Journal of Applied Laboratory Medicine最新文献_第10页

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad139

Veni Bharti, Benjamin Jung, Sarah Lam, Ansel Fabros, Rajeevan Selvaratnam

{"title":"Stability and Analytical Characterization of Voriconazole as Measured by Immunoassay.","authors":"Veni Bharti, Benjamin Jung, Sarah Lam, Ansel Fabros, Rajeevan Selvaratnam","doi":"10.1093/jalm/jfad139","DOIUrl":"10.1093/jalm/jfad139","url":null,"abstract":"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.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"565-572"},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139747554","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 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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae002

Geoffrey Omuse, Daniel Maina, Ahmed Sokwala

{"title":"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.","authors":"Geoffrey Omuse, Daniel Maina, Ahmed Sokwala","doi":"10.1093/jalm/jfae002","DOIUrl":"10.1093/jalm/jfae002","url":null,"abstract":"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.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"502-511"},"PeriodicalIF":1.8,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139933526","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

Effect of Extraction Procedure Substitution on Automated Tacrolimus, Sirolimus, and Cyclosporine Assays. 提取程序替代对自动他克莫司、西罗莫司和环孢素检测的影响

IF 2

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad128

Athanasia Chandras, Damodara R Mendu, Daniel C Kirchhoff

{"title":"Effect of Extraction Procedure Substitution on Automated Tacrolimus, Sirolimus, and Cyclosporine Assays.","authors":"Athanasia Chandras, Damodara R Mendu, Daniel C Kirchhoff","doi":"10.1093/jalm/jfad128","DOIUrl":"10.1093/jalm/jfad128","url":null,"abstract":"Background: An erroneously high tacrolimus level was reported to a clinician. A root cause analysis investigation failed to determine the cause of the error. It was suspected that the incorrect preanalytical extraction reagent and procedure was used during testing; however, how this would affect the assayed drug concentration was unclear. Here we investigated the effect of the substitution of sirolimus, tacrolimus, and cyclosporine extraction reagents on assayed drug concentration.Methods: Tacrolimus, sirolimus, and cyclosporine concentration were measured on the Abbott Architect i2000 analyzer. Each assay requires a preanalytical extraction step, with a distinct reagent. We investigated the effect of the substitution of the extraction reagents and procedure between the 3 assays on the measured drug concentration. Two experiments were performed, one on samples of known drug concentration and one on samples with no drug present.Results: Substituting cyclosporine and sirolimus extraction procedures increased assayed tacrolimus concentrations from 5.6 to 8.47 (+51.25%) and 8.13 (+45.18%) ng/mL, respectively. Extraction procedure substitutions decreased assayed sirolimus from 13.63 to 4.60 (-66.25%) and 8.07 (-40.79%) ng/mL for cyclosporine and tacrolimus. Cyclosporine concentration increased from 274.60 to 391.30 (+42.50%) ng/mL using sirolimus extraction reagents and to 757.30 (+175.78%) ng/mL using tacrolimus extraction reagents. Cross-reactivity was observed between the tacrolimus assay and sirolimus and cyclosporine extraction reagents.Conclusions: Significant changes, both positive and negative, are observed in assayed drug concentration when incorrect extraction procedures are used in the Abbott i2000 tacrolimus, sirolimus, and cyclosporine assays. Preanalytic extraction procedures should be investigated when performing root cause analysis for erroneous therapeutic drug values.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"573-578"},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139651834","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: 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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae012

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad119

Jasper X Zheng, Shelby Randall, Kristin Grimsrud, Scott Bainbridge, Nam K Tran

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae006

Nadine Pouw, Joke van der Linden, Sonja Teuben, Snježana Kos

{"title":"Clinically Relevant Laboratory Monitoring of Gender-Affirming Hormone Therapy in Transgender People-Experiences from a Teaching Hospital in the Netherlands.","authors":"Nadine Pouw, Joke van der Linden, Sonja Teuben, Snježana Kos","doi":"10.1093/jalm/jfae006","DOIUrl":"10.1093/jalm/jfae006","url":null,"abstract":"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.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"440-455"},"PeriodicalIF":2.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140060728","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

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

Journal of Applied Laboratory Medicine 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

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfae009

Thomas Kampfrath, Felix Leung

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad098

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

Journal of Applied Laboratory Medicine Pub Date : 2024-05-02 DOI: 10.1093/jalm/jfad138

Weizhi Cheng, Shengkai Yan, Richard Pang

引用次数: 0