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同一核酸筛查系统升级前后的比较

Comparison of the same nucleic acid screening system before and after upgrade

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目的 为确保同一核酸筛查系统升级前后设备结果的可靠性,对华益美核酸血液筛查系统升级前后设备(升级设备HAMILTON-STARIVD+ABI7500 2套、未升级HAMILTON-STAR+ABI7500 1套)进行比较分析.方法 通过3套设备的通量测试,筛查系统一致性比对试验以及对监控指标的统计分析,对筛查系统进行整体评估.结果 通量测试中3台核酸检测(nucleic acid testing,NAT)系统满负荷运行均可测96个孔位(pool),且运行期间无故障发生.HAMILTON-STARIVD比HAMILTON-STAR缩短2h 18min.在核酸筛查系统一致性比对验证中,3套NAT系统筛查结果与血清盘一致.2021年1月—2022年9月检测核酸标本,HAMILTON-STAR和HAMILTON-STARIVD的NAT阳性检出率分别为0.05%和0.07%,阳性检出率差异无统计学意义(x2=2.055,P>0.05).NAT混检阳性率分别为1.05%和1.46%,混检阳性率差异有统计学意义(x2=4.651,P<0.05).NAT拆分阳性率分别为39.22%和40.07%,拆分阳性率差异无统计学意义(x2=0.013,P>0.05).结论 华益美核酸筛查系统HAMILTON-STAR和HAMILTON-STARIVD设备均运行较稳定,具备血液筛查所要求的检测能力,且HAMILTON-STARIVD核酸提取时间效率更高,混检阳性率更高.
Objective To ensure the reliability of equipment results before and after the upgrade of the same nucleic acid screening system,and to compare and analyze the equipment before and after the upgrade of Huayimei Nucleic Acid Blood Screening System(two sets of the upgraded equipment HAMILTON-STARIVD+ABI7500 and one set of the non-upgraded equipment HAMILTON-STAR+ABI7500).Methods The overall assessment of the screening system was carried out through the flux test of the three sets of equipment,the consistency comparison test of the detection system,and the statistical analysis of the monitoring index.Results In the flux test,96 pools could be measured by the three nucleic acid testing(NAT)systems running at full capacity,and no fault occurred during the operation.The detection time using HAMILTON-STARIVD was 2 hours 18 minutes shorter than HAMILTON-STAR.In the consistency comparison and verification of the nucleic acid screening systems,the detection results of the three sets of NAT systems were consistent with those of the serum disc assay.From January 2021 to September 2022 with the testing of nucleic acid samples,the positive NAT detection rates of HAMILTON-STAR and HAMILTON-STARIVD were 0.05%and 0.07%,respectively.The difference in the positive detection rates was not statistically significant(x2=2.055,P>0.05).The positive rates of NAT mixed detection were 1.05%and 1.46%,respectively,and the difference in the positive rates of mixed detection was statistically significant(x2=4.651,P<0.05).The positive split ratios of NAT were 39.22%and 40.07%,respectively,and the difference in the positive split ratios was not statistically significant(x2=0.013,P>0.05).Conclusion Both HAMILTON-STAR and HAMILTON-STARIVD equipments of Huayimei nucleic acid screening system operate stably and have the detection ability required for blood screening.Besides,HAMILTON-STARIVD has a higher efficiency of nucleic acid extraction time and a higher positive rate of mixed detection.

Blood stationMixed systemNucleic acid testingBefore and after upgradeComparisonConsistency

白彤彤、阮朝良、王学刚、孙国栋、韩永红、张毓、杨亚男

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邯郸市疾病预防控制中心,河北邯郸 056008

邯郸市中心血站

血站 混样系统 核酸检测 升级前后 比较 一致性

河北省医学科学研究课题计划

20191820

2024

医学动物防制
中国民主促进会河北省委员会

医学动物防制

CSTPCD
影响因子:0.553
ISSN:1003-6245
年,卷(期):2024.40(1)
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