International journal of laboratory hematology最新文献

Objectives: The all-trans-retinoic acid (ATRA) treatment used in acute promyelocytic leukemia (APL) has the particularity of inducing differentiation of the leukemia cells. As a result, within the same smear, several stages of cellular differentiation of the granular lineage are present, which can make it difficult to distinguish elements when counting cells.

Methods: The aim of this study is to use the technical data from Sysmex haematology equipment in patients with APL to improve their cytological monitoring and harmonize blood count results from one operator to another. We collected 132 samples from patients with APL over a period of 45 days from the day of diagnosis and divided them into two groups: presence or absence of blast cells on the blood smear.

Results: Seven parameters of leukocyte subpopulations were selected for cytological monitoring. We developed a decision algorithm based on these, including decision thresholds for predicting the presence or absence of blasts. These data were verified on a validation cohort of 110 samples with APL, set up at a different site from the training cohort. The algorithm predicted the presence of blast cells in these samples with a sensitivity of 84.6% and a specificity of 86.7%.

Conclusion: In the context of cytological monitoring of patients with APL, the study of technical data has not been developed yet, despite the fact that this is a difficult and sometimes nonhomogeneous task from one operator to another. The proposed algorithm could be a facilitating tool in cytology to harmonize practices both within and between sites.

Background: G6PD deficiency affects about 500 million people worldwide and is prevalent in many malaria-endemic settings. People with G6PD deficiency are at risk of hemolysis when exposed to certain medications, including 8-aminoquinoline drugs used to treat Plasmodium vivax malaria. Increasing access to testing for G6PD deficiency at or near the point of care is critical to expanding the safe treatment of P. vivax malaria. We aimed to evaluate the performance of a semiquantitative test for G6PD deficiency, the SD Biosensor Standard G6PD Test with the Brewer's method, in a reference site for the treatment of infectious diseases.

Method: We evaluate the diagnostic accuracy performance of the SD Biosensor Standard G6PD Test in 125 individuals with infectious diseases and other illnesses.

Main results: We observed a trend of concordance between the G6PD status (Deficient or Normal), with low frequencies of discordances in the screenings. The strength of agreement between G6PD tests was classified as almost perfect in all participants (k = 0.82, 95% CI = 0.66, 0.97) and in sex subgroups: females (k = 0.83, 95% CI = 0.59, 1.00) and males (k = 0.81, 95% CI = 0.59, 1.00). The total concordance percentage (number of concordances/total) was 95% for females, 97% for males, and 96% overall.

Conclusion: The SD Biosensor STANDARD G6PD test is an innovative point-of-care solution. It offers quantitative measurement of glucose-6-phosphate dehydrogenase activity while normalizing for hemoglobin levels. This advancement enables its use in lower-tier clinical and laboratory settings, expanding access to accurate G6PD testing.

Introduction: This study provides a comprehensive verification and comparative evaluation of four hematology analyzers (HA) with a five-part differential blood count (5-DIFF) (Siemens Advia 2120i, Sysmex XN-1000, Mindray BC-5310CRP, Beckman Coulter DxH 900).

Methods: The parameters of complete blood count (CBC) with 5-DIFF were examined. The verification protocol assessed precision, accuracy, linearity, limits of blank (LoB), detection (LoD) and quantification (LoQ), and carryover. Advia 2120i served as the reference HA for accuracy assessment. Statistical analysis was performed using MedCalc and MS Excel. Acceptance criteria followed manufacturer specifications and biological variability analytical performance specifications (APS).

Results: All analyzers showed acceptable precision for most CBC parameters, while XN-1000 and DxH 900 showed the best repeatability. BC-5310 CRP showed the highest proportion of parameters exceeding acceptance criteria: low leukocytes in control (2.9%), and low platelets (6.1%) as well as low (16.4%) and high (4.1%) leukocytes in patient samples. Advia 2120i showed suboptimal repeatability at low hemoglobin in control (53 g/L, CV 1.1%) and low leukocytes (4.7%) for patient samples. Platelet repeatability varied most (CV 5.4%-9.7%). Platelet accuracy was significantly different on XN-1000 (p = 0.04) and BC-5310CRP (p = 0.05). Determined LoQ for leukocytes were: 0.1 (Advia 2120i) and 0.3 × 10⁹/L (XN-1000, BC-5310CRP, DxH 900). LoQ for platelets: 3 (Advia 2120i), 4 (XN-1000), 5 (DxH 900), and 10 × 10⁹/L (BC-5310CRP). Linearity was confirmed for all, wherein Mindray had slightly wider 95%-CI. No carryover was observed.

