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Correction to: AACC Guidance Document on Laboratory Investigation of Acute Kidney Injury. 更正:AACC 急性肾损伤实验室调查指导文件。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae012
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引用次数: 0
Stability and Analytical Characterization of Voriconazole as Measured by Immunoassay. 用免疫测定法测定伏立康唑的稳定性和分析特性
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad139
Veni Bharti, Benjamin Jung, Sarah Lam, Ansel Fabros, Rajeevan Selvaratnam

Background: Voriconazole is a broad-spectrum triazole antifungal agent recommended for invasive fungal diseases, including invasive aspergillosis. Therapeutic drug monitoring via voriconazole target trough concentration is important to ensure efficacy while preventing toxicity. Our aim was to determine the stability of voriconazole as adapted and measured by an immunoassay.

Methods: Plasma from patient samples (n = 45) evaluated by a liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was compared against an ARK immunoassay method, adapted and optimized on the Abbott Alinity c analyzer. Stability of voriconazole and analytical performance of ARK immunoassay was assessed, including functional sensitivity, limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), linearity, and precision.

Results: ARK voriconazole immunoassay was highly correlated (Pearson R = 0.988) to the LC-MS/MS method, with an average bias of 0.09 mg/L (2%). CV at LoQ of 0.5 mg/L was 3.7% while the functional sensitivity was established at 0.05 mg/L. Overall imprecision with liquid quality control material obtained from ARK was 5.0%, 6.3%, and 5.9% at 1 mg/L, 5 mg/L, and 10 mg/L, respectively. Limit of blank and LoD were 0.02 mg/L and 0.05 mg/L, respectively. Voriconazole in lithium heparin plasma separator tube declines over time, with a decrease that is more evident near or above toxic concentrations.

Conclusion: Voriconazole collected in gel separation tubes declines over time, possibly due to absorptive properties. Voriconazole measurements by immunoassay and LC-MS/MS demonstrated acceptable comparability with sufficient level of sensitivity and precision.

背景:伏立康唑是一种广谱三唑类抗真菌药物,建议用于治疗侵袭性真菌病,包括侵袭性曲霉菌病。通过伏立康唑目标谷浓度进行治疗药物监测对于确保疗效同时预防毒性非常重要。我们的目的是通过免疫测定法确定伏立康唑的稳定性:采用液相色谱-串联质谱(LC-MS/MS)方法对患者样本(n = 45)中的血浆进行评估,并与雅培 Alinity c 分析仪上经过调整和优化的 ARK 免疫测定方法进行比较。评估了伏立康唑的稳定性和 ARK 免疫分析法的分析性能,包括功能灵敏度、空白限 (LoB)、检出限 (LoD) 和定量限 (LoQ)、线性度和精密度:ARK 伏立康唑免疫测定与 LC-MS/MS 方法高度相关(Pearson R = 0.988),平均偏差为 0.09 mg/L(2%)。当 LoQ 为 0.5 mg/L 时,CV 为 3.7%,而功能灵敏度为 0.05 mg/L。从 ARK 获得的液体质控材料在 1 mg/L、5 mg/L 和 10 mg/L 时的总体不精确度分别为 5.0%、6.3% 和 5.9%。空白限和 LoD 分别为 0.02 mg/L 和 0.05 mg/L。肝素锂血浆分离管中的伏立康唑会随着时间的推移而下降,在接近或高于毒性浓度时下降更为明显:结论:在凝胶分离管中收集的伏立康唑会随着时间的推移而下降,这可能是由于吸收特性造成的。免疫测定法和 LC-MS/MS 法测定的伏立康唑具有可接受的可比性、足够的灵敏度和精确度。
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引用次数: 0
The New Creatinine-Based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 Equation: Potential Impact on Screening for Chronic Kidney Disease in an Asymptomatic Black African Population. 基于肌酸酐的慢性肾脏病流行病学合作(CKD-EPI)2021 新方程:对无症状非洲黑人慢性肾病筛查的潜在影响。
IF 1.8 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae002
Geoffrey Omuse, Daniel Maina, Ahmed Sokwala

Background: In 2021, a new Chronic Kidney Disease Epidemiology (CKD-EPI) Collaboration equation was introduced that excluded race correction. We set out to compare estimated glomerular filtration rate (eGFR) determined using the creatinine-based CKD-EPI 2009 and 2021 equations and the reclassification of chronic kidney disease (CKD) eGFR staging to explore the potential ramifications of adopting the 2021 equation on reported eGFR and CKD staging.

