全自动酶免分析仪与自动核酸纯化仪在基层血站的应用效果探究  

Exploration on the Application Effect of Fully Automatic Enzyme Immunoassay Analyzer and Automatic Nucleic Acid Purification Instrument in Grassroots Blood Stations

作　　者：双莉华 范彩霞 黄康 吴晨 SHUANG Li-hua;FAN Cai-xia;HUANG Kang;WU Chen(Quality Control Department,Fuzhou Central Blood Station,Jiangxi Fuzhou 344000)

机构地区：[1]抚州市中心血站质管科,江西抚州344000

出　　处：《中国医疗器械信息》2023年第21期98-100,共3页China Medical Device Information

摘　　要：目的:探究分析在基层血站全自动酶免分析仪与自动核酸纯化仪的运用价值。方法:选取2020年1月~2022年12月某基层血站无偿献血样本共计76528例,其中,2020年检测总数为24407例,2021年检测总数为25709例,2022年检测总数为26412例,使用全自动酶免分析仪与自动核酸纯化仪,首先实施酶免检测,如若检验结果为阳性直接判定,对于特殊样本,实施酶免检测与核酸并行检测,观察分析在乙型肝炎病毒检测、丙型肝炎病毒检测、艾滋病毒检测、梅毒检测中不合格情况。结果:(1)分析2020年~2022年酶免检测结果,在2020年,乙型肝炎阳性病毒检出率最高达到0.37%,梅毒病毒阳性检出率0.33%次之;在2021年,乙型肝炎病毒阳性检出率最高达到0.40%,梅毒病毒阳性检出率0.14%次之;在2022年,乙型肝炎病毒阳性检出率达到0.33%,梅毒病毒阳性检出率0.11%次之。(2)2020年核酸检测共检测出乙型肝炎阳性数51例,阳性率0.21%;2021年共检测出乙型肝炎阳性数33例,阳性率0.13%,人类免疫缺陷病毒阳性数1例,阳性率0.004%;2022年共检测出乙型肝炎阳性数42例,阳性率0.16%。结论:利用全自动酶免分析仪与自动核酸纯化仪,进行核酸检测和免疫检测平行筛查,能够发挥优势互补的作用,可降低输血传播疾病残余风险,有效控制输血传播的病毒性疾病,为输血者提供安全保障。Objective:To explore the application value of fully automated enzyme immunoassay analyzer and automatic nucleic acid purification instrument in grassroots blood stations.Methods:A total of 76528 unpaid blood donation samples were selected from a grassroots blood station from January 2020 to December 2022.Among them,the total number of tests in 2020 was 24407,the total number of tests in 2021 was 25709,and the total number of tests in 2022 was 26412.Using a fully automatic enzyme immunoassay analyzer and an automatic nucleic acid purifier,enzyme immunoassay was first performed.If the test result is positive,it can be directly determined.For special samples,enzyme immunoassay and nucleic acid parallel testing are performed,observe and analyze the unqualified situation in the detection of hepatitis B virus,hepatitis C virus,HIV and syphilis.Results:①Analyzing the results of enzyme immunoassay from 2020 to 2022,the highest detection rate of hepatitis B virus reached 0.37%in 2020,followed by a positive detection rate of syphilis virus of 0.33%;In 2021,the highest positive detection rate of hepatitis B virus reached 0.40%,followed by a positive detection rate of syphilis virus of 0.14%;In 2022,the positive detection rate of hepatitis B virus reached 0.33%,followed by the positive detection rate of syphilis virus of 0.11%.②In 2020,a total of 51 positive cases of hepatitis B were detected,accounting for 0.21%;In 2021,there will be 33 positive cases of hepatitis B,accounting for 0.13%,and 1 positive case of HIV,accounting for 0.004%;In 2022,a total of 42 positive cases of hepatitis B were detected,accounting for 0.16%.Conclusion:Using a fully automated enzyme immunoassay analyzer and an automated nucleic acid purification device for parallel screening of nucleic acid and immune tests can play a complementary role in reducing the residual risk of transfusion transmitted diseases,effectively controlling viral diseases transmitted by transfusion,and providing safety guarantees for blood transfusions.

关 键 词：全自动酶免分析仪 自动核酸纯化仪 基层血站 

分 类 号：TH776[机械工程—仪器科学与技术]