International journal of laboratory hematology最新文献

{"title":"Multicenter Interlaboratory Study of Thrombin Generation Assay in Healthy Adults Using the ST Genesia Analyzer With the STG-ThromboScreen Reagent (With and Without Thrombomodulin).","authors":"Diego Velasco-Rodríguez, María Marcos-Jubilar, Inés Martínez-Alfonzo, Laura Martos, Carlos Aguilar, Noelia Vilalta, Dolors Llobet, Ana Marco-Rico, David Aragoneses, Pascual Marco, Luciana Ricca, David Ferreira, Sara Lopes, João Mariano-Pego, Ángel Bernardo, Antonio Moscardó, Santiago Bonanad, Susana Gassiot, Isabel Gutiérrez-Jomarrón, Jose Antonio Páramo, Pilar Llamas-Sillero, Joan Carles Reverter","doi":"10.1111/ijlh.70168","DOIUrl":"10.1111/ijlh.70168","url":null,"abstract":"<p><strong>Introduction: </strong>Fully automated thrombin generation (TG) assays facilitate the transition from research to clinical application. We conducted a multicenter inter-laboratory study using the ST Genesia analyzer to evaluate assay performance and establish reference intervals in healthy adults from Spain and Portugal.</p><p><strong>Methods: </strong>In this multicenter study, plasma samples from healthy adult volunteers were analyzed across 12 laboratories following a harmonized protocol. TG was measured using the STG-ThromboScreen reagent in the presence and absence of thrombomodulin (TM). Analytical performance and reference intervals were assessed.</p><p><strong>Results: </strong>Within-run and intra-day precision were excellent (coefficient of variation < 10%) for all TG parameters except velocity index. Normalization reduced interlaboratory variability for amplitude-based parameters such as endogenous thrombin potential (ETP) and peak height, whereas its effect was less pronounced for velocity index. Satisfactory interlaboratory performance (|z| ≤ 2) was achieved in 96%-98% of results, and normalized parameters showed minimal bias across centers. In 252 healthy adults, median normalized values were: ETP 131% (IQR 118-142), peak height 116% (IQR 104-127), lag time 2.6 min (IQR 2.3-2.8), and time-to-peak 5.5 min (IQR 5.0-5.9). Median ETP inhibition in the presence of TM was 47.2% (IQR 35.1-61.8). Age had a modest influence on TG parameters, whereas sex differences were observed.</p><p><strong>Conclusions: </strong>This multicenter interlaboratory study in the Iberian Peninsula demonstrates high reproducibility of TG measurement using the ST Genesia platform with the STG-ThromboScreen reagent. These findings support its use for standardized TG assessment and provide reference intervals for clinical and research settings.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1189-1200"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555124/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148213862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Point-Of-Care Testing of Fibrinogen by the qLab FIB System in Patients Taking Direct Oral Anticoagulants (DOACs).","authors":"Christopher Long, Stephen MacDonald, Andrea Myers, Claudia Rodiera, Sharad Agrawal, Florian Falter","doi":"10.1111/ijlh.70115","DOIUrl":"10.1111/ijlh.70115","url":null,"abstract":"<p><strong>Introduction: </strong>Fibrinogen deficiency is common in acute haemorrhage and requires prompt treatment to prevent exacerbation of coagulopathy. Conventional lab measurements are time consuming, leading to delayed intervention or empirical fibrinogen replacement, potentially exposing patients to unnecessary transfusion. The qLabs FIB system offers rapid point-of-care measurement of fibrinogen at the bedside; however, its use in patients taking Direct Oral Anticoagulants (DOACs) has not been evaluated.</p><p><strong>Methods: </strong>Thirty patients chronically anticoagulated with Apixaban or Edoxaban undergoing catheter ablation procedures for atrial fibrillation were recruited. Citrated blood samples were taken from each patient and assessed using the qLab FIB system, and lab-based Clauss assay (HemosIL Q.F.A. Thrombin (QFA), Werfen, Bedford, USA). DOAC levels were also measured, then removed using DOAC-Remove (Quadratech, UK) to assess their impact. Statistical analysis was performed using Bland-Altman, Passing-Bablok regression and paired t-tests.