Methods: We analyzed secondary data previously utilized to determine reference intervals among Black African individuals residing in urban towns in Kenya. Serum creatinine was measured using a standardized modified Jaffé kinetic method on a Beckman AU5800 analyzer. Glomerular filtration rate (GFR) was estimated using both the 2009 and 2021 CKD-EPI creatinine equations. Classification of CKD based on eGFR was performed using the Kidney Disease: Improving Global Outcomes (KDIGO) practice guidelines.

Results: Using 533 study samples, the median eGFR was highest when determined using the race-corrected CKD-EPI 2009 equation. The CKD-EPI 2021 equation yielded a median eGFR that was similar to the non-race-corrected CKD-EPI 2009 equation. The race-corrected CKD-EPI 2009 equation classified 93.6% of participants into CKD stage G1 compared with 85.6% by the CKD-EPI 2021 equation. The CKD-EPI 2021 equation classified 14.3% of participants into CKD stage G2 compared to 6.4% by the race-corrected CKD-EPI 2009 equation.

Conclusions: The CKD-EPI 2021 equation gave a comparable eGFR to the non-race-corrected CKD-EPI 2009 equation and its implementation in laboratories reporting eGFR in Kenya will help in identifying patients with an appropriate decrease in renal function.

背景:2021年,新的慢性肾脏病流行病学(CKD-EPI)合作方程被引入,其中不包括种族校正。我们对使用基于肌酐的 CKD-EPI 2009 和 2021 方程确定的估计肾小球滤过率(eGFR)以及慢性肾脏病(CKD)eGFR 分期的重新分类进行了比较,以探讨采用 2021 方程对报告的 eGFR 和 CKD 分期的潜在影响:我们分析了以前用于确定居住在肯尼亚城镇的非洲黑人参考区间的二手数据。血清肌酐是在贝克曼 AU5800 分析仪上使用标准化的改良贾菲动力学法测定的。肾小球滤过率(GFR)采用 2009 年和 2021 年 CKD-EPI 肌酐方程进行估算。根据 eGFR 对 CKD 进行分类,采用的是肾脏病:结果:结果:在 533 个研究样本中,使用经种族校正的 CKD-EPI 2009 方程确定的 eGFR 中位数最高。CKD-EPI 2021方程得出的eGFR中位数与未经种族校正的CKD-EPI 2009方程相似。经种族校正的 CKD-EPI 2009 方程将 93.6% 的参与者划分为 CKD G1 期,而 CKD-EPI 2021 方程则将 85.6% 的参与者划分为 G1 期。CKD-EPI 2021方程将14.3%的参与者划分为CKD G2期,而种族校正后的CKD-EPI 2009方程则将6.4%的参与者划分为CKD G2期:CKD-EPI 2021方程得出的eGFR与未经种族校正的CKD-EPI 2009方程相当,在肯尼亚报告eGFR的实验室中采用该方程将有助于识别肾功能适当下降的患者。
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引用次数: 0
Not Carfentanil-A Case of Unexpected Xylazine Detection. 不是卡芬太尼--一个意外检测到 Xylazine 的案例。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad119
Jasper X Zheng, Shelby Randall, Kristin Grimsrud, Scott Bainbridge, Nam K Tran

Historically, xylazine has been utilized in veterinary medicine for decades as an anesthetic and analgesic sedative to facilitate safe handling, diagnostic testing, and surgical procedures in large animals. Currently, xylazine is an emerging threat to human health. It has been detected in the illicit drug supply chain, often as an adulterant. It has been more commonly added to illicit substances, most notably fentanyl, by drugmakers to enhance drug effect. End users are often unaware of its presence. This is alarming given the large number of xylazine-involved overdose deaths while laboratory detections are deficient and reversal agents are absent. Herein, we present the first documented case of xylazine identified via gas chromatography-tandem mass spectrometry at University of California Davis Health despite a peculiarly mild clinical presentation. We hope to increase awareness of this potentially fatal adulterant that is often missed in evaluation and engender further opportunities to study this ongoing issue.

