1、检验系统精密度和准确度在用户端的确认检验系统精密度和准确度在用户端的确认Clinical and Laboratory Standards Institute(CLSI)Clinical and Laboratory Standards Institute(CLSI)-User Verification of Performance for Precision and Trueness EP15-A2-User Verification of Performance for Precision and Trueness EP15-A2医学实验室精密度和准确度的确认EP15A2UserVerif
2、icationofPerformanceforPrecisionandTru1 精密度实验精密度实验 （Precision ExperimentPrecision Experiment）准确度准确度临床标本比对实验临床标本比对实验 （Comparison of Patient Samples ExperimentComparison of Patient Samples Experiment）准确度准确度用已定值标准物质检验用已定值标准物质检验 （Demonstration of Trueness With Reference MaterialsDemonstration of Truenes
3、s With Reference Materials）医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru2精密度实验精密度实验（Precision ExperimentPrecision Experiment）重复性重复性s sr r（Repeatability Standard DeviationRepeatability Standard Deviation）总不精密度总不精密度s sl l（With-laboratory Standard DeviationWith-laboratory Standar
4、d Deviation）例一：例一：葡萄糖葡萄糖（GlucoseGlucose）浓度浓度（C C）=140mg/dL=140mg/dL；标示精密度标示精密度（claimedclaimed）：r r=1.0mg/dL=1.0mg/dL；l l=2.0mg/dL=2.0mg/dL；医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru3实验数据处理及详解实验数据处理及详解医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru4实验数据处
5、理及详解实验数据处理及详解医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru5 （）555idxx=（140+138.33+143.67+142.67+142）5 =141.33 计算总体均值（Grand Mean）：x医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru6 （S Sr r）重复性重复性（Repeatability Standard DeviationRepeatability Standard Deviati
6、on）525242322212,runrunrunrunrunaveragerunsdsdsdsdsdsd=（0+0.3334+0.3334+0.3334+1）5 =0.40004 1、2、2,averagerunrsds=0.632 1 mg/dL医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru7计算扩展计算扩展r rv：自由度（Degrees Of Freedom）C：自由度为10置信度为97.5%卡平方分布值（）扩展r =vcr（Verification value）r=1（mg/dL）；v =10；
7、C =20.482=1.431 sr =0.632 1.431;可以认为待验重复性（sr）与标示的重复性（claimed）r 保持一致，待验系统重复性（sr）被证实。（结论）医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru8（S Sl l）总不精密度总不精密度（With-laboratory Standard DeviationWith-laboratory Standard Deviation）=(（140-141.33)2+(138.33-141.33)2+(143.67-141.33)2+(142.6
8、7-141.33)2+(142-141.33)2）4 =4.622251、4)(5122ddbxxssr =0.632；医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru9（S Sl l）总不精密度总不精密度（With-laboratory Standard DeviationWith-laboratory Standard Deviation）2、=SQRT(230.40004+4.62225)；221brlssnns=2.21 2 mg/dL 医学实验室精密度和准确度的确认EP15A2UserVerifi
9、cationofPerformanceforPrecisionandTru10计算扩展计算扩展l lT：合成自由度（Degrees Of Freedom）C：自由度为4置信度为97.5%卡平方分布值（）扩展l =Tcl（Verification value）l=2（mg/dL）；T =4；C =11.14；D=52=3.16 sl =2.21 3.16;可以认为待验重复性（sl）与标示的重复性（claimed）l 保持一致，待验系统重复性（sl）被证实。（结论）)1)()1()()1(2224222DsnsDnnssnTbrbr=4.47医学实验室精密度和准确度的确认EP15A2UserVer
10、ificationofPerformanceforPrecisionandTru11The operating characteristic curve 医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru12准确度准确度 临床标本比对实验临床标本比对实验（Comparison of Patient Samples Comparison of Patient Samples ExperimentExperiment）例二：例二：1 1、葡萄糖、葡萄糖（glucose）标示偏倚（claimed bias or p
