Department of Clinical Pharmacy, Radboud University Nijmegen Medical Center and Nijmegen Institute for Infection, Inflammation and Immunity (N4i), Nigmegen, The Netherlands.
Ther Drug Monit. 2011 Apr;33(2):239-43. doi: 10.1097/FTD.0b013e31820fa528.
The International Interlaboratory Quality Control Program for Measurement of Antiretroviral Drugs in Plasma was initiated in 1999 by Radboud University Nijmegen Medical Center, The Netherlands, and continued later on in collaboration with the Dutch Association for Quality Assessment in Therapeutic Drug Monitoring and Clinical Toxicology (www.kkgt.nl). The aim of this analysis was to evaluate the first 10 years of the Program and to determine variables associated with reporting of less accurate results. Two rounds are organized annually in which blind samples are shipped to participants containing a low, medium, or high concentration of each antiretroviral drug. Any reported result that deviates more than 20% from the spiked concentration is defined as inaccurate. By the end of 2009, the number of laboratories participating in the Program had increased to 56; 44 (79%) are located in Europe. A total of 12,798 test results was available for analysis, of which 2104 (16.4%) were reported as inaccurate. Performance was best for samples containing nevirapine (mean of inadequate scores per round: 11.1%) and lopinavir (11.9%) and worst for indinavir (18.7%), atazanavir (18.9%), saquinavir (19.6%), and nelfinavir (21.3%). High and medium concentrations were less frequently reported as inaccurate than low concentrations: 13.5%, 13.0%, and 22.4%, respectively. Although the overall performance of the laboratories varied per year, a trend was visible for improvement over time with 19.9% of the results being inaccurate in 2002 (n = 20 laboratories) to 15.7% in 2009 (n = 56 laboratories). The Program provides a proficiency testing program in which laboratories are alerted to potential analytical errors while performing therapeutic drug monitoring in HIV-infected patients. Laboratories should put more effort in adequately analyzing concentrations of antiretroviral drugs with low minimum effective concentrations.
国际抗逆转录病毒药物血浆测量实验室间质量控制计划始于 1999 年，由荷兰奈梅亨拉德堡大学医学中心发起，并于后来与荷兰治疗药物监测和临床毒理学质量评估协会（www.kkgt.nl）合作继续开展。本分析旨在评估该计划的前 10 年，并确定与报告结果不够准确相关的变量。该计划每年组织两轮，将包含低、中、高各浓度抗逆转录病毒药物的盲样寄送给参与者。任何偏离加标浓度超过 20%的报告结果都被定义为不准确。截至 2009 年底，参与该计划的实验室数量增加到 56 个；其中 44 个（79%）位于欧洲。共有 12798 个测试结果可用于分析，其中 2104 个（16.4%）被报告为不准确。对于含有奈韦拉平（每轮平均不充分评分：11.1%）和洛匹那韦（11.9%）的样本，结果表现最好，而对于茚地那韦（18.7%）、阿扎那韦（18.9%）、沙奎那韦（19.6%）和奈非那韦（21.3%）的结果表现最差。高浓度和中浓度比低浓度更不容易报告为不准确：分别为 13.5%、13.0%和 22.4%。尽管实验室的整体表现每年都有所不同，但随着时间的推移，趋势是在不断改善，2002 年有 19.9%的结果（n=20 个实验室）不准确，到 2009 年（n=56 个实验室）则下降到 15.7%。该计划提供了一个能力验证计划，使实验室在对 HIV 感染患者进行治疗药物监测时能够注意到潜在的分析误差。实验室应更加努力地充分分析最低有效浓度较低的抗逆转录病毒药物浓度。