</p><p><strong>Results: </strong>A strong linear correlation (r = 0.88) was observed between the two methods; however, the qLabs FIB system consistently overestimated fibrinogen levels compared to the Clauss assay, with a mean bias of +0.50 g/L (95% LOA: -0.03 to +1.02 g/L). The Passing-Bablok slope of 0.64 suggested that overestimation might be more pronounced at lower fibrinogen concentrations. DOAC presence did not significantly alter measurement results (p = 0.380), and DOAC concentration did not correlate with the measurement discrepancy.</p><p><strong>Conclusion: </strong>The qLabs FIB system is a viable method for rapid assessment of fibrinogen levels in patients anticoagulated with DOACs. However, the presence of overestimation bias may have implications for clinical decision making.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1158-1164"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147792919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance Evaluation of the Sysmex 'RBC Defect Workflow Optimisation' Flag for the Detection of Haemoglobinopathies and Iron Deficiency Anaemia.","authors":"M Van Vlierberghe, H Louagie, T Ghys, S Degandt","doi":"10.1111/ijlh.70135","DOIUrl":"10.1111/ijlh.70135","url":null,"abstract":"<p><strong>Objectives: </strong>Haemoglobinopathies are among the most common inherited disorders worldwide. Early detection of heterozygous carriers remains essential for appropriate diagnosis and counselling. The Sysmex 'RBC Defect Workflow Optimisation' (RWO) flag is a recently introduced automated tool designed to identify red cell abnormalities suggestive of heterozygous haemoglobinopathies (HGB HTZ), sickle cell disease (SCD), and iron deficiency anaemia (IDA). This study evaluated the diagnostic performance of the RWO flag in routine practice.</p><p><strong>Methods: </strong>Over 6 months (March-August 2025), 405 samples flagged by RWO (HGB HTZ, SCD, IDA) were prospectively evaluated, and positive predictive values (PPVs) were calculated. In addition, a retrospective analysis of the RWO HGB HTZ, SCD flag was performed on 122 consecutive haemoglobin analyses to assess diagnostic accuracy metrics. Finally, the HGB HTZ β-thalassaemia flag was compared with an external discriminant index, %MicroRBC/%HypoHe ratio (cut-off of 3.7).</p><p><strong>Results: </strong>Prospectively, the Sysmex RWO flag demonstrated PPVs of 81.9% for HGB HTZ, 68.7% for IDA, and 100% for SCD (n = 1). For IDA, PPV increased when analysis was restricted to different exclusion criteria. Retrospective sensitivity for HGB HTZ and SCD was only 25.0%, further clarified in this study. Diagnostic performance of the HGB HTZ β-thalassaemia flag was broadly comparable to that of the %MicroRBC/%HypoHe ratio.</p><p><strong>Conclusions: </strong>The Sysmex RWO flag represents a feasible and effective screening tool for heterozygous haemoglobinopathies and sickle cell disease in routine clinical practice. Despite modest retrospective sensitivity, its high predictive value and workflow efficiency support its use as a trigger for targeted haemoglobin analysis in everyday laboratory diagnostics.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1211-1217"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147847940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Tfh Cells and Related Molecules in CML-CP Patients With Different Molecular Responses.","authors":"Yulian Wang, Suxia Geng, Xiaomei Chen, Lisi Huang, Xin Huang, Qiong Luo, Lingji Zeng, Ping Wu, Yuchen Zhang, Kaifan Liu, Xin Du, Jianyu Weng, Peilong Lai","doi":"10.1111/ijlh.70160","DOIUrl":"10.1111/ijlh.70160","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to characterize T follicular helper (Tfh) cell differentiation and related molecular profiles in chronic-phase chronic myeloid leukemia (CML-CP) patients with distinct molecular responses and to explore immune correlates of treatment outcomes.</p><p><strong>Methods: </strong>Peripheral blood CD4⁺ T cells were analyzed in 125 CML-CP patients (8 newly diagnosed, 71 MMR, and 46 pre-MMR) and 22 healthy donors. We assessed CD4⁺ T subset distribution and expression of Tfh-related molecules including Bcl6, Blimp1, PD-1, PD-L1, and PD-L2.</p><p><strong>Results: </strong>Newly diagnosed and pre-MMR patients exhibited decreased CD4⁺ T cell proportions compared to healthy donors and MMR patients (p < 0.05), while pre-MMR patients had elevated frequencies of CD4⁺CXCR5⁺PD-1⁺ Tfh cells and increased PD-1 expression on CD4⁺ T cells (p < 0.05). Bcl6, PD-1, and PD-L1 were upregulated in pre-MMR cases, whereas Blimp1 and PD-L2 remained unaltered.