassay coefficients of variation of plasma samples (1 to 6 log10 IU/ml)

ranged between 0.05 to 8.34% and 0.16 to 3.48% for the Abbott PCR, 1.53 to

26.85% and 0.50 to 12.89% for artus-DB, and 0.29 to 7.42% and 0.94 to 3.01% for

artus-DSP, respectively. Ninety HBV clinical samples were used for comparison of

assays, and paired quantitative results showed strong correlation by linear

regression analysis (artus-DB with Abbott PCR, r = 0.95; Abbott PCR with

artus-DSP, r = 0.97; and artus-DSP with artus-DB, r = 0.94). Bland-Altman

analysis showed a good level of agreement for Abbott PCR and artus-DSP, with a

mean difference of 0.10 log10 IU/ml and limits of agreement of –0.91 to 1.11

log10 IU/ml. No genotype-specific bias was seen in all three systems for HBV

genotypes A, C, and D, which are predominant in this region. This finding

illustrates that the Abbott real-time HBV and artus-DSP systems show more

comparable performance than the artus-DB system, meeting the current guidelines

for assays to be used in the management of hepatitis B.

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* Corresponding author. Mailing address: Department of Clinical Virology,

Christian Medical College, Vellore 632004, India. Phone: 91 416 2282717. Fax: 91

416 2232035. E-mail: priyaabraham@....

Published ahead of print on 27 July 2011.