Original Article
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 7, 2014; 20(33): 11762-11769
Published online Sep 7, 2014. doi: 10.3748/wjg.v20.i33.11762
Comparison of Abbott and Da-an real-time PCR for quantitating serum HBV DNA
Ning Qiu, Rui Li, Jian-Guo Yu, Wen Yang, Wei Zhang, Yong An, Tong Li, Xue-En Liu, Hui Zhuang
Ning Qiu, Rui Li, Tong Li, Xue-En Liu, Hui Zhuang, Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China
Jian-Guo Yu, Wen Yang, Wei Zhang, Yong An, Department of Internal Medicine, Liver Disease Center, No. 88 Hospital of People’s Liberation Army, Taian 27100, Shandong Province, China
Author contributions: Qiu N and Li R performed the majority of experiments; Yu JG, Yang W, Zhang W and An Y managed the clinical therapy and collected serum samples; Qiu N and Liu XE performed the analysis and interpretation of data; Liu XE designed this comparative study and was involved in writing and editing the manuscript; Li T and Zhuang H revised the manuscript critically for important content.
Supported by A Major Science and Technology Special Project of China Twelfth Five-year Plan, No. 2013ZX10002004 and No. 2012ZX10002003
Correspondence to: Xue-En Liu, MD, Associate Professor of Microbiology, Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, No. 38 Xueyuan Road, Haidian District, Beijing 100191, China. xueenliu@bjmu.edu.cn
Telephone: +86-10-82802413 Fax: +86-10-82802413
Received: December 2, 2013
Revised: March 27, 2014
Accepted: April 21, 2014
Published online: September 7, 2014
Processing time: 278 Days and 20.3 Hours
Abstract

AIM: To compare the performance of the Da-an real-time hepatitis B virus (HBV) DNA assay and Abbott RealTime HBV assay.

METHODS: HBV DNA standards as well as a total of 180 clinical serum samples from patients with chronic hepatitis B were measured using the Abbott and Da-an real-time polymerase chain reaction (PCR) assays. Correlation and Bland-Altman plot analysis was used to compare the performance of the Abbott and Da-an assays. The HBV DNA levels were logarithmically transformed for analysis. All statistical analyses were performed using SPSS for Windows version 18.0. The correlation between the two assays was analyzed by Pearson’s correlation and linear regression. The Bland-Altman plots were used for the analysis of agreement between the two assays. A P value of < 0.05 was considered statistically significant.

RESULTS: The HBV DNA values measured by the Abbott or Da-an assay were significantly correlated with the expected values of HBV DNA standards (r = 0.999, for Abbott; r = 0.987, for Da-an, P < 0.001). A Bland-Altman plot showed good agreement between these two assays in detecting HBV DNA standards. Among the 180 clinical serum samples, 126 were quantifiable by both assays. Fifty-two samples were detectable by the Abbott assay but below the detection limit of the Da-an assay. Moreover, HBV DNA levels measured by the Abbott assay were significantly higher than those of the Da-an assay (6.23 ± 1.76 log IU/mL vs 5.46 ± 1.55 log IU/mL, P < 0.001). A positive correlation was observed between HBV DNA concentrations determined by the two assays in 126 paired samples (r = 0.648, P < 0.001). One hundred and fifteen of 126 (91.3%) specimens tested with both assays were within mean difference ± 1.96 SD of HBV DNA levels.

CONCLUSION: The Da-an assay presented lower sensitivity and a narrower linear range as compared to the Abbott assay, suggesting the need to be improved.

Keywords: Hepatitis B virus; Hepatitis B virus DNA quantitation; Real-time polymerase chain reaction; Chronic hepatitis B; Antiviral therapy

Core tip: The hepatitis B virus (HBV) DNA values measured by the Abbott or Da-an real-time polymerase chain reaction assay were significantly correlated with the expected values of HBV DNA standards. A Bland-Altman plot showed good agreement between the assays. For clinical evaluation, HBV DNA levels derived from the Abbott assay were significantly higher than those of the Da-an assay.