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Are analytical performance specifications derived from reference intervals of any use in the veterinary clinical laboratory? A preliminary study on the empirical biological variation model 从参考区间得出的分析性能指标在兽医临床实验室中是否有用?关于经验生物变异模型的初步研究。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-18 DOI: 10.1111/vcp.13317
Simone Manzocchi, Liesl J. van Rooyen

Background

Analytical performance specifications (APS) are vital for method evaluation and quality control validation. However, the limited availability of biological variation (BV) data, regulatory guidelines, and expert opinion (EO) may present challenges in veterinary medicine. The empirical biological variation (EBV) approach, based on population reference intervals (pRI), has emerged as an alternative method to derive APS in human medicine.

Objectives

This study aimed to assess the practicality and usefulness of the EBV approach in deriving performance limits for various measurands in dogs and cats.

Methods

Eight hematology and 13 biochemistry measurands were analyzed in dogs and cats. Estimates of combined biologic variation based on traditional biological (CVB) and EBV-derived (CVE*) formulas were calculated and assessed for evidence of correlation. Performance limits for expanded uncertainty/total error and imprecision were compared among EO, BV, and EBV.

Results

Strong and significant correlations were found between CVB and CVE* for both dogs (r = .86, p < .00001) and cats (r = 0.95, p < .00001). The EBV-derived APS were generally comparable to EO and BV, with a subjective criterion of 1.5% difference for imprecision and 3% for total error/expanded uncertainty.

Conclusion

The EBV approach, using pRI, shows promise as a surrogate marker for biological variation and as a practical tool for determining performance limits in dogs and cats. Assuming accurate pRI generated on analyzers with stable analytical performance, this approach could offer benefits when expert recommendations or robust BV studies are lacking or yield conflicting results. Further research is needed to explore the applicability and advantages of the EBV in veterinary medicine.

背景:分析性能指标(APS)对于方法评估和质量控制验证至关重要。然而,生物变异(BV)数据、监管指南和专家意见(EO)的有限可用性可能会给兽医学带来挑战。基于群体参考区间(pRI)的经验生物变异(EBV)方法已成为人类医学中推导APS的替代方法:本研究旨在评估 EBV 方法在推导犬和猫各种测量指标的性能限值时的实用性和有用性:方法:分析了犬和猫的 8 种血液学和 13 种生化测量指标。计算基于传统生物学公式 (CVB) 和 EBV 衍生公式 (CVE *) 的综合生物变异估计值,并评估其相关性。比较了 EO、BV 和 EBV 的扩大不确定性/总误差和不精确度的性能限制:结果:发现两只狗的 CVB 和 CVE * 之间存在明显的强相关性(r = .86,p 结论:CVB 和 CVE * 之间存在明显的强相关性:使用 pRI 的 EBV 方法有望成为生物变异的替代标记和确定犬猫性能限制的实用工具。假设在分析性能稳定的分析仪上生成了准确的 pRI,那么当缺乏专家建议或缺乏可靠的 BV 研究或研究结果相互矛盾时,这种方法就能带来益处。还需要进一步的研究来探索 EBV 在兽医学中的适用性和优势。
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引用次数: 0
What is your diagnosis? A blood film and saliva direct smear from two inland bearded dragons (Pogona vitticeps) 您的诊断结果是什么?两只内陆胡须龙(Pogona vitticeps)的血片和唾液直接涂片。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-18 DOI: 10.1111/vcp.13326
Carolina Azevedo, Alisa Rassin, Emily E. Brenner, James F. X. Wellehan, Carolyn Cray, Nicole I. Stacy
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引用次数: 0
Association of leukergy (in vitro leukocyte aggregation) with systemic inflammation in dogs and cats (2017–2022) 狗和猫的白细胞过敏(体外白细胞聚集)与全身炎症的关联(2017-2022 年)。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-18 DOI: 10.1111/vcp.13325
Rose D. Nolen-Walston, Darko Stefanoski, Francisco O. Conrado

Background

Leukergy is the phenomenon of aggregation of leukocytes on a peripheral blood film, and in humans, it is used as an indicator of systemic inflammation and infection.

