2014年全国血清治疗药物监测(卡马西平、地高辛、苯妥英、茶碱、丙戊酸)室内质量控制结果分析
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摘要
目的调查全国血清治疗药物监测(卡马西平、地高辛、苯妥英、茶碱、丙戊酸)室内质量控制的精密度现状,并与目前所确定的室内质量控制精密度的评价标准进行比较,提出改进措施。方法采用基于Web方式的室间质量评价(EQA)软件系统,收集2014年2月份参加全国血清治疗药物监测EQA计划的175家实验室的室内质量控制数据,包括当月的和累积的室内质量控制变异系数、质控规则、所使用的方法、仪器、室内质控品的厂家等信息。使用Microsoft Excel 2013和SPSS 13.0对数据进行分析。将EQA范围(地高辛为20%,其余项目为25%)定义为允许总误差(TEa),将1/3TEa和1/4TEa定义为允许不精密度的评价标准,计算这5个项目的室内质量控制变异系数的通过率。血清治疗药物监测项目的允许不精密度评价标准为8.33%(1/3TEa)和6.25%(1/4TEa),地高辛为6.67%(1/3TEa)和5%(1/4TEa)。结果分别有94家、97家、61家、43家和116家实验室回报了卡马西平、地高辛、苯妥英、茶碱、丙戊酸的室内质控数据。>60%的实验室(63.93%~76.29%)使用伯乐检测系统,只有<40%的实验室(23.71%~36.07%)使用其他检测系统。不同项目间的室内质控变异系数通过率都存在显著统计学差异,卡方值为10.689~19.255,均P<0.05。不同检测系统间,只有丙戊酸在当月和累积不精密度在1/3TEa时的通过率存在显著统计学差异(P<0.05)。结论通过对当月和累积的室内质控数据的变异系数的监测,并将室内质量控制数据计算的变异系数与相关要求进行比较,可以评价该检测系统的不精密度水平是否满足规定的质量要求。
Objective To investigate the coefficient of variations(CV)of internal quality control(IQC)of therapeutic drug monitoring in serum(carbamazepine, digoxin, phenytoin, theophylline and valproic acid), and compare with the quality specification derived from allowable total error(TEa). Methods Data was collected by Web-based submission system,the 175 laboratories which enrolled in 2014 therapeutic drug monitoring in serum external quality assessment(EQA) program attended. The data included: the CV of February of 2014 and long-term cumulative data,method and instrument,etc. Microsoft Excel 2013 and SPSS 13.0 was used to analyze the data.The evaluation standard of EQA was considered as TEa(25% and 20% for digoxin). 1/3TEa(8.33% and 6.67% for digoxin)and 1/4TEa(6.25% and 5% for digoxin)were determined to be the evaluation standard of CV of IQC. Results From 175 laborctories 94, 97, 61, 43 and 116 laboratories reported effective results of IQC material of carbamazepine, digoxin, phenytoin, theophylline and valproic acib, respectively. More than 60% laboratories used Bio-Rad measurement system(63.93%-76.29%). Less than 40% laboratories used other measurement systems(23.71%-36.07%). There were significant differences(P <0.05) of the acceptable rates of CV between test items(χ2: 10.689-19.255,P <0.05). There was no significant difference of the acceptable rate of CV between different measurement systems except valproic acid evaluated by 1/3TEa(P <0.05). Conclusion It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumulative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification.
Objective To investigate the coefficient of variations(CV)of internal quality control(IQC)of therapeutic drug monitoring in serum(carbamazepine, digoxin, phenytoin, theophylline and valproic acid), and compare with the quality specification derived from allowable total error(TEa). Methods Data was collected by Web-based submission system,the 175 laboratories which enrolled in 2014 therapeutic drug monitoring in serum external quality assessment(EQA) program attended. The data included: the CV of February of 2014 and long-term cumulative data,method and instrument,etc. Microsoft Excel 2013 and SPSS 13.0 was used to analyze the data.The evaluation standard of EQA was considered as TEa(25% and 20% for digoxin). 1/3TEa(8.33% and 6.67% for digoxin)and 1/4TEa(6.25% and 5% for digoxin)were determined to be the evaluation standard of CV of IQC. Results From 175 laborctories 94, 97, 61, 43 and 116 laboratories reported effective results of IQC material of carbamazepine, digoxin, phenytoin, theophylline and valproic acib, respectively. More than 60% laboratories used Bio-Rad measurement system(63.93%-76.29%). Less than 40% laboratories used other measurement systems(23.71%-36.07%). There were significant differences(P <0.05) of the acceptable rates of CV between test items(χ2: 10.689-19.255,P <0.05). There was no significant difference of the acceptable rate of CV between different measurement systems except valproic acid evaluated by 1/3TEa(P <0.05). Conclusion It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumulative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification.
引文
[1]Veenstra D,Burke W.Pharmacogenomics and public health[J].Public Health Genomics,2009,12(3):131-133.
[2]闫颖,张顺利,钟堃,等.2010~2012年度治疗药物监测室间质评结果分析[J].中国药物警戒,2013,10(12):755-759.
