非法药物供应在过去几个月里发生了快速变化，硝唑烷、美托咪定、环氯芬等新型合成物质接连出现。针对新出现物质的快速检测正以惊人的速度被开发并推向市场，这些检测能在几分钟内出结果。如果所在州已将其非刑事化，执法部门、法医、雇主、社区组织甚至普通公众都可以使用它们。但治疗过量用药患者的医生却不能。
The illicit drug supply has changed rapidly over the last few months, with nitazenes, medetomidine, cychlorphine, and other novel synthetic substances appearing in rapid succession. Rapid tests for emerging substances are being developed and marketed with impressive speed, and these can return results within minutes. Law enforcement, medical examiners, employers, community organizations and even the general public can use them, if their states have decriminalized them. Physicians treating overdoses cannot.
这种反差难以忽视：一种检测可被用来解雇员工或支持刑事案件，却无法供急诊室里争分夺秒抢救患者生命的医生使用。
The contrast is hard to ignore: A test can be used to fire someone or support a criminal case, yet it remains unavailable to the physician in an emergency room trying to save that person’s life, when minutes are essential.
这种分歧主要源于监管层面。许多针对新型毒品的检测被标注为“仅限法医用途”，而用于活体患者的临床检测需要获得美国食品药品监督管理局（FDA）作为诊断工具的批准。因此，遵守联邦法律和资金政策的医疗诊所无法合法使用这些检测。
The divide is largely regulatory. Many tests for emerging drugs are labeled for forensic use only, and clinical tests for living patients require approval by the Food and Drug Administration (FDA) as a diagnostic tool. As such, they cannot legally be used by medical clinics that adhere to federal law and funding policies.
用于患者护理的检测必须符合FDA对临床诊断的要求。即时检测——在病床旁或附近进行的检测——还需要额外认定该检测足够简单、风险足够低，从而符合《临床实验室改进修正案》（CLIA）豁免资格的标准。这种监管区分有其正当理由。用于做出医疗决策的检测应当准确、可靠，并被适当解读。快速筛查并非确定性毒理学分析，不应被视为此类分析。
Tests used in patient care must meet FDA requirements for clinical diagnostics. Point-of-care testing—testing performed at or near the bedside—also requires an additional determination that the test is simple and low-risk enough to qualify for waived status under the Clinical Laboratory Improvement Amendments (CLIA). There is a legitimate reason for that regulatory distinction. Tests used to make medical decisions should be accurate, reliable, and interpreted appropriately. A rapid screen is not definitive toxicology, and it should not be treated as such.
芬太尼展示了为什么速度至关重要。2023年初，我们指出，快速芬太尼检测在临床医学之外已经存在，然而医院却依赖昂贵的质谱检测，这种检测可能需要一个小时甚至更长时间，前提是院内刚好有相关设备。等到获得美国食品药品监督管理局（FDA）批准和临床实验室改进修正案（CLIA）豁免的快速芬太尼检测问世时，非法市场已经再次发生了变化。
Fentanyl shows why speed matters. In early 2023, we pointed out that rapid fentanyl tests already existed outside clinical medicine, yet hospitals relied on expensive spectrometry testing that could take an hour or longer, if the equipment was available onsite at all. By the time FDA-cleared and CLIA-waived rapid fentanyl tests arrived, the illicit market had already changed again.
从2020年开始，赛拉嗪在芬太尼供应链中蔓延，带来了一个新的临床难题：纳洛酮可以逆转阿片类药物，但对赛拉嗪无效。即使给予纳洛酮，患者也可能仍然处于危险的镇静或不稳定状态。此外，赛拉嗪还与坏死性皮肤伤口有关，这会增加败血症的风险，其戒断综合征也比单纯的阿片类药物更复杂、更难治疗。
Starting in 2020, xylazine spread through the fentanyl supply, introducing a new clinical hurdle: naloxone reverses opioids, but not xylazine. Patients can remain dangerously sedated or unstable even after naloxone is given. Further, xylazine is associated with necrotic skin wounds that increase risk of sepsis, and withdrawal syndromes that are more complex to treat than opioids alone.
