Drug Testing and Analysis最新文献_第5页

A “Pheraplex” Capsule Labeled as Desoxymethyltestosterone From the Market Turned Out to Be 17,17-Dimethyl-18-nor-5α-androst-13-en-3β-ol 市场上一种标记为脱氧甲基睾酮的“Pheraplex”胶囊原来是17,17-二甲基-18-no -5α-androst-13-en-3β-醇。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-23 DOI: 10.1002/dta.3912

Sisi Zhu, Shan Wang, Xin Liu, Lisi Zhang

{"title":"A “Pheraplex” Capsule Labeled as Desoxymethyltestosterone From the Market Turned Out to Be 17,17-Dimethyl-18-nor-5α-androst-13-en-3β-ol","authors":"Sisi Zhu, Shan Wang, Xin Liu, Lisi Zhang","doi":"10.1002/dta.3912","DOIUrl":"10.1002/dta.3912","url":null,"abstract":"<div>\u0000 \u0000 In an effort to conduct a desoxymethyltestosterone (DMT) administration study to replenish excretion urine inventory of Beijing Anti-Doping Laboratory for quality assurance purpose, a product labeled as “Pheraplex” was purchased from the internet. The product's label indicated that each capsule contained 10 mg of 17α-methyl-etioallocholan-2-ene-17β-ol (DMT), along with medicinal corn starch and gelatin. To verify the product's contents, gas chromatography tandem quadrupole mass spectrometry (GC–MS/MS) was employed to analyze the active ingredient and compare it with the reference materials of DMT. Surprisingly, the results revealed that the product did not contain DMT or any other steroids monitored in the initial testing procedure of our laboratory. Subsequently, nuclear magnetic resonance was utilized to identify the compound's structure, which was determined to be 17,17-dimethyl-18-nor-5α-androst-13-en-3β-ol. This compound was referred to as M10 of 17α-methyltestosterone in a literature. This finding highlights the potential discrepancies between product labeling and actual contents in the supplement market, which deserves attention from the anti-doping community.\u0000 </div>","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"2032-2035"},"PeriodicalIF":2.7,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluation of Diagnostic Sensitivity and Specificity of a New Automatized Assay for Indirect Synthetic Urine Identification 评价一种新的自动化间接合成尿液鉴定方法的诊断敏感性和特异性。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-22 DOI: 10.1002/dta.3908

Laura Franke, Christian Fuczik, Dirk K. Wissenbach

{"title":"Evaluation of Diagnostic Sensitivity and Specificity of a New Automatized Assay for Indirect Synthetic Urine Identification","authors":"Laura Franke, Christian Fuczik, Dirk K. Wissenbach","doi":"10.1002/dta.3908","DOIUrl":"10.1002/dta.3908","url":null,"abstract":"<div>\u0000 \u0000 Synthetic urine mimicking normal urine is difficult detectable by standard specimen validity testing. In this study, the VDx True Urine LD Test and True Urine SD Test, analysing ‘long duration’ (LD) and ‘short duration’ (SD) markers, were evaluated for their ability to detect synthetic urine. Two synthetic urines from the US market and 1188 real-life urine specimens were analysed for LD markers, SD markers, uric acid and temperature. Forty-seven specimens (set 1) showed uric acid and/or temperature suspicious results and were analysed by LC–MS/MS for 10 endogenous biomolecules. Diagnostic sensitivities and specificities were calculated for LD and SD markers based on uric acid and LC–MS/MS results of set 1. The false-positive rate of the SD marker was further evaluated with uric acid results of the other 1141 specimens (set 2). Additionally, direct synthetic urine markers were analysed by LC-(HR)MS. Uric acid and LC–MS/MS could identify synthetic urine. In one US synthetic urine, low concentrations of uric acid were found. Specimens of the Austrian/German region were reliably classified congruently by both methods. The LD and the SD markers detected both synthetic urines. For set 1, the LD had 100% sensitivity and 88.9% specificity, and the SD had 84.2% sensitivity and 44.4% specificity for authentic/synthetic specimens. In set 2, the SD marker specificity depended on the upper limit of the acceptance criteria. In one US synthetic urine, carbendazim was identified. Overall, several tests should be applied to confirm authentic or synthetic urine. Especially, simultaneous analysis of indirect and direct synthetic urine markers should be considered.\u0000 </div>","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"2022-2031"},"PeriodicalIF":2.7,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Infant Death due to Cannabis Ingestion 婴儿因吸食大麻而死亡。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-21 DOI: 10.1002/dta.3904

