Valentine-Thon E
Labor Schiwara, von Winterfeld, Pfanzelt, Kunz, Bremen, Germany.
J Clin Microbiol. 1995 Feb;33(2):477-80. doi: 10.1128/jcm.33.2.477-480.1995.
The sensitivity, specificity, reproducibility, detection level, and quantification potential of the SHARP Signal System for enzymatic detection of amplified hepatitis B virus (HBV) DNA in clinical samples were evaluated by testing 104 samples in parallel in a SHARP PCR, an in-house HBV PCR, and a dot blot hybridization assay for semiquantification. SHARP PCR showed a sensitivity of 100%, a specificity of 92.3% (resolved, 100%), a reproducibility of 92.3% (all discrepant serum samples involved very low levels of HBV DNA), and a detection level of at least 3.5 pg/ml. Clinically relevant quantification of the amplified products was not feasible.
通过在SHARP聚合酶链反应(PCR)、内部乙肝病毒PCR以及用于半定量的斑点印迹杂交试验中对104份临床样本进行平行检测,评估了用于临床样本中扩增乙型肝炎病毒(HBV)DNA酶促检测的SHARP信号系统的灵敏度、特异性、重现性、检测水平和定量潜力。SHARP PCR显示灵敏度为100%,特异性为92.3%(校正后为100%),重现性为92.3%(所有存在差异的血清样本均涉及极低水平的HBV DNA),检测水平至少为3.5 pg/ml。对扩增产物进行临床相关的定量是不可行的。