摘要
目的评估乳糜、溶血对Cobas s201 TaqScreen MPX试剂检测准确性的影响。方法采用可疑干扰物按照分级稀释的原理加入正常标本,进一步结合目测法和生化检测对比分析第一代、第二代试剂的抗干扰效果,并制作干扰实验标准图谱应用于常规检测中。结果溶血标准管核酸检测(nucleic acid testing, NAT)无假阳性结果;第一代、第二代试剂中,红细胞体积比占5%、15%的溶血标本中HIV、HCV、HBV等病毒的单混检检出率均为100%,第一代、第二代试剂中血细胞比容为10%的溶血标本HCV单混检检出率均为94.4%,差异无统计学意义(P> 0.05);乳糜标准管NAT无假阳性结果;第一、二代试剂检测中,混检和单检的重度乳糜标本对HIV、HCV、HBV等病毒的检出率均为100%,且在4℃保存至第3天对HIV、HCV、HBV等病毒的检出率均为100%,NAT检出率比较差异无统计学意义(P>0.05)。结论第一代、第二代MPX试剂抗干扰性能好,完全可以满足常规NAT对献血员标本的筛查。
Objective To evaluate the effect of chylemia and hemolysis on the accuracy of Cobas S201 TaqScreen MPX reagents. Methods The endogenous suspicious interfering substance（hemoglobin/chyle granules）were added to normal specimens to evaluate the effect of interference by standard tube comparison and grading method of interfering substance, and the standard spectrum of interference experiment was prepared for routine nucleic acid detection. Results There was no false positive result in the hemolysis standard nucleic acid testing（NAT） tube. In the first and second generation of reagents, the rate of single or mixed detection of HIV, HCV and HBV in 5% and 15% of hemolytic specimen were100%, and the rate of single or mixed detection of HCV in the first and second generation reagent was 94.4%, and there was no significant difference（P〉0.05）. There was no false positive result in the chylemia standard NAT tube. In the first and second generation reagent test, the rate of single or mixed detection of HIV, HCV and HBV in chylous specimen was100%, and the chylemia detection rate of HIV, HCV and HBV in 4℃ to the third day was 100%. Compared with the NAT detection rate, there was no significant difference（P〉0.05）. Conclusion The first and second generation of MPX reagents have good anti-interference performance and can fully meet the needs of the routine screening of blood donors by NAT.
作者
冷婵
刘正敏
王瑞
孟令志
李江
葛红卫
Leng Chan;Liu Zhengmin;Wang Rui;Meng Lingzhi;Li Jiang;Ge Hongwei(Beijing Red Cross Blood Center,Beijing 100088,China)
出处
《北京医学》
CAS
2018年第9期888-892,共5页
Beijing Medical Journal
基金
卫生部卫生行业科研专项(201002005)
