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自建微流控-芯片法检测布鲁氏菌的性能验证及评价

Performance verification and evaluation of self⁃built microfluidic chip for Brucella detection
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摘要 目的采用自建微流控-芯片法检测系统对本实验室于2021年5月至2022年8月期间收集保存的布鲁氏菌阳性菌株、阳性血清、阴性血清进行检测,验证自建系统检测布鲁氏菌核酸的主要性能是否满足相关标准。方法依据CNAS-GL039:2019《分子诊断检验程序性能验证指南》、《实验室自建分子诊断项目基本要求专家共识》、《布鲁菌病诊疗专家共识》相关要求,对自建微流控-芯片法检测系统的符合率、重复性、检出限、交叉反应、抗干扰能力、敏感性及特异性进行验证及评价。结果自建检测系统与经血培养鉴定为布鲁氏菌阳性菌株、体检者阴性标本检测结果的阳性符合率为100%,阴性符合率为100%,总符合率为100%;1.50×10^(8)CFU/mL、500 CFU/mL布鲁氏菌阳性标本重复性检出率均为100%;检出限浓度(1000 copies/mL)企业参考品20次重复检测结果均为阳性;七种交叉反应病原体标本检测中,布鲁氏菌核酸结果均为阴性;在混有干扰物质的弱阳性布鲁氏菌标本检测中,布鲁氏菌核酸结果均为阳性;在布鲁氏菌感染检测中的敏感性和特异性分别为89.88%、95.74%。结论微流控-芯片法检测系统的符合率、重复性、检出限、抗干扰能力、交叉反应、敏感性及特异性性能指标均符合相关标准及检测要求,可用于临床检测工作。 Objective To detect positive strains,and positive/negative serum samples of Brucella collected and stored in our laboratory from May 2021 to August 2022,to verify whether the self-built system met the standards for detecting Brucella nucleic acid.Methods The selt-built microfluidic chip detection system was evaluated and verified for its coincidence rate,repeatability,detection-limit,cross-reaction,anti-interfer-ence ability,sensitivity,and specificity.This evaluation was conducted according to the CNAS-GL039:2019,Expert Consensus on Basic Requirements of Laboratory Self-Built Molecular Diagnostic Projects and Expert Con-sensus on Brucellosis Diagnosis and Treatment.Results The selt-built microfluidic chip detection system showed a 100%coincidence rate for detecting positive Brucella strains,and negative samples from physical ex-aminers when compare to blood culture.The repeatability of detecting positive Brucella samples with 1.50×10^(8) CFU/mL and 500 CFU/mL was 100%.The detection-limit concentration(1000 copies/mL)of the enterprise ref-erence material was successfully detected in all 20 repeated tests.No Brucella nucleic acids were detected in the detection of seven cross-reaction pathogens.However,Brucella nucleic acids were detected in the detection of weakly positive Brucella samples mixed with interfering substances.The sensitivity and specificity of detecting Brucella were 89.88%and 95.74%,respectively.Conclusion The selt-built microfluidic chip detection system demonstrated a high coincidence rate,repeatability,detection-limit,and anti-interference ability,lack of cross-reaction,and satisfactory sensitivity and specificity.Therefore,this system can be applied for clinical detection.
作者 董占柱 陈昊 孙欣 包春喜 李英智 牛艺卿 李翔 郝明媛 杜彦丹 DONG Zhanzhu;CHEN Hao;SUN Xin;BAO Chunxi;LI Yingzhi;NIU Yiqing;LI Xiang;HAO Min-gyuan;DU Yandan(Department of Clinical Laboratory,Inner Mongolia Forestry General Hospital,The Second Clinical Medical College of Inner Mongolia University for Nationalities,Yakeshi,Inner Mongolia,China,022150;Department of Ophthalmology,Inner Mongolia Forestry General Hospital,The Second Clinical Medical College of Inner Mongolia University for Nationalities,Yakeshi,Inner Mongolia,China,022150;Department of Cardiology,Inner Mongolia Forestry General Hospital,The Second Clinical Medical College of Inner Mongolia University for Nationalities,Yakeshi,Inner Mongolia,China,022150;Department of Nuclear Medicine,Inner Mongolia Forestry General Hospital,The Second Clinical Medical College of Inner Mongolia University for Nationalities,Yakeshi,Inner Mongolia,China,022150;Department of Clinical Laboratory,The Second Clinical Medical College of Inner Mongolia University for Nationalities,The First peoples Hospital of Horqin district,Tongliao City,Inner Mongolia,China,028000;Department of Clinical Laboratory,Hulunbuir Infectious Disease Hospital,Zhalantun,Inner Mongolia,China,162650)
出处 《分子诊断与治疗杂志》 2024年第2期207-211,共5页 Journal of Molecular Diagnostics and Therapy
基金 内蒙古自治区卫生健康科技计划项目(202201609)。
关键词 布鲁氏菌 微流控-芯片 性能验证 Brucella Microfluidic chip Performance verification
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