Objectives

To assess the association of leukergy on blood film examination with biochemical and clinical evidence of systemic inflammation, infection, neoplasia, or specific organ system disease.

Methods

A case–control study using retrospective analysis (2017–2022) identified all canine and feline patients that had been presented to an academic referral center with a finding of leukergy on peripheral blood film and an equal number of species-matched controls.

Results

A total of 127 cases (canine n = 44, feline n = 83) were identified, as well as 127 controls. Feline samples were 7.6× more likely to exhibit leukergy (0.019%) than canine (0.0025%). A positive association was noted between leukergy and higher globulin concentrations in dogs (marginal difference 0.5 mg/dL, P = .016) and cats (marginal difference 0.67 mg/dL, P = <.001). Cats with leukergy had higher WBC counts and were less likely to be diagnosed with cardiac or urinary tract disease than controls. Dogs with leukergy had lower WBC counts and were more likely to be febrile but were less likely to have urinary tract disease than controls. No association was found with neutrophil toxic change or band forms, systemic antimicrobial therapy, or signalment.

Conclusions

We conclude that there is a positive association between increased globulin concentrations and leukergy and inconsistent associations between leukergy and other markers of inflammation or infection. Leukergy is rare overall but markedly more common in cats than dogs.

背景:白细胞聚集是一种外周血片上的白细胞聚集现象:白细胞增多症是外周血片上白细胞聚集的现象,在人类中,它被用作全身炎症和感染的指标:评估血片检查中的白细胞增多与全身炎症、感染、肿瘤或特定器官系统疾病的生化和临床证据之间的关联:一项采用回顾性分析方法的病例对照研究(2017-2022年)确定了所有在学术转诊中心就诊并在外周血片上发现白细胞增多症的犬科和猫科患者,以及同等数量的物种匹配对照组:结果:共发现 127 例病例(犬类 44 例,猫科 83 例)和 127 例对照。猫科动物样本出现白血病的几率(0.019%)是犬科动物(0.0025%)的 7.6 倍。狗(边际差异为 0.5 毫克/分升,P = .016)和猫(边际差异为 0.67 毫克/分升,P = 结论:白细胞增多症与球蛋白浓度升高之间存在正相关:我们得出结论:球蛋白浓度升高与白细胞增多症之间存在正相关,而白细胞增多症与其他炎症或感染标记物之间的相关性不一致。白细胞增多症总体上比较罕见,但在猫中明显比在狗中更常见。
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引用次数: 0
Performance evaluation of the Sysmex XN-1000V in side-by-side comparison with the Siemens ADVIA 120 and manual methods for healthy CD Sprague–Dawley rats and CD-1 mice Sysmex XN-1000V 与西门子 ADVIA 120 和手动方法并排比较,对健康 CD Sprague-Dawley 大鼠和 CD-1 小鼠进行性能评估。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-02 DOI: 10.1111/vcp.13314
Jill M. Schroeder, Hsiu-Yung C. Lee, Albert E. Schultze

Background

The Sysmex XN-1000V automated hematology analyzer with multispecies software was released in June 2017 for use in research laboratories. Laser light, impedance, fluorescent staining, and fluorescent flow cytometry are used to analyze whole blood for CBC, reticulocyte counts, and WBC counts, including a 5-part differential leukocyte analysis.

Objectives

A side-by-side comparison of the Sysmex XN-1000V with the Siemens ADVIA 120 in analyzing blood from healthy mice and rats will provide insight into the performance of the new analyzer and its capabilities for use in drug development studies. Method correlation analyses on normal mouse and rat hematology data collected with both analyzers and manual reference methods will help determine the reliability of the data produced using the Sysmex XN-1000V analyzer.

Methods

Whole blood samples collected in K2EDTA from healthy CD-1 mice and CD Sprague–Dawley rats were analyzed in parallel with the XN-1000V and ADVIA 120 analyzers. Male and female mice, approximately 6–9 weeks old, and male and female rats, approximately 7–9 weeks old, were included in this study. Manual reference methods for WBC differential leukocyte analysis and packed cell volume (PCV) measurements were also performed. EP Evaluator version 11.2 (Data Innovations LLC, South Burlington, VT, USA) was used for method comparison statistical analysis.

Results

Most hematologic parameters for naïve mice and rats achieved correlation in the fair to excellent range, with the majority showing very good to excellent correlation with low biases (<11.0%) for cohorts analyzed separately and when cohort data were combined.

Conclusions

The Sysmex XN-1000V Hematology Analyzer provided comparable results to those obtained from the Siemens ADVIA 120. We found the Sysmex XN-1000V Hematology Analyzer to be acceptable for use in drug development studies for rats and mice.

背景介绍Sysmex XN-1000V 自动血液分析仪与多物种软件于 2017 年 6 月发布,供研究实验室使用。激光、阻抗、荧光染色和荧光流式细胞仪用于分析全血的 CBC、网织红细胞计数和白细胞计数,包括 5 部分白细胞差异分析:Sysmex XN-1000V 与西门子 ADVIA 120 在分析健康小鼠和大鼠血液时的并排比较将有助于深入了解新分析仪的性能及其在药物开发研究中的应用能力。对使用这两种分析仪和手动参考方法收集的正常小鼠和大鼠血液学数据进行方法相关性分析,将有助于确定使用 Sysmex XN-1000V 分析仪生成的数据的可靠性:用 XN-1000V 和 ADVIA 120 分析仪同时分析从健康的 CD-1 小鼠和 CD Sprague-Dawley 大鼠采集的 K2 EDTA 全血样本。研究对象包括约 6-9 周大的雌雄小鼠和约 7-9 周大的雌雄大鼠。还进行了白细胞差异分析和包装细胞体积(PCV)测量的手动参考方法。EP Evaluator 11.2 版(Data Innovations LLC,South Burlington,VT,USA)用于方法比较统计分析:结果:新手小鼠和大鼠的大多数血液学参数的相关性在一般到优秀之间,大多数参数的相关性在非常好到优秀之间,偏差较小(结论:Sysmex XN-1 是一种新型的血液学分析仪:Sysmex XN-1000V 血液分析仪提供的结果与西门子 ADVIA 120 的结果相当。我们认为 Sysmex XN-1000V 血液分析仪可用于大鼠和小鼠的药物开发研究。
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引用次数: 0
The importance of quality control validation and relationships with total error quality goals and bias in the interpretation of laboratory results 质量控制验证的重要性以及与总误差质量目标和实验室结果解释偏差之间的关系。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-02 DOI: 10.1111/vcp.13321
Kathleen Freeman, Stefanie Klenner-Gastreich, Jérémie Korchia

The objective of a quality system is to provide accurate and reliable results for clinical decision-making. One part of this is Quality Control (QC) validation. QC validation is not routinely applied in veterinary laboratories. This leads to the inappropriate usage of random QC rules without knowing the Probability of error detection (Ped) and Probability of false rejection (Pfr) of a method. In this paper, we will discuss why QC validation is important, when it should be undertaken, why QC validation is done, and why it is not commonly done. We will present the role of total analytical error (TEa) in the QC validation process and the challenges when a consensus TEa has not been published. Finally, we will also discuss the possibilities of ‘gray zone’ determinations and mention the effects of bias on the quality of results. Reasons for the low prevalence of performing QC validation may include (a) lack of familiarity with the concept, (b) lack of time and resources needed to conduct QC validation, and (c) lack of TEa goal for some measurands. If no TEa is available, the user may elect to use a ‘reverse approach’ to QC validation. This uses the CV and bias generated from the evaluation of QC measurements, specifying Ped, Pfr, and N (number of QC measurements/run). This identifies the lowest total error that can be controlled under these defined conditions, thus enabling the laboratory to have an estimate of the ‘gray zone’ associated with results generated with a specific assay.

