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Use of clinical biological tests of haemostasis to evaluate topical haemostatics 使用止血临床生物测试评估局部止血剂。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-29 DOI: 10.1111/ijlh.14235
Fabien Nativel, Sophie Tollec, Kamel-Olivier Sellal, Marc Trossaërt, Gaël Grimandi

Introduction

In addition to traditional means, topical haemostatics are currently used to avoid haemorrhage during surgery. Although they have been reported to be effective, there is a low level of proof of their clinical efficacy, which is at odds with their levels of use. This study used two methods to better understand their in vitro mechanism of action.

Methods

Two clinical biology assays were used to measure the action of topical haemostatics on primary and secondary haemostasis. Calibrated samples of collagen sponges and polypropylene non-woven gauze were tested. Platelet aggregation was assessed using a multichannel aggregometer. A thrombin generation assay (TGA) was used with a fluorogenic readout. Tissue factor solutions were used to activate coagulation.

Results

In terms of primary haemostasis, collagen sponges stimulated platelet aggregation, in particular between 2 and 5 min after incubation with platelet-rich plasma and with no dose effect. In regard to coagulation, the kinetics of thrombin generation was enhanced. Polypropylene non-woven gauze did not exhibit any effect on platelet aggregation, although it did have a weak effect on the kinetics of thrombin generation.

Conclusion

Collagen is well known to exert a haemostatic effect due to its action on platelet aggregation. By contrast, polypropylene non-woven gauze has not been shown to have any effect on platelet aggregation other than a minor impact on thrombin generation. The results obtained with the devices tested are in agreement with the literature. Platelet aggregation biological assays and TGA measurements appear to be suitable for evaluation of these medical products.

简介:除传统方法外,目前还使用局部止血剂来避免手术中的大出血。尽管有报道称这些止血剂有效,但其临床疗效的证据却不多,这与它们的使用水平不符。本研究采用两种方法来更好地了解其体外作用机制:方法:使用两种临床生物学检测方法来测量局部止血剂对原发性和继发性止血的作用。测试了胶原海绵和聚丙烯无纺布的校准样本。使用多通道聚集仪对血小板聚集进行评估。凝血酶生成试验(TGA)采用荧光读数。组织因子溶液用于激活凝血:结果:在初级止血方面,胶原蛋白海绵能刺激血小板聚集,尤其是在与富血小板血浆孵育 2 至 5 分钟后,且无剂量效应。在凝血方面,凝血酶的生成动力学得到增强。聚丙烯无纺布对血小板聚集没有任何影响,但对凝血酶的生成动力学有微弱影响:结论:众所周知,胶原蛋白对血小板聚集有止血作用。相比之下,聚丙烯无纺纱布除了对凝血酶的生成有轻微影响外,尚未证明对血小板聚集有任何影响。测试设备得出的结果与文献一致。血小板聚集生物测定和 TGA 测量似乎适用于评估这些医疗产品。
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引用次数: 0
Relapsed B-cell prolymphocytic leukemia (B-PLL) with distinctive granular inclusion bodies 复发的 B 细胞前淋巴细胞白血病(B-PLL)伴有明显的颗粒状包涵体。
IF 2.2 4区 医学 Q3 HEMATOLOGY Pub Date : 2024-01-29 DOI: 10.1111/ijlh.14237
Mei-Yu Su, Tsung-Chih Chen, Chieh-Lin Jerry Teng, Cheng-Han Wu
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引用次数: 0
Validation of a novel algorithm with a high specificity in ruling out MDS 验证一种新型算法,该算法在排除 MDS 方面具有很高的特异性。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-29 DOI: 10.1111/ijlh.14234
Felicitas Schulz, Kathrin Nachtkamp, Howard S. Oster, Moshe Mittelman, Norbert Gattermann, Sarah Schweier, Carmen Barthuber, Ulrich Germing

Introduction

A previously published web-based App using Gradient-boosted models (GBMs) of eight laboratory parameters was established by Oster et al. to facilitate diagnosis or exclusion of myelodysplastic syndromes (MDS) in patients.

Methods

To validate their algorithm, we compared 175 anemic patients with MDS diagnosis from our German MDS Registry with 1378 non-MDS anemic patients who consulted various specialties in the Düsseldorf university hospital.

