利用甲型流感病毒阳性临床标本制备质控品  

Preparation of quality control products using positive samples of influenza A virus

作　　者：李瑜霞[1] 石翰铂 余斐[1] 郑书发[1] 崔大伟[3] 曹红翠[4] LI Yuxia;SHI Hanbo;YU Fei;ZHENG Shufa;CUI Dawei;CAO Hongcui(Center of Clinical Laboratory;Key Laboratory of Precision Diagnosis and Treatment for Hepatobiliary and Pancreatic Tumor of Zhejiang Proviace;Department of Blood Transfusion;State Key Laboratory and Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases,First Affiliated Hospital,School of Medicine,Zhejiang Univerity,Hangzhou 310003,Zhefiang,China)

机构地区：[1]浙江大学医学院附属第一医院检验科,杭州310003 [2]浙江大学医学院附属第一医院浙江省肝胆胰肿瘤精准诊治研究重点实验室,杭州310003 [3]浙江大学医学院附属第一医院输血科,杭州310003 [4]浙江大学医学院附属第一医院传染病诊治协同创新中心,杭州310003

出　　处：《临床检验杂志》2018年第8期634-636,共3页Chinese Journal of Clinical Laboratory Science

基　　金："十三五"国家科技重大专项(2017ZX10103008)

摘　　要：目的制备一种能适用于甲型流感病毒核酸提取和PCR检测全过程的质控品。方法采用TRIzol试剂灭活高、中、低3种浓度的甲型流感病毒阳性的痰液标本,分析TRIzol试剂对检测结果的影响;放置于35℃以及反复冻融,评估灭活后标本的稳定性;并在不同实验室间采用不同试剂进行适用性评价。结果 TRIzol试剂对核酸检测无影响,处理后的高、中、低浓度标本反复冻融40次病毒浓度无明显降低,变异系数分别为1.26%、1.54%、1.54%,均低于试剂盒批内精密度。TRIzol试剂处理的标本在35℃环境保存40 d后高、中、低浓度变异系数分别为3.13%、2.77%、2.20%,变异系数均低于试剂盒批间精密度。在不同单位采用不同试剂均能检测出高、中、低不同浓度质控品。结论采用TRIzol试剂灭活甲型流感病毒阳性标本制备的质控品在瓶间差、热稳定和长期保存时效等方面性能较优,可成为日后临床实验室开展甲型流感病毒核酸检测的理想质控品。Objective To prepare a quality control product suitable for monitoring the whole process of nucleic acid extraction and PCR detection of influenza A virus. Methods The sputum samples with high, medium and low concentrations of influenza A virus were inactivated by TRIzol reagent, and the effect of TRIzol reagent on the detection results was analyzed. Then, the inactivated sputum samples were placed at different temperatures or repeated freezing and thawing, and their stability were evaluated. Their applicability in different laboratories and different reagents was also evaluated. Results There was no any influence of TRIzol reagent on the nucleic acid detection of influenza A virus. The virus concentrations of the inactivated samples with high, medimn and low concentrations of in- fluenza A virus had no significant decrease after 40 times of repeated freezing and thawing, and the coefficients of variation （CVs） were 1.26%, 1.54%, and 1.54%, respectively, for high, medium and low concentrations of samples, which were lower than the within-run precision of the kit. The CVs of the high, medium and low concentrations of samples treated with TRIzol reagent and stored at 35 22 for 40 days were 3.13%, 2.77% and 2.20%, respectively, which were lower than the between-run precision of the kit. Tile high, medium and low concentrations of quality control products could be detected by different reagents in different laboratories. Conclusion There are better performance in the difference among bottles, heat stability and long-term storage for the quality control products prepared with the influenza A virus-positive samples inactivated by TRIzol reagent, which may be an ideal quality control product for the nucleic acid detection of influenza A virus in clinical laboratories.

关 键 词：甲型流感病毒 TRIZOL 病毒灭活 质控品 

分 类 号：R446[医药卫生—诊断学]