Comparison of Clinical Application of the Abbott HBV PCR Kit and the Versant HBV DNA 3.0 Test to Measure Serum Hepatitis B Virus DNA in Taiwanese Patients

oleh: Jeng-Fu Yang, Ya-Yun Lin, Jee-Fu Huang, Shu-Fen Liu, Pei-Yu Chu, Ming-Yen Hsieh, Zu-Yau Lin, Shinn-Cherng Chen, Liang-Yen Wang, Chia-Yen Dai, Wan-Long Chuang, Ming-Lung Yu

Format: Article
Diterbitkan: Wiley 2009-08-01

Deskripsi

With an estimated 350–400 million people worldwide chronically infected with hepatitis B virus (HBV), and the subsequent serious complications caused by liver damage including cirrhosis, liver failure, and hepatocellular carcinoma, HBV infection remains a global health issue, particularly in Taiwan, an HBV-hyperendemic area. Sensitive and accurate quantification of HBV DNA is necessary to monitor patients with chronic hepatitis B who are receiving antiviral therapy to determine treatment response and adapt therapy. We evaluated and compared the clinical performance of two HBV DNA assays based on different technologies: the RealArt™ HBV™ PCR Kit (Abbott HBV DNA PCR kit, real-time polymerase chain reaction assay, detection limit: 27IU/mL) and the VERSANT bDNA 3.0 assay (Bayer, branched DNA signal amplification assay, detection limit: 357 IU/mL). Serum levels of HBV DNA in 173 chronic HBV carriers were determined using both the RealArt™ HBV™ PCR Kit and the VERSANT bDNA 3.0 test. Of the 173 samples analyzed for baseline viral load detection, HBV DNA was quantifiable in 147 patients (82.1%) by the RealArt™ HBV™ PCR Kit, which was significantly higher than the 92 (53.2%) samples quantified by the VERSANT bDNA 3.0 assay. A total of 86 (49.7%) samples were quantifiable by both assays, whereas 25 (14.5%) were below the detection limit of both assays. The HBV DNA quantification values measured by the RealArt™ HBV™ PCR Kit and the VERSANT bDNA 3.0 assay were positively correlated (Spearman's rank correlation coefficient r = 0.932, p < 0.001). On average, the results derived from the RealArt™ HBV™ PCR Kit were 0.67 log lower than those of the VERSANT bDNA 3.0 assay. HBV DNA concentrations were significantly higher in 63HBV e antigen (HBeAg) seropositive patients than in 110 HBeAg-seronegative patients (5.42 ± 2.34 logs vs. 3.21 ± 2.27 logs, p < 0.001). The RealArt™ HBV™ PCR Kit is more sensitive and has a wider dynamic range than the VERSANT bDNA 3.0 assay in the clinical setting of chronic hepatitis B patients. The sensitivity and wide dynamic range of the PCR assay allow optimal monitoring and timely adaptation of antiviral therapy. Nevertheless, the HBV DNA values measured by the RealArt™ HBV™ PCR Kit and the VERSANT bDNA 3.0 assay were significantly correlated.