Levy Sharon, Sherritt Lon, Vaughan Brigid L, Germak Matthew, Knight John R
Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
Pediatrics. 2007 Apr;119(4):e843-8. doi: 10.1542/peds.2006-2278.
The objective of this study was to estimate from a random urine drug-testing program for adolescents the proportion of drug tests that are susceptible to interpretation errors.
This was a secondary analysis of a clinical database and chart review from an adolescent outpatient substance abuse program at a large children's hospital. We analyzed from 110 adolescent patients (13-21 years of age) all 710 urine drug test results that were collected between December 2002 and July 2005 and 85 original laboratory reports for tests that were collected between December 2002 and May 2006 and were confirmed positive for opioids. We calculated the percentage of tests that were too dilute to interpret (potential false-negatives) and the percentage of confirmed positive tests for oxycodone that did not result in a positive initial screen (potential false-negatives). We also reviewed clinical information to determine whether confirmed positive tests resulted from legitimate use of prescription or over-the-counter medication (potential false-positives).
Of 710 drug tests, 40 negative tests were too dilute to interpret properly, and 45 of 217 positive tests resulted from prescription medication use for a total of 85 tests that were susceptible to error. Of the 85 confirmatory laboratory reports reviewed, 43 were positive for oxycodone, but only 16 of these had produced a positive opiate screen.
Unless proper procedures are used in collecting, analyzing, and interpreting laboratory testing for drugs, there is a substantial risk for error.
本研究的目的是通过一项针对青少年的随机尿液药物检测计划,估算易出现解读错误的药物检测比例。
这是对一家大型儿童医院青少年门诊药物滥用项目的临床数据库及病历审查进行的二次分析。我们分析了110名青少年患者(13至21岁)在2002年12月至2005年7月期间采集的所有710份尿液药物检测结果,以及在2002年12月至2006年5月期间采集且经确认阿片类药物呈阳性的85份原始实验室检测报告。我们计算了稀释过度无法解读的检测比例(潜在假阴性)以及经确认羟考酮呈阳性但初始筛查未呈阳性的检测比例(潜在假阴性)。我们还审查了临床信息,以确定经确认的阳性检测是否因合法使用处方药或非处方药所致(潜在假阳性)。
在710次药物检测中,40次阴性检测稀释过度无法正确解读,217次阳性检测中有45次是因使用处方药导致的,总计85次检测易出现错误。在审查的85份确认性实验室报告中,43份羟考酮呈阳性,但其中只有16份在阿片类药物筛查中呈阳性。
除非在药物实验室检测的采集、分析和解读过程中采用适当程序,否则存在重大错误风险。