中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2014年
3期
173-178
,共6页
高半胱氨酸%临床酶试验%免疫测定
高半胱氨痠%臨床酶試驗%免疫測定
고반광안산%림상매시험%면역측정
Homocysteine%Clinical enzyme tests%Immunoassay
目的 评估6种同型半胱氨酸(Hcy)循环酶法检测系统的分析性能.方法 方法学评价研究.应用美国临床和实验室标准化协会(CLSI) EP5-A2、EP15-A2、EP7-A2、EP6-A 、EP9-A2方法验证6种甲基转移酶循环法检测系统的精密度、正确度、抗干扰性、分析测量范围(AMR)、以及其与雅培(Abbott)化学发光微粒子免疫检测系统(CMIA)的相关性和偏差.采用美国国家标准技术研究所(NIST)有证参考物质SRM 1955、美国病理学家协会(CAP)发放的室间质评物(CR-B和CR-A)以及卫生部临床检验中心发放的室间质评物验证不同系统检测Hcy正确度.回归分析采用PassingBablok,回归线性检测采用Cusum方法,相关分析采用Pearson,偏差分析应用Bland-Altman.结果 Hcy浓度(10～ 22 μmol/L)时除A1系统低水平外,其他批内均＜5％,批间均＜6.7％.正确度验证显示A1 ～ D2、CMIA系统测定NIST SRM 1955在低、中、高水平的最大绝对偏倚分别为-3.36、1.43、2.24 μmol/L.测定CAP和卫生部临检中心室间质评物显示除A1系统外,其他系统偏倚均＜总允许误差(TEa)2.50 μmol/L或靶值±20％.干扰分析显示Hb和TBil对测定干扰较明显.A1～D2系统AMR上限分别为47.30、69.76、72.10、73.96、46.23、48.98 μtmol/L.相关分析显示6种系统与CMIA系统检测结果间相关性较好,r均＞0.975(P ＜0.01,n＞40).6种系统与CMIA系统的平均绝对偏差最大为2.9 μmol/L.结论 应用自动生化仪的循环酶法检测Hcy具有良好的精密度、线性范围和抗干扰能力,但部分检测系统性能需要进一步改进,且与CMIA系统间存在一定偏差,同时循环酶法检测系统不适用于尿液样本.
目的 評估6種同型半胱氨痠(Hcy)循環酶法檢測繫統的分析性能.方法 方法學評價研究.應用美國臨床和實驗室標準化協會(CLSI) EP5-A2、EP15-A2、EP7-A2、EP6-A 、EP9-A2方法驗證6種甲基轉移酶循環法檢測繫統的精密度、正確度、抗榦擾性、分析測量範圍(AMR)、以及其與雅培(Abbott)化學髮光微粒子免疫檢測繫統(CMIA)的相關性和偏差.採用美國國傢標準技術研究所(NIST)有證參攷物質SRM 1955、美國病理學傢協會(CAP)髮放的室間質評物(CR-B和CR-A)以及衛生部臨床檢驗中心髮放的室間質評物驗證不同繫統檢測Hcy正確度.迴歸分析採用PassingBablok,迴歸線性檢測採用Cusum方法,相關分析採用Pearson,偏差分析應用Bland-Altman.結果 Hcy濃度(10～ 22 μmol/L)時除A1繫統低水平外,其他批內均＜5％,批間均＜6.7％.正確度驗證顯示A1 ～ D2、CMIA繫統測定NIST SRM 1955在低、中、高水平的最大絕對偏倚分彆為-3.36、1.43、2.24 μmol/L.測定CAP和衛生部臨檢中心室間質評物顯示除A1繫統外,其他繫統偏倚均＜總允許誤差(TEa)2.50 μmol/L或靶值±20％.榦擾分析顯示Hb和TBil對測定榦擾較明顯.A1～D2繫統AMR上限分彆為47.30、69.76、72.10、73.96、46.23、48.98 μtmol/L.相關分析顯示6種繫統與CMIA繫統檢測結果間相關性較好,r均＞0.975(P ＜0.01,n＞40).6種繫統與CMIA繫統的平均絕對偏差最大為2.9 μmol/L.結論 應用自動生化儀的循環酶法檢測Hcy具有良好的精密度、線性範圍和抗榦擾能力,但部分檢測繫統性能需要進一步改進,且與CMIA繫統間存在一定偏差,同時循環酶法檢測繫統不適用于尿液樣本.
