title: Comparison of Abbott and Da-an real-time PCR for quantitating serum HBV DNA.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The Da-an assay presented lower sensitivity and a narrower linear range as compared to the Abbott assay, suggesting the need to be improved.
authors.affiliation: 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.
authors.forename: Ning
authors.initials: N
authors.lastname: Qiu
authors.affiliation: 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.
authors.forename: Rui
authors.initials: R
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Jian-Guo
authors.initials: JG
authors.lastname: Yu
authors.affiliation: 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.
authors.forename: Wen
authors.initials: W
authors.lastname: Yang
authors.affiliation: 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.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: 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.
authors.forename: Yong
authors.initials: Y
authors.lastname: An
authors.affiliation: 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.
authors.forename: Tong
authors.initials: T
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Xue-En
authors.initials: XE
authors.lastname: Liu
authors.affiliation: 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.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhuang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002138:Calibration; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006515:Hepatitis B virus / Q000235:genetics*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D011237:Predictive Value of Tests; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D019562:Viral Load; D055815:Young Adult
chemical_list: D015415:Biomarkers; D004279:DNA, Viral
keywords: Antiviral therapy; Chronic hepatitis B; Hepatitis B virus; Hepatitis B virus DNA quantitation; Real-time polymerase chain reaction