Quantitation of HBV DNA in human serum using a branched DNA (bDNA) signal amplification assay.
Quantitation of HBV DNA in human serum using a branched DNA (bDNA) signal amplification assay.
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使用分支 DNA (bDNA) 信号放大测定对人血清中的 HBV DNA 进行定量。
DOI：
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发表时间：
1995
影响因子：
3.5
通讯作者：
R. Perrillo
中科院分区：
文献类型：
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作者：
D. Hendricks;B. J. Stowe;B. Hoo;J. Kolberg;B. Irvine;P. Neuwald;M. Urdea;R. Perrillo
本研究的目的是建立一种非放射性同位素分支DNA(BDNA)信号放大分析方法，用于定量检测人血清中的乙肝病毒(HBVDNA)。定量由标准曲线确定，并表示为HBVDNA当量/毫升(Eq/毫升；285,000 Eq=1pg双链HBVDNA)。BDNA分析的定量动态范围接近四对数，分析检测下限约为100,000 Eq/mL。为了确保99.7%的特异性，定量限被设定为70万Eq/mL。当新手使用者使用不同的试剂组进行测定时，量化值的测定间变异系数在10%到15%之间。用BDNA检测，慢性乙肝患者HBe抗原阳性标本中HBVdna的检出率为94%~100%，而HBe抗原阴性标本中HBVdna的检出率为27%~31%。对于接受抗病毒治疗的乙肝病毒感染患者，BDNA检测可作为预后和治疗监测的有用工具。
The aim of this study was to establish the performance characteristics of a nonradioisotopic branched DNA (bDNA) signal amplification assay for quantitation of hepatitis B virus (HBV) DNA in human serum. Quantitation was determined from a standard curve and expressed as HBV DNA equivalents/mL (Eq/mL; 285,000 Eq = 1 pg of double stranded HBV DNA). The bDNA assay exhibited a nearly four log dynamic range of quantitation and an analytical detection limit of approximately 100,000 Eq/mL. To ensure a specificity of 99.7%, the quantitation limit was set at 700,000 Eq/mL. The interassay percent coefficient of variance for quantification values ranged from 10% to 15% when performed by novice users with different sets of reagents. Using the bDNA assay, HBV DNA was detected in 94% to 100% of hepatitis B e antigen-positive specimens and 27% to 31% of hepatitis B e antigen-negative specimens from chronic HBV-infected patients. The bDNA assay may be useful as a prognostic and therapy monitoring tool for the management of HBV-infected patients undergoing antiviral treatment.