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

針對台灣慢性B型肝炎患者以Abbott HBV PCR Kit 和 VERSANT HBV DNA 3.0 Test 定量血清中HBV DNA值的臨床應用與比較

楊正福(Jeng-Fu Yang) ； 林雅雲(Ya-Yun Lin) ； 黃志富(Jee-Fu Huang) ； 劉淑芬(Shu-Fen Liu) ； 褚佩瑜(Pei-Yu Chu) ； 謝明彥(Ming-Yen Hsieh) ； 林子堯(Zu-Yau Lin) ； 陳信成(Shinn-Cherng Chen) ； 王良彥(Liang-Yen Wang) ； 戴嘉言(Chia-Yen Dai) ； 莊萬龍(Wan-Long Chuang) ； 余明隆(Ming-Lung Yu)

《The Kaohsiung Journal of Medical Sciences》 25卷8期 (2009/08) Pp. 413-422

摘要

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(superscript ™) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit, which was significantly higher than the 92 (53.2%) samples quantified by the VERSANT bDNA 3.0 assay. Atotal 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(superscript TM) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit were 0.67 log lower than those of the VERSANT bDNA3.0 assay. HBV DNA concentrations were significantly higher in 63 HBV 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(superscript TM) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit and the VERSANT bDNA 3.0 assay were significantly correlated.

關鍵字

bDNA3.0 assay ； HBeAg ； HBV DNA PCR Kit ； HBV DNA quantification ； HBV infection

並列摘要

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(superscript ™) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit, which was significantly higher than the 92 (53.2%) samples quantified by the VERSANT bDNA 3.0 assay. Atotal 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(superscript TM) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit were 0.67 log lower than those of the VERSANT bDNA3.0 assay. HBV DNA concentrations were significantly higher in 63 HBV 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(superscript TM) HBV(superscript TM) 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(superscript TM) HBV(superscript TM) PCR Kit and the VERSANT bDNA 3.0 assay were significantly correlated.

並列關鍵字

bDNA3.0 assay ； HBeAg ； HBV DNA PCR Kit ； HBV DNA quantification ； HBV infection