Background Point-of-care (POC) urine drug testing is a useful adjunct to self-reporting in rapid access addiction medicine settings to immediately guide patient management. However, available POC immunoassays have limitations including cross-reactivity with unrelated compounds or low sensitivity that may cause false results. Here, we assessed the performance of a multi-drug test panel by comparing against gold-standard liquid chromatography tandem mass spectrometry (LC-MS/MS) testing. Methods 102 residual urine specimens were assayed using a competitive lateral flow immunoassay (LFA) for 10 drugs: 2-ethylene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP, methadone metabolite), buprenorphine, morphine, hydromorphone, oxycodone, fentanyl, cocaine, methamphetamine, amphetamine, and benzodiazepines (BTNX Rapid ResponseTM Multi-Drug Panel). Results were compared to those obtained by LC-MS/MS (n=67, 66%) or kinetic interaction of microparticles in solution automated immunoassay (KIMS) (Roche Diagnostics, n=35, 33%). Broad spectrum LC-MS/MS results were reviewed in entirety for discordant cases, particularly in false positives to identify the presence of any known cross-reacting compounds. Results Of 10 drugs evaluated, four demonstrated ≥95% agreement with LC-MS/MS or KIMS immunoassay (EDDP, buprenorphine, oxycodone, methamphetamine). Fentanyl demonstrated the highest false negative rate of 44% (LFA cut-off: 10 ng/mL) followed by amphetamines (22%, cut-off: 1000 ng/mL). Morphine and hydromorphone demonstrated false positive rates of 14% and 18%, respectively, with most cases likely due to cross-reacting opiate or opioid metabolites. Benzodiazepines (target: Oxazepam) demonstrated false positive and negative rates of 13% and 24%, respectively. Conclusions To our knowledge, this is the first study to evaluate the performance of the BTNX multi-drug test panel against definitive testing in urine samples. While good concordance was observed for most drugs, high rates of discordant results for fentanyl and others emphasize the need for confirmatory testing by methods with higher sensitivity and specificity. Careful consideration prior to implementation would be essential, including physician education, interpretative comments, and training resources.

中文翻译：

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B-262 在门诊快速成瘾医学诊所应用之前对尿液药物检测的即时侧流免疫分析进行验证


背景 护理点 (POC) 尿液药物检测是快速获取成瘾药物环境中自我报告的有用辅助手段，可立即指导患者管理。然而，现有的 POC 免疫测定具有局限性，包括与不相关化合物的交叉反应或可能导致错误结果的低灵敏度。在这里，我们通过与金标准液相色谱串联质谱 (LC-MS/MS) 测试进行比较来评估多药物测试组的性能。方法 使用竞争性侧流免疫分析 (LFA) 对 102 份残余尿液标本中的 10 种药物进行了检测：2-乙烯-1,5-二甲基-3,3-二苯基吡咯烷（EDDP，美沙酮代谢物）、丁丙诺啡、吗啡、氢吗啡酮、羟考酮、芬太尼、可卡因、甲基苯丙胺、安非他明和苯二氮卓类药物（BTNX 快速反应™ 多药组合）。将结果与通过 LC-MS/MS (n=67, 66%) 或溶液自动免疫测定 (KIMS) 中微粒动力学相互作用获得的结果进行比较（罗氏诊断公司，n=35, 33%）。对广谱 LC-MS/MS 结果进行了全面审查，以找出不一致的情况，特别是在误报中，以确定是否存在任何已知的交叉反应化合物。结果 在评估的 10 种药物中，有 4 种与 LC-MS/MS 或 KIMS 免疫测定（EDDP、丁丙诺啡、羟考酮、甲基苯丙胺）的一致性≥95%。芬太尼的假阴性率最高，为 44%（LFA 截止值：10 ng/mL），其次是安非他明（22%，截止值：1000 ng/mL）。吗啡和氢吗啡酮的假阳性率分别为 14% 和 18%，大多数病例可能是由于阿片或阿片类代谢物的交叉反应所致。苯二氮卓类药物（目标：奥沙西泮）的假阳性率和阴性率分别为 13% 和 24%。 结论 据我们所知，这是第一项评估 BTNX 多药物测试组与尿液样本确定测试性能的研究。虽然大多数药物都观察到良好的一致性，但芬太尼和其他药物的不一致结果比例很高，这强调了需要通过具有更高灵敏度和特异性的方法进行验证性测试。实施前仔细考虑至关重要，包括医生教育、解释性评论和培训资源。