Donata Favretto, Antonello Cirnelli, Roberto Pertile, Raffaella Stimamiglio, Clara Cestonaro, Oriana Cuman, Anna Pagliaro, Fabio Mattiazzi, Cristina Basso, Maddalena Galeazzi

{"title":"Infant Death due to Cannabis Ingestion","authors":"Donata Favretto, Antonello Cirnelli, Roberto Pertile, Raffaella Stimamiglio, Clara Cestonaro, Oriana Cuman, Anna Pagliaro, Fabio Mattiazzi, Cristina Basso, Maddalena Galeazzi","doi":"10.1002/dta.3904","DOIUrl":"10.1002/dta.3904","url":null,"abstract":"A child died in the emergency room of a local hospital a few hours after ingesting a substance the color of cork and the consistency of earth. At home, a modest amount of resinous substance was found. At the hospital, the child exhibited alterations in walking, balance, and consciousness. Intubation was needed for the onset of dyspnea, so fentanyl and ketamine were administered during the procedure. A sample of blood was also collected for clinical investigation. During the autopsy, cadaveric samples were collected. Autopsy evaluation revealed multiorgan congestion in the brain, lung, liver, and kidney. Histological investigations were inconclusive. A thorough toxicological investigation was undertaken by immunochemical technique, gas chromatography–mass spectrometry (GC–MS), and liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) on samples of blood, bile, urine, organs, gastric content, and head hair. Toxicological analysis detected cannabinoids, ketamine, norketamine, and fentanyl in blood drawn from the emergency room. Cannabinoids were also observed in postmortem central blood, peripheral blood, urine, bile, brain, lung, and liver samples. Hair analysis showed tetrahydrocannabinol, cannabidiol, cannabinol, methadone and metabolites, cocaine and metabolites, ketamine, morphine, 6-monoacetylmorphine, and fentanyl. Gastric content revealed traces of cannabis products. Acute cannabis intoxication in the context of chronic exposure to numerous drugs has been considered responsible for the death. An increasing number of intoxication cases are being reported worldwide due to the legalization of cannabis. In most cases, these are adults suffering from preexisting conditions, whereas data on younger individuals are still scarce. In this paper, the case of a child who died from acute intoxication due to ingestion of hashish is presented.","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"2014-2021"},"PeriodicalIF":2.7,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/dta.3904","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144118465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Doping Control of Ranitidine in Horses 马用雷尼替丁的兴奋剂控制。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-20 DOI: 10.1002/dta.3909

Helen S. M. Ho, James X. Mizzi, Emmie N. M. Ho, Wing-Tak Wong

{"title":"Doping Control of Ranitidine in Horses","authors":"Helen S. M. Ho, James X. Mizzi, Emmie N. M. Ho, Wing-Tak Wong","doi":"10.1002/dta.3909","DOIUrl":"10.1002/dta.3909","url":null,"abstract":"<div>\u0000 \u0000 Ranitidine is a histamine H2-receptor antagonist commonly used to treat gastric ulceration in horses. The author's laboratory conducted a study some years ago in the early 2000s on its metabolism as well as its urinary elimination profile in two geldings. With the technology advancement as well as popularity of blood for doping control testing, the laboratory has recently conducted another administration trials of the substance in six horses to study the in vivo metabolism of ranitidine, aiming to identify and reinvestigate the appropriate target(s) for controlling misuse of ranitidine in horses as well as to study its elimination in blood. To study the elimination and biotransformation of ranitidine, administration experiments were performed by giving six castrated horses (geldings) each 25 mL of Ulcerguard oral paste (equivalent to 9.8 g of ranitidine) in the morning and 20 mL of oral paste (equivalent to 7.9 g of ranitidine) in the afternoon daily for eight consecutive days. The postulated in vivo metabolites included ranitidine-S-oxide (M1), ranitidine-N-oxide (M2), desmethylranitidine (M3a/b) and furoic acid analogue of ranitidine (M4), resulting from oxidation, demethylation and oxidative deamination of ranitidine. To control the misuse of ranitidine in horses, elimination profiles of urinary and plasma ranitidine were established. Free ranitidine was detectable for at most 8 days and 72 h in urine and plasma, respectively. Both metabolites ranitidine-S-oxide and ranitidine-N-oxide were detected for 8 days, and therefore, they could be monitored alongside the parent drug as evidence that the substance has gone through the horse's body.\u0000 </div>","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"2005-2013"},"PeriodicalIF":2.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identification of the Novel Synthetic Opioid N-Pyrrolidino Isotonitazene at an Australian Drug Checking Service 新型合成阿片类药物n -吡咯利迪诺异戊二烯在澳大利亚药品检验中心的鉴定。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-19 DOI: 10.1002/dta.3910