11、ercent bias）：不超过2.0mg/dL（C=126mg/dL）2 2、-谷氨酰转移酶谷氨酰转移酶（-Glutamyl Transferase）标示偏倚（claimed bias or percent bias）：不超过2%（U/L）3 3、尿素、尿素（urea）标示偏倚（claimed bias or percent bias）：不超过2%（mmol/L）医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru131 1、葡萄糖实验数据处理及详解、葡萄糖实验数据处理及详解医学实验室精密度和准确度的确认EP
12、15A2UserVerificationofPerformanceforPrecisionandTru14计算偏差及相对偏差（bias and percent bias）nbbIii1=5020 =2.5 2 mg/dL1)(2nbbsIiib=SQRT(35719)=4.33 nbbIii%=47.2220 =2.36%1)%(%2%nbbsIiib=SQRT(346.0819)=4.27%医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru15医学实验室精密度和准确度的确认EP15A2UserVerific
13、ationofPerformanceforPrecisionandTru16计算扩展计算扩展（Verification limits bias Verification limits bias）bst：自由度为19置信度为99%的单尾T分布值“2.539”=4.33；n =20=2.0 2.46 =-0.46、4.46 =2.5 4.46;可以认为待验系统与标示保持一致，待验系统准确性被证实。（结论）Verification limits(bias)=nstbb医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTr
14、u17医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru18The operating characteristic curve 医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru192 2、-谷氨酰转移酶实验数据处理及详解谷氨酰转移酶实验数据处理及详解（U/LU/L）医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru20计算偏差及相对偏差
15、（bias and percent bias）nbbIii1=32.520 =1.6251)(2nbbsIiib=SQRT(73.9719)=1.973 nbbIii%=29.6220 =1.481%2%1)%(%2%nbbsIiib=SQRT(33.49519)=1.328%待验系统偏差小于标示，准确性被证实医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru21医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru22医学实验
16、室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru233 3、尿素实验数据处理及详解、尿素实验数据处理及详解（mmol/Lmmol/L）医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru24计算偏差及相对偏差（bias and percent bias）nbbIii1=8.4420 =0.421)(2nbbsIiib=SQRT(1.1419)=0.244 nbbIii%=103.520 =5.175%2%1)%(%2%nbbsIii
17、b=SQRT(41.88719)=1.485%医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru25医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru26计算扩展计算扩展（Verification limits bias Verification limits bias）bs%t：自由度为19置信度=1%的单尾T分布值“2.539”=1.485%；n =20=2%0.843%=1.157%、2.843%=5.175%2.84
18、3%;不能认为待验与标示保持一致，应在结果中报告此差异。（结论）Verification limits =nstbb%(percent bias)医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru27医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru28准确度准确度 用已定值标准物质检验用已定值标准物质检验（Demonstration of Trueness With Reference Demonstration of T
19、rueness With Reference MaterialsMaterials）例三：例三：葡萄糖葡萄糖（GlucoseGlucose）定值标物浓度定值标物浓度（C C）=40 40 mg/dLmg/dL；n=135 n=135 组实验室独立平行定值组实验室独立平行定值 标准差（标准差（s peer group peer group）=1.73=1.73 mg/dLmg/dL；医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru29实验数据处理及详解实验数据处理及详解医学实验室精密度和准确度的确认EP15A
20、2UserVerificationofPerformanceforPrecisionandTru30)(109876543211xxxxxxxxxxxnii1、=37.7（mg/dL）2、10101iiniixnxx=3773、9)(1)(1012122iiniixxxnxxs=0.94、2xxss=0.949医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru31计算扩展计算扩展（Verification intervalVerification interval）grouppeerst：自由度为9置信度为=1%的单尾T分布值“2.821”=1.73；标物浓度（assigned value）=40=37.7 2.71 =34.99、40.41 34.99 （assigned value）=40 40.41;可以认为待验系统测定结果与标物已定值保持一致，待验系统准确性被证实。（结论）nssgrouppeerb=0.419；sx=0.949Verification interval =2212,1bxnsstx医学实验室精密度和准确度的确认EP15A2UserVerificationofPerformanceforPrecisionandTru32
