检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2014年
3期
241-244
,共4页
蒋玲丽%王雪亮%肖艳群%王华梁
蔣玲麗%王雪亮%肖豔群%王華樑
장령려%왕설량%초염군%왕화량
不确定度%聚合酶链反应%乙型肝炎
不確定度%聚閤酶鏈反應%乙型肝炎
불학정도%취합매련반응%을형간염
Uncertainty%Polymerase chain reaction%Hepatitis B
目的:探讨利用质控数据评定荧光定量聚合酶链反应(PCR)测定HBV DNA测量不确定度的可行性。方法用批内不精密度和批间不精密度数据评定A类不确定度;分别用参加卫生部临床检验中心和美国病理学家协会(CAP)的室间质评数据评定B类不确定度;最后评定合成不确定度和扩展不确定度。结果利用卫生部临床检验中心室间质评反馈结果评定的扩展不确定度(k=1.96,n=1)在检测值为104~105和106~107 IU/mL时分别为0.5216和0.5298;利用CAP能力比对反馈结果评定的扩展不确定度(k=1.96,n=1)在检测值为104~105和106~107 IU/mL时分别为0.9731和0.9775。结论目前用室间质评数据评定PCR测定HBV DNA的不确定度不能真实反映实验室的不确定度,使用国家标准物质评定不确定度更合适。
目的:探討利用質控數據評定熒光定量聚閤酶鏈反應(PCR)測定HBV DNA測量不確定度的可行性。方法用批內不精密度和批間不精密度數據評定A類不確定度;分彆用參加衛生部臨床檢驗中心和美國病理學傢協會(CAP)的室間質評數據評定B類不確定度;最後評定閤成不確定度和擴展不確定度。結果利用衛生部臨床檢驗中心室間質評反饋結果評定的擴展不確定度(k=1.96,n=1)在檢測值為104~105和106~107 IU/mL時分彆為0.5216和0.5298;利用CAP能力比對反饋結果評定的擴展不確定度(k=1.96,n=1)在檢測值為104~105和106~107 IU/mL時分彆為0.9731和0.9775。結論目前用室間質評數據評定PCR測定HBV DNA的不確定度不能真實反映實驗室的不確定度,使用國傢標準物質評定不確定度更閤適。
목적:탐토이용질공수거평정형광정량취합매련반응(PCR)측정HBV DNA측량불학정도적가행성。방법용비내불정밀도화비간불정밀도수거평정A류불학정도;분별용삼가위생부림상검험중심화미국병이학가협회(CAP)적실간질평수거평정B류불학정도;최후평정합성불학정도화확전불학정도。결과이용위생부림상검험중심실간질평반궤결과평정적확전불학정도(k=1.96,n=1)재검측치위104~105화106~107 IU/mL시분별위0.5216화0.5298;이용CAP능력비대반궤결과평정적확전불학정도(k=1.96,n=1)재검측치위104~105화106~107 IU/mL시분별위0.9731화0.9775。결론목전용실간질평수거평정PCR측정HBV DNA적불학정도불능진실반영실험실적불학정도,사용국가표준물질평정불학정도경합괄。
Objective To investigate the uncertainty of hepatitis B virus (HBV ) DNA determination by fluorescence quantitative polymerase chain reaction (PCR ) according to quality control data, and evaluate the feasibility.Methods The uncertainty of Type A was evaluated by the data of within-run and between-run coefficients of variation.The uncertainty of Type B was evaluated according to the data of external quality assessments from the National Center for Clinical Laboratory and College of American Pathologists(CAP).The combined uncertainties and expanded uncertainties were evaluated and analyzed.Results The expanded uncertainties in 104-105 IU/mL and 106-107 IU/mL concentrations were 0.521 6 and 0.529 8(k=1.96,n=1),according to the data from the National Center for Clinical Laboratory.The expanded uncertainties in 104-105 IU/mL and 106-107 IU/mL concentrations were 0.973 1 and 0.977 5 (k=1.96,n=1),according to the data from CAP.Conclusions It is not bilievable to evaluate the uncertainty of HBV DNA determination by fluorescence quantitative PCR,and it is suitable to evaluate the uncertainty using the results traced back to the national standard substance.