CAJ | 학술논문

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。
목적：조사전국혈청치료약물감측（잡마서평、지고신、분타영、다감、병무산）실내질량공제적정밀도현상，병여목전소학정적실내질량공제정밀도적평개표준진행비교，제출개진조시。방법채용기우Web방식적실간질량평개（EQA）연건계통，수집2014년2월빈삼가전국혈청치료약물감측EQA계화적175가실험실적실내질량공제수거，포괄당월적화루적적실내질량공제변이계수、질공규칙、소사용적방법、의기、실내질공품적엄가등신식。사용Microsoft Excel 2013화SPSS 13.0대수거진행분석。장EQA범위（지고신위20%，기여항목위25%）정의위윤허총오차（TEa），장1/3TEa화1/4TEa정의위윤허불정밀도적평개표준，계산저5개항목적실내질량공제변이계수적통과솔。혈청치료약물감측항목적윤허불정밀도평개표준위8.33%（1/3TEa）화6.25%（1/4TEa），지고신위6.67%（1/3TEa）화5%（1/4TEa）。결과분별유94가、97가、61가、43가화116가실험실회보료잡마서평、지고신、분타영、다감、병무산적실내질공수거。＞60%적실험실（63.93%～76.29%）사용백악검측계통，지유＜40%적실험실（23.71%～36.07%）사용기타검측계통。불동항목간적실내질공변이계수통과솔도존재현저통계학차이，잡방치위10.689～19.255，균P＜0.05。불동검측계통간，지유병무산재당월화루적불정밀도재1/3TEa시적통과솔존재현저통계학차이（P＜0.05）。결론통과대당월화루적적실내질공수거적변이계수적감측，병장실내질량공제수거계산적변이계수여상관요구진행비교，가이평개해검측계통적불정밀도수평시부만족규정적질량요구。
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.