Abstract
BackgroundHepatitis B virus (HBV) DNA levels are crucial for managing chronic hepatitis B (CHB). It was unclear whether Daan real-time polymerase chain reaction test (Daan test) or COBAS TaqMan HBV DNA Test (Cobas TaqMan) was superior in measuring different HBV DNA levels in clinical specimens.MethodsWe enrolled 67 treatment-naïve, HBV surface antigen-positive CHB patients (high baseline viral levels) who received either lamivudine/adefovir or entecavir. Serum samples were tested at baseline and treatment week 24 using the Daan test and Cobas TaqMan.ResultsIn the 67-baseline samples, the HBV DNA levels with the Cobas TaqMan (7.90 ± 0.73 log10 IU/mL) were significantly greater than those of the Daan test (7.11 ± 0.44 log10 IU/mL; P < 0.001). Of the 67 24-week samples (low viral levels), the Cobas TaqMan detected 59 (88.1%; 8 undetected); the Daan test detected 33 (49.3%; 34 undetected; P < 0.001). The Cobas TaqMan detected HBV DNA in 26 of 34 samples undetectable by the Daan test (range, 1.4–3.7 log10 IU/mL) or 38% of samples (26/67). The reductions in viral load after 24 weeks of oral antiviral treatment in the 33 samples that were positive for both the Daan test and the Cobas TaqMan test were significantly different (3.59 ± 1.11 log10 IU/mL versus 4.87 ± 1.58 log10 IU/mL, respectively; P = 0.001). Spearman correlation analysis showed positive correlation between results from two tests (rp = 0.602,P<0.001). The HBV genotypes and the anti-viral treatment did not affect the measurements of the HBV DNA by the Daan assay and the Cobas Taqman assay.ConclusionThe Cobas Taqman was more sensitive at low viral loads than the Daan test and the change from complete to partial virological response could affect clinical decisions. The Cobas Taqman may be more appropriate for detection of HBV DNA levels.
Highlights
Hepatitis B virus (HBV) DNA levels are crucial for managing chronic hepatitis B (CHB)
From July, 2011 to March, 2012, we enrolled a cohort of 67 treatment-naive patients (48 males, 19 females), who were diagnosed with hepatitis B virus e antigen (HBeAg)-positive CHB with high viral loads at baseline
Demographics Sixty-seven treatment-naïve patients (48 male, 19 female) who were diagnosed with hepatitis B virus e antigen (HBeAg) positive CHB with high viral load at baseline from July 2011 to March 2012 were enrolled in a multicenter prospective trial
Summary
Hepatitis B virus (HBV) DNA levels are crucial for managing chronic hepatitis B (CHB) It was unclear whether Daan real-time polymerase chain reaction test (Daan test) or COBAS TaqMan HBV DNA Test (Cobas TaqMan) was superior in measuring different HBV DNA levels in clinical specimens. Measurement of HBV DNA levels is the most direct and effective way to assess HBV management and high HBV DNA levels are risk factors for development of fibrosis, cirrhosis, hepatocellular carcinoma, and drug resistance [11]. Yuan and colleagues [13] found that only 38% of serum samples (161 of 425) of Chinese CHB patients had detectable HBV DNA levels by a liquid hybridization method (Digene Hybrid Capture II test (Digene test; Digene, Gathersburg, MD, USA); but HBV DNA levels were detected in 89% of these samples (383/425) by the real-time polymerase chain reaction (PCR) method, Cobas TaqMan assay (Cobas TaqMan, Roche Molecular Systems, Inc., Branchburg, NJ). Comparison of the accuracy and detectable range between the different PCR tests suggest that the Cobas TaqMan assay (Cobas TaqMan) shows similar sensitivity and specificity rates to the RealArt assay (Abbott, North Chicago, IL USA) [3]
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