摘要
目的研制HPV（6／11），（16／18）型核酸质控品应用于实时荧光PCR检测分析的室内质量控制。方法采用HPV（6／11）型和HPV（16／18）型荧光定量PCR诊断试剂盒，对患者的分泌物进行FQ-PCR检测。提取双阳性分泌物，经适当灭活后，将HPV（6／11），（16／18）型核酸模式的阳性混合标本经过回收、防腐、调剂及分装等流程，制成中、高值各3个批次的质控品，完成校准和比对试验。分别进行不少于6个月的室内质控检测，观察其稳定性，确定其靶值。计算5，CV，绘制质控图。结果各批次质控品前6个月的HPV（6／11），（i6／18）型核酸质控品相对稳定（P〈0．05）。质控物高低值的变异范围分别为1．99％和2．61％（CV〈5％），批问差CV〈10％，稳定性好。结论HPV型模式的阳性混合标本制备定量检测的HPV（6／11），（16／18）型核酸质控品的稳定性好，可用于HPV（6／11），（16／18）型核酸荧光定量的PCR诊断的室内质量控制，测定结果能反应标本的真实性，有一定的临床实用价值。
Objective To develop of HPV （6/11）, （16/18） nucleic acid control materials used in real-time fluorescence PCR assay analysis of internal quality control. Methods With of HPV （6/11） type and HPV （16/18） fluorescence quantitative PCR diagnostic kit,detected the secretions of patients with FQ-PCR. Extraction of double-positive secretions inactivated, ac- cording to HPV （6/11）, （16/18）-type nucleic acid positive mixed mode specimens, after recovery, corrosion,dispensing and repackaging process, made of high values of three batches of quality control materials and completed the calibration and com- parisontest. Then made not less than eight months of internal quality control inspection,observation of its stability,and de- termined its target value,calculation,s, CV, drawing quality control chart. Results Each batch quality control materials of the first six months of HPV （6/11）, （16/18） nucleic acid control materials was relatively stable （ P〈 0.05）, the range of variation of quality control high and low values were 1.99% ,2.61% （CV（5G） and between-run CV〈10%. Conclusion Positive mixed sample preparation for quantitative detection of HPV type model of HPV （6/11）, （16/18） nucleic acid con- trol materials had stability and it can be used for HPV （6/11）, （16/18） nucleic acid fluorescence quantitative PCR diagnostic internal quality control, determination of the results reflect the authenticity of the specimens, the clinical value.
出处
《现代检验医学杂志》
CAS
2012年第5期154-157,共4页
Journal of Modern Laboratory Medicine
