外部质量评估系统的技术和健康治理方面,用于血液中的经典和新型精神活性物质分析测试
Francesca Di Gaudio1, Vita Giaccone2, Annamaria Cucina2
1PROMISE, University of Palermo, Piazza delle Cliniche, 2, Palermo 90127, Italy; Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Chromatography and Mass Spectrometry Section, Quality Control and Chemical Risk (CQRC), Via del Vespro, 133, Palermo 90127, Italy.
Journal of pharmaceutical and biomedical analysis
|May 10, 2024
概括
这项研究对意大利实验室进行了评估.
科学领域:
- 法医毒理学 法医毒理学
- 分析化学 分析化学
- 药理学 药理学是指药理学的学科.
背景情况:
- 新型精神活性物质 (NPS) 由于其多样性和流行程度而带来挑战.
- 医疗保健实验室需要可靠的方法来检测生物样本中的NPS.
- 西西里CRQ实验室和Istituto Superiore di Sanità (ISS) 发起了一项外部质量评估 (EQA) 研究.
研究的目的:
- 评估意大利实验室在识别NPS和传统滥用药物 (DOA) 中的熟练程度.
- 为了比较NPS检测不同分析技术的有效性.
- 促进协作,并建立NPS识别的共同标准.
主要方法:
- 一项EQA研究涉及22个意大利医疗保健实验室.
- 血液样本中含有各种NPS和DOA的低度 (2-10 ng/mL).
- 使用气体染色学-质谱学 (GC-MS),液体染色学-质谱学 (LC-MS) 和免疫酶法进行分析.
主要成果:
- 液体染色学-质谱学 (LC-MS) 是主要的技术 (约. 百分之九十).
- 观察到大约40%的虚假阴性结果,特别是5-AB-PINACA.
- 使用LC-MS的实验室证明了优越的特异性和灵敏性.
结论:
- 外部质量评估 (EQA) 对于确定微量分子检测的最佳分析技术至关重要.
- LC-MS方法在生物矩阵中对NPS识别具有显著的优势.
- 这项EQA倡议促进方法共享,旨在标准化NPS检测标准.
关键词:
滥用药物的药物滥用外部质量评估 外部质量评估在ISO/IEC 1702525标准中.在ISO/IEC1704343标准中.国家安全系统 (NPS) 是一个国家安全系统.测试绩效评价 测试绩效评价 测试绩效评价更多相关视频
相关概念视频
Drug Control Governance: Regulatory Bodies and Their Impact
157
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
157
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Quality Assurance
123
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
123
Pharmacovigilance
826
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
826
Drug Concentrations: Measurements
361
Drug concentration is the quantity of a drug present in a biological sample. Measuring drug amounts in biological samples allows the clinician to understand how a drug is absorbed, distributed, metabolized, and excreted. Samples can be obtained through invasive or non-invasive methods. Invasive techniques involve surgical or parenteral interventions to gather blood, cerebrospinal fluid, or tissue biopsy. Conversely, non-invasive approaches provide samples like urine, feces, and saliva.
Plasma...
Plasma...
361