Results

Based on hemoglobin level, leukocyte and platelet count, mean corpuscular volume, absolute neutrophil count, absolute monocyte count, glucose and creatinine, plus the patients' gender and age, we could not reproduce a high negative predictive value (NPV), but confirmed a useful specificity of 90.9% and a positive predictive value (PPV) of 77.1%. 1192 of 1378 controls were correctly categorized as “probably not MDS (pnMDS)” patients. A total of 65 patients were wrongly classified as “probable MDS (pMDS),” of whom 48 had alternative explanations for their altered laboratory results. In a second analysis, we included 29 patients with chronic myelomonocytic leukemia (CMML) resulting in only one label as possible MDS, suggesting that highly proliferative bone marrow disorders are correctly excluded.

Conclusion

The possibility of reliably excluding MDS from differential diagnosis based on peripheral blood lab work appears to be attractive for patients and physicians alike while the confirmation of MDS diagnosis still requires a bone marrow biopsy.

简介奥斯特(Oster)等人利用梯度增强模型(Gradient-boosted models,GBMs)建立了一个基于网络的应用程序,用于诊断或排除骨髓增生异常综合征(MDS)患者:为了验证他们的算法,我们将德国 MDS 登记处的 175 名确诊为 MDS 的贫血患者与杜塞尔多夫大学医院各专科就诊的 1378 名非 MDS 贫血患者进行了比较:根据血红蛋白水平、白细胞和血小板计数、平均血球容积、中性粒细胞绝对计数、单核细胞绝对计数、血糖和肌酐以及患者的性别和年龄,我们无法再现较高的阴性预测值 (NPV),但确认了 90.9% 的有用特异性和 77.1% 的阳性预测值 (PPV)。1378 例对照中,有 1192 例被正确归类为 "可能不是 MDS(pnMDS)"患者。共有 65 名患者被错误地归类为 "可能是 MDS (pMDS)",其中 48 名患者的实验室结果改变有其他解释。在第二项分析中,我们纳入了 29 名慢性粒细胞白血病(CMML)患者,结果只有一名患者被标记为可能的 MDS,这表明高度增生性骨髓疾病被正确排除:结论:根据外周血化验结果从鉴别诊断中可靠排除 MDS 的可能性似乎对患者和医生都很有吸引力,但 MDS 的确诊仍需要骨髓活检。
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引用次数: 0
Acute myeloid leukemia with misleading cytology 急性髓性白血病,细胞学检查有误导。
IF 2.2 4区 医学 Q3 HEMATOLOGY Pub Date : 2024-01-23 DOI: 10.1111/ijlh.14233
Mayssa Gaaloul, Madalina Uzunov, Karim Maloum, Elise Sourdeau

A 78-year-old woman presented with asthenia and superficial bleeding. Blood tests revealed pancytopenia with neutropenia (0.38 × 109/L), anemia (94 g/L), and thrombocytopenia (50 × 109/L). The peripheral blood smear showed 9% immature hypergranular atypical cells morphologically looking like abnormal promyelocytes and frequently containing bundles of Auer rods (Figure 1A–C). No schistocytes were present. Hemostasis tests revealed features of disseminated intravascular coagulation with hypofibrinogenemia (0.6 g/L), elevated D-dimer (7038 mg/L), decreased factor V (61%), and prolonged prothrombin time (19.1 s). The activated partial thromboplastin time was normal (35.5 s). Bone marrow aspirate smear showed 24% cells morphologically looking like abnormal promyelocytes with bundles of Auer rods (Figure 1D), and moderate dysplasia (hypo or agranularity and some dystrophic megakaryocytes). Flow cytometry analysis identified a blastic population extending to the maturing granulocyte region, expressing CD45 (dim), CD33, CD13, cytoplasmic-myeloperoxidase and CD117 (dim) without CD34, HLA-DR or CD15 expression (Figure 2).

This clinical and biological presentation was consistent with acute promyelocytic leukemia (APL). She received a plasma transfusion and all-trans-retinoic acid. However, karyotyping and fluorescent in situ hybridization did not detect t(15;17) or any other abnormality. Molecular testing showed mutations of TET2 (c.3729dup, 45%; c.3409+2T>A, 49%), SRSF2 (c.284C>A, 45%), and BRAF (c.1803A>T, 2%), but not PML::RARA rearrangement. These results excluded the diagnosis of APL and acute myeloid leukemia (AML) with dysplasia was retained. Treatment was switched and she received an induction chemotherapy with a combination of Idarubicine and cytarabine (“3 + 7”).

In this case, the cytopenias and the morphological abnormalities suggested AML with dysplasia, but morphology mimicked APL complicated with disseminated intravascular coagulation. Promyelocytes with bundles of Auer rods are characteristically found in APL but are not specific, being rarely reported in non-APL myeloid neoplasms. Only a few cases of AML mimicking APL have been reported. They often present with cytogenetic abnormalities [(inv)16, t(8;21), t(7;11), etc.].1, 2 Our patient displayed normal karyotype but a myelodysplastic syndrome mutational profile. This case highlights the importance of rapid cytogenetic and molecular testing for an accurate characterisation of AML as recommended by World Health Organization,3 to quickly initiate the appropriate treatment.

MG and ES collected all the biological data, MU and KM provided clinical data. All authors contributed to writing the manuscript.

一名 78 岁的妇女因气喘和浅表出血就诊。血液检查显示全血细胞减少,伴有中性粒细胞减少(0.38×109/L)、贫血(94 克/升)和血小板减少(50×109/L)。外周血涂片显示有 9% 不成熟的高颗粒非典型细胞,形态上看起来像异常的原幼细胞,并经常含有成束的 Auer 杆状细胞(图 1A-C)。没有血吸虫。止血试验显示弥散性血管内凝血特征,低纤维蛋白原血症(0.6 克/升),D-二聚体升高(7038 毫克/升),V因子降低(61%),凝血酶原时间延长(19.1 秒)。活化部分凝血活酶时间正常(35.5 秒)。骨髓穿刺涂片显示,24%的细胞在形态上看起来像异常的原核细胞,带有成束的Auer棒(图1D),以及中度发育不良(低粒或粒小和一些萎缩性巨核细胞)。流式细胞术分析确定了一个延伸至成熟粒细胞区域的可塑性群体,表达 CD45(暗淡)、CD33、CD13、细胞质-骨髓过氧化物酶和 CD117(暗淡),但无 CD34、HLA-DR 或 CD15 表达(图 2)。她接受了血浆输注和全反式维甲酸治疗。然而,核型分析和荧光原位杂交没有检测到t(15;17)或任何其他异常。分子检测显示,TET2(c.3729dup,45%;c.3409+2T>A,49%)、SRSF2(c.284C>A,45%)和BRAF(c.1803A>T,2%)发生了突变,但没有发现PML::RARA重排。这些结果排除了 APL 的诊断,保留了伴有发育不良的急性髓性白血病(AML)的诊断。她接受了伊达比星和阿糖胞苷联合诱导化疗("3 + 7")。在这个病例中,细胞减少和形态异常提示急性髓性白血病伴有发育不良,但形态学模仿了APL并发弥散性血管内凝血。带有Auer杆束的前骨髓细胞是APL的特征性表现,但并不具有特异性,在非APL髓样肿瘤中也鲜有报道。只有少数几例模仿 APL 的 AML 病例被报道过。这些病例通常伴有细胞遗传学异常[(inv)16、t(8;21)、t(7;11)等]。本病例强调了快速细胞遗传学和分子检测的重要性,以便按照世界卫生组织的建议3准确描述急性髓细胞性白血病的特征,从而快速启动适当的治疗。MG和ES收集了所有生物学数据,MU和KM提供了临床数据。所有作者都参与了手稿的撰写。
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引用次数: 0
Reference intervals of cell population data parameters in Sysmex XN-Series and its patterns of changes from early adulthood to geriatric ages in South Korea 韩国 Sysmex XN 系列细胞群数据参数的参考区间及其从成年早期到老年期的变化规律。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-23 DOI: 10.1111/ijlh.14231
Yong Jun Choi, Ju-Heon Park, Seon Cho, Hyeran Park, Suyoung Kim, Eunjoo Kwon, Han-Ik Cho, Eun-Hee Nah

Introduction

Cell population data (CPD) parameters may be putative biomarkers for the screening of various diseases including some infections and myelodysplastic syndrome. This study aimed to establish the age- and sex-specific reference intervals (RIs) for the CPD parameters in the Korean population.

Methods

The reference population for the RIs of CPD parameters comprised 124 856 subjects aged 20–99 years. CPD parameters were obtained from Sysmex XN-2000 (Kobe, Japan) datasets from 17 health promotion centers in 13 South Korean cities. We determined significant partitions for age and sex, and calculated RIs according to Clinical and Laboratory Standards Institute C28-A3 guidelines.

Results

The side scattered light intensity in the neutrophil area and the lymphocyte area did not require sex-related partitioning except in those over the age of 50, among whom the lower limit (LL) and upper limit (UL) were lower in females. However, the side scattered light distribution width in the lymphocyte area required age- and sex-related partitioning, in which LL and UL were higher in females. The LL and UL of the fluorescent light distribution width were higher in males in the neutrophil area and higher in females in the lymphocyte area, but age-related partitioning was not required. The forward scattered light intensity in the neutrophil area, lymphocyte area, and monocyte area did not require age-related partitioning in males.

