Performance characteristics of two real-time PCR assays for quantification of hepatitis B virus DNA.
Detection and quantification for hepatitis B virus (HBV) DNA has been an essential tool in the clinical setting. We aimed to assess clinical performance of the RealArt HBV TM PCR (RealArt) assay and the COBAS TaqMan HBV (COBAS) assay. Serum levels of HBV DNA in 146 treatment-naïve chronic HBV (CHB) Taiwanese patients (118 males, 47 HBeAg + ; mean age, 34.7+/-13.0 y) were determined by both assays. The detection rate by the RealArt assay was 85.6% (125/146), which was not significantly different from the COBAS assay (89.7%, 131/146). The detection rate was also not significantly different between both assays irrespective of HBeAg seropositivity. The 2 assays were also comparable regarding quantification rate (92.8%, 116/125 vs 93.1%, 122/131). There was a positive correlation in the 109 specimens measurable by both assays (r=0.94,p<0.001). The mean HBV DNA level measured by the COBAS assay was significantly higher than the RealArt assay (5.24+/-1.83 vs 4.79+/-2.09 log IU/ml, p<0.001). This study demonstrated that both RealArt and COBAS assays were comparable regarding clinical performance in HBV DNA measurement.
Lin
Ya-Yun
YY
Department of Preventive Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Huang
Jee-Fu
JF
Liu
Shu-Fen
SF
Yu
Ming-Lung
ML
Tsai
Chiu-Hung
CH
Yang
Jeng-Fu
JF
Lin
I-Ling
IL
Dai
Chia-Yen
CY
Lin
Zu-Yau
ZY
Chen
Shinn-Chern
SC
Chang
Wen-Yu
WY
Chuang
Wan-Long
WL
D000293:Adolescent; D000328:Adult; D000368:Aged; D004279:DNA, Viral / Q000097:blood* / Q000235:genetics; D005260:Female; D006515:Hepatitis B virus / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013223:Statistics as Topic; D013624:Taiwan; D019562:Viral Load / Q000379:methods*; D055815:Young Adult
D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic