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

Better Prediction of Clinical Outcome with Estimated Glomerular Filtration Rate by CKD-EPI 2021. 用 CKD-EPI 2021 估算肾小球滤过率能更好地预测临床结果。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-10-04 DOI: 10.1093/jalm/jfae103

Kwang Seob Lee, Jaehyeok Jang, Hanmil Jang, Hyein Kang, John Hoon Rim, Jong-Baeck Lim

{"title":"Better Prediction of Clinical Outcome with Estimated Glomerular Filtration Rate by CKD-EPI 2021.","authors":"Kwang Seob Lee, Jaehyeok Jang, Hanmil Jang, Hyein Kang, John Hoon Rim, Jong-Baeck Lim","doi":"10.1093/jalm/jfae103","DOIUrl":"https://doi.org/10.1093/jalm/jfae103","url":null,"abstract":"Background: While the real-world impact of estimated glomerular filtration rate (eGFR) equation change on clinical outcome in a longitudinal cohort setting is limited, external valuation of equation performance should be performed in different population cohorts. This study aimed to compare differential impacts of eGFR values, calculated by 5 equations in a Korean patient population, on clinical outcomes.Methods: This retrospective longitudinal follow-up cohort study analyzed 23 246 participants with standardized creatinine/cystatin C assay-based laboratory results. The primary exposure was baseline eGFR calculated by 5 different equations including the recently developed 2021 race-free Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. Clinical outcomes including all-cause mortality, renal replacement therapy, and albuminuria were analyzed to estimate the hazard ratio of the eGFR on clinical outcomes.Results: Among the 5 equations, CKD-EPI 2021 with creatinine and cystatin C (CKD-EPI 2021-CrCys) showed an earlier increase in hazard ratios for all clinical outcomes, while CKD-EPI 2012 with cystatin C showed a higher hazard ratio for all-cause mortality at low eGFR. Replacing CKD-EPI 2012 with CKD-EPI 2021-CrCys, 5.4% of patients with mortality and 3.3% of patients who received renal replacement therapy were reclassified to a lower risk stage.Conclusions: The 2021 CKD-EPI equations were acceptable in a Korean population, with better predictive power for clinical outcomes when compared to previous equations. The updated race-free factors for eGFR calculation improved identification of patients at risk for clinical outcomes.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376161","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

Clinician-Ordered Peripheral Smear Review by a Pathologist Has Low Clinical Utility-A Reference Laboratory Perspective. 临床医生委托病理学家进行外周血涂片复查的临床效用较低--参考实验室的观点。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-10-04 DOI: 10.1093/jalm/jfae101

Sanjai Nagendra, Jamie Mongillo, Krystin Dodge, Pratistha Ranjitkar, Betty Burns, Lavonda Allen

{"title":"Clinician-Ordered Peripheral Smear Review by a Pathologist Has Low Clinical Utility-A Reference Laboratory Perspective.","authors":"Sanjai Nagendra, Jamie Mongillo, Krystin Dodge, Pratistha Ranjitkar, Betty Burns, Lavonda Allen","doi":"10.1093/jalm/jfae101","DOIUrl":"https://doi.org/10.1093/jalm/jfae101","url":null,"abstract":"Background: Clinician-ordered peripheral smear review by pathologist (CPSR) is commonly ordered and has been recommended for decades. However, the clinical utility of this labor-intensive test in the reference laboratory has not been examined. The objective of this study is to assess hematologic abnormalities identified in CPSR orders and to correlate them with complete blood count (CBC) and laboratory-derived smear review (LDSR) in the reference laboratory.Methods: Two hundred consecutive CPSRs with corresponding CBCs from April 2023 were run by Sysmex® XN-11 analyzers, and their peripheral smears were examined by a board-certified hematopathologist. Hematologic abnormalities of CPSRs were assessed, and the correlation between CPSR and CBC/LDSR was reviewed.Results: Nearly one-third of CPSRs (29%) had normal peripheral smears and CBCs. The majority of CPSRs showed nonspecific quantitative abnormalities. When compared against CPSR results, LDSR criteria identified 100% of hematologic abnormalities appropriately. Samples that were not flagged for review by LDSR rules were also reviewed (n = 174) to rule out clinically meaningful false negatives. One minor discrepancy (0.6% of cases) of small platelet aggregates was observed in a patient with a reported platelet count of 139 K/uL that was missed by the LDSR process.Conclusions: In the reference laboratory setting, our findings demonstrate that LDSR adequately detects significant hematologic abnormalities and, therefore, CPSR should be discontinued.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376162","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