数十年来,恶嗪一直被兽医学用作麻醉和镇痛镇静剂,以促进大型动物的安全处理、诊断检测和外科手术。目前,异丙嗪正在对人类健康构成威胁。在非法药物供应链中发现了它,通常是作为一种掺杂物。更常见的情况是,制药商将其添加到非法药物(最著名的是芬太尼)中,以增强药物效果。最终用户往往不知道它的存在。这一点令人震惊,因为在实验室检测不充分和缺乏逆转剂的情况下,却有大量因服用过量过量使用异丙嗪而死亡的案例。在本文中,我们介绍了加利福尼亚大学戴维斯分校健康中心通过气相色谱-串联质谱法发现的第一例异丙嗪病例,尽管该病例的临床表现非常轻微。我们希望提高人们对这种在评估中经常被忽略的潜在致命掺假剂的认识,并为研究这一持续存在的问题提供更多机会。
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引用次数: 0
Clinically Relevant Laboratory Monitoring of Gender-Affirming Hormone Therapy in Transgender People-Experiences from a Teaching Hospital in the Netherlands. 变性人性别确认激素疗法的临床相关实验室监测--荷兰一家教学医院的经验。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae006
Nadine Pouw, Joke van der Linden, Sonja Teuben, Snježana Kos

Background: Transgender care is shifting from academic to nonacademic settings leading to use of common (immunoassay) compared to sophisticated (mass spectrometry) methods to monitor estradiol and testosterone during gender-affirming hormone therapy (GAHT). The type of assay can influence results and have significant implications for clinical decision making. An evidence gap is present in recommendations regarding the assay needed to monitor GAHT. The present study aimed to summarize current evidence and evaluate immunoassay estradiol and testosterone concentrations in transgender people visiting a nonacademic hospital for GAHT.

Methods: Clinical practice guidelines on GAHT and scientific literature on assay methodologies were screened and summarized. Laboratory and medical data from 252 patients who visited the transgender outpatient clinic of the Maasstad Hospital for GAHT between 2020 and 2022 were retrospectively analyzed.

Results: Our research showed that the most used clinical practice guidelines for GAHT provide hormonal target values without recommending a preferred method. A comprehensive literature search on agreement between immunoassay and mass spectrometry showed substantial heterogeneity in results. Retrospective analysis of our immunoassay measured data in transgender people showed hormonal changes during GAHT that are to be expected from the medication used.

Conclusions: We demonstrate that laboratory monitoring of GAHT in a nonacademic hospital can be done safely by immunoassay in most cases. Only in cases where clinical observation is discordant with the hormonal results do more sophisticated methods need to be deployed. A best practice model was proposed for transgender care in nonacademic hospitals.

背景:变性护理正从学术环境转向非学术环境,导致在性别确认激素疗法(GAHT)期间使用普通(免疫测定法)与复杂(质谱法)的方法来监测雌二醇和睾酮。检测方法的类型会影响检测结果,并对临床决策产生重大影响。关于监测 GAHT 所需的检测方法的建议存在证据缺口。本研究旨在总结目前的证据,并评估在一家非学术性医院接受 GAHT 治疗的变性人的免疫测定雌二醇和睾酮浓度:筛选并总结了有关 GAHT 的临床实践指南和有关检测方法的科学文献。回顾性分析了 2020 年至 2022 年期间在 Maasstad 医院变性门诊就诊的 252 名 GAHT 患者的实验室和医疗数据:我们的研究表明,最常用的GAHT临床实践指南提供了激素目标值,但并未推荐首选方法。关于免疫测定和质谱分析之间一致性的全面文献检索显示,结果存在很大的不一致性。我们对变性人的免疫测定测量数据进行了回顾性分析,结果显示在 GAHT 期间激素发生了变化,而这种变化是所使用的药物所预期的:我们的研究表明,在大多数情况下,非学术性医院可以通过免疫测定安全地对变性手术进行实验室监测。只有在临床观察与荷尔蒙检测结果不一致的情况下,才需要采用更复杂的方法。为非学术医院的变性人护理提出了一个最佳实践模式。
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引用次数: 0
ADLM Guidance Document on Laboratory Diagnosis of Respiratory Viruses. ADLM 呼吸道病毒实验室诊断指导文件。
IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae010
Gregory J Berry, Tulip A Jhaveri, Paige M K Larkin, Heba Mostafa, N Esther Babady

