中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2011年
3期
271-275
,共5页
沈伟锋%范骏%邵平扬%胡敏君%王兆丰%张黎霞%丁韧烨%杨清萍%王宇军
瀋偉鋒%範駿%邵平颺%鬍敏君%王兆豐%張黎霞%丁韌燁%楊清萍%王宇軍
침위봉%범준%소평양%호민군%왕조봉%장려하%정인엽%양청평%왕우군
不确定度%肝炎病毒,乙型%DNA,病毒%聚合酶链反应
不確定度%肝炎病毒,乙型%DNA,病毒%聚閤酶鏈反應
불학정도%간염병독,을형%DNA,병독%취합매련반응
Uncertainty%Hepatitis B virus%DNA,viral%Polymerase chain reaction
目的 对不同检测系统HBV DNA测定结果进行不确定度评定和量值溯源,探讨不同检测系统HBV DNA测定结果的可比性,为实验室检验结果互认和实验室认可提供实验数据.方法 以国家标准物质作为"正确性质控物质",参考NATA颁布的"化学测量结果不确定度评定与报告导则",对不同检测系统HBV DNA测定结果的不确定度进行评定,并将结果溯源至国家标准物质;根据CLSI的EP9-A2文件要求,对不同检测系统HBV DNA测定结果进行比对分析和偏差评估,以检测系统偏倚的不确定度(ub)作为判断依据,将t(0.05sv)√u2b1+u2b2作为临床可接受的判断标准,评价不同检测系统HBV DNA测定结果的可比性.结果 3个检测系统测定HBV DNA国家标准物质所得的均值(-y)不同,分别为6.15、5.88、6.31,除检测系统A的偏倚无统计学意义(P＞0.05)外,检测系统B、C的偏倚均具有统计学意义(P均＜0.05);3个检测系统HBV DNA测定结果的扩展不确定度(U)也不同,但均在卫生部临床检验中心室间质量评价中规定的最大允许范围(±0.5)之内.经溯源至国家标准物质后,3个检测系统测定患者样本HBV DNA结果分别为:(5.45±1.23)、(5.55±1.32)、(5.42±1.25)lg(kIU/L),差异具有统计学意义(F=5.63,P＜0.05).3个检测系统测定结果两两比较显示,检测系统A与C比较,测定结果差异无统计学意义(q=1.85,P＞0.05);检测系统A与B比较,测定结果差异有统计学意义(q=5.12,P＜0.05);检测系统B与C比较,测定结果差异有统计学意义(q=6.85,P＜0.05).3个检测系统中,任意两个检测系统间HBV DNA测定结果的偏差均无统计学意义(P均＞0.05),表明检测系统间测定结果的偏差临床可以接受,测定结果具有可比性.结论 当不同实验室HBV DNA检验结果进行比较与互认时,应对各检测系统进行不确定度评定和量值溯源,并对不同检测系统间测定结果进行偏差评估,判断其临床可接受性,以保证检验结果的准确性和可比性.
目的 對不同檢測繫統HBV DNA測定結果進行不確定度評定和量值溯源,探討不同檢測繫統HBV DNA測定結果的可比性,為實驗室檢驗結果互認和實驗室認可提供實驗數據.方法 以國傢標準物質作為"正確性質控物質",參攷NATA頒佈的"化學測量結果不確定度評定與報告導則",對不同檢測繫統HBV DNA測定結果的不確定度進行評定,併將結果溯源至國傢標準物質;根據CLSI的EP9-A2文件要求,對不同檢測繫統HBV DNA測定結果進行比對分析和偏差評估,以檢測繫統偏倚的不確定度(ub)作為判斷依據,將t(0.05sv)√u2b1+u2b2作為臨床可接受的判斷標準,評價不同檢測繫統HBV DNA測定結果的可比性.結果 3箇檢測繫統測定HBV DNA國傢標準物質所得的均值(-y)不同,分彆為6.15、5.88、6.31,除檢測繫統A的偏倚無統計學意義(P＞0.05)外,檢測繫統B、C的偏倚均具有統計學意義(P均＜0.05);3箇檢測繫統HBV DNA測定結果的擴展不確定度(U)也不同,但均在衛生部臨床檢驗中心室間質量評價中規定的最大允許範圍(±0.5)之內.經溯源至國傢標準物質後,3箇檢測繫統測定患者樣本HBV DNA結果分彆為:(5.45±1.23)、(5.55±1.32)、(5.42±1.25)lg(kIU/L),差異具有統計學意義(F=5.63,P＜0.05).3箇檢測繫統測定結果兩兩比較顯示,檢測繫統A與C比較,測定結果差異無統計學意義(q=1.85,P＞0.05);檢測繫統A與B比較,測定結果差異有統計學意義(q=5.12,P＜0.05);檢測繫統B與C比較,測定結果差異有統計學意義(q=6.85,P＜0.05).3箇檢測繫統中,任意兩箇檢測繫統間HBV DNA測定結果的偏差均無統計學意義(P均＞0.05),錶明檢測繫統間測定結果的偏差臨床可以接受,測定結果具有可比性.結論 噹不同實驗室HBV DNA檢驗結果進行比較與互認時,應對各檢測繫統進行不確定度評定和量值溯源,併對不同檢測繫統間測定結果進行偏差評估,判斷其臨床可接受性,以保證檢驗結果的準確性和可比性.