</p><p><strong>Conclusion: </strong>Pre-MMR CML-CP is accompanied by aberrant Tfh cell differentiation and an immunosuppressive immune signature linked to suboptimal molecular responses. Targeting immune checkpoints or modulating Tfh cell homeostasis may help improve therapeutic outcomes in CML-CP.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1133-1140"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148201723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Performance of the STic Expert HIT Kit and the Diagnostic Dilemma of Borderline Results in Heparin Induced Thrombocytopenia.","authors":"Surbhi Dahiya, Jyoti Kotwal, Sabina Langer, Pallavi Prakhar, Sachita Pandey","doi":"10.1111/ijlh.70127","DOIUrl":"10.1111/ijlh.70127","url":null,"abstract":"<p><strong>Introduction: </strong>Rapid immunoassays are widely used for diagnosing heparin-induced thrombocytopenia (HIT). The STic Expert HIT kit is commonly employed, but its diagnostic accuracy in unselected, real-world populations requires robust evaluation against an appropriate reference standard. This study evaluates the diagnostic accuracy of the STic Expert HIT kit using the heparin-induced platelet aggregation test (PAT) as the comparator.</p><p><strong>Methods: </strong>This cross-sectional diagnostic accuracy study was conducted from January 2023 to April 2025. A consecutive series of 320 patients with suspected HIT underwent parallel testing with the STic Expert HIT kit (index test) and PAT (comparator). The 4T score was calculated prospectively for all patients. Borderline visual results on the STic kit were classified according to epidemiological recommendations: as false negative if PAT-positive and false positive if PAT-negative. Diagnostic accuracy measures-sensitivity, specificity, predictive values, and likelihood ratios-were calculated with 95% confidence intervals. The study is reported in accordance with the STARD 2015 checklist.</p><p><strong>Results: </strong>Among 320 consecutive patients (median age 45.6 years; range 0.19-89), the prevalence of PAT-confirmed HIT was 16.3% (52/320). Following the STARD guidelines, the STic Expert HIT kit demonstrated a sensitivity of 57.5% (95% CI: 42.2-71.6) and specificity of 92.5% (95% CI: 88.8-95.1). The positive predictive value was 58.8% (95% CI: 46.2-70.4) and negative predictive value was 92.1% (95% CI: 89.6-94.1). The positive likelihood ratio was 7.67 (95% CI: 5.10-11.52) and negative likelihood ratio was 0.46 (95% CI: 0.32-0.66). The area under the ROC curve was 0.75 (95% CI: 0.67-0.83). Borderline results constituted 6.6% (21/320) of tests; of these, 33.3% (7/21) were true positives and 66.7% (14/21) were false positives.</p><p><strong>Conclusion: </strong>In this large, real-world diagnostic accuracy study, the STic Expert HIT kit demonstrated limited sensitivity for HIT diagnosis. The test is not suitable for ruling out HIT due to its suboptimal sensitivity. Borderline results are common and require integration with pre-test probability. These findings highlight the need for confirmatory functional testing in suspected HIT, particularly in high-probability settings.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1165-1172"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147792942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Somatic Mutations on Treatment Response and Resistance in Chronic Myeloid Leukemia.","authors":"Shruti Mishra, Kailash Kumar, Dinesh Kumar, Ashwin Kamak, Lovely Singh, Nilesh Kumar","doi":"10.1111/ijlh.70165","DOIUrl":"10.1111/ijlh.70165","url":null,"abstract":"<p><strong>Introduction: </strong>Tyrosine kinase inhibitors (TKIs) have transformed the treatment of chronic myeloid leukemia (CML); yet, diverse molecular responses and resistance persist. BCR::ABL1 kinase-domain (TKD) mutations constitute just a fraction of this resistance, and the impact of additional somatic mutations on disease progression and early molecular response remains incompletely defined.</p><p><strong>Methods: </strong>This single-centre cohort study analyzed 109 NGS-tested patients with CML, comprising 44 with TKI-resistant disease and 65 newly diagnosed patients. Targeted next-generation sequencing using a 135-gene myeloid panel was performed on 109 patients. An additional pilot subgroup of 30 TKI-resistant patients underwent BCR::ABL1 kinase-domain analysis by PCR/Sanger sequencing and was analyzed separately. Molecular response was assessed using BCR::ABL1 transcript levels on the International Scale and interpreted according to ELN 2020 recommendations.