CAJ | 학술논문

目的应用酶学参考方法实验室网络赋值的人源冰冻血清做校准品,探求实现不同检测系统间检测结果一致性的途径,为实验室确定适合的项目校准方式提供参考方法.方法量值溯源研究.由首都医科大学附属北京朝阳医院、北京航天总医院、首都医科大学附属北京世纪坛医院、中国医学科学院北京协和医院、北京利德曼生化股份有限公司、四川迈克生物科技股份有限公司6家实验室组成的酶学参考方法实验室网络使用国际临床化学和检验医学联合会(IFCC)推荐的磷酸肌酸激酶(CK)、乳酸脱氢酶(LDH)参考测量程序为新鲜冰冻混合人血清赋值,再用此赋值血清做统一的酶校准品,于2012年2月校准8套北京地区的单点校准模式的常规检测系统.每日校准程序校准各系统后顺序检测定值血清、原系统厂家校准品、质控品和患者样本;患者样本为北京市临床检验中心于2011年9月至11月收集的中国医学科学院阜外心血管病医院患者验后血清样本.再固定10日平均校准系数(以下简称:固定K均值),并用它替换每日校准系数,以固定K均值重新计算获得上述相应的结果,比较两者的室内精密度.计算患者样本校准前、后的均值、标准差、变异系数(CV)以及原系统校准品的偏移等统计学指标.结果定值血清校准后,8台常规检测系统原系统校准品赋值的偏移有不同,CK、LDH各有2个校准品赋值偏移＞5％;患者样本CK结果系统问CV分别由3.78％和4.44％下降到0.74％和0.89％;LDH由4.11％和4.08％下降到1.08％和1.28％.每日校准与固定K均值两种校准方式比较结果显示:CK项目K值的CVs≤1.00％、LDH项目CVs≤2.50％的检测系统,各样本的系统内CVs分别小于1.50％和3.00％;且两种校准方式原系统校准品、质控品及患者样本的CV均没有明显差异;而对于CK项目K值CV＞ 1.00％、LDH项目CV＞2.50％的系统,系统内CV明显增大;并有系统显示,各样本固定K均值的CV较每日校准的CV明显增大.结论使用参考方法实验室网络赋值的冰冻人源血清做统一的酶校准品,校准不同的单点校准模式的开放检测系统,可实现CK、LDH检测结果的一致性,并使结果溯源至参考方法.实验室应基于检测系统的稳定性确定适宜的校准方式. 目的應用酶學參攷方法實驗室網絡賦值的人源冰凍血清做校準品,探求實現不同檢測繫統間檢測結果一緻性的途徑,為實驗室確定適閤的項目校準方式提供參攷方法.方法量值溯源研究.由首都醫科大學附屬北京朝暘醫院、北京航天總醫院、首都醫科大學附屬北京世紀罈醫院、中國醫學科學院北京協和醫院、北京利德曼生化股份有限公司、四川邁剋生物科技股份有限公司6傢實驗室組成的酶學參攷方法實驗室網絡使用國際臨床化學和檢驗醫學聯閤會(IFCC)推薦的燐痠肌痠激酶(CK)、乳痠脫氫酶(LDH)參攷測量程序為新鮮冰凍混閤人血清賦值,再用此賦值血清做統一的酶校準品,于2012年2月校準8套北京地區的單點校準模式的常規檢測繫統.每日校準程序校準各繫統後順序檢測定值血清、原繫統廠傢校準品、質控品和患者樣本;患者樣本為北京市臨床檢驗中心于2011年9月至11月收集的中國醫學科學院阜外心血管病醫院患者驗後血清樣本.再固定10日平均校準繫數(以下簡稱:固定K均值),併用它替換每日校準繫數,以固定K均值重新計算穫得上述相應的結果,比較兩者的室內精密度.計算患者樣本校準前、後的均值、標準差、變異繫數(CV)以及原繫統校準品的偏移等統計學指標.結果定值血清校準後,8檯常規檢測繫統原繫統校準品賦值的偏移有不同,CK、LDH各有2箇校準品賦值偏移＞5％;患者樣本CK結果繫統問CV分彆由3.78％和4.44％下降到0.74％和0.89％;LDH由4.11％和4.08％下降到1.08％和1.28％.每日校準與固定K均值兩種校準方式比較結果顯示:CK項目K值的CVs≤1.00％、LDH項目CVs≤2.50％的檢測繫統,各樣本的繫統內CVs分彆小于1.50％和3.00％;且兩種校準方式原繫統校準品、質控品及患者樣本的CV均沒有明顯差異;而對于CK項目K值CV＞ 1.00％、LDH項目CV＞2.50％的繫統,繫統內CV明顯增大;併有繫統顯示,各樣本固定K均值的CV較每日校準的CV明顯增大.結論使用參攷方法實驗室網絡賦值的冰凍人源血清做統一的酶校準品,校準不同的單點校準模式的開放檢測繫統,可實現CK、LDH檢測結果的一緻性,併使結果溯源至參攷方法.實驗室應基于檢測繫統的穩定性確定適宜的校準方式.
