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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
Inappropriate Laboratory Testing: The Hidden Cost to the Environment-Time for a Database of Associated Costs. 不适当的实验室检测:环境的隐性成本--建立相关成本数据库的时机已到。
IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae043
Timothy F Lang
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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
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
Comparison of 2 Serum Free Light Chain Assays with Creatinine Normal and Abnormal Populations Demonstrates the Need for Standardization. 将两种血清游离轻链检测法与肌酐正常和异常人群进行比较,显示出标准化的必要性。
IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae065
Mark Griffiths, Pow Lee Cheng, Xiao Yan Wang, Randal Schneider, Vathany Kulasingam

Background: The objective of this study was to compare The Binding Site's Freelite on Optilite and Diazyme's Kappa/Lambda free light chains (K/L FLC) on Abbott Architect c8000 with healthy and renal insufficient populations and to evaluate their respective reference intervals for serum free light chains (sFLCs).

Methods: Two hundred sixty serum samples were measured for creatinine and sFLCs by both assays and a subset by immunofixation electrophoresis. Verification of manufacturer-defined reference intervals was assessed.

Results: Kappa free light chains (KFLC) showed excellent correlation of 0.998 R2 with a slope of 0.73. For Lambda free light chains (LFLC), an acceptable correlation of 0.953 R2 was found with a slope of 1.50 as well as a skewness-based difference with a -12.70 intercept. Healthy estimated glomerular filtration rate (eGFR) ≥60 reference interval verification of central 95% could not be confirmed for either Freelite or Diazyme although LFLC was much closer than KFLC for both assays with Freelite KFLC recovering only 37% of values within reference interval claims. The K/L FLC ratio did not meet 100% claim for both Freelite (91%) and Diazyme (95%) among those with eGFR ≥60. Samples with eGFR ≤59 had increasingly higher levels of KFLC and LFLC for both assays. When comparing worsening eGFR status, Freelite recovered increasingly higher ratios while Diazyme recovered increasingly lower ratios.

Conclusions: Healthy reference intervals could not be verified for either Freelite or Diazyme. Renal reference intervals for Freelite are currently warranted while they are not recommended for Diazyme. The differences between these 2 assays can be minimized by standardization efforts such as recalibration.

背景:本研究的目的是比较Optilite上The Binding Site的Freelite和雅培Architect c8000上Diazyme的Kappa/Lambda游离轻链(K/L FLC)对健康人群和肾功能不全人群的检测结果,并评估它们各自的血清游离轻链(sFLCs)参考区间:采用这两种检测方法对 2600 份血清样本进行肌酐和 sFLCs 检测,并对一部分样本进行免疫固定电泳检测。对制造商定义的参考区间进行了验证评估:结果:卡帕游离轻链(KFLC)显示出极好的相关性,R2为0.998,斜率为0.73。λ游离轻链(LFLC)的相关性为 0.953 R2,斜率为 1.50,基于偏度的差异截距为-12.70。Freelite和Diazyme的健康估计肾小球滤过率(eGFR)≥60参考区间验证的中心95%都无法确认,尽管这两种检测方法的LFLC比KFLC更接近,Freelite的KFLC只恢复了参考区间要求内37%的值。在eGFR≥60的样本中,Freelite(91%)和Diazyme(95%)的K/L FLC比值均未达到100%的要求。对于 eGFR ≤59 的样本,两种检测方法的 KFLC 和 LFLC 水平都越来越高。在比较恶化的 eGFR 状态时,Freelite 恢复的比率越来越高,而 Diazyme 恢复的比率越来越低:结论:Freelite和Diazyme都无法验证健康参考区间。结论:Freelite和Diazyme的健康参考区间都无法验证,目前需要Freelite的肾脏参考区间,而不建议使用Diazyme。这两种检测方法之间的差异可通过重新校准等标准化工作降至最低。
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引用次数: 0
Differences in Cardiac Troponin T Composition in Myocardial Infarction and End-Stage Renal Disease Patients: A Blood Tube Effect? 心肌梗死和终末期肾病患者心肌肌钙蛋白 T 组成的差异:血管效应?
IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-09-03 DOI: 10.1093/jalm/jfae052
Wim H M Vroemen, Ellen J S Denessen, William P T M van Doorn, Kelly E J M Pelzer, Tilman M Hackeng, Elisabeth J R Litjens, Yvonne M C Henskens, Frank M van der Sande, Will K W H Wodzig, Jeroen P Kooman, Otto Bekers, Douwe de Boer, Alma M A Mingels

