学术论著ZHONGGUOYIXUEZHUANGBEI39中国医学装备2023年8月第20卷第8期ChinaMedicalEquipment2023AugustVol.20No.8*基金项目：军队生物安全研究专项资助项目(19SWAQ06)“超级细菌生物学特性及防控技术的研究”①解放军总医院第五医学中心南院区检验科北京100073*通信作者：pipi780816@aliyun.com；lba@263.net作者简介：袁方，女，(1989-)，本科学历，主管技师，从事医院分子诊断技术及研究工作。[文章编号]1672-8270(2023)08-0039-05[中图分类号]R446[文献标识码]APerformanceverificationandevaluationofPCRsystemindetectingHCMVDNA/YUANFang,TONGLi-wei,YANYan,etal//ChinaMedicalEquipment,2023,20(8):39-43.[Abstract]Objective:Toconductperformanceverificationandevaluationofreal-timefluorescentquantitative-polymerasechainreaction(FQ-PCR)systemindetectinghumancytomegalovirusdeoxyribonucleicacid(HCMVDNA)soastosatisfythedemandsofclinicaldetection.Methods:Theclinicalsamplesofhospitalandthestandardsamplesprovidedbythirdpartywerecollected,andthereal-timeFQ-PCRsystemwasadoptedtodetecttheperformanceofHCMVDNAreagentandconductevaluation.Theaccuracy,measurementprecision(intrabatchrepeatabilityandinterbatchprecision),linearinterval,detectionlimit,anti-interferenceability,crossreactionandotherperformanceofthedetectionmethodofHCMVDNAFQ-PCRsystemwereverifiedandevaluatedaccordingtothecorrespondingrequirementsoftheseriesofdocumentsofandofChinaNationalAccreditationServiceforConformityAssessment,andtheEPseriesfilesofClinicalandLaboratoryStandardsInstitute(CLSI)ofAmerican.Results:TheaccuracyofFQ-PCRsystemwaswithinthepermissiblerangeindetectingHCMVDNA,andthecoefficientsofvariation(CVs)ofprecisionofintrabatchrepeatabilityoflowandhighconcentrationssamples(1.72E+04copies/mland2.74E+09copies/ml)wererespectively3.90%and0.11%,andtheinterbatchprecisionCVsofthemwererespectively4.05%and0.94%.Thelinearrelationshipwasfavorablewithintherangebetween4.00E+02and4.00E...
