Comparison of the COBAS TaqMan HBV test with the COBAS Amplicor monitor test for measurement of hepatitis B virus DNA in serum.
Quantitation of low hepatitis B virus (HBV) DNA levels in patients with chronic hepatitis B is important for monitoring natural history of disease and treatment efficacy. This study aimed to compare the quantitation range and analytical sensitivity of the newly developed COBAS TaqMan HBV test (TaqMan test) with the COBAS Amplicor HBV Monitor Test (Amplicor test), using the Eurohep HBV reference plasma and serum samples from patients. Serial dilutions (2.7x10(1)-2.7x10(8) copies/ml) of the Eurohep HBV reference plasma and 50 serum samples from chronic hepatitis B patients were tested by both assays. The TaqMan test could detect seven (2.7x10(2)-2.7x10(8) copies/ml) of eight dilutions of the reference plasma, while the Amplicor test could only detect three of them (2.7x10(3)-2.7x10(5) copies/ml). The HBV DNA values measured by the TaqMan test correlated very well with the theoretical Eurohep standard values (r=0.998, P<0.001). There were good correlations between the HBV DNA levels measured by the two assays on both the Eurohep reference plasma (r=0.993, P<0.001) and serum samples from patients (r=0.904, P<0.001). Compared to the Amplicor test, the TaqMan test had a higher sensitivity (50 vs. 300 copies/ml), shorter assay time (6 vs. 10 hr), and wider dynamic range (8 vs. 3 logs), and was more cost-effective in a clinical setting. These data indicate that the TaqMan test is an excellent tool for HBV DNA quantitation.
Sum
Simon Siu-Man
SS
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.
Wong
Danny Ka-Ho
DK
Yuen
John Chi-Hang
JC
Lai
Ching-Lung
CL
Yuen
Man-Fung
MF
D000293:Adolescent; D000328:Adult; D000368:Aged; D001331:Automation / Q000295:instrumentation / Q000379:methods; D017931:DNA Primers; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006509:Hepatitis B / Q000097:blood* / Q000175:diagnosis; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification* / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D017931:DNA Primers; D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic