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Robustness assessment of an automated AI-based white blood cell morphometric analysis system using different smear preparation methods. 使用不同涂片制备方法对基于人工智能的自动白细胞形态分析系统进行鲁棒性评估。
Pub Date : 2024-07-25 DOI: 10.1111/ijlh.14350
Mendamar Ravzanaadii, Yuki Horiuchi, Yosuke Iwasaki, Akihiko Matsuzaki, Kimiko Kaniyu, Jing Bai, Aya Konishi, Jun Ando, Miki Ando, Yoko Tabe

Introduction: Numerous AI-based systems are being developed to evaluate peripheral blood (PB) smears, but the feasibility of these systems on different smear preparation methods has not been fully understood. In this study, we assessed the impact of different smear preparation methods on the robustness of the deep learning system (DLS).

Methods: We collected 193 PB samples from patients, preparing a pair of smears for each sample using two systems: (1) SP50 smears, prepared by the DLS recommended fully automated slide preparation with double fan drying and staining (May-Grunwald Giemsa, M-G) system using SP50 (Sysmex) and (2) SP1000i smears, prepared by automated smear preparation with single fan drying by SP1000i (Sysmex) and manually stained with M-G. Digital images of PB cells were captured using DI-60 (Sysmex), and the DLS performed cell classification. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were used to evaluate the performance of the DLS.

Results: The specificity and NPV for all cell types were 97.4%-100% in both smear sets. The average sensitivity and PPV were 88.9% and 90.1% on SP50 smears, and 87.0% and 83.2% on SP1000i smears, respectively. The lower performance on SP1000i smears was attributed to the intra-lineage misclassification of neutrophil precursors and inter-lineage misclassification of lymphocytes.

Conclusion: The DLS demonstrated consistent performance in specificity and NPV for smears prepared by a system different from the recommended method. Our results suggest that applying an automated smear preparation system optimized for the DLS system may be important.

导言:目前正在开发许多基于人工智能的系统来评估外周血(PB)涂片,但这些系统在不同涂片制备方法上的可行性尚未得到充分了解。在本研究中,我们评估了不同涂片制备方法对深度学习系统(DLS)稳健性的影响:我们从患者身上采集了 193 份 PB 样本,使用两种系统为每个样本制备了一对涂片:(1)SP50 涂片,由 DLS 推荐的全自动玻片制备双风扇干燥和染色(May-Grunwald Giemsa,M-G)系统使用 SP50(Sysmex)制备;(2)SP1000i 涂片,由 SP1000i(Sysmex)自动涂片制备单风扇干燥和手动 M-G 染色制备。使用 DI-60(Sysmex)捕捉 PB 细胞的数字图像,并用 DLS 进行细胞分类。灵敏度、特异性、阳性预测值(PPV)和阴性预测值(NPV)用于评估 DLS 的性能:两组涂片中所有细胞类型的特异性和 NPV 均为 97.4%-100%。SP50涂片的平均灵敏度和预测值分别为88.9%和90.1%,SP1000i涂片的平均灵敏度和预测值分别为87.0%和83.2%。SP1000i涂片的性能较低的原因是中性粒细胞前体的行内分类错误和淋巴细胞的行间分类错误:DLS在特异性和NPV方面的表现与推荐方法不同的系统制备的涂片一致。我们的结果表明,应用针对 DLS 系统优化的自动涂片制备系统可能非常重要。
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引用次数: 0
Evaluation of artificial intelligence-assisted morphological analysis for platelet count estimation. 评估人工智能辅助形态分析在血小板计数估算中的应用。
Pub Date : 2024-07-20 DOI: 10.1111/ijlh.14345
Ping Guo, Chi Zhang, Dandan Liu, Ziyong Sun, Jun He, Jianbiao Wang

Introduction: This study aims to assess the performance of the platelet count estimation using artificial intelligence technology on the MC-80 digital morphology analyzer.

Methods: Digital morphology analyzer uses two different computational principles for platelet count estimation: based on PLT/RBC ratio (PLT-M1) and estimate factor (PLT-M2). 977 samples with various platelet counts (low, median, and high) were collected. Out of these, 271 samples were immunoassayed using CD61 and CD41 antibodies. The platelet counts obtained from the hematology analyzer (PLT-I and PLT-O), digital morphology analyzer (PLT-M1 and PLT-M2), and flow cytometry (PLT-IRM) were compared.

Results: There was no significant deviation observed before and after verification for both PLT-M1 and PLT-M2 across the analysis range (average bias: -0.845/-0.682, 95% limit of agreement (LOA): -28.675-26.985/-29.420-28.056). When platelet alarms appeared, PLT-M1/PLT-M2 showed the strongest correlation with PLT-IRM than PLT-I with PLT-IRM (r: 0.9814/0.9796 > 0.9601). The correlation between PLT-M1/PLT-M2 and PLT-IRM was strong for samples with interference, such as large platelets or RBC fragments, but relatively weak in small RBCs. The deviation between PLT-M1 and PLT-M2 is related to the number of RBCs. Compared with PLT-I, PLT-M1/PLT-M2 showed higher accuracy for platelet transfusion decisions, especially for samples with low-value PLT.

Conclusion: The novel platelet count estimation on the MC-80 digital morphology analyzer provides high accuracy, especially the reviewed result, which can effectively confirm suspicious platelet count.

导言本研究旨在评估 MC-80 数字形态分析仪使用人工智能技术估算血小板计数的性能:数字形态分析仪使用两种不同的计算原理估算血小板计数:基于 PLT/RBC 比率(PLT-M1)和估算因子(PLT-M2)。收集了 977 份不同血小板计数(低、中、高)的样本。其中 271 份样本使用 CD61 和 CD41 抗体进行了免疫测定。对血液分析仪(PLT-I 和 PLT-O)、数字形态分析仪(PLT-M1 和 PLT-M2)和流式细胞仪(PLT-IRM)得出的血小板计数进行了比较:在整个分析范围内,PLT-M1 和 PLT-M2 在验证前后均未观察到明显偏差(平均偏差:-0.845/-0.682,95% 一致度(LOA):-28.675-26.985/-29.420-28.056)。当血小板警报出现时,PLT-M1/PLT-M2 与 PLT-IRM 的相关性比 PLT-I 与 PLT-IRM 的相关性强(r:0.9814/0.9796 > 0.9601)。对于大血小板或红细胞碎片等干扰样本,PLT-M1/PLT-M2 与 PLT-IRM 的相关性很强,但对于小红细胞,相关性相对较弱。PLT-M1 和 PLT-M2 之间的偏差与红细胞数量有关。与 PLT-I 相比,PLT-M1/PLT-M2 对血小板输注决策的准确性更高,尤其是对低值 PLT 样本:结论:在 MC-80 数字形态分析仪上进行的新型血小板计数估算具有很高的准确性,尤其是复核结果,可有效确认可疑血小板计数。
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引用次数: 0
Effect of emicizumab on activated clotting time performed on i-STAT Alinity analyzer. 埃米珠单抗对 i-STAT Alinity 分析仪测定的活化凝血时间的影响。
Pub Date : 2024-07-18 DOI: 10.1111/ijlh.14343
Landry Seyve, Jean Baptiste Prigent, Caroline Lo Presti, Damien Bédague, Gautier Szymanski, Bénédicte Bulabois, Claire Barro, Raphaël Marlu
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引用次数: 0
Utilization of international normalized ratio-derived formula to predict plasma rivaroxaban level-Validation study and real-world experience. 利用国际正常化比率公式预测血浆利伐沙班水平--验证研究和实际经验。
Pub Date : 2024-07-17 DOI: 10.1111/ijlh.14347
Chun-Fun Sin, Ka-Ping Wong, Chun Wah Siu, Tsz-Fu Wong, Hoi-Man Wong

Introduction: Specific assays of plasma rivaroxaban level are not always readily available with short turnaround time, which hamper the management of urgent clinical situations. In this study, we aimed to build a predictive formula of plasma rivaroxaban levels from international normalized ratio (INR) value and validated in real world clinical situations.

Methods: Ninety-four patients who were taking rivaroxaban participated in the study. Patients were randomized into testing cohort and validation cohorts. The prediction formula was built from the testing cohort and then validated in validation cohort. The predictive performance was further validated on real-world clinical requests.

Results: The root mean square error (RMSE) of the predictive formula for the testing and validation cohorts were 61.81 and 69.32 ng/mL, respectively. The sensitivity and specificity for the formula to predict the threshold plasma rivaroxaban level of 75 ng/mL were 95% (95% CI: 85.4%-100%) and 87.5% (95% CI: 71.3%-100%), respectively, in real-world clinical situations.

Conclusion: Plasma rivaroxaban level of threshold level of 75 ng/mL can be calculated from prediction formula by INR value with satisfactory accuracy and it can be used to guide the decision for reversal.

简介:血浆利伐沙班水平的特异性检测方法并非总能在短时间内获得,这妨碍了对紧急临床情况的处理。本研究旨在根据国际正常化比值(INR)建立血浆利伐沙班水平的预测公式,并在实际临床情况中进行验证:94名服用利伐沙班的患者参与了研究。患者被随机分为测试组和验证组。根据测试组群建立预测公式,然后在验证组群中进行验证。在真实世界的临床要求中进一步验证了预测性能:结果:测试组和验证组预测公式的均方根误差(RMSE)分别为 61.81 和 69.32 纳克/毫升。在实际临床情况下,该公式预测血浆利伐沙班阈值水平为75纳克/毫升的灵敏度和特异度分别为95%(95% CI:85.4%-100%)和87.5%(95% CI:71.3%-100%):结论:血浆利伐沙班水平的阈值为75纳克/毫升,可以通过INR值的预测公式计算出,准确性令人满意,可用于指导逆转的决策。
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引用次数: 0
The ratio of bone marrow myeloid progenitor cell proportion to mature lymphocytes proportion can effectively differentiate aplastic anemia and hypoplastic myelodysplastic syndrome and evaluate the quality of bone marrow aspirates. 骨髓髓系祖细胞与成熟淋巴细胞的比例可有效区分再生障碍性贫血和骨髓增生异常综合征,并评估骨髓穿刺的质量。
Pub Date : 2024-07-17 DOI: 10.1111/ijlh.14346
Zhen Li, Jian Zhang, Jingying Han, Qian Wang, Hui Sun, Zhifen Zhang, Tianpu Liu, Yena Che, Jing Wang, Jie Wang, Lulu Xu, Lu Pan, Li Li

Introduction: Aplastic anemia (AA) and hypoplastic myelodysplastic syndrome (MDS-h) are bone marrow failure disease and difficult to distinguish merely by morphological analysis. In this study, we investigated the value of flow cytometry (FCM) in the differential diagnosis of AA and MDS-h.

Methods: We included 822 patients (626 control, 69 AA, 22 MDS-h and 105 dilution patients) from January 2017 to December 2022 for a retrospective study. Bone marrow myeloid progenitor (MP) cell and mature lymphocytes proportions were analyzed by FCM. The ratio of MP cell proportion and mature lymphocytes proportion, MPLR, was calculated. Data were compared by Kruskal-Wallis test. Differential diagnostic efficacy was evaluated by receiver operating characteristic (ROC) curve. Cutoff value was determined by the maximum Youden index.

Results: Bone marrow MP cell proportion and MPLR of MDS-h patients were higher than AA patients. Mature lymphocytes proportion of MDS-h patients was lower than AA patients. Area under ROC curve (AUC of ROC) of MP cell proportion, MPLR and mature lymphocytes proportion to distinguish AA from MDS-h were 0.992, 0.988, and 0.850, respectively. Moreover, MPLR of dilution patients was higher than AA patients but lower than MDS-h patients. The AUC of ROC curves of MPLR to distinguish MDS-h and AA from dilution were 0.854 and 0.871, respectively.

Conclusion: Bone marrow MP cell proportion and MPLR can effectively discriminate AA from MDS-h with similar differential efficacy, which is higher than mature lymphocytes proportion. Moreover, MPLR can evaluate the quality of bone marrow aspirates, which would interfere with the differential diagnosis.

导言:再生障碍性贫血(AA)和低增生性骨髓增生异常综合征(MDS-h)是骨髓衰竭性疾病,仅通过形态学分析难以区分。在这项研究中,我们探讨了流式细胞术(FCM)在 AA 和 MDS-h 鉴别诊断中的价值:我们纳入了2017年1月至2022年12月的822名患者(626名对照组患者、69名AA患者、22名MDS-h患者和105名稀释患者)进行回顾性研究。通过FCM分析骨髓髓系祖细胞(MP)和成熟淋巴细胞的比例。计算骨髓髓系祖细胞和成熟淋巴细胞的比例,即 MPLR。数据比较采用 Kruskal-Wallis 检验。通过接收者操作特征曲线(ROC)评估鉴别诊断效果。根据最大尤登指数确定临界值:结果:MDS-h 患者的骨髓 MP 细胞比例和 MPLR 均高于 AA 患者。MDS-h患者的成熟淋巴细胞比例低于AA患者。MP细胞比例、MPLR和成熟淋巴细胞比例区分AA和MDS-h的ROC曲线下面积(AUC)分别为0.992、0.988和0.850。此外,稀释患者的 MPLR 高于 AA 患者,但低于 MDS-h 患者。MPLR区分MDS-h和AA与稀释的ROC曲线的AUC分别为0.854和0.871:结论:骨髓MP细胞比例和MPLR能有效区分AA和MDS-h,其鉴别效力相似,均高于成熟淋巴细胞比例。此外,MPLR 还能评估骨髓穿刺的质量,这将干扰鉴别诊断。
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引用次数: 0
Comparison of blood cell counts in leukemoid reaction and chronic myeloid leukemia: A study using Scopio blood cell counter with statistical analysis. 类白血病反应和慢性髓性白血病的血细胞计数比较:使用 Scopio 血细胞计数器进行的研究与统计分析。
Pub Date : 2024-07-14 DOI: 10.1111/ijlh.14341
Alaa S Hrizat, Jerald Z Gong
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引用次数: 0
Methods, precision, and analytical sensitivity of a novel low-plasma-volume assay of fibrinolytic capacity utilizing the euglobulin fraction. 利用优球蛋白部分进行纤维蛋白溶解能力的新型低血浆容量测定的方法、精确度和分析灵敏度。
Pub Date : 2024-07-09 DOI: 10.1111/ijlh.14340
Steven Bruzek, Marisol Betensky, Anthony A Sochet, Neil A Goldenberg, Vera Ignjatovic

Introduction: Fibrinolysis is a critical aspect of the hemostatic system, with assessment of fibrinolytic potential being critical to predict bleeding and clotting risk. We describe the method for a novel low-plasma-volume assay of fibrinolytic capacity utilizing the euglobulin fraction (the "modified mini-euglobulin clot lysis assay [ECLA]"), its analytic sensitivity to alterations in key fibrinolytic substrates/regulators, and its initial applications in acute and convalescent disease cohorts.

Methods: The modified mini-ECLA requires 50 μL of plasma, a maximal read time of 3 h (with most results available within 60 min), and is entirely performed in a 96-well microplate. Assay measurements were obtained in a variety of commercial control and deficient plasmas representing clinically relevant hypo- and hyperfibrinolytic states, and in three distinct adolescent cohorts with acute or convalescent illness: critically ill, following endotracheal intubation; acute COVID-19-related illness; and ambulatory, 3 months following a venous thromboembolic event.

Results: In 100% and 75% deficient plasmas, hypofibrinolysis for plasminogen-deficient, fibrinolysis for alpha-2-antiplasmin-deficient, and hyperfibrinolysis for plasminogen activator inhibitor-1-deficient plasmas were observed.

Conclusion: The modified mini-ECLA Clot Lysis Time Ratio ("CLTR") demonstrated moderate-strength correlations with the Clot Formation and Lysis (CloFAL) assay, is analytically sensitive to altered fibrinolytic states in vitro, and correlates with clinical outcomes in preliminarily-studied patient populations.

简介:纤溶是止血系统的一个重要方面,评估纤溶潜能对于预测出血和凝血风险至关重要。我们介绍了利用优球蛋白部分("改良型迷你优球蛋白凝块溶解试验[ECLA]")对纤溶能力进行新型低血浆容量测定的方法、其对关键纤溶底物/调节因子变化的分析灵敏度以及在急性和康复性疾病队列中的初步应用:方法:改良型迷你 ECLA 需要 50 μL 血浆,最长读取时间为 3 小时(大多数结果可在 60 分钟内获得),并且完全在 96 孔微孔板中进行。在代表临床相关的纤溶不足和纤溶亢进状态的各种商用对照血浆和缺陷血浆中,以及在患有急性或康复性疾病的三个不同青少年组群中进行了测定:危重病人,气管插管后;与 COVID-19 相关的急性疾病;以及非住院病人,静脉血栓栓塞事件后 3 个月:结果:在100%和75%缺乏血浆中,观察到纤溶酶原缺乏的纤溶不足、α-2-抗蛋白酶缺乏的纤溶不足和纤溶酶原激活物抑制剂-1缺乏的纤溶亢进:结论:改良的微型ECLA凝块溶解时间比("CLTR")与凝块形成和溶解(CloFAL)测定具有中等强度的相关性,对体外纤溶状态的改变具有分析敏感性,并与初步研究的患者群体的临床结果相关。
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引用次数: 0
A diagnostic pitfall due to lymphoplasmacytic morphology in plasma cell leukemia. 浆细胞白血病淋巴浆细胞形态导致的诊断误区。
Pub Date : 2024-07-07 DOI: 10.1111/ijlh.14339
Shuhei Kurosawa, Takako Yokota, Yusuke Takada, Yoko Tateishi, Hiroyuki Hayashi, Tomonori Nakazato
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引用次数: 0
Advantages of patient-based real-time quality control applications in modern quality assurance strategies. 基于患者的实时质量控制应用在现代质量保证战略中的优势。
Pub Date : 2024-07-05 DOI: 10.1111/ijlh.14338
Tony Badrick, Jean-Marc Giannoli, Huub van Rossum
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引用次数: 0
Predictive model of the efficiency of hematopoietic stem cell collection in patients with multiple myeloma and lymphoma based on multiple peripheral blood markers. 基于多种外周血标志物的多发性骨髓瘤和淋巴瘤患者造血干细胞采集效率预测模型。
Pub Date : 2024-07-03 DOI: 10.1111/ijlh.14337
Longrong Ran, Yu Peng, Mingyu Zhao, Xin Luo, Shuang Chen, Xinyi Tang, Yakun Zhang, Lian Li, Liangmei Li, Wei Zhang, Tingting Jiang, Xuelian Wu, Renzhi Hu, Yao Liu, Zailin Yang

Introduction: Autologous hematopoietic stem cell transplantation (ASCT) has gained extensive application in the treatment of lymphoma and multiple myeloma (MM). Plenty of studies demonstrate that peripheral blood indicators could be considered potential predictive biomarkers for hematopoietic stem cells (HSCs) collection efficiency, including white blood cell count (WBC), monocyte count (Mono), platelet count (PLT), hematocrit, and hemoglobin levels. Currently, clinically practical predictive models based on these peripheral detection indicators to quickly, conveniently, and accurately predict collection efficiency are lacking.

Methods: In total, 139 patients with MM and lymphoma undergoing mobilization and collection of ASCT were retrospectively studied. The study endpoint was successful collection of autologous HSCs. We analyzed the effects of clinical characteristics and peripheral blood markers on collection success, and screened variables to establish a prediction model. We determined the optimal cutoff value of peripheral blood markers for predicting successful stem cell collection and the clinical value of a multi-marker prediction approach. We also established a prediction model for collection efficacy.

Results: Univariate and multivariate logistic regression analyses showed that the mobilization regimen, Mono, PLT, mononuclear cell count (MNC), and peripheral blood CD34+ cell count (PB CD34+ counts) were significant predictors of successful collection of peripheral blood stem cells (PBSC). Two predictive models were constructed based on the results of multivariate logistic analyses. Model 1 included the mobilization regimen, Mono, PLT, and MNC, whereas Model 2 included the mobilization regimen, Mono, PLT, MNC, and PB CD34+ counts. Receiver operating characteristic (ROC) curve analysis showed that the PB CD34+ counts, Model 1, and Model 2 could predict successful HSCs collection, with cutoff values of 26.92 × 106/L, 0.548, and 0.355, respectively. Model 1 could predict successful HSCs collection with a sensitivity of 84.62%, specificity of 75.73%, and area under the curve (AUC) of 0.863. Model 2 could predict successful HSCs collection with a sensitivity of 83.52%, specificity of 94.17%, and AUC of 0.946; thus, it was superior to the PB CD34+ counts alone.

Conclusion: Our findings suggest that the combination of the mobilization regimen, Mono, PLT, MNC, and PB CD34+ counts before collection has predictive value for the efficacy of autologous HSCs collection in patients with MM and lymphoma. Using models based on these predictive markers may help to avoid over-collection and improve patient outcomes.

导言:自体造血干细胞移植(ASCT)已广泛应用于淋巴瘤和多发性骨髓瘤(MM)的治疗。大量研究表明,外周血指标可被视为造血干细胞采集效率的潜在预测生物标志物,包括白细胞计数(WBC)、单核细胞计数(Mono)、血小板计数(PLT)、血细胞比容和血红蛋白水平。目前,还缺乏基于这些外周检测指标的临床实用预测模型,以快速、方便、准确地预测采集效率:方法:回顾性研究了 139 名接受动员和 ASCT 采集的 MM 和淋巴瘤患者。研究终点是成功采集自体造血干细胞。我们分析了临床特征和外周血标志物对采集成功率的影响,并筛选变量建立了预测模型。我们确定了预测干细胞成功采集的最佳外周血标志物截断值,以及多标志物预测方法的临床价值。我们还建立了一个采集疗效预测模型:单变量和多变量逻辑回归分析表明,动员方案、Mono、PLT、单核细胞计数(MNC)和外周血CD34+细胞计数(PB CD34+计数)是成功采集外周血干细胞(PBSC)的重要预测指标。根据多变量逻辑分析结果构建了两个预测模型。模型1包括动员方案、Mono、PLT和MNC,而模型2包括动员方案、Mono、PLT、MNC和PB CD34+计数。接收者操作特征曲线(ROC)分析表明,PB CD34+ 计数、模型 1 和模型 2 可预测造血干细胞的成功采集,其临界值分别为 26.92 × 106/L、0.548 和 0.355。模型 1 预测造血干细胞采集成功的灵敏度为 84.62%,特异度为 75.73%,曲线下面积(AUC)为 0.863。模型 2 预测造血干细胞采集成功的灵敏度为 83.52%,特异性为 94.17%,曲线下面积(AUC)为 0.946;因此,它优于单纯的 PB CD34+ 计数:我们的研究结果表明,采集前动员方案、Mono、PLT、MNC 和 PB CD34+ 计数的组合对 MM 和淋巴瘤患者自体造血干细胞采集的疗效具有预测价值。使用基于这些预测指标的模型可能有助于避免过度采集并改善患者预后。
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引用次数: 0
期刊
International journal of laboratory hematology
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