中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2015年
34期
2754-2759
,共6页
周文宾%李臣宾%张海鹏%成斐%彭明婷
週文賓%李臣賓%張海鵬%成斐%彭明婷
주문빈%리신빈%장해붕%성비%팽명정
凝血因子Ⅷ%凝血因子Ⅸ%参考物质%可比性%互通性
凝血因子Ⅷ%凝血因子Ⅸ%參攷物質%可比性%互通性
응혈인자Ⅷ%응혈인자Ⅸ%삼고물질%가비성%호통성
Coagulation factor Ⅷ%Coagulation factor Ⅸ%Reference material%Comparability%Commutability
目的 评价凝血因子Ⅷ(FⅧ)和Ⅸ(FⅨ)活性国内常用检测系统的结果可比性以及参考物质的互通性.方法 参照美国临床实验室标准化协会(CLSI) EP-30文件和行业标准WS/T 356-2011的互通性评价方法进行实验.将不同浓度水平且覆盖临床检测范围的FⅧ和FⅨ活性检测样本,5个批号自制参考物质(F20140601 ～ F20140605)和英国国家生物制品检定所(NIBSC)标准品(SSCLOT4)分别用Stago STA-R Evolution、IL ACL TOP700和Sysmex CA7000全自动凝血分析仪及配套试剂进行FⅧ和FⅨ活性检测.3个检测系统依次进行2个系统间的结果比较.分别对2个系统临床样本的检测结果进行线性回归并计算偏差,以相关系数和偏差超出可接受范围的样本比例评价检测结果的可比性.剔除偏差超出可接受范围的结果后,再次进行线性回归并计算临床样本检测结果对应Y预测值双侧95％预测区间,绘制互通性评价图对自制参考物质和NIBSC标准品的互通性进行评价.结果 临床样本FⅧ和FⅨ浓度的分布范围为0.5％～ 218.0％和1.6％～156.5％,能够覆盖临床常见浓度水平和满足参考物质互通性评价的要求.不同系统FⅧ和FⅨ检测结果的R2为0.89 ～0.94和0.81～0.93,偏差超出可接受范围的比例均＜10％,可认为3个系统FⅧ和FⅨ活性检测结果的可比性可被接受.根据可比性偏差可接受范围,删除偏差超出可接受范围的临床样本检测结果后,FⅧ活性检测分别有42份、41份和45份临床样本的结果用于自制参考物质和NIBSC凝血标准品的互通性分析,FⅨ活性检测分别有44份、42份和41份临床样本的结果用于互通性分析.5个批号10支自制参考物质和NIBSC凝血标准品的检测结果均落在95％预测区间内,表明其在3个检测系统间均具有互通性.结论 对于FⅧ活性检测,不同检测系统间的结果可比性较好,FⅨ活性检测系统间的可比性尚可接受.自制参考物质和NIBSC标准品用于不同检测系统具有互通性.
目的 評價凝血因子Ⅷ(FⅧ)和Ⅸ(FⅨ)活性國內常用檢測繫統的結果可比性以及參攷物質的互通性.方法 參照美國臨床實驗室標準化協會(CLSI) EP-30文件和行業標準WS/T 356-2011的互通性評價方法進行實驗.將不同濃度水平且覆蓋臨床檢測範圍的FⅧ和FⅨ活性檢測樣本,5箇批號自製參攷物質(F20140601 ～ F20140605)和英國國傢生物製品檢定所(NIBSC)標準品(SSCLOT4)分彆用Stago STA-R Evolution、IL ACL TOP700和Sysmex CA7000全自動凝血分析儀及配套試劑進行FⅧ和FⅨ活性檢測.3箇檢測繫統依次進行2箇繫統間的結果比較.分彆對2箇繫統臨床樣本的檢測結果進行線性迴歸併計算偏差,以相關繫數和偏差超齣可接受範圍的樣本比例評價檢測結果的可比性.剔除偏差超齣可接受範圍的結果後,再次進行線性迴歸併計算臨床樣本檢測結果對應Y預測值雙側95％預測區間,繪製互通性評價圖對自製參攷物質和NIBSC標準品的互通性進行評價.結果 臨床樣本FⅧ和FⅨ濃度的分佈範圍為0.5％～ 218.0％和1.6％～156.5％,能夠覆蓋臨床常見濃度水平和滿足參攷物質互通性評價的要求.不同繫統FⅧ和FⅨ檢測結果的R2為0.89 ～0.94和0.81～0.93,偏差超齣可接受範圍的比例均＜10％,可認為3箇繫統FⅧ和FⅨ活性檢測結果的可比性可被接受.根據可比性偏差可接受範圍,刪除偏差超齣可接受範圍的臨床樣本檢測結果後,FⅧ活性檢測分彆有42份、41份和45份臨床樣本的結果用于自製參攷物質和NIBSC凝血標準品的互通性分析,FⅨ活性檢測分彆有44份、42份和41份臨床樣本的結果用于互通性分析.5箇批號10支自製參攷物質和NIBSC凝血標準品的檢測結果均落在95％預測區間內,錶明其在3箇檢測繫統間均具有互通性.結論 對于FⅧ活性檢測,不同檢測繫統間的結果可比性較好,FⅨ活性檢測繫統間的可比性尚可接受.自製參攷物質和NIBSC標準品用于不同檢測繫統具有互通性.