Respiratory viral infections are among the most frequent infections experienced worldwide. The COVID-19 pandemic has highlighted the need for testing and currently several tests are available for the detection of a wide range of viruses. These tests vary widely in terms of the number of viral pathogens included, viral markers targeted, regulatory status, and turnaround time to results, as well as their analytical and clinical performance. Given these many variables, selection and interpretation of testing requires thoughtful consideration. The current guidance document is the authors' expert opinion based on the preponderance of available evidence to address key questions related to best practices for laboratory diagnosis of respiratory viral infections including who to test, when to test, and what tests to use. An algorithm is proposed to help laboratories decide on the most appropriate tests to use for the diagnosis of respiratory viral infections.

呼吸道病毒感染是全球最常见的感染之一。COVID-19 大流行凸显了检测的必要性,目前有多种检测方法可用于检测各种病毒。这些检测方法在包含的病毒病原体数量、针对的病毒标记物、监管状态、结果的周转时间以及分析和临床表现等方面存在很大差异。鉴于存在诸多变数,选择和解释检测方法需要深思熟虑。本指导文件是作者根据大量现有证据提出的专家意见,旨在解决与呼吸道病毒感染实验室诊断最佳实践有关的关键问题,包括对谁进行检测、何时进行检测以及使用何种检测方法。本指南提出了一种算法,以帮助实验室决定在诊断呼吸道病毒感染时使用最合适的检测方法。
{"title":"ADLM Guidance Document on Laboratory Diagnosis of Respiratory Viruses.","authors":"Gregory J Berry, Tulip A Jhaveri, Paige M K Larkin, Heba Mostafa, N Esther Babady","doi":"10.1093/jalm/jfae010","DOIUrl":"10.1093/jalm/jfae010","url":null,"abstract":"<p><p>Respiratory viral infections are among the most frequent infections experienced worldwide. The COVID-19 pandemic has highlighted the need for testing and currently several tests are available for the detection of a wide range of viruses. These tests vary widely in terms of the number of viral pathogens included, viral markers targeted, regulatory status, and turnaround time to results, as well as their analytical and clinical performance. Given these many variables, selection and interpretation of testing requires thoughtful consideration. The current guidance document is the authors' expert opinion based on the preponderance of available evidence to address key questions related to best practices for laboratory diagnosis of respiratory viral infections including who to test, when to test, and what tests to use. An algorithm is proposed to help laboratories decide on the most appropriate tests to use for the diagnosis of respiratory viral infections.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140854075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Beginner's Guide to Laboratory-Vendor Relationships. 实验室与供应商关系新手指南》。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae009
Thomas Kampfrath, Felix Leung
{"title":"A Beginner's Guide to Laboratory-Vendor Relationships.","authors":"Thomas Kampfrath, Felix Leung","doi":"10.1093/jalm/jfae009","DOIUrl":"https://doi.org/10.1093/jalm/jfae009","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: An Opioid Hiding in Plain Sight: Loperamide-Induced False-Positive Fentanyl and Buprenorphine Immunoassay Results. 更正:一种隐藏在视线中的阿片类药物:洛哌丁胺诱导的芬太尼和丁丙诺啡免疫测定结果假阳性。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad098
{"title":"Correction to: An Opioid Hiding in Plain Sight: Loperamide-Induced False-Positive Fentanyl and Buprenorphine Immunoassay Results.","authors":"","doi":"10.1093/jalm/jfad098","DOIUrl":"10.1093/jalm/jfad098","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71487246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Difficulties in Implementing a Process That Uses Internal Quality Control Materials for Traceability Verification of Measurement Procedures. 使用内部质量控制材料对测量程序进行可追溯性验证的过程中遇到的困难。
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad138
Weizhi Cheng, Shengkai Yan, Richard Pang
{"title":"Difficulties in Implementing a Process That Uses Internal Quality Control Materials for Traceability Verification of Measurement Procedures.","authors":"Weizhi Cheng, Shengkai Yan, Richard Pang","doi":"10.1093/jalm/jfad138","DOIUrl":"10.1093/jalm/jfad138","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139747553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Acute Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers: A Randomized Trial. 摄入洋甘菊对健康志愿者血液凝固测试的急性影响:随机试验
IF 2 Q2 Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad120
Reona Kimura, Jonathon A Schwartz, Jamie L Romeiser, Lisa Senzel, Dennis Galanakis, Darcy Halper, Elliott Bennett-Guerrero