不久之后，美托咪定取代了赛拉嗪的供应。它同样对纳洛酮没有反应，会导致深度镇静和心血管不稳定，而且它的戒断综合征——可能在某人停止使用后短短几小时内出现——会引发极端的高血压和心动过速，这已与年轻人的心脏病发作联系在一起。了解这些情况可以显著改变患者的治疗或出院计划。
Not long after, medetomidine overtook xylazine supplies. It, too, does not react to naloxone, causes profound sedation and cardiovascular instability, and its withdrawal syndrome—which can come on just hours after someone stops using it—can trigger extreme hypertension and tachycardia that has been connected to heart attacks in younger people. Knowing these facts could significantly alter a patient’s treatment or discharge plan.
目前还没有针对这两种药物或是其他令人担忧的新型化学物质（如环氯啡，一种在芬太尼检测中无法显示的阿片类药物）的即时检测（point-of-care）手段。正因如此，临床医生不得不依赖执法部门查获的样品信息、公共卫生警报以及数月前的死亡数据，而不是床边检测。这些数据处于孤岛状态，既不易获取也难以整合。
There are no point-of-care tests for either of these drugs or other alarming and novel chemicals like cychlorphine, an opioid that does not show up on fentanyl tests. Because of that, clinicians have to follow information from law-enforcement seizures, public-health alerts, and months-old fatality data rather than from tests at the bedside. These data are in siloes and not easy to access or combine.
其结果是一个这样的系统：它能在临床医生识别出活体患者体内的违禁药物之前，就先在查获的样品和尸检中识别出新兴药物。有一种更好的方法。
The result is a system that can identify emerging drugs in seized samples and autopsies before clinicians can identify them in living patients. There is a better approach.
FDA 应建立一条针对新兴毒品威胁的临床检测快速通道，当美国疾病控制与预防中心（CDC）或国家毒品控制政策办公室等机构认定某种物质构成重大且日益增长的公共卫生担忧时，即可启动该通道。该机构已有一条双重通道，制造商可借此同时申请特别许可和 CLIA（临床实验室改进修正案）豁免。这一框架可被优先并加以调整以应对新兴毒品，而非强迫每一种新威胁都走常规审批时间表。
The FDA should establish an expedited pathway for clinical tests targeting emerging drug threats, triggered when agencies such as the U.S. Centers for Disease Control and Prevention (CDC) or the Office of National Drug Control Policy identify a substance of significant and growing public-health concern. The agency already has a dual pathway through which manufacturers can seek a special clearance and a CLIA waiver together. That framework could be prioritized and adapted for emerging drugs rather than forcing each new threat through the ordinary timeline.
联邦机构还可协助资助独立验证。新兴毒品的经济特性比较特殊：一种物质可能迅速出现、传播不均，且在制造商能够证明开展大规模临床研究的成本合理之前，就已被另一种物质取代。如果新毒品的威胁重大，联邦和州机构可填补这一空白。市场规模小，不代表公共卫生或公共安全需求小。
Federal agencies could also help fund independent validation. The economics of emerging drugs are unusual: a substance can appear quickly, spread unevenly, and be replaced by something else before a manufacturer can justify the cost of extensive clinical studies. Federal and state agencies could make up this gap if the threat of the new drug is significant. A small market does not mean a small public health or public safety need.
这绝不意味着要假装检测试纸就是质谱仪。即时检测应明确被视为推定性检测。阳性结果可在必要时通过确证性检测加以确认。毕竟，临床诊疗很少仅依赖单一完美的信息来源。
None of this requires pretending a test strip is mass spectrometry. Point-of-care testing should be explicitly treated as presumptive. Positive results can be confirmed when necessary. Clinical care rarely rests on a single perfect source of information, anyway.
医生早已习惯将不完整的病史、体格检查、生命体征、实验室结果和治疗反应结合起来做决策。快速毒品筛查只会成为工具箱里的又一件工具，帮助驱散毒品供应变化带来的迷雾。
Physicians already make decisions by combining an imperfect history, physical examination, vital signs, laboratory results, and response to treatment. A rapid drug screen would simply be another tool in that toolbox that helps dispel the fog of drug supply changes.
此外，其价值超越了单个患者。更完善的医院数据可成为预警系统，而非事后记录一场已在进行中的危机。急诊科处于过量用药危机的最前线；它们应能在床边使用最创新的检测工具，因为几分钟就能决定生死。
Further, the value extends beyond the individual patient. Better hospital data could become an early-warning system rather than a retrospective record of a crisis already underway. Emergency departments are on the front lines of the overdose crisis; they should have access to the most innovative testing tools at the bedside, when minutes can make a difference.