CAJ | 학술논문

目的对实验室现用生化检验部分项目的生物参考区间进行验证,确保其适用于本实验室,为临床提供准确的诊断依据.方法参照NCCLS C28-A2推荐方法,先对实验室2台生化分析系统性能进行验证;无性别生物差异项目验证选择一组(20名)健康参考个体,有性别生物差异项目选取男、女两组(各20名),验证存在疑问项目,另外选取男、女两组健康参考个体.采集符合要求健康参考个体标本,按实验室标准化操作程序(SOP)文件要求进行规范检测,拜耳ADVIA 1650生化分析系统检测标本,分析实验结果情况.结果经验证2台生化分析系统性能符合要求;参与验证的16个项目中,健康参考个体组检测结果:γ谷氨酰转移酶(GGT)、高密度脂蛋白胆固醇(HDL.C)5%以上在现用的生物参考区间以外;总蛋白95%结果在现用的生物区间内;其余项目100%在现用的生物区间内.结论本次验证的项目除GGT、HDL-C外,现用的生物参考区间适用于本实验室,可以继续使用;实验的验证具有科学的说服力,容易发现生物参考区间的偏离,建立完善的验证制度、程序,值得推广应用.
목적 대실험실현용생화검험부분항목적생물삼고구간진행험증,학보기괄용우본실험실,위림상제공준학적진단의거.방법 삼조NCCLS C28-A2추천방법,선대실험실2태생화분석계통성능진행험증;무성별생물차이항목험증선택일조(20명)건강삼고개체,유성별생물차이항목선취남、녀량조(각20명),험증존재의문항목,령외선취남、녀량조건강삼고개체.채집부합요구건강삼고개체표본,안실험실표준화조작정서(SOP)문건요구진행규범검측,배이ADVIA 1650생화분석계통검측표본,분석실험결과정황.결과 경험증2태생화분석계통성능부합요구;삼여험증적16개항목중,건강삼고개체조검측결과:γ곡안선전이매(GGT)、고밀도지단백담고순(HDL.C)5%이상재현용적생물삼고구간이외;총단백95%결과재현용적생물구간내;기여항목100%재현용적생물구간내.결론 본차험증적항목제GGT、HDL-C외,현용적생물삼고구간괄용우본실험실,가이계속사용;실험적험증구유과학적설복력,용역발현생물삼고구간적편리,건립완선적험증제도、정서,치득추엄응용.
Objective To validate the biology reference interval of the Dartial biochemistry test items and provide accurate diagnosis basis for the clinic.Methods According to NCCLS C28-A2 recommendation method,two biochemistry analyzers'performance was validated.20 healthy persons for the asexual biological difference project and female group as well as male group (each group consist of 20 persons)for the sex biology difference project were recruited according to the laboratory SOP.If the validation had doubt,other two groups were need.The sera from these individuals were examined by the full-automatic ADVIA 1650 biochemistry analysis system.Results Two full-automatic ADVIA 1650 biochemistry analyzes conformed to the requirements.In 16 test items participating in this investigation.the analysis showed more than 5%results fell outside the biology reference interval for GGT and HDL-C,whereas 95% results fell in the biology reference interval for TP.All other results fell in the biology reference interval.Conclusions This validation indicats that except GGT and HDL-C,the biology reference intervals which are currently being used are suitable for our laboratory.This verification is persuasive and calpable of finding the deviation of biology reference interval.Setting up verification system warrants further generalization.