</p><p><strong>Results: </strong>Somatic mutations were identified in 52.3% of TKI-resistant and 29.2% of newly diagnosed patients. All Cohort 1 blast-crisis patients were mutation-positive, and several concurrent abnormalities were more common in Cohort 1 than in Cohort 2, indicating clonal complexity. In Cohort 2, MMR was achieved in 28/39 (71.8%) mutation-negative and 6/13 (46.2%) mutation-positive patients. Mutation-positivity at baseline was associated with reduced MMR chances but not statistically significant (odds ratio 0.34; 95% confidence interval 0.09-1.23; p = 0.099). ASXL1 emerged as the most common non-ABL1 mutation but was not statistically significant.</p><p><strong>Conclusions: </strong>In this Indian CML cohort, somatic mutations were prevalent in TKI-resistant disease, linked to advanced phase and clonal complexity, and demonstrated a non-significant trend toward lower early MMR at diagnosis, highlighting the importance of genomic testing in this context.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1141-1148"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555106/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148201818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunophenotypic, Genetic, and Clinical Features Associated With RUNX1 Mutation in Acute Leukemias and Chronic Myeloid Neoplasms.","authors":"Yi Han Xia, Eric McGinnis","doi":"10.1111/ijlh.70145","DOIUrl":"10.1111/ijlh.70145","url":null,"abstract":"<p><strong>Introduction: </strong>RUNX1 is a commonly mutated transcriptional regulator of hematopoiesis in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Mutated RUNX1 (mRUNX1) may associate with cross-lineage immunophenotypic aberrancy, presenting potential complications for blast lineage assignment at diagnosis.</p><p><strong>Methods: </strong>Clinical and laboratory data were reviewed for patients with RUNX1 mutations (N = 125) at Vancouver General Hospital from 2016 to 2022. Diagnostic flow cytometry data were reanalyzed, and RUNX1 mutation characteristics and associations with pathologic, comutation, and flow cytometric features were assessed.</p><p><strong>Results: </strong>Missense RUNX1 mutations (overall 42.9% missense, 57.1% truncating) were enriched in the runt homology domain (RHD; 81.7%, Adj. p = 0.011). Several recurrent hotspot mutations were seen, including common hotspot variants. The most commonly comutated genes with RUNX1 in both acute leukemia with mRUNX1 and MDS-mRUNX1 were ASXL1 (44.4%; 59.3%), SRSF2 (40.7%; 37.3%), and TET2 (35.8%; 55.9%). The mRUNX1 group demonstrated frequent positivity for B-lymphoid markers, with 14.4% having increased expression in at least three B-lineage markers. Differences in antigen expression were associated with RUNX1 mutation type and location, with increased CD10 expression associated with RUNX1 mutations in the RHD (Adj. p = 0.02764), and increased CD79a expression associated with RUNX1 missense mutations (Adj. p = 0.004452).</p><p><strong>Conclusion: </strong>In our cohort, we observed missense variants clustering in the RHD and recurrence of common pathogenic variants. Higher-risk comutations were found in a substantial fraction of mRUNX1 cases which may contribute to its adverse risk associations. Comparable degrees of aberrancy in B-lineage markers were seen in mRUNX1 patients versus the comparator cohorts of MPAL-wtRUNX1 and AML with rearranged RUNX1.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":"1094-1102"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147950510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"VEXAS Syndrome Associated With a Non-Canonical UBA1 p.Ala478Ser Variant: Diagnostic and Clinical Implications.","authors":"Ilaria Scarpelli, Mario Uhr, Leda Leoncini, Ida Martinelli","doi":"10.1111/ijlh.70254","DOIUrl":"https://doi.org/10.1111/ijlh.70254","url":null,"abstract":"","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149120892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the HemoScreen Point-Of-Care Haematology Analyser With Sysmex XN, Beckman Coulter DxH 560 and HORIBA Yumizen H550 in Patients With Abnormal Blood Counts.","authors":"Katarína Hradská, Martin Pulcer, Michaela Skořupová, Tereza Popková, Michal Kaščák, Jana Mihályová, Ivo Demel, Barbora Dluhošová, Kateřina Benková, Juraj Ďuraš, Soňa Kolářová, Veronika Hanzelková, Simona Pulcerová, Roman Hájek","doi":"10.1111/ijlh.70253","DOIUrl":"https://doi.org/10.1111/ijlh.70253","url":null,"abstract":"<p><strong>Introduction: </strong>HemoScreen is a portable point-of-care testing (POCT) haematology analyser capable of measuring 20 complete blood count (CBC) parameters, including a 5-part leukocyte differential, from venous and capillary blood. This study compared selected CBC and white blood cell (WBC) differential parameters obtained using HemoScreen with those from three conventional haematology analysers: Sysmex XN, Beckman Coulter DxH 560, and HORIBA Yumizen H550 in abnormal samples.