International Journal of Laboratory Hematology最新文献

{"title":"Next Generation Digital Morphology: Blast Preclassification in Bone Marrow Aspirates","authors":"John Donald Marra, Gina Zini","doi":"10.1111/ijlh.70174","DOIUrl":"10.1111/ijlh.70174","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Morphologic evaluation of peripheral blood (PB) smears and bone marrow aspirates (BMA) remains central to the diagnosis of acute leukemias, particularly for the identification and quantification of blasts. However, this process is time-consuming, operator-dependent, and subject to inter-observer variability. Recent advances in artificial intelligence (AI), particularly deep learning, have enabled the development of automated systems for leukocyte classification and blast detection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We performed a narrative review of the literature on AI-based approaches for morphologic evaluation in hematology, focusing on blast recognition and leukemia screening. Both classical machine learning and deep learning methodologies were analyzed, along with their application to PB smears and BMA samples. In addition, currently available commercial digital morphology platforms were reviewed with respect to their performance in blast detection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Classical machine learning approaches demonstrated good performance on maturing cells of most lineages, and moderate performance in blast recognition, limited by reliance on manually selected features. Deep learning models, particularly convolutional neural networks, achieved improved accuracy and near-human performance in PB smear analysis, with reported sensitivities and specificities often exceeding 90% for blast detection. However, performance in BMA analysis remains more variable due to increased cellular complexity. Commercial platforms show high concordance with manual microscopy for mature leukocyte classification, but more modest accuracy for immature and neoplastic cells, including blasts.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>AI-based digital morphology systems are promising tools for supporting morphologic evaluation in hematology laboratories. While current platforms improve efficiency and standardization, limitations in blast detection accuracy and generalizability prevent their use as standalone diagnostic tools. Further development, including large-scale validation and improved model interpretability, will be essential for their integration into routine clinical practice. The International Council for Standardization in Haematology (ICSH) presently suggests prudence in the widespread clinical adoption of AI-driven bone marrow analysis systems, except within environments that are properly validated, approved by regulatory authorities, and supported by rigorous quality assura","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"988-999"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.70174","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284996","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}

{"title":"Beta Thalassemia and Chronic Myeloid Leukemia: Dual Diagnosis Under the Microscope","authors":"Paige Muir, Mohammad Bahmanyar, Hamish Nicolson, Hayley Merkeley","doi":"10.1111/ijlh.70142","DOIUrl":"10.1111/ijlh.70142","url":null,"abstract":"<p>A 28-year-old male with non-transfusion-dependent hemoglobin E-beta thalassemia (baseline hemoglobin 100 g/L) and enlarged spleen (17.8 cm) was admitted to hospital for investigation of progressive leukocytosis, splenomegaly and right hip pain. He was admitted 2 weeks prior for pneumonia in the context of respiratory symptoms and infiltrates on chest imaging, with a progressive anemia (hemoglobin 37 g/L) in the absence of bleeding. He was noted to have a markedly elevated white blood cell count of 180 × 10<sup>9</sup>/L with 33% neutrophils, 37% immature granulocytes, no initial eosinophilia or basophilia and 2.7% myeloblasts on peripheral blood flow cytometry, from a normal baseline the year prior (Table 1). He was treated with a course of antibiotics and 6 units of packed red blood cells. Given the improvement in his cell count indices at discharge (Table 1), his clinical picture was thought to represent an acute reactive extramedullary hematopoietic process in the setting of pneumonia. However, a neoplastic process, specifically chronic myeloid leukemia (CML), was on the differential given the degree of left-shift and basophilia at the time of discharge. Fluorescence In Situ Hybridization (FISH) for <i>BCR::ABL1</i> fusion was sent and was positive with a baseline International Scale (IS) burden 190% (log burden 0.28), confirming a diagnosis of CML. There were no other abnormalities identified on FISH including JAK2, FGFR1, or PDGFRA/B, and the karyotype was 46,XY,t(9;22)(q34;q11.2). His Sokal index was 1.1 points (intermediate risk) and EUTOS long term survival (ELTS) score was 2.5 (high risk).</p><p>He was readmitted for bone marrow investigation and treatment initiation. His blood film demonstrated characteristic features of beta thalassemia (microcytic anemia with codocytes and dacrocytes, coarse basophilic stippling, polychromasia and nucleated red cells) and CML (left shifted neutrophilic leukocytosis with predominance of myelocytes and metamyelocytes, monocytosis, basophilia, eosinophilia and circulating blasts) (Figure 1A). Bone marrow aspirate was a dry tap. Trephine biopsy revealed 100% cellularity (Figure 1B) with left shifted granulocytic hyperplasia, increased eosinophils and basophils, paratrabecular expansion of immature granulocytes, sparse erythroid islands and scattered small megakaryocytes with hyposegmented nuclei (Figure 1C,D). Reticulin stain showed grade 2/3 myelofibrosis based on the World Health Organization 5th edition classification. These findings reflect a composite of underlying hemoglobinopathy-related changes and superimposed leukemic involvement from CML. In thalassemia, chronic ineffective hematopoiesis leads to increased hematopoietic drive and marrow hyperplasia, resulting in hypercellularity and rarely marrow fibrosis, as seen in this case [<span>1</span>]. These changes overlap morphologically with those of CML, which is also associated with myeloid predominance. Furthermore, myeloproliferation seen wit","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"931-933"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.70142","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147870755","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}

{"title":"Neutrophil-Mediated Platelet Phagocytosis: Implications of Anticoagulant Additives in Blood Collection Tubes for the Diagnosis of HIT","authors":"Mohammad Amir, Gregory Sergeant, Veerle Peeters","doi":"10.1111/ijlh.70141","DOIUrl":"10.1111/ijlh.70141","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"934-936"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147944049","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}

{"title":"Clonal Hematopoiesis and CAR T Cell Therapy: From Biological Crosstalk to Clinical Implications","authors":"Wei Du,&nbsp;Shunsuke Koga,&nbsp;Guang Yang,&nbsp;Saar Gill,&nbsp;Adam Bagg","doi":"10.1111/ijlh.70181","DOIUrl":"10.1111/ijlh.70181","url":null,"abstract":"<p>Clonal hematopoiesis (CH) is increasingly recognized as a significant biological phenomenon in aging and cancer, marked by the expansion of hematopoietic stem and progenitor cells harboring somatic mutations in genes associated with myeloid neoplasms. While CH is strongly linked to a spectrum of inflammatory diseases and hematologic malignancies, its role in shaping responses to cancer immunotherapy—especially chimeric antigen receptor (CAR) T cell therapy—has only recently begun to emerge. This review explores the interplay between CH and CAR T cell therapy, highlighting CH prevalence in treated populations, post-therapy clonal dynamics, inflammatory toxicities, and risk of therapy-related myeloid neoplasms. We also discuss the differential effects of specific CH mutations on hematopoiesis, immune cell function, and CAR T cell persistence. Understanding the functional implications of CH in the context of CAR T cell therapy holds the potential to refine patient selection, tailor toxicity management, and develop personalized immunotherapeutic approaches.</p>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"961-971"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.70181","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148303965","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}

{"title":"Acute Myeloid Leukemia With Florid Plasmacytoid Dendritic Cell Expansion and Aberrant Expression of CD19","authors":"Afshin Shameli,&nbsp;Russell K. Dorer","doi":"10.1111/ijlh.70101","DOIUrl":"10.1111/ijlh.70101","url":null,"abstract":"&lt;p&gt;A man in his 60s with no significant past medical history presented with fever, shortness of breath, severe pancytopenia (hemoglobin, 50 g/L, platelet, 9 × 10&lt;sup&gt;9&lt;/sup&gt;/L, neutrophil, 0.1 × 10&lt;sup&gt;9&lt;/sup&gt;/L) and circulating unclassified cells. Bone marrow aspirate smears revealed a predominance of two mononuclear cell populations: a population of blasts with round nuclei, dispersed chromatin, prominent nucleoli and scant cytoplasm, and a second population of cells with oval nuclei and elongated blue cytoplasmic pseudopods, morphologically compatible with plasmacytoid dendritic cells (pDCs) (Figure 1A–C). Dysplastic megakaryocytes were present. Blasts comprised approximately 40% of the marrow cellularity by CD34 immunostain (Figure 1D) and were positive for CD117 (Figure 1E), CD123 (moderate, Figure 1F), CD19 (moderate, Figure 1G), CD79a (dim/minor subset), myeloperoxidase (subset, Figure 1H), lysozyme (subset), and CD4 (dim/subset, Figure 1I), and negative for CD10 and CD20. pDCs comprised approximately 50% of the cellularity with bright expression of CD123 (Figure 1F), and were positive for CD4 (bright, Figure 1I), and CD19 (dim, Figure 1G), and negative for CD34 (Figure 1D), CD117 (Figure 1E), myeloperoxidase (Figure 1H), and lysozyme. Both populations were negative for CD56 (Figure 1J) and TCL1. Interestingly, pDCs formed sheets that were spatially separated from the sheets of blasts. Cytogenetic study showed a trisomy 11. Next-generation sequencing revealed mutations in &lt;i&gt;RUNX1&lt;/i&gt; (variant allele frequency (VAF), 34%), &lt;i&gt;U2AF1&lt;/i&gt; (VAF, 48%), and &lt;i&gt;FLT3&lt;/i&gt;-ITD (allele ratio, 0.970). Expression of B-lymphoid markers was insufficient for a mixed phenotype classification, and a diagnosis of acute myeloid leukemia with pDC expansion (pDC-AML) was established.&lt;/p&gt;&lt;p&gt;pDC-AML is defined by pDC differentiation more than 2% of the marrow elements [&lt;span&gt;1&lt;/span&gt;] and is characterized by a high frequency of &lt;i&gt;RUNX1&lt;/i&gt; alterations [&lt;span&gt;1-3&lt;/span&gt;] and poor prognosis [&lt;span&gt;1&lt;/span&gt;]. Other common mutations in pDC-AML include &lt;i&gt;ASXL1&lt;/i&gt;, &lt;i&gt;DNMT3A&lt;/i&gt;, &lt;i&gt;SRSF2&lt;/i&gt;, &lt;i&gt;BCOR&lt;/i&gt;, &lt;i&gt;NRAS&lt;/i&gt;, &lt;i&gt;FLT3&lt;/i&gt;, &lt;i&gt;TET2&lt;/i&gt;, &lt;i&gt;PHF6&lt;/i&gt;, &lt;i&gt;IDH1&lt;/i&gt;, &lt;i&gt;SF3B1&lt;/i&gt;, and &lt;i&gt;TP53&lt;/i&gt; [&lt;span&gt;1, 2&lt;/span&gt;]. The frequency of pDCs can be variable, ranging from 2% to 36%, with a median of approximately 7% [&lt;span&gt;1-3&lt;/span&gt;], and they often show interstitial distribution intermixed with blasts [&lt;span&gt;1, 2&lt;/span&gt;]. Here we report an unusual case of pDC-AML with florid pDC proliferation in sheets that are spatially separated from the sheets of blast. In addition to the &lt;i&gt;RUNX1&lt;/i&gt; mutation, the leukemia harbored &lt;i&gt;FLT3&lt;/i&gt;-ITD mutation that has been linked with increased pDC frequency in AML. We noted an unusual expression of CD19 both on blasts (strong) and pDCs (dim). Cross-lineage expression of B and T lymphoid markers such as cytoplasmic CD3, CD5, CD7, CD19, and cytoplasmic CD79a is commonly seen in pDC-AML [&lt;span&gt;1-3&lt;/span&gt;] with these markers are typi","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"919-920"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.70101","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147597129","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}

{"title":"Neither Fish nor Fowl-Cerebriform Variant of TCL1-Family Negative T-Prolymphocytic Leukemia","authors":"Ting Hon Stanford Li,&nbsp;Ching Tung Yuen,&nbsp;Shing Po Chan,&nbsp;Ka Yan Ng,&nbsp;Wai Shan Wong","doi":"10.1111/ijlh.70140","DOIUrl":"10.1111/ijlh.70140","url":null,"abstract":"","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"928-930"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847886","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}