Blake Curtis, Douglas J. Lawes, David Caldicott, Malcolm D. McLeod

{"title":"Identification of the Novel Synthetic Opioid N-Pyrrolidino Isotonitazene at an Australian Drug Checking Service","authors":"Blake Curtis, Douglas J. Lawes, David Caldicott, Malcolm D. McLeod","doi":"10.1002/dta.3910","DOIUrl":"10.1002/dta.3910","url":null,"abstract":"2-Benzylbenzimidazole opioids and related derivatives, also known as ‘nitazenes’, present a growing threat to public health. Emerging in Europe in 2019, the nitazene group of drugs is a recent addition to the novel synthetic opioid class and has been associated internationally with adverse effects in drug users, overdose clusters and significant mortality. The high potency of many nitazene derivatives, which can in many cases exceed that of fentanyl, poses a significant challenge to the public health and early warning systems used to detect and respond to the emergence of new high-risk substances. This report describes close collaboration between an Australian drug checking service and a nearby university laboratory to identify and characterise the novel synthetic opioid N-pyrrolidino isotonitazene in an expected oxycodone sample presented by a member of the public. Though no prior publications are available describing the presence of this nitazene in the drug market, previously reported in vitro evaluation of this compound reveals it to be among the most potent nitazene opioid agonists known. The study highlights the rapid response possible though engaging drug users with drug checking services as a market monitor and early warning system to alert health services and the broader community to the presence of unexpected, high-risk substances. Integration of well-resourced and supported drug checking services provides a powerful approach to tackle the public health threats associated with novel synthetic opioids and other drugs of concern.","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"1996-2004"},"PeriodicalIF":2.7,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/dta.3910","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Metabolic Identification Based on Proposed Mass Fragmentation Pathways of the Anabolic Steroid Bolasterone by Gas Chromatography Tandem Mass Spectrometry 气相色谱串联质谱法鉴定合成类固醇类固醇甾酮的质量碎片化途径。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-19 DOI: 10.1002/dta.3903

Anca Raluca Muresan, Khandoker Asiqur Rahaman, Farzana Binte Rafique, Junghyun Son, Min-Jung Kang, Oh-Seung Kwon

{"title":"Metabolic Identification Based on Proposed Mass Fragmentation Pathways of the Anabolic Steroid Bolasterone by Gas Chromatography Tandem Mass Spectrometry","authors":"Anca Raluca Muresan, Khandoker Asiqur Rahaman, Farzana Binte Rafique, Junghyun Son, Min-Jung Kang, Oh-Seung Kwon","doi":"10.1002/dta.3903","DOIUrl":"10.1002/dta.3903","url":null,"abstract":"Bolasterone (7α,17α-dimethyl-androsta-4-en-17β-ol-3-one) was registered on the World Anti-Doping Agency's Prohibited list of substances. This study was aimed at evaluating the metabolism of bolasterone through in vitro (liver microsomes) and in vivo (rat urine) experiments to propose mass fragmentation pathways of the metabolites by gas chromatography–quadrupole tandem mass spectrometry (GC-EI-MS/MS). Their plausible chemical structures were suggested based on their fragmentation pathways to overcome the lack of available authentic standards. A total of 12 metabolites (5 mono-hydroxylated M1 to M5 and 7 di-hydroxylated M6 to M12) after trimethylsilylation were observed. Key diagnostic ions included m/z 403 (mono-hydroxylated) and m/z 491 (di-hydroxylated) with m/z 143, indicating an intact D ring (M1 to M5, M7, M9, M10, M11). Hydroxylation at the D ring (M6, M12) was characterized by ions m/z 231 or 219. Hydroxylation at the A (M5, M7) or B (M2/M3, M10) rings corresponded to m/z 281 and hydroxylation at C12 of the C ring (M4, M10) was indicated by m/z 285. Based on the comparison with bolasterone analogues such as testosterone and methyltestosterone and the interpretation of fragmentation pathways, the mono-hydroxylation metabolites M1 (at C11), M2/M3 (at C6), M4 (at C12), M5 (at C2), and di-hydroxylation metabolites M6 (at C11 and C16), M7 (at C2 and C11), M10 (at C6 and C12), and M12 (at C12 and C16) were proposed. The hydroxylation sites of M8, M9, and M11 could not be determined. This data can be useful for identifying hydroxylated metabolites by interpreting mass spectra of anabolic steroids with no standards available.","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"1985-1995"},"PeriodicalIF":2.7,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/dta.3903","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144092380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States 在美国销售的Kratom产品的化学分析和生物碱摄入量。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-16 DOI: 10.1002/dta.3906