质量体系的目标是为临床决策提供准确可靠的结果。质量控制 (QC) 验证是其中的一部分。在兽医实验室中,质量控制验证并非常规应用。这导致在不了解某种方法的错误检测概率(Ped)和错误拒绝概率(Pfr)的情况下,不恰当地使用随机质控规则。本文将讨论质控验证为何重要、何时应进行质控验证、为何要进行质控验证以及为何不常进行质控验证。我们将介绍总分析误差 (TEa) 在质量控制验证过程中的作用,以及在尚未公布一致的 TEa 时所面临的挑战。最后,我们还将讨论 "灰色区域 "测定的可能性,并提及偏差对结果质量的影响。进行质量控制验证的普及率较低的原因可能包括:(a) 对这一概念缺乏了解;(b) 缺乏进行质量控制验证所需的时间和资源;(c) 缺乏某些测量值的 TEa 目标。如果没有 TEa,用户可选择使用 "逆向方法 "进行 QC 验证。这种方法使用质控测量评估产生的 CV 和偏差,指定 Ped、Pfr 和 N(质控测量/运行次数)。这样就能确定在这些规定条件下可控制的最低总误差,从而使实验室能够估算出与特定检测结果相关的 "灰色区域"。
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引用次数: 0
What is your diagnosis? Fine needle aspirate from a cutaneous mass in a cat 您的诊断结果是什么?从一只猫的皮肤肿块中进行细针穿刺。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-02 DOI: 10.1111/vcp.13318
Kathryn H. Shaffert, Kayla B. Sample, Jennifer L. Grady, Gisela Martinez-Romero, Francisco O. Conrado
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引用次数: 0
Osteosarcoma of the wing in a sulfur-crested cockatoo 一只硫冠凤头鹦鹉的翅膀骨肉瘤。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-02 DOI: 10.1111/vcp.13322
Sydney A. Hastain, Lauren Mumm, Sarah Ozawa, Olivia Petritz, Chris Gaudette, Brigid V. Troan, Devorah M. Stowe

A 26-year-old female sulfur-crested cockatoo (Cacatua galerita) was evaluated for vocalizing through the night and extending her right wing. Physical examination revealed a large, firm mass extending from the humerus to the distal aspect of the elbow. Computed tomography confirmed a large aggressive mass of the right distal humerus with a large soft tissue component, severe osteolysis, and adjacent periosteal proliferation. Fine-needle aspirates of the mass were most compatible with sarcoma, and osteosarcoma was prioritized. An unstained slide was treated with nitroblue tetrazolium chloride/5-bromo-4-chloro-3-indolyl phosphate toluidine salt-phosphatase (NBT/BCIP) substrate for ALP detection and was strongly positive, confirming a diagnosis of osteosarcoma. A month later, the patient underwent wing amputation and arrested during recovery from anesthesia. Post-mortem examination and histopathology were consistent with osteosarcoma. This case report highlights a rare occurrence of osteosarcoma in a cockatoo as well as its cytologic and histologic features. Additionally, this report provides support for NBT/BCIP application in ALP-expressing tumors, a cytochemical stain that has been minimally investigated in avian species.

