检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2009年
10期
737-741
,共5页
丙氨酸氨基转移酶%天门冬氨酸氨基转移酶%乳酸脱氧酶%参考方法
丙氨痠氨基轉移酶%天門鼕氨痠氨基轉移酶%乳痠脫氧酶%參攷方法
병안산안기전이매%천문동안산안기전이매%유산탈양매%삼고방법
Alanine aminotransferase%Aspartate aminotransferase%Lactate dehydrngenase%Reference method
目的 分析2006年度至2007年度连续2年参加国际临床化学联合会(IFCC)的参考实验室丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、乳酸脱氢酶(LDH)的室间质评(RELA)结果及卫生部临床检验标准委员会(以下简称卫生部)的酶学室间比对结果,评估其所用测定参考方法的检测质量及其完善程度.方法 根据IFCC公布的ALT、AST、LDH的测定参考方法的标准操作程序(SOP)进行测定,根据<分析测量中不确定度的量化>(QUAM 2000)计算合成标准不确定度.用日本临床检验标准协议会(JCCLS)旭化成株式会社认证酶标准物质评估参考方法的分析性能(准确度与不精密度).结果 2006年度的国际RELA与卫生部酶学室间比对结果室内变异系数(CV)均在1.5%～2.1%,2007年度的国际RELA结果与卫生部酶学室间比对结果室内CV均在1.1%以下,且本实验室与总体均值的偏倚整体低于2006年度,除2006年度卫生部酶学室间比对结果有3个值与总体均值的偏倚(7.99%,-7.02%,-13.97%)超过允许偏倚外,其余值均在允许偏倚范围内.ALT、AST、LDH标准物质室内CV均在1%以下,且均值偏倚靶值均低于1%.结论 本实验室所用测定ALT、AST、LDH的参考方法已比较成熟稳定,2007年度的实验室比对结果优于2006年度.
目的 分析2006年度至2007年度連續2年參加國際臨床化學聯閤會(IFCC)的參攷實驗室丙氨痠氨基轉移酶(ALT)、天門鼕氨痠氨基轉移酶(AST)、乳痠脫氫酶(LDH)的室間質評(RELA)結果及衛生部臨床檢驗標準委員會(以下簡稱衛生部)的酶學室間比對結果,評估其所用測定參攷方法的檢測質量及其完善程度.方法 根據IFCC公佈的ALT、AST、LDH的測定參攷方法的標準操作程序(SOP)進行測定,根據<分析測量中不確定度的量化>(QUAM 2000)計算閤成標準不確定度.用日本臨床檢驗標準協議會(JCCLS)旭化成株式會社認證酶標準物質評估參攷方法的分析性能(準確度與不精密度).結果 2006年度的國際RELA與衛生部酶學室間比對結果室內變異繫數(CV)均在1.5%～2.1%,2007年度的國際RELA結果與衛生部酶學室間比對結果室內CV均在1.1%以下,且本實驗室與總體均值的偏倚整體低于2006年度,除2006年度衛生部酶學室間比對結果有3箇值與總體均值的偏倚(7.99%,-7.02%,-13.97%)超過允許偏倚外,其餘值均在允許偏倚範圍內.ALT、AST、LDH標準物質室內CV均在1%以下,且均值偏倚靶值均低于1%.結論 本實驗室所用測定ALT、AST、LDH的參攷方法已比較成熟穩定,2007年度的實驗室比對結果優于2006年度.
목적 분석2006년도지2007년도련속2년삼가국제림상화학연합회(IFCC)적삼고실험실병안산안기전이매(ALT)、천문동안산안기전이매(AST)、유산탈경매(LDH)적실간질평(RELA)결과급위생부림상검험표준위원회(이하간칭위생부)적매학실간비대결과,평고기소용측정삼고방법적검측질량급기완선정도.방법 근거IFCC공포적ALT、AST、LDH적측정삼고방법적표준조작정서(SOP)진행측정,근거<분석측량중불학정도적양화>(QUAM 2000)계산합성표준불학정도.용일본림상검험표준협의회(JCCLS)욱화성주식회사인증매표준물질평고삼고방법적분석성능(준학도여불정밀도).결과 2006년도적국제RELA여위생부매학실간비대결과실내변이계수(CV)균재1.5%～2.1%,2007년도적국제RELA결과여위생부매학실간비대결과실내CV균재1.1%이하,차본실험실여총체균치적편의정체저우2006년도,제2006년도위생부매학실간비대결과유3개치여총체균치적편의(7.99%,-7.02%,-13.97%)초과윤허편의외,기여치균재윤허편의범위내.ALT、AST、LDH표준물질실내CV균재1%이하,차균치편의파치균저우1%.결론 본실험실소용측정ALT、AST、LDH적삼고방법이비교성숙은정,2007년도적실험실비대결과우우2006년도.
Objective To analyze the results of three enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH)]in the ring trials of Reference Laboratories In Medicine (RELA) organized by International Federation of Clinical Chemistry(IFCC) and the ring trials organized by National Center for Clinical Laboratory (NCCL) in 2006 and 2007, and evaluate the analytic characteristic and reliability of the reference methods of ALT,AST and LDH. Methods ALT, AST, and LDH were measured by the standard operating procedure (SOP) of reference methods published by IFCC, and the combined standard uncertainty was calculated according to Quantifying Uncertainty in Analytical Measurement (QUAM) 2000. The analytic characteristic of the reference methods was evaluated by human enzyme calibrators of Asahi Kasei Pharma corporation from Japanese Committee for Clinical Laboratory Standards (JCCLS). Results The within-laboratory coefficient of variation (CV) of the three enzymes was ranged from 1.5%-2.1% in the 2006 ring trials of RELA organized by IFCC and NCCL, while the within-laboratory CV of the three enzymes was less than 1.1% in the 2007 ring trials, and the bias (%) was less than that in 2006. The values were within the deviation acceptance range except for the values of three samples(7.99% , -7.02%, - 13.97%). The within-laboratory CV of ALT, AST and LDH of the human enzyme calibrators of Asahi Kasei Pharma corporation were less than 1%, and the mean value deviation from target values was less than 1%. Conclusions The reference methods for the measurement of catalytic activity of ALT, AST and LDH have been improved and stable in our laboratory, and the results in the 2007 ring trials excelled those in the 2006 ring trials.
