中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2013年
9期
801-805
,共5页
张传宝%赵海舰%马嵘%张江涛%王抒%陈文祥
張傳寶%趙海艦%馬嶸%張江濤%王抒%陳文祥
장전보%조해함%마영%장강도%왕서%진문상
胆固醇%自动化%临床化学试验
膽固醇%自動化%臨床化學試驗
담고순%자동화%림상화학시험
Cholesterol%Automation%Clinical chemistry tests
目的 评价7种开放式胆固醇测定自动生化分析系统的精密度、线性、抗干扰能力、正确度.方法 方法评价研究.选择2012年北京中生、北京柏定、上海复星长征、浙江东瓯、上海科华、四川迈克和日本和光7个厂家的胆固醇氧化酶法测定试剂及其校准品,与日立7170自动生化分析仪组成7种开放式分析系统.按照美国临床和实验室标准化研究院(CLSI)的EP5-A2文件,对这7种系统进行重复性变异系数及实验室内变异系数评价;依据EP6-A文件进行线性评价,线性样本的浓度分别为0、2.07、4.14、6.21、8.28、10.35、12.93、20.69、25.86 mmol/L;按照EP7-A2进行干扰实验,干扰物质包括血红蛋白、维生素C(抗坏血酸)及乳糜;正确度评价采用我国血脂标准化计划的方式进行,样本为参考方法定值为2.88 ~ 5.42 mmol/L的10个浓度的血清盘.结果 7种开放式系统测定低值样本(2.71 mmol/L)时重复性CV分别为0.54%、0.79%、0.56%、0.51%、0.56%、0.48%、0.49%,实验室内CV分别为1.00%、1.06%、1.28%、0.89%、1.08%、1.13%、1.05%;测定高值样本(5.12 mmol/L)时的批内CV分别为0.40%、0.41%、0.51%、0.48%、0.47%、0.45%、0.47%,实验室内CV分别为0.82%、0.69%、1.27%、0.70%、0.70%、1.08%、0.69%;系统A、B、D、F的线性范围上限为12.93 mmol/L,系统C、E、G的线性范围上限为20.69 mmol/L;乳糜浓度1.6%或血红蛋白4 g/L时对7种系统的无明显干扰;在干扰百分偏差的绝对值不超过4%的情况下,7种系统能耐受的维生素C干扰浓度分别为228、215、225、2840、2840、217、2840μmol/L.正确度验证中,7种系统的CV均满足≤3%的要求,偏倚(bias)分别为-0.72%、-1.15%、-2.03%、-2.51%、-0.21%、2.45%、0.78%.结论 7种系统在精密度、线性、正确度、抗干扰能力方面的性能均能满足临床使用的要求;部分产品在抗干扰能力、正确度方面还有改进的余地.
目的 評價7種開放式膽固醇測定自動生化分析繫統的精密度、線性、抗榦擾能力、正確度.方法 方法評價研究.選擇2012年北京中生、北京柏定、上海複星長徵、浙江東甌、上海科華、四川邁剋和日本和光7箇廠傢的膽固醇氧化酶法測定試劑及其校準品,與日立7170自動生化分析儀組成7種開放式分析繫統.按照美國臨床和實驗室標準化研究院(CLSI)的EP5-A2文件,對這7種繫統進行重複性變異繫數及實驗室內變異繫數評價;依據EP6-A文件進行線性評價,線性樣本的濃度分彆為0、2.07、4.14、6.21、8.28、10.35、12.93、20.69、25.86 mmol/L;按照EP7-A2進行榦擾實驗,榦擾物質包括血紅蛋白、維生素C(抗壞血痠)及乳糜;正確度評價採用我國血脂標準化計劃的方式進行,樣本為參攷方法定值為2.88 ~ 5.42 mmol/L的10箇濃度的血清盤.結果 7種開放式繫統測定低值樣本(2.71 mmol/L)時重複性CV分彆為0.54%、0.79%、0.56%、0.51%、0.56%、0.48%、0.49%,實驗室內CV分彆為1.00%、1.06%、1.28%、0.89%、1.08%、1.13%、1.05%;測定高值樣本(5.12 mmol/L)時的批內CV分彆為0.40%、0.41%、0.51%、0.48%、0.47%、0.45%、0.47%,實驗室內CV分彆為0.82%、0.69%、1.27%、0.70%、0.70%、1.08%、0.69%;繫統A、B、D、F的線性範圍上限為12.93 mmol/L,繫統C、E、G的線性範圍上限為20.69 mmol/L;乳糜濃度1.6%或血紅蛋白4 g/L時對7種繫統的無明顯榦擾;在榦擾百分偏差的絕對值不超過4%的情況下,7種繫統能耐受的維生素C榦擾濃度分彆為228、215、225、2840、2840、217、2840μmol/L.正確度驗證中,7種繫統的CV均滿足≤3%的要求,偏倚(bias)分彆為-0.72%、-1.15%、-2.03%、-2.51%、-0.21%、2.45%、0.78%.結論 7種繫統在精密度、線性、正確度、抗榦擾能力方麵的性能均能滿足臨床使用的要求;部分產品在抗榦擾能力、正確度方麵還有改進的餘地.