对一只 26 岁的雌性硫冠凤头鹦鹉(Cacatua galerita)进行了评估,发现它在夜间发声并伸展右翼。体格检查发现一个大而坚实的肿块从肱骨延伸到肘部远端。计算机断层扫描证实,右侧肱骨远端有一个巨大的侵袭性肿块,肿块中含有大量软组织成分、严重的骨溶解和邻近的骨膜增生。肿块的细针穿刺最符合肉瘤的特征,因此骨肉瘤被列为优先考虑的病例。用硝基蓝氯化四氮唑/5-溴-4-氯-3-吲哚磷酸甲苯盐-磷酸酶(NBT/BCIP)底物检测ALP,结果呈强阳性,确诊为骨肉瘤。一个月后,患者接受了截肢手术,并在麻醉恢复过程中死亡。死后检查和组织病理学结果与骨肉瘤一致。本病例报告重点介绍了凤头鹦鹉骨肉瘤的罕见病例及其细胞学和组织学特征。此外,该报告还支持将 NBT/BCIP 应用于 ALP 表达的肿瘤,而这种细胞化学染色法在鸟类中的应用还很少。
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引用次数: 0
What is your diagnosis? Cranial coelomic mass in a western hognose snake (Heterodon nasicus) 您的诊断结果是什么?一条西部吻蛇(Heterodon nasicus)的颅腔肿块。
IF 1.2 4区 农林科学 Q2 Veterinary Pub Date : 2024-01-02 DOI: 10.1111/vcp.13324
Alexandria Argue, Shawn Thomas, Sarah Cudd, Laura McCarthy, Elise E. B. LaDouceur
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引用次数: 0
Low-cost veterinary clinical diagnostics. Ryane E. Englar, Sharon M. Dial (Eds.), Hoboken, NJ, USA: Wiley Blackwell. 2023. pp. 368. $109.99 (hardcover). ISBN: 978-1-119-71450-7 低成本兽医临床诊断。Ryane E.Englar, Sharon M.Dial (Eds.), Hoboken, NJ, USA: Wiley Blackwell.2023. pp.368.368. 109.99 美元(精装)。ISBN: 978-1-119-71450-7
IF 1.2 4区 农林科学 Q3 VETERINARY SCIENCES Pub Date : 2023-12-28 DOI: 10.1111/vcp.13296
Lucia Sanchini
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引用次数: 0
An IRONic case of PIMA PIMA 的铁一般的案例。
IF 1.2 4区 农林科学 Q3 VETERINARY SCIENCES Pub Date : 2023-12-28 DOI: 10.1111/vcp.13323
Megan J. Crawford, Allison R. Rogich, Michael A. Scott, Cynthia A. Lucidi
<p>An 8-year-old spayed female Labrador retriever that was presented for a wellness examination at a referring practice had mild anemia with a hematocrit that progressed from 32% to 25% over the next 5 weeks. The dog's reticulocyte concentration was 26 400/μL on day 23, supporting nonregenerative anemia, and no cause was apparent from clinical and laboratory findings. This prompted the submission of bone marrow core and aspirate samples to our laboratory on day 38. These revealed ineffective erythroid hyperplasia with complete maturation but a predominance of rubricytes, rubriphagocytosis, mild lymphoplasmacytosis, and mild to regionally severe collagen myelofibrosis, all supportive of precursor-targeted immune-mediated anemia (PIMA).<span><sup>1</sup></span> Hemosiderin was markedly increased in aspirate smears and in most regions of the core. No blood transfusions had been given. Immunosuppressive treatment with prednisone was started, but the dog was euthanized 10 days later due to poor clinical progression.</p><p>Plasma cells in the bone marrow commonly contained coarse crystalline cytoplasmic inclusions that were green to brown in aspirate smears (Wright-Giemsa stain) and golden-brown in tissue sections (H&E stain) (Figure 1); the plasma cells otherwise lacked atypia. The granules were suggestive of iron, and Prussian blue positivity confirmed iron-rich inclusions. Histologic sections of liver collected at necropsy showed no increase in iron within hepatocytes or Kupffer cells.</p><p>Bone marrow siderotic plasma cells are rarely reported in nonalcoholic human patients, and the authors are unaware of reports in domestic mammals. In people, they have been associated mostly with conditions involving altered iron homeostasis and/or ineffective erythropoiesis: (1) systemic or marrow hemosiderosis from iron-loading anemias (e.g., megaloblastic anemia, sideroblastic anemias, refractory anemia with multilineage dysplasia, and pyruvate kinase-deficiency), recurrent transfusions, or hereditary hemochromatosis,<span><sup>2</sup></span> but not with iron accumulation from chronic inflammation,<span><sup>2, 3</sup></span> and (2) marrow disease secondary to chronic alcoholism, which is associated with nutritional deficiencies and megaloblastic or sideroblastic anemias with ineffective erythropoiesis and low to high amounts of hemosiderin.<span><sup>2, 4</sup></span> More rarely, plasma cell iron inclusions have been reported in people without clear evidence of altered iron homeostasis or ineffective erythropoiesis, for example, a minority of people with malignancies, including plasma cell myeloma.<span><sup>3, 5</sup></span> Similar to most affected people, the dog in this report had ineffective erythropoiesis and increased marrow hemosiderin that suggests altered iron homeostasis, perhaps related to increased erythroferrone production.<span><sup>6</sup></span> In people, transmission electron microscopy of siderotic plasma cells has shown increased
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引用次数: 0
期刊
Veterinary clinical pathology
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