PDF(Pubmed)
Abstract：
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.
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.
摘要：
背景：芬太尼测试条（FTS）是设计用于检测尿液中ng/mL芬太尼水平的侧向流免疫测定条。2021年，美国疾病控制中心和药物滥用与心理健康管理局表示，联邦资金可用于采购FTS，用于政府批准的减少伤害的战略，如药物检查。FTS市场在美国和加拿大迅速扩张。然而,任何一个政府都没有监管监督，以确保正在销售的用于药物检查的FTS的适当功能。
方法：许多品牌的FTS已迅速进入减害市场，引起人们对他们从品牌到品牌、从批次到批次的表现的可重复性和准确性的担忧。本评论中提供了一些示例。在2000年代中期，许多国家资助了疟疾的侧流免疫测定，并在2020年再次发现了类似的产品质量问题，当时COVID-19检测需求巨大。高需求与低水平的监管和执法相结合，导致一些制造商在没有足够的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制定大量检查计划。已经开发了一套用于进行测试和传达结果的简单协议，并在本期的以下观点论文中进行了描述。
结论：在缺乏政府监管和执法的情况下，减少伤害社区应该实施FTS批次检查计划。根据以前疟疾诊断批次检查计划的经验，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。传播结果将有助于减少伤害的组织，以确保他们用于药物检查的FTS适合该目的。
方法：许多品牌的FTS已迅速进入减害市场，引起人们对他们从品牌到品牌、从批次到批次的表现的可重复性和准确性的担忧。本评论中提供了一些示例。在2000年代中期，许多国家资助了疟疾的侧流免疫测定，并在2020年再次发现了类似的产品质量问题，当时COVID-19检测需求巨大。高需求与低水平的监管和执法相结合，导致一些制造商在没有足够的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制定大量检查计划。已经开发了一套用于进行测试和传达结果的简单协议，并在本期的以下观点论文中进行了描述。
结论：在缺乏政府监管和执法的情况下，减少伤害社区应该实施FTS批次检查计划。根据以前疟疾诊断批次检查计划的经验，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。传播结果将有助于减少伤害的组织，以确保他们用于药物检查的FTS适合该目的。
