摘要
目的建立检测巨细胞病毒污染的PCR检测方法，并制备检测试剂盒。方法采用TaqMan探针，选择保守序列CMV-pp65设计引物，荧光定量病毒载量；对试剂盒进行敏感性、重复性和特异性等测试；对31份临床阳性血清标本和106份正常献血者血浆标本进行检测，并与国内同类试剂盒进行比较。结果该试剂盒检测线性定量范围可达202～3．6×10^9copies／ml，敏感性为360copies／ml，CV值在1％左右，特异性高，临床标本检测的符合率为100％。本试剂盒与国内已上市试剂盒比较，具有较好的相关性、更高的敏感性和更宽的定量检测范围。结论制备的试剂盒特异性和敏感性均较高，适用于临床上的病毒检测。
Objective To develop the PCR for determination of cytomegalovirus （CMV） infection and prepare the corresponding kit. Methods Develop a real-time fluorescent PCR by using TaqMan probe and the primers designed according to conserved CMV-pp65 seqaence. Test the prepared kit for sensitivity, reproducibility and specificity. Thirty-one CMV-posifive serum specimens isolated in clinic and 106 plasma specimens from heathy donors were determined by the kit, and the results were compared with those by imported kit of the same kind. Results The linearquantitafive scope and sensitivity of the kit were 202 - 3.6 × 10^9 copies/ml and 360 copies/ml respectively. The CV of determination resuits was about 1%. The coincidence rate of determination results by the kit with those of clinical diagnosis was 100%. The determination result by the kit showed good relationship to that by imported kit. Compared with imported kit, the prepared kit showed high sensitivity and wide linear quantitative scope. Conclusion The prepared kit showed high specificity and sensitivity, and was suitable for the clinical determination of CMV.
出处
《中国生物制品学杂志》
CAS
CSCD
2008年第3期231-234,共4页
Chinese Journal of Biologicals
关键词
巨细胞病毒
聚合酶链式反应
敏感性
特异性
Cytomegalovirus （CMV）
Polymerase chain reaction （PCR）
Semitivity
Speeificity
