Department of Pathology, Brigham and Women's Hospital, Boston, MA.
Department of Pathology, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.
Pain Physician. 2018 Nov;21(6):E583-E592.
The technical advantages of direct-to-definitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) urine testing for monitoring patient compliance in pain management are well known. However, the design and implementation of LC-MS/MS methods are more controversial, including factors such as determining appropriate cutoffs, specimen processing (e.g., specimen hydrolysis), reporting of qualitative and/or quantitative results, and test menu.
The objective of the research was to compare the clinical performance of our previous urine pain toxicology panel, a combination of immunoassay (IA) screens and LC-MS/MS, to our current pain toxicology panel, which features direct-to-definitive LC-MS/MS for 34 drugs and metabolites.
Six months of results from our previous pain toxicology panel were compared to 5.5 months of results from our current pain toxicology panel, enabling us to make conclusions regarding clinical performance.
The research took place at Brigham and Women's Hospital in Boston, MA.
The percentage of false positive IA results was evaluated for our previous pain toxicology panel. The positivity rates for each drug and/or metabolite were calculated for both the previous and current panels, including rates of detection of both prescribed and illicit drugs. The turnaround time (TAT), direct and send-out costs associated with each approach, as well as projected cost savings were also determined.
False positive rates with IA ranged from 0% to 29%; the highest false positive rate was seen for 6-acetylmorphine (6-AM). The elimination of IA, addition of metabolites, and/or lowering of cutoffs increased the detection rate of 6-AM, benzoylecgonine (cocaine metabolite), fentanyl, morphine, and oxycodone. The ability to differentiate compliance from simulated compliance improved after eliminating specimen hydrolysis. The TAT improved significantly and projected yearly cost savings with the current panel was $95,003 (USD). In our opinion, qualitative results appeared sufficient to assess compliance in the majority of cases.
Our study was performed in a single academic center in a specific geographic region; therefore, our results may not be generalizable to other types of centers or regions.
Direct-to-definitive LC-MS/MS testing has several clinical benefits, including reduction of false positive results, improved assessment of patient compliance, decreased TAT, and increased detection of drug use and abuse. Cost savings were also realized using this approach.
Direct-to-definitive, LC-MS/MS, immunoassay, sensitivity, cost, pain management, turnaround time, patient compliance.
直接进行液相色谱-串联质谱（LC-MS/MS）尿液检测以监测疼痛管理患者的依从性，其技术优势众所周知。然而，LC-MS/MS 方法的设计和实施更具争议性，包括确定适当的截止值、样本处理（例如样本水解）、定性和/或定量结果的报告以及检测菜单等因素。
本研究旨在比较我们之前的尿液疼痛毒物组合检测（免疫测定[IA]筛查与 LC-MS/MS 的结合）与我们目前的疼痛毒物检测之间的临床性能，目前的检测方法为 34 种药物和代谢物的直接到明确的 LC-MS/MS。
比较我们之前的疼痛毒物学面板的 6 个月结果与我们当前的疼痛毒物学面板的 5.5 个月结果，以便对临床性能做出结论。
马萨诸塞州波士顿的布莱根妇女医院。
评估我们之前的疼痛毒物学面板中 IA 假阳性结果的百分比。计算了之前和当前面板中每种药物和/或代谢物的阳性率，包括检测到的规定药物和非法药物的比率。还确定了每种方法的周转时间（TAT）、直接和发送费用以及预计的节省成本。
IA 的假阳性率范围为 0%至 29%；6-乙酰吗啡（6-AM）的假阳性率最高。消除 IA、添加代谢物和/或降低截止值增加了 6-AM、苯甲酰可卡因为（可卡因代谢物）、芬太尼、吗啡和羟考酮的检测率。消除样本水解后，区分依从性和模拟依从性的能力得到了改善。TAT 显著改善，目前的面板预计每年可节省 95,003 美元（美元）。在我们看来，定性结果足以评估大多数情况下的依从性。
我们的研究在一个特定地理区域的单一学术中心进行；因此，我们的结果可能不适用于其他类型的中心或地区。
直接进行 LC-MS/MS 检测具有多项临床优势，包括减少假阳性结果、改善患者依从性评估、缩短 TAT 以及增加药物使用和滥用的检测。使用这种方法还实现了成本节约。
直接到明确、LC-MS/MS、免疫测定、灵敏度、成本、疼痛管理、周转时间、患者依从性。