</p><p><strong>Methods: </strong>Venous and capillary blood was collected from 137 patients with haematological disorders and healthy donors. We evaluated WBC, absolute neutrophil count (ANC), haemoglobin (HGB), and platelets (PLT). Statistical analysis included Passing-Bablok regression analysis, Cusum test, Wilcoxon signed-rank test, and Hodges-Lehmann median difference analysis.</p><p><strong>Results: </strong>Comparison of venous and capillary blood measurements using HemoScreen demonstrated no significant deviation from linearity for any evaluated parameter according to the Cusum test (p = 0.14-0.98). Although statistically significant differences were observed for ANC (p = 0.0201) and PLT (p = 0.0026), the median differences remained small and clinically irrelevant. Comparison of venous blood measurements between HemoScreen and conventional analysers demonstrated strong analytical agreement without significant deviation from linearity. Statistically significant differences were observed in several comparisons, particularly for PLT and HGB measurements; however, the approximate relative bias remained within external quality assessment limits in most comparisons, with greater variability for PLT in the ≤ 50 × 10⁹/L subgroup.</p><p><strong>Conclusions: </strong>HemoScreen demonstrated good analytical agreement with all evaluated haematology analysers and may represent a reliable complementary POCT tool for routine haematological monitoring, including patients with abnormal blood counts.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149066885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Differentiating β-Thalassaemia From Iron Deficiency: Performance and Cut-Off Dependency of More Than 40 Red Cell Discrimination Indices in a Large German Cohort.","authors":"Rafid Al-Nabhan, Dani Hakimeh, Lena Oevermann","doi":"10.1111/ijlh.70252","DOIUrl":"https://doi.org/10.1111/ijlh.70252","url":null,"abstract":"<p><strong>Background: </strong>Since the 1970s, more than 40 red blood cell-based formulas have been proposed to differentiate β-thalassaemia trait (BTT) from iron deficiency (ID) and iron deficiency anaemia (IDA), the main causes of microcytic anaemia. In Germany, where haemoglobinopathies are rare in the autochthonous population but increasingly encountered due to migration, rapid, low-cost screening tools are of growing importance. This study benchmarked more than 40 published discrimination indices (1973-2024) in a large laboratory dataset and explored new formulas.</p><p><strong>Methods: </strong>In a retrospective analysis, 1316 of 5715 screened records met predefined criteria and were stratified into a BTT group (n = 953) and an ID/IDA group (n = 363). Diagnostic performance was assessed using sensitivity, specificity, Youden's index and ROC analysis.</p><p><strong>Results: </strong>No established index reliably separated BTT from ID/IDA, and performance was strongly cut-off-dependent: the best indices reached AUCs of approximately 0.80 with their published cut-offs (e.g., Wongprachum, 0.803) but up to 0.879 on cut-off-independent ROC analysis (Jayabose), indicating that published cut-offs are not directly transferable between populations. In the independent test dataset, three newly derived formulas performed comparably to the best published indices (AUCs 0.916-0.923 vs. up to 0.915); rather than outperforming existing models, their advantage lies in offering selectable cut-offs for sensitivity-, specificity- or balance-oriented use.</p><p><strong>Conclusions: </strong>Local validation of discrimination indices and cut-offs is essential before clinical use. Simple CBC-based formulas may serve as low-cost preselection tools to identify individuals requiring further evaluation. As the new formulas were validated internally only, external validation is required before clinical application.</p>","PeriodicalId":94050,"journal":{"name":"International journal of laboratory hematology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149027195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}