{"title":"Validation of Automated Fragmented Red Cell Count by the Sysmex XN-9000: Correlation With Microscopy and Impact of Microcytosis/Hypochromia","authors":"Xian Cai,&nbsp;Guiling Li,&nbsp;Hongying Tang,&nbsp;Jin Zhao,&nbsp;Fei Ma","doi":"10.1111/ijlh.70171","DOIUrl":"10.1111/ijlh.70171","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>This study aimed to evaluate the analytical performance and screening performance of fragmented red cell (FRC) enumeration by the reticulocyte (RET) channel of the Sysmex XN-9000 automated hematology analyzer and to determine its correlation with manual microscopy with a specific focus on the confounding effects of microcytosis and hypochromia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Peripheral blood samples from 209 patients with anemia who had positive FRC% flagged by the analyzer and 200 healthy individuals were analyzed. The FRC percentage (FRC%) was measured both by the automated analyzer and by standard manual microscopy. Statistical analyses, including correlation studies, receiver operating characteristic (ROC) curve, and Bland–Altman agreement analysis, were performed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The area under the ROC curve for instrument-measured FRC% was 0.927, indicating potential diagnostic screening performance. Using manual microscopy as the reference method, the correlation coefficient for FRC% measured by the RET channel was 0.66, indicating a moderate correlation between the two methods. Bland–Altman analysis revealed a mean bias of −0.91% (limits of agreement: −4.61% to 2.79%) with 78.9% of instrument results reading higher than microscopy. The upper reference limit for FRC% in the healthy cohort was established at 0.17%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The automated FRC% measurement on the XN-9000 serves as an effective screening tool. However, confirmatory manual microscopic review remains essential for samples with positive automated results or those exhibiting abnormal MicroR% and Hypo-He% values.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"1040-1046"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148304368","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}

{"title":"Performance of Automated Hematology Analyzer Criteria in Detecting Peripheral Blood Smear Abnormalities: A Systematic Literature Review","authors":"Elizabeth L. Courville,&nbsp;Michelle Grant,&nbsp;Emily Mason,&nbsp;Xueyan Chen,&nbsp;Giuseppe d'Onofrio,&nbsp;Ben Hedley,&nbsp;John L. Frater,&nbsp;Madhu M. Ouseph,&nbsp;Gina Zini,&nbsp;Stefanie McFadden,&nbsp;Jin-Yeong Han,&nbsp;Cara Shirai,&nbsp;Amrom Obstfeld,&nbsp;Lauren H. Yaeger,&nbsp;Olga Pozdnyakova","doi":"10.1111/ijlh.70139","DOIUrl":"10.1111/ijlh.70139","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>Criteria for visual examination of stained peripheral blood smear (PBS) differ among institutions in the United States and internationally. In an effort to standardize review criteria, the International Consensus Group for Hematology Review (ICGHR) proposed in 2005 a consensus list of rules for CBC findings that should trigger a review of automated cell counter results and potentially lead to further testing or blood smear review. The primary aim of this paper is to report on the published literature in the past 20 years regarding PBS review criteria and their ability to identify relevant peripheral blood abnormalities.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We performed a systematic review of the published literature from 2005 to 2025 to investigate and summarize PBS review criteria and performance in the context of automated hematology analyzers in clinical laboratories.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 5351 citations, 68 studies met our search criteria. These studies included 22 countries and all major hematology analyzer manufacturers. Marked variability was observed in study populations, analyzer flagging criteria, details of PBS visual review, definitions of a “positive” smear, and approaches to statistical data analysis. Across studies, the blast flag sensitivity ranged from 18% to 100% while the blast flag specificity ranged from 17% to 100%. Wide ranges in sensitivity/specificity were also seen for atypical and/or abnormal lymphocyte flags across studies. For studies analyzing the same patient population, less striking variation was seen across instruments.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This systematic review provides a 20-year overview of the literature, highlighting significant variability in PBS review criteria, dependence on study design and hematology analyzer, and the importance of developing harmonized evidence-based guidelines.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"1008-1022"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ijlh.70139","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147876935","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}