Background: Cardiac troponin T (cTnT) is key in diagnosing myocardial infarction (MI) but is also elevated in end-stage renal disease (ESRD) patients. Specific larger cTnT proteoforms were identified for the acute phase of MI, while in serum of ESRD patients solely small cTnT fragments were found. However, others allocated this to a pre-analytic effect due to abundant thrombin generation in serum. Therefore, we investigated the effect of various anticoagulation methods on cTnT composition and concentration and compared the cTnT composition of MI and ESRD patients.

Methods: The agreement of cTnT concentrations between simultaneously collected serum, lithium-heparin (LH) plasma, and ethylenediaminetetraacetic acid (EDTA) plasma was studied using the high-sensitivity (hs-)cTnT immunoassay. cTnT proteoform composition was investigated in a standardized time-dependent manner through spike experiments and in simultaneously collected blood matrixes of MI and ESRD patients.

Results: Excellent hs-cTnT concentration agreements were observed across all blood matrixes (slopes > 0.98; 95% CI, 0.96-1.04). Time-dependent degradation (40 kDa intact:29 kDa fragment:15 to 18 kDa fragments) was found in LH plasma and EDTA plasma, and serum in ratios (%) of 90:10:0, 0:5:95, and 0:0:100, respectively (48 h after blood collection). Moreover, gel filtration chromatography (GFC) profiles illustrated mainly larger cTnT proteoforms in MI patients, while in ESRD patients mainly 15 to 18 kDa fragments were found for all matrices.

Conclusions: The extent of cTnT degradation in vitro is dependent on the (anti)coagulation method, without impacting hs-cTnT concentrations. Furthermore, mainly larger cTnT proteoforms were present in MI patients, while in ESRD patients mainly small 15 to 18 kDa cTnT fragments were found. These insights are essential when developing a novel hs-cTnT assay targeting larger cTnT proteoforms.

背景:心肌肌钙蛋白 T(cTnT)是诊断心肌梗死(MI)的关键,但在终末期肾病(ESRD)患者中也会升高。在心肌梗死急性期发现了特定的较大的 cTnT 蛋白形式,而在 ESRD 患者的血清中只发现了较小的 cTnT 片段。然而,其他人认为这是由于血清中大量凝血酶的产生导致的分析前效应。因此,我们研究了各种抗凝方法对 cTnT 组成和浓度的影响,并比较了 MI 和 ESRD 患者的 cTnT 组成:方法:使用高灵敏度(hs-)cTnT 免疫测定法研究了同时采集的血清、锂肝素(LH)血浆和乙二胺四乙酸(EDTA)血浆中 cTnT 浓度的一致性:结果:在所有血液基质中都观察到了良好的 hs-cTnT 浓度一致性(斜率大于 0.98;95% CI,0.96-1.04)。在 LH 血浆、EDTA 血浆和血清中发现了随时间变化的降解(40 kDa 完整片段:29 kDa 片段:15 至 18 kDa 片段),降解比例(%)分别为 90:10:0、0:5:95 和 0:0:100(采血 48 小时后)。此外,凝胶过滤层析(GFC)图谱显示,心肌梗死患者的 cTnT 蛋白形式主要较大,而 ESRD 患者在所有基质中主要发现 15 至 18 kDa 的片段:体外 cTnT 降解的程度取决于(抗)凝方法,但不会影响 hs-cTnT 的浓度。此外,在心肌梗死患者中主要存在较大的 cTnT 蛋白形式,而在 ESRD 患者中主要发现 15 至 18 kDa 的小 cTnT 片段。这些见解对于开发针对较大 cTnT 蛋白形式的新型 hs-cTnT 检测方法至关重要。
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Journal of Applied Laboratory Medicine
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