巨细胞病毒IgM抗体自制室内质控血清的应用及评价

The application and evaluation of the self-made anti-HCMV quality control serums

目的自制巨细胞病毒IgM抗体(HCMV-IgM)弱阳性外部对照质控血清,评价其临床应用的可行性。方法收集我院HCMV-IgM抗体阳性血清分别与健康人血清混合进行倍比稀释,选择S/CO在1.5~3之间稀释度制备室内质控血清,连续检测20批次,采用"即刻法"分析检测结果,20批次后结果绘制Levey-Jennings质控图,监测室内质控动态。结果自制HCMV-IgM质控血清与北京贝尔有限公司提供的质控血清,两者结果进行对比,CV值比较无统计学差异(P>0.05),自制HCMV-IgM质控血清变异系数(CV)均小于20%,稳定性符合国家质控物要求。结论自制HCMV-IgM质控血清有很好的稳定性和精密度,可作为实验室检测HCMV-IgM抗体的室内质控血清。

Objective To investigate the clinical feasibility of the anti-HCMV weakly positive serum as correlated external quality control（QC）. Methods The anti-HCMV positive serums from the HCMV-infected patients in our hospital were collected and mixed with serums from healthy controls. Then the mixtures were serially diluted and detected for their S/CO value. Under the dilution ratio,corresponding to the S/CO value between 1.5 and 3.0,the diluted serum was selected as the standard for extracting the internal QC serums. The prepared QC serums were used to detect 20 batches of samples and the results were analyzed by using the instant method. Finally,the Levey-Jennings quality control chart was drawn to monitor the dynamic of the internal quality control. Results The CV（coefficient of variation） values of the self-made anti-HCMV QC serums were compared with the QC serums supplied by Beijing Bell Company. There was no significant difference between them（P 〉0.05）. All the CV values of the self-made anti-HCMV QC serums were less than 20% and the stability was in accordance with the request of national quality content. Conclusion The self-made anti-HCMV QC serums have good stability and high degree of precision. It may be used as the internal QC serums for the laboratory examination HCMV-IgM antibody.