목적 평개응혈인자Ⅷ(FⅧ)화Ⅸ(FⅨ)활성국내상용검측계통적결과가비성이급삼고물질적호통성.방법 삼조미국림상실험실표준화협회(CLSI) EP-30문건화행업표준WS/T 356-2011적호통성평개방법진행실험.장불동농도수평차복개림상검측범위적FⅧ화FⅨ활성검측양본,5개비호자제삼고물질(F20140601 ～ F20140605)화영국국가생물제품검정소(NIBSC)표준품(SSCLOT4)분별용Stago STA-R Evolution、IL ACL TOP700화Sysmex CA7000전자동응혈분석의급배투시제진행FⅧ화FⅨ활성검측.3개검측계통의차진행2개계통간적결과비교.분별대2개계통림상양본적검측결과진행선성회귀병계산편차,이상관계수화편차초출가접수범위적양본비례평개검측결과적가비성.척제편차초출가접수범위적결과후,재차진행선성회귀병계산림상양본검측결과대응Y예측치쌍측95％예측구간,회제호통성평개도대자제삼고물질화NIBSC표준품적호통성진행평개.결과 림상양본FⅧ화FⅨ농도적분포범위위0.5％～ 218.0％화1.6％～156.5％,능구복개림상상견농도수평화만족삼고물질호통성평개적요구.불동계통FⅧ화FⅨ검측결과적R2위0.89 ～0.94화0.81～0.93,편차초출가접수범위적비례균＜10％,가인위3개계통FⅧ화FⅨ활성검측결과적가비성가피접수.근거가비성편차가접수범위,산제편차초출가접수범위적림상양본검측결과후,FⅧ활성검측분별유42빈、41빈화45빈림상양본적결과용우자제삼고물질화NIBSC응혈표준품적호통성분석,FⅨ활성검측분별유44빈、42빈화41빈림상양본적결과용우호통성분석.5개비호10지자제삼고물질화NIBSC응혈표준품적검측결과균락재95％예측구간내,표명기재3개검측계통간균구유호통성.결론 대우FⅧ활성검측,불동검측계통간적결과가비성교호,FⅨ활성검측계통간적가비성상가접수.자제삼고물질화NIBSC표준품용우불동검측계통구유호통성.
Objective To evaluate the comparability of measurement results for coagulation factor Ⅷ (FⅧ) and factor Ⅸ (FⅨ) activity and the commutability of reference materials on different measurement systems.Methods The study was performed according to CLSI guideline EP30 and China health standard WS/T 356-2011.Clinical samples with different levels of F Ⅷ and F Ⅸ which covered over the clinical analytical range,five lots of homemade reference materials (F20140601-F20140605) and a coagulation reference material (SSCLOT4) provided by NIBSC were detected for FⅧ and FⅨ activity on three popular measurement systems in China,which including Stago STA-R Evolution,IL ACL TOP700 and Sysmex CA7000 automatic coagulation analyzers using supplementary reagents.The results between measurement systems were analyzed pairwise.To evaluate the comparability,the linear regression and the biases between the results of clinical samples from two measurement systems were calculated.The comparability was evaluated by the regression coefficient and the biases inside the acceptable range.After eliminated outliers from the results,linear regressions were run again and the 95％ confidence intervals were calculated.The commutability of the homemade reference materials and NIBSC reference material were evaluated by comparing the results with the limits of the intervals.Results The ranges of FⅧ and FⅨ level of clinical samples were 0.5％-218.0％ and 1.6％-156.5％,which covered the sample levels in routine work and fit the requirements for commutability evaluation.The square of correlation coefficients (R2) of measurement results of clinical samples for FⅧ and FⅨ activity assays were 0.89-0.94 and 0.81-0.93.The proportions of outliers were all less than 10％.The comparability of measurement results of FⅧ and FⅨ in different measurement systems was acceptable.According to the acceptable criteria for bias,the measurement results of 42,41 and 45 clinical samples for FⅧ and 44,42 and 41 clinical samples for FⅨ were used in the commutability evaluation for homemade reference materials and NIBSC reference material after deleting the outliers.The five lots homemade reference materials and NIBSC reference material were all within the 95％ prediction intervals from the linear regression of clinical samples' results.Conclusions Good correlation and comparability are found for FⅧ assay and those for FⅨ assay are acceptable.All homemade reference materials and NIBSC reference material are commutable for the three measurement systems.