{"title":"Hemoscreen Point-of-Care Analyzer Compared With Sysmex XN-1000 for Complete Blood Count in Pediatric Inpatients Aged 2 Months to 17 Years","authors":"Alessio Correani,&nbsp;Beatrice Niccoletti,&nbsp;Marianna Pavani,&nbsp;Michela Sampaolo,&nbsp;Lucia Finaurini,&nbsp;Michela Pelloso,&nbsp;Martina Montagnana,&nbsp;Marco Moretti","doi":"10.1111/ijlh.70167","DOIUrl":"10.1111/ijlh.70167","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>HemoScreen is an image-based point-of-care (POC) hematology analyzer that performs complete blood counts (CBC) from small blood volumes with minimal handling. These features are particularly relevant in pediatrics; however, comparative evidence with central laboratory analyzers in children remains limited.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We compared HemoScreen POC with Sysmex XN-1000 analyzer in 141 venous K₂-EDTA samples from pediatric inpatients aged 2 months–17 years. The primary outcome was analytical agreement for white blood cells (WBC), red blood cells (RBC), and platelets (PLT). Secondary outcomes included: (1) analytical agreement for hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), and mean platelet volume (MPV); and (2) diagnostic agreement for WBC, HGB, MCV, and PLT categories. Analytical agreement was evaluated using Passing-Bablok regression, Bland–Altman analysis, and proportions exceeding total allowable error (TEa) thresholds; Spearman's correlation was used to assess the strength of association between methods. Diagnostic agreement was quantified with Cohen's <i>κ</i> before and after Passing-Bablok alignment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Correlations were strong to excellent, with no significant deviation from linearity. Mean biases were below the minimum acceptable limits for most parameters. Using the Passing-Bablok regression as the reference line, the proportion of measurements exceeding limits was below 10% for WBC, RBC, PLT, and most other CBC indices in at least one of the tested TEa thresholds. Diagnostic agreement was excellent for leukopenia, leukocytosis, thrombocytopenia, anemia, and elevated HGB; good-excellent for thrombocytosis and macrocytosis; and good for microcytosis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>In venous samples from pediatric inpatients (2 months–17 years), HemoScreen showed high analytical and diagnostic agreement with the Sysmex XN-1000, supporting its use in children's hospitals.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"1023-1031"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148213890","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}

{"title":"Clinical Validation of the MC-80 Digital Morphology Analyzer in Leukocyte Classification: A Large-Scale Comparison With Manual Microscopy","authors":"Lianjie Zhang,&nbsp;Yuhong Qin,&nbsp;Hongbin Yu,&nbsp;Lin Wang","doi":"10.1111/ijlh.70170","DOIUrl":"10.1111/ijlh.70170","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Although AI-powered digital morphology analyzers are widely used for leukocyte classification, their reliability in detecting clinically significant abnormal cells requires rigorous validation. We evaluated the Mindray MC-80 system by comparing its results with those of conventional hematology analyzers and manual microscopy to assess accuracy, sensitivity, and diagnostic limitations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We analyzed 1188 routine blood samples (881 normal, 307 abnormal). Preclassification results from the MC-80 were compared with hematology analyzer results for normal samples and with manual microscopy by senior morphologists for abnormal samples. Inter-method agreement was assessed by Passing–Bablok regression, and sensitivity and specificity were calculated using expert-reviewed findings as the reference standard.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The MC-80 preclassification demonstrated excellent correlation with reference assays, with <i>r</i> values greater than 0.9 for the majority of leukocyte subsets. Overall specificity reached over 99% for all cell populations. Excluding blasts and reactive lymphocytes, the sensitivity for all remaining cell types was higher than 90%. For clinically critical abnormal cells, the system attained 75% sensitivity for plasma cells (≥ 1%) and over 90% for the other five abnormal cell groups. Its specificity was above 90% for all abnormal cells except blasts, which had a specificity of 86.73%. Expert review further increased the correlation coefficients by 0.31% to 5.71%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The MC-80 provides robust performance for routine leukocyte classification, with a screening capability for most abnormal cells comparable to that of manual microscopy. However, its reduced sensitivity for reactive lymphocytes, blasts, and plasma cells indicates that it cannot fully replace manual review. Targeted optimization is therefore warranted before full integration into diagnostic workflows.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14120,"journal":{"name":"International Journal of Laboratory Hematology","volume":"48 5","pages":"1032-1039"},"PeriodicalIF":2.2,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148274103","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}