목적 평고6충동형반광안산(Hcy)순배매법검측계통적분석성능.방법 방법학평개연구.응용미국림상화실험실표준화협회(CLSI) EP5-A2、EP15-A2、EP7-A2、EP6-A 、EP9-A2방법험증6충갑기전이매순배법검측계통적정밀도、정학도、항간우성、분석측량범위(AMR)、이급기여아배(Abbott)화학발광미입자면역검측계통(CMIA)적상관성화편차.채용미국국가표준기술연구소(NIST)유증삼고물질SRM 1955、미국병이학가협회(CAP)발방적실간질평물(CR-B화CR-A)이급위생부림상검험중심발방적실간질평물험증불동계통검측Hcy정학도.회귀분석채용PassingBablok,회귀선성검측채용Cusum방법,상관분석채용Pearson,편차분석응용Bland-Altman.결과 Hcy농도(10～ 22 μmol/L)시제A1계통저수평외,기타비내균＜5％,비간균＜6.7％.정학도험증현시A1 ～ D2、CMIA계통측정NIST SRM 1955재저、중、고수평적최대절대편의분별위-3.36、1.43、2.24 μmol/L.측정CAP화위생부림검중심실간질평물현시제A1계통외,기타계통편의균＜총윤허오차(TEa)2.50 μmol/L혹파치±20％.간우분석현시Hb화TBil대측정간우교명현.A1～D2계통AMR상한분별위47.30、69.76、72.10、73.96、46.23、48.98 μtmol/L.상관분석현시6충계통여CMIA계통검측결과간상관성교호,r균＞0.975(P ＜0.01,n＞40).6충계통여CMIA계통적평균절대편차최대위2.9 μmol/L.결론 응용자동생화의적순배매법검측Hcy구유량호적정밀도、선성범위화항간우능력,단부분검측계통성능수요진일보개진,차여CMIA계통간존재일정편차,동시순배매법검측계통불괄용우뇨액양본.
Objective To evaluate the performance of six homocysteine (Hcy) analysis systems.Methods This is a methodological evaluation study.We analyzed six cycle enzymatic systems,and their correlation and deviation compared with chemiluminescence microparticle immunoassay (CMIA) from Abbott Architect plus i2000 system.Precision,accuracy,anti-interference and analytical measuring range (AMR)were evaluated,according to the CLSI EP5-A2,EP15-A2,EP7-A2,EP6-A,EP9-A2 guidelines.To assess the accuracy,we used the reference material SRM 1955 from National Institute of Standards and Technology (NIST),and EQA samples from CAP and National Center of Clinical Laboratory.Regression analysis was conducted using Passing-Bablok method.Linear regression measurement was performed using Cusum method,with a statistical significance level set at P ＜ 0.05.Correlation analysis was conducted using Pearson coefficient,with P ＜0.05 indicating significant difference.Deviation analysis was performed using Bland-Altman method.Results In the six systems (A1-D2) except A1,the within-run CVs were all ＜ 5％ and the between-run CVs were all ＜ 6.7％ at the Hey concentration range of 10-22 μmol/L.The accuracy validation of NIST SRM 1955 showed that the maximum absolute bias were-3.36,1.43,2.24 μmol/L at low,medium and high levels respectively.Measurement of EQA samples from CAP and National Center of Clinical Laboratory showed that the relative bias were all ＜ TEa (2.5 μmol/L or target value ±20％) in the six systems (A1-D2) except A1.Hb and TBIL interference were significant.The upper limit of AMR for six systems were 47.3,69.76,72.1,73.96,46.23 and 48.98 μmol/L respectively.The measurement results of six systems conelated well with that of CMIA system,with Pearson correlation coefficient (r) ＞ 0.975 (P ＜0.01,n ＞40).Compared with CMIA system,the Bland-Altman results showed that the maximum average absolute deviation was 2.9 μmol/L.Conclusions The cycle enzymatic method used to measure homocysteine has good precision,linear range,and anti-interference ability.But it is noticeable that the results of cycle enzymatic was higher than those of CMIA.Meanwhile,the six systems do not apply to measuring urine samples.
