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目的:通过采用定值核酸质控品进行相应稀释形成低、中、高3种浓度规格的样本进行核酸混样检测,以验证核酸筛查系统分析灵敏度是否符合要求。方法:通过对购置的商品化定值核酸室内质控品进行适当稀释制备成相应核酸检测系统检测下限(LOD)0.5倍LOD、1倍LOD、4倍LOD 3种低、中、高浓度规格,进行和献血者检测模式相同的混样检测,统计3种规格下HBV-DNA、HCV-RNA、HIV 1-RNA阳性检出率,阳性结果 Ct值平均值、标准差、变异系数以评价验证选用核酸检测系统的分析灵敏度。结果:0.5LOD范围的样本HBVDNA、HCV-RNA、HIV 1-RNA阳性检出率分别达50%、100%、95%,1LOD和4LOD范围的样本HBV-DNA、HCV-RNA、HIV 1-RNA检出率均达到100%。阳性样本的Ct值统计变异系数均小于5%。结论:采用定值核酸质控品进行核酸筛查系统分析灵敏度验证结果是可行的,对保证血液核酸筛查的质量是有意义的。
OBJECTIVE: To determine whether the sensitivity of the nucleic acid screening system meets the requirements by sampling the nucleic acid samples by diluting the samples with the low, middle and high concentration samples by using the corresponding nucleic acid control samples. Methods: Three kinds of low, medium and high density LOD, LOD, LOD and LOD of LOD were prepared by appropriate dilution of purchased commercial value nucleic acid in laboratory. The same mixed blood test was used to detect the positive detection rate of HBV-DNA, HCV-RNA and HIV 1-RNA, the average value of positive Ct, standard deviation and coefficient of variation Analysis of nucleic acid detection system sensitivity. Results: HBV-DNA, HCV-RNA, HIV 1-RNA were detected in samples of 0.5LOD range with positive detection rates of HBVDNA, HCV-RNA and HIV 1-RNA of 50%, 100%, 95%, 1LOD and 4LOD respectively The detection rate reached 100%. The positive coefficient of variation of Ct values were less than 5%. Conclusion: It is feasible to analyze the sensitivity of the nucleic acid screening system by using the calibrator nucleic acid control, which is of great significance to ensure the quality of blood nucleic acid screening.