Background: Chamomile administration may have desirable effects in the perioperative setting. Current practice, however, discourages perioperative chamomile use due to a theoretical increase in bleeding. Therefore, we evaluated if chamomile acutely (within 4 h of ingestion) prolongs coagulation assays.

Methods: Eight healthy volunteers were randomized to receive 2 interventions in a crossover design: (a) single dose of chamomile extract capsule (500 mg) and (b) single dose of chamomile tea (3 g in 150 mL water). Interventions were separated at least 3 days apart from each other. Blood was sampled pre-ingestion, 2 h post-ingestion, and 4 h post-ingestion for each intervention. The primary outcome was the maximal change in prothrombin time (PT) before vs after each intervention. Secondary outcomes included changes in international normalized ratio, activated partial thromboplastin time, thrombin time, reptilase time, and fibrinogen levels.

Results: All 8 subjects completed the study. The average pre-ingestion PT values for tea and capsules were 11.9 (1.1) s and 12.0 (0.9) s, respectively. Tea significantly increased the average maximum PT by 0.7 (0.2) s (P = 0.0078). Extract capsules increased the maximum PT by 0.3 (0.2) s (P = 0.06). Neither PT prolongation met the predefined 10% threshold for clinical significance. No significant changes in secondary outcomes were observed.

Conclusions: Chamomile tea ingestion prolongs PT. However, the clinical significance of this is unclear at this time and warrants further investigation. ClinicalTrials.gov Registration Number: NCT05272475.

背景:在围手术期使用洋甘菊可能会产生理想的效果。然而,由于理论上会增加出血量,目前的做法不鼓励在围手术期使用甘菊。因此,我们评估了甘菊是否能在急性期(摄入后 4 小时内)延长凝血测定的时间:方法:8 名健康志愿者以交叉设计的方式随机接受两种干预:(a)单剂量甘菊提取物胶囊(500 毫克)和(b)单剂量甘菊茶(3 克加 150 毫升水)。干预时间至少相隔 3 天。每种干预方法均在进食前、进食后 2 小时和进食后 4 小时采集血液样本。主要结果是每次干预前后凝血酶原时间(PT)的最大变化。次要结果包括国际标准化比率、活化部分凝血活酶时间、凝血酶时间、雷普酶时间和纤维蛋白原水平的变化:所有 8 名受试者都完成了研究。茶叶和胶囊的进食前 PT 平均值分别为 11.9 (1.1) 秒和 12.0 (0.9) 秒。茶能使平均最大 PT 值明显增加 0.7 (0.2) 秒(P = 0.0078)。提取物胶囊可使最大 PT 延长 0.3 (0.2) 秒(P = 0.06)。PT 延长均未达到预定的 10% 临床意义阈值。次要结果无明显变化:结论:饮用甘菊茶可延长 PT。结论:饮用菊花茶可延长 PT,但其临床意义目前尚不明确,值得进一步研究。ClinicalTrials.gov 注册号:NCT05272475:NCT05272475。
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引用次数: 0
期刊
Journal of Applied Laboratory Medicine
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