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Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum. 在体外诊断医疗器械法规中找到我们的方向:欧洲生物分析论坛的讨论文件。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0262
Philip Timmerman, Anna Laurén, Robert Nelson, Matthew Barfield
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引用次数: 0
Digital image colorimetry for determination of ethanol in exhaled breath condensate. 数字图像比色法测定呼出气体冷凝物中的乙醇含量。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0147
Yasaman Sefid-Sefidehkhan, Maryam Khoshkam, Samineh Raha, Fariba Pourkarim, Abolghasem Jouyban, Maryam Khoubnasabjafari, Vahid Jouyban-Gharamaleki, Elaheh Rahimpour

Aim: This study aimed to develop a colorimetric approach for quantifying ethanol using smartphone image analysis. Method: This research presents a straightforward smartphone-based colorimetric sensor that efficiently measures ethanol levels in exhaled breath condensate (EBC) samples. The process involved changing the acidic dichromate color in an ethanolic solution, followed by image analysis. Results: The results showed that this method was able to estimate ethanol concentrations in the range of 300-1500 and 1600-8000 μg ml-1 in EBC. Conclusion: This study was a follow-up study on the previous work published for the determination of ethanol in EBC samples and highlights the potential benefits of using digital images and smartphone applications for ethanol determination in biological samples.

目的:本研究旨在开发一种利用智能手机图像分析量化乙醇的比色法。方法:本研究提出了一种基于智能手机的直接比色传感器,可有效测量呼出气体冷凝物(EBC)样本中的乙醇含量。测量过程包括改变乙醇溶液中酸性重铬酸盐的颜色,然后进行图像分析。结果显示结果表明,该方法能够估算出 EBC 中的乙醇浓度范围为 300-1500 和 1600-8000 μg ml-1。结论这项研究是对之前发表的测定 EBC 样品中乙醇的工作的后续研究,突出了使用数字图像和智能手机应用测定生物样本中乙醇的潜在好处。
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引用次数: 0
Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid. 扩大检测范围,以适应血液和脑脊液中单克隆抗体的治疗定量。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2023-12-13 DOI: 10.4155/bio-2023-0179
Alejandro R Foley, Gizette Sperinde, Saloumeh K Fischer

Antibody therapeutic levels in neurodegenerative diseases are often measured in both serum and cerebrospinal fluid (CSF). Due to 0.1% drug partition from serum to CSF and the higher sensitivity needs, usually two different assays are required. The different Gyrolab Bioaffy compact discs can extend the dynamic range of assays. Here, an assay was developed and adapted on two different Gyrolab Bioaffy compact discs (200 and 4000 nl) to achieve the required sensitivity and assay dynamic range needed for the measurement of drug in both serum and CSF. This was accomplished by using the same critical reagents with minimal assay development to transition from a serum to a CSF assay.

神经退行性疾病的抗体治疗水平通常在血清和脑脊液(CSF)中同时测定。由于从血清到 CSF 的药物分配率为 0.1%,而且灵敏度要求较高,因此通常需要两种不同的检测方法。不同的 Gyrolab Bioaffy 光盘可以扩大检测的动态范围。在此,我们在两种不同的 Gyrolab Bioaffy 光盘(200 nl 和 4000 nl)上开发并调整了一种检测方法,以达到测量血清和 CSF 中药物所需的灵敏度和检测动态范围。这是通过使用相同的关键试剂实现的,从血清到脑脊液检测只需进行最少的检测开发。
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引用次数: 0
LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens. 对福尔马林固定石蜡包埋组织标本中的蛋白质生物标记物和蛋白质疗法进行液相色谱-质谱生物分析。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2024-01-16 DOI: 10.4155/bio-2023-0210
Mashanipalya G Jagadeeshaprasad, Jianing Zeng, Naiyu Zheng

Formalin-fixed paraffin-embedded (FFPE) is a form of preservation and preparation for biopsy specimens. FFPE tissue specimens are readily available as part of oncology studies because they are often collected for disease diagnosis or confirmation. FFPE tissue specimens could be extremely useful for retrospective studies on protein biomarkers because the samples preserved in FFPE blocks could be stable for decades. However, LC-MS bioanalysis of FFPE tissues poses significant challenges. In this Perspective, we review the benefits and recent developments in LC-MS approach for targeted protein biomarker and protein therapeutic analysis using FFPE tissues and their clinical and translational applications. We believe that LC-MS bioanalysis of protein biomarkers in FFPE tissue specimens represents a great potential for its clinical applications.