So I Guess I Am a Device? Making the Case for Professional Practice in the Context of the FDA's Final Rule on Laboratory-Developed Tests. 我猜我是设备？在美国食品及药物管理局关于实验室开发测试的最终规则背景下，为专业实践提供依据。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-19 DOI: 10.1093/jalm/jfae100

Andrew Bryan, Thomas E Grys, Erin H Graf

引用次数: 0

Considerations for Building a Data Science Culture for the Clinical Laboratory. 为临床实验室建立数据科学文化的注意事项。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-10 DOI: 10.1093/jalm/jfae093

Benjamin R McFadden

引用次数: 0

Proficiency Testing Customization in Clinical Trials: How the pSMILE Project Ensures High-Quality Proficiency Testing Coverage for International Laboratories. 临床试验中的能力验证定制：pSMILE 项目如何确保为国际实验室提供高质量的能力验证服务。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae050

Anne Leach, Kristin J Murphy, Mandana Godard, Matthew Schwartz, Lori J Sokoll

引用次数: 0

Correction to: Screening for Primary Aldosteronism by Mass Spectrometry Versus Immunoassay Measurements of Aldosterone: A Prospective Within-Patient Study. 更正：通过质谱法与免疫测定法测量醛固酮筛查原发性醛固酮增多症：一项病人内部的前瞻性研究。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae041

引用次数: 0

Persistent Mild Increase of Human Chorionic Gonadotropin in a Male Patient with Testicular Pain. 一名睾丸疼痛的男性患者体内的人类绒毛膜促性腺激素持续轻度升高。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae042

Carlos Castillo Pérez, Laura Rodríguez Alonso, Marta Cebrián Ballesteros, Blanca Torrubia, M J Torrejón

引用次数: 0

A Pregnant Patient with a Positive Hepatitis C Antibody. 一名丙型肝炎抗体呈阳性的孕妇。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae015

Jonathan J Tucci, Raeshun T Glover, Joesph R Wiencek

引用次数: 0

Breaking the Chain: Navigating the Pitfalls of Total Laboratory Automation. 打破枷锁：在实验室全面自动化的陷阱中航行。

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae061

Joe M El-Khoury

引用次数: 0

DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests. DxGoals：DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests.

IF 1.8

Journal of Applied Laboratory Medicine Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae054

Ngoc-Ty Nguyen, Gene A Pennello

{"title":"DxGoals: A Software Tool for Determining and Analyzing Clinically Meaningful Classification Accuracy Goals for Diagnostic Tests.","authors":"Ngoc-Ty Nguyen, Gene A Pennello","doi":"10.1093/jalm/jfae054","DOIUrl":"https://doi.org/10.1093/jalm/jfae054","url":null,"abstract":"Background: To evaluate diagnostic tests for low prevalence conditions, classification accuracy metrics such as sensitivity, specificity, and positive likelihood ratio (PLR) and negative likelihood ratio (NLR) are advantageous because they are prevalence-independent and thus estimable in studies enriched for the condition. However, classification accuracy goals are often chosen without a clear understanding of whether they are clinically meaningful. Pennello (2021) proposed a risk stratification framework for determining classification accuracy goals. A software application is needed to determine the goals and provide data analysis.Methods: We introduce DxGoals, a freely available, R-Shiny software application for determining, visualizing, and analyzing classification accuracy goals for diagnostic tests. Given prevalence p for the target condition and specification that a test's positive and negative predictive values PPVand NPV=1-cNPV should satisfy PPV>PPV* and cNPV<cNPV*, DxGoals uses Bayes Theorem to determine equivalent goals for PLR and NLR and implied goals for sensitivity and specificity. When study data are provided, DxGoals analyzes whether the determined goals are met with statistical significance. When comparing 2 tests, DxGoals translates a superiority or noninferiority goals for the differences PPV-p and p-cNPV to equivalent goals for PLR and NLR and analyzes the goals when data are provided.Results: We illustrate DxGoals on tests for penicillin allergy, ovarian cancer, and cervical cancer. The inputs cNPV*,p, and PPV* were informed by clinical management guidelines.Conclusions: DxGoals facilitates determination, visualization, and analysis of clinically meaningful standalone and comparative classification accuracy goals. It is a potentially useful tool for diagnostic test evaluation.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"9 5","pages":"952-962"},"PeriodicalIF":1.8,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120862","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