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核酸气溶胶清除仪器验证与综合评价

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基于聚合酶链式反应技术的核酸检测因其优异的特异性、灵敏度和相对便捷的操作而被广泛应用于人类及动物疫病筛查等体外诊断领域,但实验环境中极其微量的核酸污染有可能导致假阳性问题,影响检测准确性.彻底清除实验环境中的核酸片段残留,能够有效减少假阳性检测结果的出现.本研究旨在提出一种核酸气溶胶清除设备的验证与综合评价方案,通过人为模拟制造核酸气溶胶污染环境,以实时荧光定量PCR(Real-Time Quantitative Fluorescence Polymerase Chain Reaction,RT-PCR)技术检测某种市售核酸气溶胶清除仪清除前后相关核酸检测循环数阈值(Cycle Threshold,Ct)的差异,以评估仪器的核酸清除效果.结果显示,0.5 h、1 h和过夜清除后Ct值均显著下降,表明该核酸气溶胶清除仪能够满足实验室核酸清除要求,且过夜清除后Ct值为 40.00 及以上,表明过夜清除能更高效地清除空气中的气溶胶.本研究为核酸气溶胶清除仪的性能验证与综合评价提供了技术方法,为核酸分子生物学实验室的日常核酸污染清除提供了解决方案.
Study of Nucleic Acid Aerosol Scavenger Performance Evaluation Method
Nucleic acid testing based on Polymerase Chain Reaction(PCR)technology is widely used in vitro diagnostics,such as human and animal disease screening,due to its excellent specificity,sensitivity,and relatively convenient operation.However,even extremely small amounts of nucleic acid contamination may lead to false-positive problems,thereby compromising test accuracy.Thorough removal of residual nucleic acid fragments from the experimental environment can effectively reduce the occurrence of false-positive test results.This study proposes a validation and comprehensive evaluation scheme for nucleic acid aerosol pollution removal devices.By artificially simulating nucleic acid aerosol contamination,this study employed Real-Time Quantitative Polymer Chain Reaction(RT-PCR)technology to detect the differences in Cycle Threshold(Ct)values before and after the use of a commercially available nucleic acid aerosol clearance instrument.The results indicated that Ct values significantly decreased after 0.5 hours,1 hour,and overnight clearance,suggesting that the instrument meets laboratory requirements for nucleic acid clearance.Notably,the Ct value reached 40.00 or higher after overnight clearance,indicating that overnight clearance can more effectively eliminate airborne aerosols.This study provides a technical method for the performance verification and comprehensive evaluation of nucleic acid aerosol removal devices,and provides a solution for daily nucleic acid contamination removal in molecular testing laboratories.

nucleic acid detectionnucleic acid contaminationfalse-positivenucleic acid aerosol cleaning device

任宇捷、孔维恒、费永亮、杨菲、孟庆建、邱烨、刘鑫、王艺凯

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中国海关科学技术研究中心 北京 100026

海关总署(北京)国际旅行卫生保健中心 北京 100023

无锡百泰克生物技术有限公司 无锡 214000

核酸检测 核酸污染 假阳性 核酸气溶胶清除仪

海关总署科研项目

2023HK141

2024

中国口岸科学技术
中国质检报刊社

中国口岸科学技术

影响因子:0.051
ISSN:1002-4689
年,卷(期):2024.6(9)
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