福尔马林固定石蜡包埋(FFPE)是活检标本的一种保存和制备方式。FFPE 组织标本在肿瘤学研究中很容易获得,因为它们通常是为疾病诊断或确诊而收集的。FFPE 组织标本对于蛋白质生物标记物的回顾性研究非常有用,因为保存在 FFPE 块中的样本可以稳定数十年。然而,对 FFPE 组织进行 LC-MS 生物分析是一项重大挑战。在本视角中,我们回顾了利用 FFPE 组织进行靶向蛋白质生物标记物和蛋白质治疗分析的 LC-MS 方法的优势和最新进展,以及它们在临床和转化方面的应用。我们相信,LC-MS 生物分析 FFPE 组织标本中的蛋白质生物标记物具有巨大的临床应用潜力。
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引用次数: 0
WRIB Poster Awards winners 2023. 2023 年 WRIB 海报奖获奖者。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2024-01-25 DOI: 10.4155/bio-2024-0012
Jennifer Getz, Shannon McGrath, Gus Hui
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引用次数: 0
Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography-tandem mass spectrometry. 利用液相色谱-串联质谱法对兔泪液基质中的莫西沙星和酮咯酸氨丁三醇进行眼部生物分析。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-01 Epub Date: 2024-01-10 DOI: 10.4155/bio-2023-0233
Amol Chhatrapati Bisen, Rabi Sankar Bhatta

Aim: The fixed-dose combination of moxifloxacin (MOXI) and ketorolac tromethamine (KTR) is widely used for the treatment of bacterial keratitis. Thus, a new LC-MS/MS method was developed to determine MOXI and KTR in lacrimal fluid. Methods: Bioanalysis was performed using a Shimadzu 8050 LC-MS/MS in electrospray ionization-positive mode and the method was validated per US FDA guidelines. Isocratic separation was performed with a Waters Symmetry C18 column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). Results & conclusion: An easy, quick and selective method was established and applied to assess the ocular pharmacokinetic profile of a commercially available formulation containing MOXI and KTR. Based on the pharmacokinetic data, this work describes pharmacokinetics-based dosage regimen calculations and their clinical significance.

目的:莫西沙星(MOXI)和酮咯酸氨丁三醇(KTR)的固定剂量复方制剂被广泛用于治疗细菌性角膜炎。因此,我们开发了一种新的 LC-MS/MS 方法来测定泪液中的 MOXI 和 KTR。方法:使用岛津 8050 LC-MS/MS,在电喷雾离子化正离子模式下进行生物分析,并根据美国 FDA 指南对该方法进行了验证。采用 Waters Symmetry C18 色谱柱,以甲醇和含去离子水的 0.1% 甲酸(85:15, v/v)进行等度分离。结果与结论:本研究建立了一种简便、快速、选择性强的方法,用于评估含有 MOXI 和 KTR 的市售制剂的眼药代动力学特征。根据药代动力学数据,本研究阐述了基于药代动力学的剂量方案计算及其临床意义。
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引用次数: 0
Bioanalysis of six antibiotics from volumetric microsamples: a new tool for precision dosing in critically ill children. 体积微样品中六种抗生素的生物分析:一种用于危重儿童精确给药的新工具。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0171
John Takyi-Williams, Abbie D Leino, Ruiting Li, Kevin J Downes, Athena F Zuppa, Amanda Bwint, Bo Wen, Duxin Sun, Marc H Scheetz, Manjunath P Pai

Background: Volumetric absorptive microsamples (VAMS) can support pharmacokinetic / pharmacodynamic studies. We present the bioanalytical method development for the simultaneous quantification of ampicillin, cefepime, ceftriaxone, meropenem, piperacillin, tazobactam, and vancomycin from VAMS. Methods & results: Optimal extraction, chromatographic, and mass spectrometry conditions were identified. Maximum extraction recoveries included 100 μl of water for rehydration and methanol for protein precipitation. Chromatographic separation used Phenomenex Kinetex Polar C18 column with a mobile phase comprising water/acetonitrile with formic acid and was fully validated. Hematocrit effects were only observed for vancomycin. Samples were stable for 90 days at -80°C except for meropenem, which was stable for 60 days. Conclusion: Multiple antibiotics can be assayed from a single VAMS sample to facilitate pharmacokinetic/pharmacodynamic studies.

背景:体积吸收微样品(VAMS)可以支持药代动力学/药效学研究。我们介绍了同时定量氨苄西林、头孢吡肟、头孢曲松、美罗培南、哌拉西林、他唑巴坦和万古霉素的生物分析方法的发展。方法与结果:确定了最佳提取、色谱和质谱条件。最大提取回收率为复水合用水100 μl,蛋白质沉淀用甲醇100 μl。色谱分离使用Phenomenex Kinetex™Polar C18色谱柱,流动相为水/乙腈和甲酸,并经过充分验证。仅万古霉素对红细胞压积有影响。样品在-80℃下稳定90天,除美罗培南稳定60天外。结论:单一VAMS样品可检测多种抗生素,便于药代动力学/药效学研究。
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引用次数: 0
Challenges and current advances in the methodology of thyroglobulin measurements. 甲状腺球蛋白测量方法的挑战和当前进展。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2023-11-22 DOI: 10.4155/bio-2023-0149
Ilona Đorić, Sonja Šelemetjev