Conclusion

This study has determined comprehensive age- and sex-specific RIs for CPD parameters, which could help to prove the clinical significance of these parameters in the Sysmex XN-2000.

导言:细胞群数据(CPD)参数可能是筛查各种疾病(包括某些感染和骨髓增生异常综合征)的潜在生物标志物。本研究旨在确定韩国人群中细胞群数据参数的年龄和性别特异性参考区间(RIs):CPD 参数参考区间的参考人群包括 124 856 名 20-99 岁的受试者。CPD 参数来自韩国 13 个城市 17 个健康促进中心的 Sysmex XN-2000(日本神户)数据集。我们确定了年龄和性别的重要分区,并根据临床和实验室标准协会 C28-A3 指南计算了 RIs:结果:中性粒细胞区和淋巴细胞区的侧散射光强度不需要与性别相关的分区,50 岁以上者除外,其中女性的下限(LL)和上限(UL)较低。然而,淋巴细胞区的侧散射光分布宽度需要根据年龄和性别进行划分,其中女性的下限和上限较高。在中性粒细胞区域,男性的荧光分布宽度 LL 和 UL 较高,而在淋巴细胞区域,女性的荧光分布宽度 LL 和 UL 较高,但不需要与年龄相关的分区。男性中性粒细胞区、淋巴细胞区和单核细胞区的正向散射光强度不需要与年龄相关的分区:本研究为 CPD 参数确定了全面的年龄和性别特异性 RI,有助于证明这些参数在 Sysmex XN-2000 中的临床意义。
{"title":"Reference intervals of cell population data parameters in Sysmex XN-Series and its patterns of changes from early adulthood to geriatric ages in South Korea","authors":"Yong Jun Choi,&nbsp;Ju-Heon Park,&nbsp;Seon Cho,&nbsp;Hyeran Park,&nbsp;Suyoung Kim,&nbsp;Eunjoo Kwon,&nbsp;Han-Ik Cho,&nbsp;Eun-Hee Nah","doi":"10.1111/ijlh.14231","DOIUrl":"10.1111/ijlh.14231","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Cell population data (CPD) parameters may be putative biomarkers for the screening of various diseases including some infections and myelodysplastic syndrome. This study aimed to establish the age- and sex-specific reference intervals (RIs) for the CPD parameters in the Korean population.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The reference population for the RIs of CPD parameters comprised 124 856 subjects aged 20–99 years. CPD parameters were obtained from Sysmex XN-2000 (Kobe, Japan) datasets from 17 health promotion centers in 13 South Korean cities. We determined significant partitions for age and sex, and calculated RIs according to Clinical and Laboratory Standards Institute C28-A3 guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The side scattered light intensity in the neutrophil area and the lymphocyte area did not require sex-related partitioning except in those over the age of 50, among whom the lower limit (LL) and upper limit (UL) were lower in females. However, the side scattered light distribution width in the lymphocyte area required age- and sex-related partitioning, in which LL and UL were higher in females. The LL and UL of the fluorescent light distribution width were higher in males in the neutrophil area and higher in females in the lymphocyte area, but age-related partitioning was not required. The forward scattered light intensity in the neutrophil area, lymphocyte area, and monocyte area did not require age-related partitioning in males.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study has determined comprehensive age- and sex-specific RIs for CPD parameters, which could help to prove the clinical significance of these parameters in the Sysmex XN-2000.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.14231","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139543269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biological variation of thrombin generation on ST Genesia ST Genesia 上凝血酶生成的生物变异。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-22 DOI: 10.1111/ijlh.14232
M. A. van Dievoet, L. Morimont, C. Bouvy, D. Gruson, X. Stephenne, J. Douxfils
{"title":"Biological variation of thrombin generation on ST Genesia","authors":"M. A. van Dievoet,&nbsp;L. Morimont,&nbsp;C. Bouvy,&nbsp;D. Gruson,&nbsp;X. Stephenne,&nbsp;J. Douxfils","doi":"10.1111/ijlh.14232","DOIUrl":"10.1111/ijlh.14232","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Concurrent novel RGS17::BCL9 fusion and basophilia in T/B mixed phenotype acute lymphoblastic leukemia/lymphoma T/B混合表型急性淋巴细胞白血病/淋巴瘤中同时存在新型RGS17::BCL9融合和嗜碱性粒细胞增多。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-22 DOI: 10.1111/ijlh.14230
Xingqin Huang, Linglin Jiang, Ting Li, Mei Yang
{"title":"Concurrent novel RGS17::BCL9 fusion and basophilia in T/B mixed phenotype acute lymphoblastic leukemia/lymphoma","authors":"Xingqin Huang,&nbsp;Linglin Jiang,&nbsp;Ting Li,&nbsp;Mei Yang","doi":"10.1111/ijlh.14230","DOIUrl":"10.1111/ijlh.14230","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139522436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Primary plasma cell leukemia presented with atypical flower-like morphology 原发性浆细胞白血病表现为不典型的花朵样形态。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-20 DOI: 10.1111/ijlh.14229
Ljubomir Jakovic, Jelica Jovanovic, Nada Kraguljac Kurtovic, Marija Dencic Fekete, Andrija Bogdanovic
{"title":"Primary plasma cell leukemia presented with atypical flower-like morphology","authors":"Ljubomir Jakovic,&nbsp;Jelica Jovanovic,&nbsp;Nada Kraguljac Kurtovic,&nbsp;Marija Dencic Fekete,&nbsp;Andrija Bogdanovic","doi":"10.1111/ijlh.14229","DOIUrl":"10.1111/ijlh.14229","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139503238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical and genetic characterization of a protein S deficient patient with multiple thrombotic events 一名患有多种血栓事件的蛋白 S 缺乏症患者的临床和遗传特征。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-18 DOI: 10.1111/ijlh.14228
Yuan Chen, Langyi Qin, Yanhui Jin, Haixiao Xie, Lihong Yang, Mingshan Wang, Yaosheng Xie
{"title":"Clinical and genetic characterization of a protein S deficient patient with multiple thrombotic events","authors":"Yuan Chen,&nbsp;Langyi Qin,&nbsp;Yanhui Jin,&nbsp;Haixiao Xie,&nbsp;Lihong Yang,&nbsp;Mingshan Wang,&nbsp;Yaosheng Xie","doi":"10.1111/ijlh.14228","DOIUrl":"10.1111/ijlh.14228","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139492264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
ICSH review of internal quality control policy for blood cell counters ICSH 审查血细胞计数器的内部质量控制政策。
IF 3 4区 医学 Q2 Medicine Pub Date : 2024-01-12 DOI: 10.1111/ijlh.14220
Richard McCafferty, George Cembrowski, Barbara de la Salle, Mingting Peng, Eloisa Urrechaga

