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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-04 DOI: 10.1093/jalm/jfae101
Sanjai Nagendra, Jamie Mongillo, Krystin Dodge, Pratistha Ranjitkar, Betty Burns, Lavonda Allen

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.

背景:临床医生要求病理学家进行外周血涂片检查(CPSR)是常见的检查项目,几十年来一直被推荐使用。然而,参考实验室尚未对这一劳动密集型检验的临床实用性进行研究。本研究的目的是评估 CPSR 订单中发现的血液学异常,并将其与参考实验室的全血细胞计数(CBC)和实验室涂片审查(LDSR)相关联:用Sysmex® XN-11分析仪对2023年4月以来的200份连续CPSR和相应的全血细胞计数进行分析,并由一名获得医学会认证的血液病理学家对其外周涂片进行检查。对 CPSR 的血液学异常进行了评估,并审查了 CPSR 与 CBC/LDSR 之间的相关性:近三分之一的 CPSR(29%)外周涂片和全血细胞计数正常。大多数 CPSR 显示非特异性定量异常。与 CPSR 结果相比,LDSR 标准能准确识别 100% 的血液学异常。我们还对 LDSR 规则未标记的样本(n = 174)进行了复查,以排除有临床意义的假阴性。在一名报告血小板计数为 139 K/uL 的患者身上观察到了血小板小聚集的轻微差异(占病例的 0.6%),但 LDSR 流程漏检了这一差异:结论:在参考实验室环境中,我们的研究结果表明 LDSR 能充分检测出重要的血液学异常,因此应停止使用 CPSR。
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-19 DOI: 10.1093/jalm/jfae100
Andrew Bryan, Thomas E Grys, Erin H Graf
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-10 DOI: 10.1093/jalm/jfae093
Benjamin R McFadden
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae050
Anne Leach, Kristin J Murphy, Mandana Godard, Matthew Schwartz, Lori J Sokoll
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae015
Jonathan J Tucci, Raeshun T Glover, Joesph R Wiencek
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae041
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae042
Carlos Castillo Pérez, Laura Rodríguez Alonso, Marta Cebrián Ballesteros, Blanca Torrubia, M J Torrejón
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae061
Joe M El-Khoury
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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 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae054
Ngoc-Ty Nguyen, Gene A Pennello

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

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.

背景:在评估低流行率疾病的诊断检测时,灵敏度、特异性、阳性似然比(PLR)和阴性似然比(NLR)等分类准确性指标很有优势,因为这些指标与流行率无关,因此可在丰富的疾病研究中进行估计。然而,在选择分类准确性目标时,往往并不清楚这些目标是否具有临床意义。Pennello(2021 年)提出了一个用于确定分类准确性目标的风险分层框架。我们需要一款应用软件来确定目标并提供数据分析:我们介绍 DxGoals,这是一款免费提供的 R-Shiny 应用软件,用于确定、可视化和分析诊断测试的分类准确性目标。给定目标病症的流行率 p,并规定检验的阳性预测值 PPV 和阴性预测值 NPV=1-cNPV 应满足 PPV>PPV* 和 cNPVResults:我们以青霉素过敏、卵巢癌和宫颈癌检测为例说明 DxGoals。输入的 cNPV*、p 和 PPV* 均参考了临床管理指南:DxGoals有助于确定、可视化和分析具有临床意义的独立和比较分类准确性目标。结论:DxGoals 便于确定、可视化和分析具有临床意义的独立和比较分类准确性目标,是诊断测试评估的潜在有用工具。
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引用次数: 0
Minimally Invasive Blood Collection for an Mpox Serosurvey among People Experiencing Homelessness. 为在无家可归者中进行 Mpox 血清调查而进行微创采血。
IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae035
Caroline J Waddell, Gerald J Pellegrini, Neela Persad, Thomas D Filardo, Namrata Prasad, William C Carson, Terese Navarra, Michael B Townsend, Panayampalli S Satheshkumar, David Lowe, Deborah Borne, Nnenna Okoye, Julia Janssen, Anamaría Bejarano, Emily Mosites, Grace E Marx

Background: People experiencing homelessness (PEH) are underrepresented in public health and clinical research. Study methods that can improve participation by this group are needed.

Methods: In late 2022, the Centers for Disease Control and Prevention conducted an mpox serological survey using venipuncture among PEH in San Francisco, California. Blood collection by a minimally invasive device was offered if venipuncture was not possible or preferred. Participants who had a successful blood draw using the device were asked about device acceptability.

Results: Of the 209 successful blood collections, 137 (66%) were among participants who underwent venipuncture and 72 (34%) were among participants who used the device. Use of the device increased overall blood collection participation by 53%. Participants reported high acceptability and preference for the device over venipuncture.

Conclusions: Minimally invasive blood collection devices may increase participation and representation of PEH in serosurveys.

背景:无家可归者(PEH)在公共卫生和临床研究中的代表性不足。我们需要能提高这一群体参与度的研究方法:2022 年末,美国疾病控制与预防中心在加利福尼亚州旧金山对无家可归者进行了一次 mpox 血清学调查。如果无法进行静脉穿刺或不喜欢静脉穿刺,则可使用微创设备采血。对使用该设备成功采血的参与者进行了关于设备可接受性的询问:在 209 次成功采血中,137 人(66%)进行了静脉穿刺,72 人(34%)使用了该设备。该设备的使用使参与采血的总人数增加了 53%。与静脉穿刺相比,参与者对该设备的接受度和偏好度较高:微创采血设备可提高血清调查中 PEH 的参与度和代表性。
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引用次数: 0
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Journal of Applied Laboratory Medicine
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