Kessler H H, Pierer K, Dragon E, Lackner H, Santner B, Stünzner D, Stelzl E, Waitzl B, Marth E
Institute of Hygiene, KF-University Graz, Austria.
Clin Diagn Virol. 1998 Jan;9(1):37-43. doi: 10.1016/s0928-0197(97)10008-3.
The Amplicor HBV Monitor Test for quantitative determination of serum hepatitis B virus (HBV) DNA has recently been introduced. This assay is based on PCR and a non-radioactive hybridization and detection system on microwell plates.
The performance of the Amplicor HBV Monitor Test was evaluated in a routine diagnostic laboratory. The Amplicor HBV Monoitor assay was compared to the Digene Hybrid Capture System HBV DNA assay for the quantitation of HBV in patient sera.
Sensitivity and reproducibility were determined with 10-fold dilution series of two Eurohep HBV reference plasma specimens. Furthermore, 196 sera from 14 children with chronic HBV infection and interferon therapy were tested with both assays.
The detection limit was found to be 10(3) copies/ml with the Amplicor PCR assay compared to 10(6) to 10(7) copies/ml with the Digene hybridization assay. Both assays were quasi-linear over the measurable ranges. The new PCR assay proved to be very reliable. With the Amplicor PCR assay, 26.2% of the HBV DNA-positive clinical samples were found between 10(3) and 10(7) copies/ml and all of them tested below the detection limit with the hybridization assay.
The Amplicor HBV Monitor Test shows excellent sensitivity and provides a valuable tool for the detection of HBV DNA in serum. It can be used for recognizing those patients who might benefit from antiviral therapy, for evaluation of the efficacy of anti-HBV therapy, and for validation of blood products.
最近推出了用于定量测定血清乙型肝炎病毒（HBV）DNA的Amplicor HBV监测检测法。该检测基于聚合酶链反应（PCR）以及微孔板上的非放射性杂交和检测系统。
在常规诊断实验室中评估Amplicor HBV监测检测法的性能。将Amplicor HBV监测检测法与Digene杂交捕获系统HBV DNA检测法用于定量患者血清中的HBV进行比较。
使用两种欧洲肝脏研究学会（Eurohep）HBV参考血浆标本的10倍稀释系列测定灵敏度和重复性。此外，对14例慢性HBV感染且接受干扰素治疗的儿童的196份血清进行了两种检测。
发现Amplicor PCR检测法的检测限为10³拷贝/毫升，而Digene杂交检测法的检测限为10⁶至10⁷拷贝/毫升。两种检测法在可测量范围内均呈近似线性。新的PCR检测法被证明非常可靠。使用Amplicor PCR检测法，26.2%的HBV DNA阳性临床样本在10³至10⁷拷贝/毫升之间，而用杂交检测法检测时所有这些样本均低于检测限。
Amplicor HBV监测检测法显示出出色的灵敏度，为血清中HBV DNA的检测提供了有价值的工具。它可用于识别那些可能从抗病毒治疗中受益的患者，评估抗HBV治疗的疗效，以及验证血液制品。