목적 응용매학삼고방법실험실망락부치적인원빙동혈청주교준품,탐구실현불동검측계통간검측결과일치성적도경,위실험실학정괄합적항목교준방식제공삼고방법.방법 량치소원연구.유수도의과대학부속북경조양의원、북경항천총의원、수도의과대학부속북경세기단의원、중국의학과학원북경협화의원、북경리덕만생화고빈유한공사、사천매극생물과기고빈유한공사6가실험실조성적매학삼고방법실험실망락사용국제림상화학화검험의학연합회(IFCC)추천적린산기산격매(CK)、유산탈경매(LDH)삼고측량정서위신선빙동혼합인혈청부치,재용차부치혈청주통일적매교준품,우2012년2월교준8투북경지구적단점교준모식적상규검측계통.매일교준정서교준각계통후순서검측정치혈청、원계통엄가교준품、질공품화환자양본;환자양본위북경시림상검험중심우2011년9월지11월수집적중국의학과학원부외심혈관병의원환자험후혈청양본.재고정10일평균교준계수(이하간칭:고정K균치),병용타체환매일교준계수,이고정K균치중신계산획득상술상응적결과,비교량자적실내정밀도.계산환자양본교준전、후적균치、표준차、변이계수(CV)이급원계통교준품적편이등통계학지표.결과 정치혈청교준후,8태상규검측계통원계통교준품부치적편이유불동,CK、LDH각유2개교준품부치편이＞5％;환자양본CK결과계통문CV분별유3.78％화4.44％하강도0.74％화0.89％;LDH유4.11％화4.08％하강도1.08％화1.28％.매일교준여고정K균치량충교준방식비교결과현시:CK항목K치적CVs≤1.00％、LDH항목CVs≤2.50％적검측계통,각양본적계통내CVs분별소우1.50％화3.00％;차량충교준방식원계통교준품、질공품급환자양본적CV균몰유명현차이;이대우CK항목K치CV＞ 1.00％、LDH항목CV＞2.50％적계통,계통내CV명현증대;병유계통현시,각양본고정K균치적CV교매일교준적CV명현증대.결론 사용삼고방법실험실망락부치적빙동인원혈청주통일적매교준품,교준불동적단점교준모식적개방검측계통,가실현CK、LDH검측결과적일치성,병사결과소원지삼고방법.실험실응기우검측계통적은정성학정괄의적교준방식.
Objective Using the frozen human-pooled serum samples assigned by the enzymology reference procedure laboratory network as the calibrator,to find the way for harmonizing results among different measurement systems of enzymology,and providing a reference method for clinical laboratory to determine the appropriate calibration mode.Methods The study is about quantity traceability.Using the frozen human-pooled serum sample assigned by the enzymology reference laboratory network consisted of six domestic reference laboratories,namely Beijing Chaoyang Hospital affiliate of Capital University of Medical Sciences,Beijing Aerospace general Hospital,Beijing Shijitan Hospital affiliate of Capital University of Medical Sciences,Peking Union Medical College Hospital,Beijing Leadman Biochemistry Co.,Itd,Sichuan Maker Biotechnology Co.,ltd,using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference measurement procedures of creatine kinase (CK) and lactate dehydrogenase (LDH) as the same calibrator,to calibrate eight measurement systems with single point calibration mode of routine laboratories In February 2012 in Beijing.The value-assigned human sample、manufacturers' calibrators、control materials and the patient samples were detected after each measurement system was calibrated by daily calibration.The patient samples were collected by Beijing Center for Clinical Laboratories between September and November 2011 from Chinese academy of medical sciences Fuwai hospital cardiovascular disease.Then,each results were recalculated with the another procedure which was fixed by average calibration factor of ten days (hereinafter referred to as fixed K).Then,we had compared statistical results for the two procedures.The statistical indicators of mean,standard deviation,coefficient of variation of the patient samples were calculated before and after calibration and the biases of the original system calibrators were also done.Results After calibration,the biases of eight original detection system calibrators were different,two out of eight were bigger than 5％ for both CK and LDH.The coefficients of variation (CVs) of the two patient samples of CK dropped by 3.78％ and 3.78％ to 4.44％ and 3.78％ respectively ;LDH dropped by 4.11％ and 4.11％ to 4.08％ and 4.11％.The statistical results of two procedures showed that under the circumstance of the CVs of calibration factor for CK and LDH were not bigger than 1.00％ and 2.50％,the intra-detection system CVs of all the sample results were less than 1.50％ and 3.00％.It was no significant difference between the two procedures in CVs of the original system calibration product,control materials and the patient samples.While on the condition that the CVs of calibration factor for CK and LDH were larger than 1.00％ and 2.50％,the intra-detection system CVs increased and the CVs of fixed K of all samples were larger than those of daily calibration.Conclusions Using the frozen human-pooled serum samples assigned by the enzymology reference procedure laboratory network as the calibrator,to calibrator the different measurement system with calibration mode of single point,can realize the consistency of the testing results of CK and LDH,and making the results traceable to the reference measurement procedure.Laboratory should base on the stability of the detection system to determine the appropriate calibration mode.