Introduction

This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre-requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC).

Methods

The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers (Abbott Diagnostics, Beckman Coulter, Horiba Medical Diagnostic Instruments & Systems, Mindray Medical International, Siemens Healthcare Diagnostics and Sysmex Corporation) and a survey issued to 191 diagnostic laboratories in four countries (China, Republic of Ireland, Spain and the United Kingdom) on their IQC practice and approach to use of commercial IQC materials.

Results

This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial controls. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values and action limits used with control materials, and frequency of running commercial controls materials.

Conclusions

These findings and their implications for IQC Practice are discussed in this paper. They are used to inform a separate guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.

导言:本文是 ICSH 对监管机构、细胞计数器制造商和诊断实验室的血液学细胞计数器内部质量控制 (IQC) 政策和实践的审查报告。其中包括对研究结果的讨论,以及与 ICSH 有关此类政策和实践的单独指南的链接。应用内部质量控制(IQC)方法是所有临床实验室检测(包括血细胞计数(全血细胞计数,FBC 或全血计数,CBC))的基本前提:方法:ICSH 通过审查监管机构发布的指南、向六家主要细胞计数器制造商(雅培诊断、贝克曼库尔特、堀场医疗诊断仪器和系统、明德医疗国际、西门子医疗诊断和 Sysmex 公司)发放调查问卷,以及向四个国家(中国、爱尔兰共和国、西班牙和英国)的 191 家诊断实验室发放调查问卷,了解它们的 IQC 实践和使用商业 IQC 材料的方法,从而收集有关实践现状的信息:结果:这揭示了世界各地指导和实践的多样性。监管机构在各自推荐的 IQC 方法、使用商业对照的临床级别和频率,以及最终推荐的商业对照来源等方面的指导各不相同。临床实验室之间的实践多样性涵盖了所使用的 IQC 方法、目标值的推导、与对照材料一起使用的行动限值以及运行商业对照材料的频率等领域:本文讨论了这些发现及其对 IQC 实践的影响。结论:本文讨论了这些发现及其对 IQC 实践的影响,并为另一份指导文件提供了信息,该文件提出了一种统一的方法来解决诊断实验室面临的问题。
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引用次数: 0
期刊
International Journal of Laboratory Hematology
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