목적 평개7충개방식담고순측정자동생화분석계통적정밀도、선성、항간우능력、정학도.방법 방법평개연구.선택2012년북경중생、북경백정、상해복성장정、절강동구、상해과화、사천매극화일본화광7개엄가적담고순양화매법측정시제급기교준품,여일립7170자동생화분석의조성7충개방식분석계통.안조미국림상화실험실표준화연구원(CLSI)적EP5-A2문건,대저7충계통진행중복성변이계수급실험실내변이계수평개;의거EP6-A문건진행선성평개,선성양본적농도분별위0、2.07、4.14、6.21、8.28、10.35、12.93、20.69、25.86 mmol/L;안조EP7-A2진행간우실험,간우물질포괄혈홍단백、유생소C(항배혈산)급유미;정학도평개채용아국혈지표준화계화적방식진행,양본위삼고방법정치위2.88 ~ 5.42 mmol/L적10개농도적혈청반.결과 7충개방식계통측정저치양본(2.71 mmol/L)시중복성CV분별위0.54%、0.79%、0.56%、0.51%、0.56%、0.48%、0.49%,실험실내CV분별위1.00%、1.06%、1.28%、0.89%、1.08%、1.13%、1.05%;측정고치양본(5.12 mmol/L)시적비내CV분별위0.40%、0.41%、0.51%、0.48%、0.47%、0.45%、0.47%,실험실내CV분별위0.82%、0.69%、1.27%、0.70%、0.70%、1.08%、0.69%;계통A、B、D、F적선성범위상한위12.93 mmol/L,계통C、E、G적선성범위상한위20.69 mmol/L;유미농도1.6%혹혈홍단백4 g/L시대7충계통적무명현간우;재간우백분편차적절대치불초과4%적정황하,7충계통능내수적유생소C간우농도분별위228、215、225、2840、2840、217、2840μmol/L.정학도험증중,7충계통적CV균만족≤3%적요구,편의(bias)분별위-0.72%、-1.15%、-2.03%、-2.51%、-0.21%、2.45%、0.78%.결론 7충계통재정밀도、선성、정학도、항간우능력방면적성능균능만족림상사용적요구;부분산품재항간우능력、정학도방면환유개진적여지.
Objective to evaluate the analytical performance of 7 open automatic biochemistry analysis systems in terms of precision,linearity,anti-interference ability and trueness on determination of cholesterol.Methods Performance verification test.There were 7 open analysis measurement systems composed of 7 kits as well as calibrators from Biosina,Baiding,Fosun,Dongou,Kehua,Maker and Wako company respectively,and Hitachi 7170 automatic analyzer were chosen as test systems.The repeatability CV and inter-lab CV were assessed according to Clinical and Laboratory Standards Institute (CLSI) protocol EP5-A2.The linearity range was evaluated on the basis of CLSI EP6-A,the series concentrations of cholesterol were 0,2.07,4.14,6.21,8.28,10.35,12.93,20.69 and 25.86 mmol/L cholesterol.Hemoglobin,ascorbic acid (vitamin C) and intralipid were applied as interfere materials in interference testing according to CLSI EP7-A2.The trueness was evaluated on the basis of China national lipids standardization program,the concentrations of 10 samples ranged from 2.88 to 5.42 mmol/L measured by reference methods.Results When the low level sample (2.71 mmol/L) measured,the repeatability CV were 0.54%,0.79%,0.56%,0.51%,0.56%,0.48% and 0.49% respectively,intra-lab CV were 1.00%,1.06%,1.28%,0.89%,1.08%,1.13% and 1.05% respectively.When the high level sample (5.12 mmol/L) measured,the respective repeatability CV were 0.40%,0.41%,0.51%,0.48%,0.47%,0.45% and 0.47%,the respective intra-lab CV were 0.82%,0.69%,1.27%,0.70%,0.70%,1.08% and 0.69%.The upper limits of linearity range of A,B,D,F was 12.93 mmol/L and for C,E,G was 20.69 mmol/L.There is no significant interference on 7 systems with chyle concentration of 1.6% or hemoglobin concentration of 4 g/L.Given the interference bias ≤ 4%,the interference concentrations of ascorbic acid were 228,215,225,2840,2840,217 and 2840 μmol/L respectively.In trueness verification experiment,the bias of 7 systems all met the target value (≤ 3%).Conclusion The analytical performance of 7 systems in terms of precision,linearity,trueness and anti-interference all met the requirements of clinical specifications.The performance of anti-interference and measurement trueness of several systems could be improved.