[3]鲁静,陈天朝.超高效液相色谱法测定血清中苯妥英钠、苯巴比妥和卡马西平的浓度[J].中国临床药理学杂志,2015,31(2):119-121.
[4]朱翠平,刘俊.355例次地高辛血清浓度监测结果及影响因素分析[J].药学与临床研究,2014,22(2):171-173.
[5]孙旭颖,张美微,李水军.液相色谱-串联质谱法监测血清茶碱浓度及室间质量评价[J].检验医学,2014,29(11):1144-1150.
[6]胡伟,马爱玲,刘宣彤,等.RP-HPLC法同时测定人血清中4种抗癫痫药的浓度[J].中国现代药物应用,2015,9(4):234-236.
[7]赵海建,张传宝,王薇,等.脂类检验项目室内质控变异系数分析[J],中华检验医学杂志,2012,35(12):1172-1175.
[8]Fraser CG.General strategies to set quality specifications for reliability performance characteristics[J].Scand J Clin Lab Invest,1999,59(7):487-490.
[9]Skitek M.Acceptability limits based on biology goals in haematology EQAS[J].Accred Qual Assur,2005,10(3):112-115.
[10]Klee GG.Establishment of outcome-related analytic performance goals[J].Chin Chem,2010,56(5):714-722.
[11]王治国.临床检验质量控制技术(第3版)[M].北京:人民卫生出版社,2014:121-142.
[12]陈文样,申子瑜,杨振华.临床检验分析质量指标的设定[J].中华检验医学杂志,2006,29(4):298-300.
[13]何法霖,白玉,王薇,等.由生物学变异确定的质量规范在常规化学室间质评和室内质控中的应用[J].中华检验医学杂志,2012,35(6):531-537.
[14]Ricos C,Alvarez V,Cava F,et al.Current databases on biological variation:pros,cons and progress[J].Scand J Clin Lab Invest,1999,59(7):491-500.
[15]王治国.临床检验生物学变异与参考区间[M].北京:人民卫生出版社,2012:16-32.
[16]Kinns H,Pitkin S,Housley D,et al.Internal quality control:best practice[J].J Clin Pathol,2013,66(12):1.
[17]肖亚玲,王薇,王治国.ISO 15189:2012与室内质量控制[J].临床检验杂志,2014,32(2):124-125.
[18]王治国.应用操作过程规范图设计临床检验室内质控方法[J].中国卫生统计,2003,20(5):292-295.
[19]王治国.临床检验方法确认与性能验证[M].北京:人民卫生出版社,2009:404-408.
[2]闫颖,张顺利,钟堃,等.2010~2012年度治疗药物监测室间质评结果分析[J].中国药物警戒,2013,10(12):755-759.
[3]鲁静,陈天朝.超高效液相色谱法测定血清中苯妥英钠、苯巴比妥和卡马西平的浓度[J].中国临床药理学杂志,2015,31(2):119-121.
[4]朱翠平,刘俊.355例次地高辛血清浓度监测结果及影响因素分析[J].药学与临床研究,2014,22(2):171-173.
[5]孙旭颖,张美微,李水军.液相色谱-串联质谱法监测血清茶碱浓度及室间质量评价[J].检验医学,2014,29(11):1144-1150.
[6]胡伟,马爱玲,刘宣彤,等.RP-HPLC法同时测定人血清中4种抗癫痫药的浓度[J].中国现代药物应用,2015,9(4):234-236.
[7]赵海建,张传宝,王薇,等.脂类检验项目室内质控变异系数分析[J],中华检验医学杂志,2012,35(12):1172-1175.
[8]Fraser CG.General strategies to set quality specifications for reliability performance characteristics[J].Scand J Clin Lab Invest,1999,59(7):487-490.
[9]Skitek M.Acceptability limits based on biology goals in haematology EQAS[J].Accred Qual Assur,2005,10(3):112-115.
[10]Klee GG.Establishment of outcome-related analytic performance goals[J].Chin Chem,2010,56(5):714-722.
[11]王治国.临床检验质量控制技术(第3版)[M].北京:人民卫生出版社,2014:121-142.
[12]陈文样,申子瑜,杨振华.临床检验分析质量指标的设定[J].中华检验医学杂志,2006,29(4):298-300.
[13]何法霖,白玉,王薇,等.由生物学变异确定的质量规范在常规化学室间质评和室内质控中的应用[J].中华检验医学杂志,2012,35(6):531-537.
[14]Ricos C,Alvarez V,Cava F,et al.Current databases on biological variation:pros,cons and progress[J].Scand J Clin Lab Invest,1999,59(7):491-500.
[15]王治国.临床检验生物学变异与参考区间[M].北京:人民卫生出版社,2012:16-32.
[16]Kinns H,Pitkin S,Housley D,et al.Internal quality control:best practice[J].J Clin Pathol,2013,66(12):1.
[17]肖亚玲,王薇,王治国.ISO 15189:2012与室内质量控制[J].临床检验杂志,2014,32(2):124-125.
[18]王治国.应用操作过程规范图设计临床检验室内质控方法[J].中国卫生统计,2003,20(5):292-295.
[19]王治国.临床检验方法确认与性能验证[M].北京:人民卫生出版社,2009:404-408.