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,according 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 determined 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<5%) 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 control 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.%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s,CV,绘制质控图.结果 各批次质控品前6个月的HPV(6/11),(16/18)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%),批间差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.
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