Precision Diagnostics, San Diego, CA.
Pain Physician. 2017 Nov;20(7):E1107-E1113.
Urine drug testing is used by health care providers to determine a patient's compliance to their prescribed regimen and to detect non-prescribed medications and illicit drugs. However, the cutoff levels used by clinical labs are often arbitrarily set and may not reflect the urine drug concentrations of compliant patients.
Our aim was to test the hypothesis that commonly used cutoffs for many prescribed and illicit drugs were set too high, and methods using these cutoffs may yield a considerable number of false-negative results. The goals of this study were to outline the way to analyze patient results and estimate a more appropriate cutoff, develop and validate a high sensitivity analytical method capable of quantitating drugs and metabolites at lower than the commonly used cutoffs, and determine the number of true positive results that would have been missed when using the common cutoffs.
This was a retrospective study of urine specimens submitted for urine drug testing as part of the monitoring of prescription drug compliance described in chronic opioid therapy treatment guidelines.
The study was set in a clinical toxicology laboratory, using specimens submitted for routine analysis by health care providers in the normal course of business.
Lognormal distributions of test results were generated and fitted with a trendline to estimate the required cutoff level necessary to capture the normal distributions of each drug for the patient population study. A validated laboratory derived liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis capable of achieving the required cutoff levels was developed for each drug and/or metabolite.
The study shows that a lognormal distribution of patient urine test results fitted with a trendline is appropriate for estimating the required cutoff levels needed to assess medication adherence. The study showed a wide variation in the false-negative rate, ranging from 1.5% to 94.3% across a range of prescribed and illicit drugs.
The patient specimens were largely sourced from patients in either a long-term pain management program or in treatment for substance use disorder in the US. These specimens may not be representative of patients in other types of treatment or in countries with different approaches to these issues.
The high-sensitivity method reduces false-negative results which could negatively impact patient care. Clinicians using less sensitive methods for detecting and quantifying drugs and metabolites in urine should exercise caution in assessing patient adherence using and changing the treatment plan based on those results.
Urine drug testing, patient adherence, clinical toxicology, immunoassay, LC-MS, definitive drug testing, REMS, negative test results, false negative.
医疗保健提供者使用尿液药物检测来确定患者对其规定治疗方案的依从性，并检测非处方药物和非法药物。然而，临床实验室使用的截止值通常是任意设定的，可能无法反映依从性患者的尿液药物浓度。
我们的目的是检验一个假设，即许多规定和非法药物的常用截止值设定得过高，并且使用这些截止值的方法可能会产生相当数量的假阴性结果。本研究的目的是概述分析患者结果和估计更合适的截止值的方法，开发和验证一种能够定量低于常用截止值的药物和代谢物的高灵敏度分析方法，并确定使用常用截止值时会错过的真实阳性结果数量。
这是一项回顾性研究，对作为慢性阿片类药物治疗治疗指南中规定药物依从性监测一部分而提交的尿液药物检测标本进行研究。
研究在临床毒理学实验室中进行，使用医疗保健提供者在正常业务过程中提交的常规分析标本。
生成测试结果的对数正态分布，并拟合趋势线，以估计捕获研究人群中每种药物的正态分布所需的截止值水平。为每种药物和/或代谢物开发了一种经过验证的实验室衍生的液相色谱串联质谱（LC-MS/MS）分析方法，该方法能够达到所需的截止值。
研究表明，拟合趋势线的患者尿液测试结果的对数正态分布适用于估计评估药物依从性所需的截止值水平。研究表明，在一系列规定和非法药物中，假阴性率存在很大差异，范围从 1.5%到 94.3%。
患者标本主要来自美国长期疼痛管理计划中的患者或物质使用障碍治疗中的患者。这些标本可能不能代表其他类型治疗中的患者或对这些问题采取不同方法的国家的患者。
高灵敏度方法可减少可能对患者护理产生负面影响的假阴性结果。使用尿液中药物和代谢物检测和定量的灵敏度较低的方法的临床医生在根据这些结果评估患者依从性并改变治疗计划时应谨慎行事。
尿液药物检测、患者依从性、临床毒理学、免疫测定、LC-MS、明确药物检测、REMS、阴性检测结果、假阴性。