목적 대불동검측계통HBV DNA측정결과진행불학정도평정화량치소원,탐토불동검측계통HBV DNA측정결과적가비성,위실험실검험결과호인화실험실인가제공실험수거.방법 이국가표준물질작위"정학성질공물질",삼고NATA반포적"화학측량결과불학정도평정여보고도칙",대불동검측계통HBV DNA측정결과적불학정도진행평정,병장결과소원지국가표준물질;근거CLSI적EP9-A2문건요구,대불동검측계통HBV DNA측정결과진행비대분석화편차평고,이검측계통편의적불학정도(ub)작위판단의거,장t(0.05sv)√u2b1+u2b2작위림상가접수적판단표준,평개불동검측계통HBV DNA측정결과적가비성.결과 3개검측계통측정HBV DNA국가표준물질소득적균치(-y)불동,분별위6.15、5.88、6.31,제검측계통A적편의무통계학의의(P＞0.05)외,검측계통B、C적편의균구유통계학의의(P균＜0.05);3개검측계통HBV DNA측정결과적확전불학정도(U)야불동,단균재위생부림상검험중심실간질량평개중규정적최대윤허범위(±0.5)지내.경소원지국가표준물질후,3개검측계통측정환자양본HBV DNA결과분별위:(5.45±1.23)、(5.55±1.32)、(5.42±1.25)lg(kIU/L),차이구유통계학의의(F=5.63,P＜0.05).3개검측계통측정결과량량비교현시,검측계통A여C비교,측정결과차이무통계학의의(q=1.85,P＞0.05);검측계통A여B비교,측정결과차이유통계학의의(q=5.12,P＜0.05);검측계통B여C비교,측정결과차이유통계학의의(q=6.85,P＜0.05).3개검측계통중,임의량개검측계통간HBV DNA측정결과적편차균무통계학의의(P균＞0.05),표명검측계통간측정결과적편차림상가이접수,측정결과구유가비성.결론 당불동실험실HBV DNA검험결과진행비교여호인시,응대각검측계통진행불학정도평정화량치소원,병대불동검측계통간측정결과진행편차평고,판단기림상가접수성,이보증검험결과적준학성화가비성.
Objective To study the uncertainty and traceability of HBV DNA assays and discuss the comparability of results among different detection systems. Methods Different detecting systems were used to detect HBV DNA using the national standard substance as "quality control substance". The uncertainty of the results was evaluated referring "Guidelines for estimating and reporting measurement uncerTAinty of chemical test results" of NATA The results were traced back to the national standard substance. According to the CLSI document EP9-A2, the results were analyzed and subjected to bias estimation with the t(0.05sv) √u2b1+ u2b2 as the criterion clinically accepted to investigate the comparability of different detecting systems. Results The means (-y) measured by 3 HBV DNA assay systems were 6.15,5.88,and 6.31 lg(kIU/L) respectively. Except system A,both the biases of system B and C had statistical significance (all P ＜ 0. 05) and expanded uncertainty of three detection systems was varied, but the difference was within the maximum acceptable range (± 0. 5) of the external quality assessment by National Center for Clinical Laboratory. Being traceable to national standard substance, the results of HBV DNA of the three detecting systems were (5.45 ± 1.23), (5.55 ± 1.32) and (5.42 ± 1.25) lg(kIU/L), respectively.There was significant difference among three systems (F = 5.63, P ＜ 0. 05). Comparing system A and B,there was significant difference in statistic (q = 5. 12, P ＜ 0. 05) and the difference between system B and C also had statistically significant (q = 6. 85, P ＜ 0. 05), but the results between system A and C had no statistical difference (q = 1.85,P ＞ 0. 05). Among these three systems, the difference of any two detection systems had no statistical significance (all P ＞ 0. 05). It showed that system bias was acceptable in clinical application and the results between different systems were comparable. Conclusions It is necessary to estimate the uncertainty and traceability when comparing the HBV DNA assay among the different labs. It also needs to estimate the bias of different systems and evaluate the clinical acceptability to ensure the accuracy and comparability of the results.