Abhisheak Sharma, Kirsten E. Smith, Michelle A. Kuntz, Erin C. Berthold, Omar I. Elashkar, Nicholas Guadagnoli, Siva Rama Raju Kanumuri, Sushobhan Mukhopadhyay, Leigh V. Panlilio, David H. Epstein, Christopher R. McCurdy

{"title":"Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States","authors":"Abhisheak Sharma, Kirsten E. Smith, Michelle A. Kuntz, Erin C. Berthold, Omar I. Elashkar, Nicholas Guadagnoli, Siva Rama Raju Kanumuri, Sushobhan Mukhopadhyay, Leigh V. Panlilio, David H. Epstein, Christopher R. McCurdy","doi":"10.1002/dta.3906","DOIUrl":"10.1002/dta.3906","url":null,"abstract":"<div>\u0000 \u0000 Previously, we used ecological momentary assessment (EMA) to evaluate motivations and temporal patterns of kratom use for 15 days among US adult kratom consumers (N = 357). Here we present the content analyses of the products used during that nationwide study, with quantification of 10 kratom alkaloids. The samples (N = 341) were primarily whole-leaf products, not extracts, and were similar to each other in their alkaloid composition, closely matching the chromatographic-mass spectrometry fingerprint expected for Mitragyna speciosa leaf material. We found no evidence of adulteration with illicit or prescription drugs. With participants' self-reported data on kratom amount per use, we calculated mitragynine intake per use: mean 31.3 mg and median 25.4 mg (range 2.0–205.9 mg). With self-reported data on frequency, we calculated mitragynine intake per day, it ranged from 78.3 to 134.6 mg (mean) or 50.8 to 101.6 mg (median). This is the most comprehensive analysis of US whole-leaf kratom products to date. The coupling of self-report and product sample-analysis data to quantify daily alkaloid intake is foundational for designing controlled clinical trials of kratom in healthy volunteers. These findings on kratom products' chemical composition and daily kratom alkaloid consumption can also inform clinicians, policymakers, and consumers, particularly for whole-leaf material.\u0000 </div>","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"1974-1984"},"PeriodicalIF":2.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144074886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Growing Trend of Novel or Experimental Substances Not Approved for Human Use Sold as Consumer Products Poses Threat to Athletes, Service Members, and Public Health 未经批准供人使用的新型或实验性物质作为消费品销售的增长趋势对运动员、服务人员和公众健康构成威胁。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-16 DOI: 10.1002/dta.3907

Amy Eichner, Andrea T. Lindsey, Jon Coyles

引用次数: 0

Exposure to Drugs of Abuse in Children and Adolescents Investigated by Hair Analysis 用毛发分析调查儿童和青少年药物滥用暴露情况。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-15 DOI: 10.1002/dta.3900

Clara Cestonaro, Claudio Terranova, Massimo Carollo, Alessia Russo, Anna Aprile, Donata Favretto

