University of Notre Dame, Notre Dame, IN, USA.
Lifespan Academic Medical Center, Providence, RI, USA.
Harm Reduct J. 2024 Jun 15;21(1):115. doi: 10.1186/s12954-024-01025-7.
Fentanyl test strips (FTS) are lateral flow immunoassay strips designed for detection of ng/mL levels of fentanyl in urine. In 2021, the US Centers for Disease Control and the Substance Abuse and Mental Health Administration stated that federal funds could be used for procurement of FTS for harm reduction strategies approved by the government such as drug checking. The market for FTS has expanded rapidly in the US and Canada. However, there is no regulatory oversight by either government to ensure proper function of FTS that are being marketed for drug checking.
Many brands of FTS have rapidly entered the harm reduction market, creating concerns about the reproducibility and accuracy of their performance from brand to brand and lot to lot. Some examples are provided in this Comment. Similar problems with product quality were observed in the mid 2000's when lateral flow immunoassays for malaria were funded in many countries and again in 2020, when COVID-19 tests were in huge demand. The combination of high demand and low levels of regulation and enforcement led some manufacturers to join the goldrush without adequate field testing or quality assurance. We argue that the harm reduction community urgently needs to set a lot checking program in place. A set of simple protocols for conducting the tests and communicating the results have been developed, and are described in the following Perspectives paper in this issue.
In the absence of governmental regulation and enforcement, the harm reduction community should implement a FTS lot checking program. Based on previous experience with the malaria diagnostic lot checking program, this inexpensive effort could identify products that are not suitable for harm reduction applications and provide valuable feedback to manufacturers. Dissemination of the results will help harm reduction organizations to ensure that FTS they use for drug checking are fit for the purpose.
芬太尼检测条（FTS）是一种侧向流动免疫测定条，旨在检测尿液中 ng/mL 水平的芬太尼。2021 年，美国疾病控制与预防中心和物质滥用与心理健康服务管理局表示，联邦资金可用于采购经政府批准的减少伤害策略的 FTS，如药物检测。FTS 的市场在美国和加拿大迅速扩大。然而，两国政府都没有监管来确保正在用于药物检测的 FTS 能够正常运行。
许多品牌的 FTS 迅速进入减少伤害市场，这引发了人们对其品牌和批次之间性能重现性和准确性的担忧。本评论提供了一些示例。在 2000 年代中期，当许多国家都资助了疟疾的侧向流动免疫测定时，以及在 2020 年，当对 COVID-19 检测的需求巨大时，都观察到了类似的产品质量问题。高需求与低监管和执法水平相结合，导致一些制造商在没有充分现场测试或质量保证的情况下加入了淘金热。我们认为，减少伤害社区迫切需要建立一个批次检查计划。已经制定了一套用于进行测试和传达结果的简单协议，并在本期《视角》论文中进行了描述。
在缺乏政府监管和执法的情况下，减少伤害社区应实施 FTS 批次检查计划。基于之前疟疾诊断试剂盒的检查计划经验，这种廉价的努力可以识别不适合减少伤害应用的产品，并为制造商提供有价值的反馈。结果的传播将有助于减少伤害组织确保他们用于药物检测的 FTS 符合目的。