Thyroglobulin (Tg) is a large protein secreted exclusively by the thyroid gland. In a clinical setting, it is measured for the purpose of follow-up of thyroidectomy patients. However, Tg measurements are often impeded by the presence of Tg autoantibodies and/or heterophylic antibodies that interfere with most measuring platforms. This presents a global problem in thyroid cancer patients who need to be postoperatively monitored for recurrent or residual disease. Therefore, in this paper we offer an overview of the existing methodologies and alternative approaches for Tg measurements that are a focus of research worldwide. These include Tg mRNA measurements, exosomal Tg detection, the use of alternative analytes (liquid biopsies) and the development of new approaches for preanalytical sample treatment.

甲状腺球蛋白(Tg)是一种由甲状腺分泌的大蛋白。在临床环境中,它被测量为甲状腺切除术患者的随访目的。然而,Tg测量经常受到Tg自身抗体和/或干扰大多数测量平台的异源抗体的存在的阻碍。这提出了一个全球性的问题,甲状腺癌患者谁需要术后监测复发或残留的疾病。因此,在本文中,我们提供了现有的方法和替代方法的Tg测量的概述,这是全球研究的焦点。这些包括Tg mRNA测量,外泌体Tg检测,替代分析物(液体活检)的使用以及分析前样品处理新方法的开发。
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引用次数: 0
Free hemoglobin determination at patients' bedside to evaluate hemolysis. 床边检测游离血红蛋白评价溶血情况。
IF 1.8 4区 医学 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-01-01 Epub Date: 2023-12-05 DOI: 10.4155/bio-2023-0116
Bastien Baud, Anne Marie Dupuy, Samuel Zozor, Stéphanie Badiou, Anne Sophie Bargnoux, Olivier Mathieu, Jean Paul Cristol

Background: The authors report the relevance of using a point of care test (Helge®) for free hemoglobin determination and concordance of the values the with Cobas® 8000 and spectrophotometer methods. Results: The within-run of the point of care test was <3%. Good correlations among the three methods were observed and an acceptable concordance for hemolysis index values from 50 mg/dl. An excellent agreement between the Cobas 8000 and the spectrophotometer was found. Conclusion: Automated methods represent methods of choice for free hemoglobin determination. An advantage of the Helge system is that it can be applied to samples experiencing a delay in evaluation due to the long distance between the collection site and the central laboratory. Another advantage is its use at the bedside, in the monitoring of extracorporeal membrane oxygenation patients.

背景:作者报告了使用护理点试验(Helge®)测定游离血红蛋白的相关性,以及与Cobas®8000和分光光度计方法的一致性。结论:自动化方法是游离血红蛋白测定的首选方法。Helge系统的一个优点是,它可以应用于由于采集地点和中心实验室之间的距离较远而导致评估延迟的样品。另一个优点是它可以在床边使用,用于监测体外膜氧合患者。
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引用次数: 0
An interview with Bioanalysis: speaking with the 2023 Reid bursary award winners - part 2. 生物分析访谈:与2023年里德奖学金获得者对话--第二部分。
IF 1.9 4区 医学 Q3 BIOCHEMICAL RESEARCH METHODS Pub Date : 2024-01-01 Epub Date: 2024-03-26 DOI: 10.4155/bio-2024-0051
Olga Begou, Artemis Lioupi, Georgina Page, Shwan Ahmed, Svenja Stiltz, Rebecca Dowell, Jack Lodge

The 25th edition of the International Reid Bioanalytical Forum (REID) was held at the Cambridge Belfry (Cambourne, UK) between 4 and 7 September 2023 and hosted approximately 100 delegates, the majority of whom were attending the event for their first time.REID encourages early-career researchers to present their work and have a bursary program to help provide them support. At the 2023 event, REID welcomed 15 bursary winners to provide them with the opportunity to participate in their first international meeting, network with their peers and make their first oral, or poster presentation. The bursary winners also had the opportunity to interview with the Bioanalysis journal and their responses to the interview questions are transcribed below in this second part of two.

第25届国际里德生物分析论坛(REID)于2023年9月4日至7日在英国剑桥贝尔福里(Cambourne)举行,约有100名代表参加,其中大部分是首次参加该活动。REID 鼓励早期职业研究人员展示自己的工作,并设有助学金计划为他们提供支持。在 2023 年的会议上,REID 邀请了 15 位助学金获得者,为他们提供了首次参加国际会议、与同行交流并进行首次口头或海报展示的机会。助学金获得者还有机会接受《生物分析》杂志的采访,他们对采访问题的回答转录在下面的第二部分(共两篇)中。
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引用次数: 0
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Bioanalysis
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