{"title":"Exposure to Drugs of Abuse in Children and Adolescents Investigated by Hair Analysis","authors":"Clara Cestonaro, Claudio Terranova, Massimo Carollo, Alessia Russo, Anna Aprile, Donata Favretto","doi":"10.1002/dta.3900","DOIUrl":"10.1002/dta.3900","url":null,"abstract":"<div>\u0000 \u0000 Hair testing is a very effective method for drug use investigation. The finding of drugs of abuse in children hair may reflect environmental exposure, accidental ingestion, passive inhalation, intentional administration, and, in case of neonates and infants, in-utero and breast exposure. Despite its increasing use, interpretation of children hair analysis remains difficult, cut-off values used in adults cannot be applied, and no reference ranges for different age groups currently exist. To contribute to the identification of a reference framework for hair analysis in children and adolescents, a comparison of data gathered from different geographical areas could be useful. With this view, this study shows the results of hair analysis of children and adolescents who underwent testing for clinical purposes in a hospital setting in north-east Italy. Cocaine represents the most frequently detected drug in all age groups (overall, 94 positives). The highest number and ratio of cocaine positivity was found among children aged 1–3 years (21 out of 32 children; 65.6%) and the highest concentration among infants within 1 year. The results suggest that exposure to drugs of abuse represents a nonnegligible problem particularly in infants and toddlers, which requires special attention in clinical and social setting. In view of the multiple possible ways of exposure, it is essential to perform a case-by-case evaluation and to collect as much information as possible to frame the case and to implement the most effective child protection measures.\u0000 </div>","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"1965-1970"},"PeriodicalIF":2.7,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144074888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study 危险药品表面擦拭取样：欧洲实验室间比较研究。

IF 2.7 3区医学

Drug Testing and Analysis Pub Date : 2025-05-05 DOI: 10.1002/dta.3902

Roland B. van den Berg, Ewelina Korczowska, Mónica S. F. Santos, Maria Francisca Portilha-Cunha, Ana R. L. Ribeiro, Lucie Bláhová, Luděk Bláha, Claudia Vom Eyser, Jochen Tuerk, Richard C. J. M. van Rossen, Erik B. Wilms, Mirjam Crul

{"title":"Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study","authors":"Roland B. van den Berg, Ewelina Korczowska, Mónica S. F. Santos, Maria Francisca Portilha-Cunha, Ana R. L. Ribeiro, Lucie Bláhová, Luděk Bláha, Claudia Vom Eyser, Jochen Tuerk, Richard C. J. M. van Rossen, Erik B. Wilms, Mirjam Crul","doi":"10.1002/dta.3902","DOIUrl":"10.1002/dta.3902","url":null,"abstract":"Workplace monitoring of hazardous medicinal products (HMPs) using surface wipe sampling is becoming common practice in many European hospitals and pharmacies. However, no independent quality control is available to validate wiping procedures and analytical methods. This study aimed to conduct a Europe-wide interlaboratory comparison (ILC) program to independently and blindly assess laboratory performance and variability in HMP detection. Four European laboratories participated in the study. Six HMPs—cyclophosphamide, etoposide, gemcitabine, ifosfamide, methotrexate, and paclitaxel—were prepared at four concentrations (5000, 2000, 200, and 20 ng/mL) and applied to a 400-cm2 stainless-steel surface, then wiped by the coordinating body according to each laboratory's protocol. Wipe samples were distributed to individual laboratories, where blind analyses were conducted. Target criteria for accuracy and recovery were set at 70%–130% and 50%–130%, respectively. Of the 80 samples, 69 (86%) met accuracy targets, and 70 (88%) met recovery targets. Accuracy was often overestimated for the lowest concentrations of cyclophosphamide, etoposide, methotrexate, and paclitaxel by Laboratory A. Laboratory D showed low accuracy for paclitaxel at three lower concentrations. Among the 10 samples that did not meet recovery targets, all were below 50% and involved etoposide and paclitaxel. This ILC program demonstrates a viable method for evaluating laboratory performance in HMP detection, offering an external validation mechanism for surface wipe sampling methods. A future goal is to establish a global ILC program with a designated coordinating body for managing it effectively.","PeriodicalId":160,"journal":{"name":"Drug Testing and Analysis","volume":"17 10","pages":"1955-1964"},"PeriodicalIF":2.7,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/dta.3902","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0