Conclusion: While all analyzers demonstrated acceptable performance for the majority of evaluated specifications, Sysmex XN-1000 and Beckman Coulter DxH 900 achieved the most favorable overall performance.

Introduction: We investigated the stability and accuracy of platelets with MgSO₄ and compared the results of blood counts between MgSO₄ and K2EDTA.

Methods: Platelet stability as a function of time was assessed on the XN Sysmex analyzer by comparing the percentage deviation to the desirable bias of the EFLM. Accuracy was determined by calculating the LoQ of platelets corresponding to a CV of 10%. Results from 250 patients were compared between K2EDTA and MgSO₄.

Results: At 20°C, platelets were stable for 24 h in impedance, 10 h in fluorescence and at 4°C for 4 h in impedance, 2 h in fluorescence. This decrease is related to the formation of platelet aggregates. For platelets in fluorescence, LoQ is 4 × 10⁹/L using MgSO₄. The results of the complete blood count did not differ between K2EDTA and MgSO₄ except for the MCV, for which the median relative bias (MRB) with respect to K2EDTA was -5.6%. For MgSO₄ platelets, the MRB is 2.9% in fluorescence and 11.9% in impedance.

Conclusion: The use of MgSO₄ with the XN produces results comparable to those obtained with K2EDTA, except for those related to MCV and for impedance platelets.

Introduction: D-dimers are produced by lysis of cross-linked fibrin. In children, D-dimer testing is used to evaluate disseminated intravascular coagulation (DIC) and some inflammatory states, but its use is not validated for screening or ruling out suspected venous thromboembolic events (VTE). In adults, D-dimers are used to evaluate DIC, and a low D-dimer level is used to exclude VTE in patients when combined with a low or moderate probability of VTE.

Methods: To assess D-dimer utilization and opportunities for improvement, we conducted a retrospective, consecutive-case cohort study (with ethics approval) of patients who had D-dimer tests at Hamilton hospitals, from 06/2022 to 05/2023.

Results: D-dimer levels were evaluated for 175 children and 200 adults (respective results, children/adults: median ages: 12/63, ranges 0-17/18-94 years), and an overlapping cohort of 99 consecutive persons with ≥ 5 D-dimer determinations. Most patients had D-dimer tests in emergency departments (60%/62%) and elevated D-dimer levels (55%/61%). Reasons for D-dimer assessment included: suspected VTE (50%/70%), DIC (17%/3.5%), childhood inflammatory conditions (23%/0%), and "off-label" uses (e.g., arterial thrombosis assessment; 5%/22%). VTE likelihood and DIC scores were rarely documented. Patients with multiple tests accounted for 15% of D-dimer workload. Among patients with multiple tests for DIC, most had overt DIC on initial assessment, with declining D-dimer levels over 10-14 days, including patients who died.

Conclusion: VTE and DIC assessment was the most common reason for D-dimer assessments for children and adults. Quality improvement initiatives are needed to improve relevant clinical VTE and DIC score documentation and D-dimer test utilization.

Introduction: Thrombosis is a leading cause of mortality in polycythemia vera (PV), yet little is known about early predictors of thrombosis progression. Emerging evidence links systemic inflammation to thrombosis risk. This study assessed hematological inflammatory parameters, including the neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), for their utility in predicting thrombosis progression in PV.

Methods: This retrospective study analyzed 102 PV patients (2008-2024) and 115 healthy controls. Clinical and laboratory data, including thrombotic events, were examined. Patients were stratified into low-and high-risk groups, further categorized by thrombosis progression. Inflammatory biomarkers were derived from baseline blood counts.

Results: Median follow-up was 51 months, the 10-year thrombotic events-free survival rate was 84.30%, and 21 patients (20.59%) showed thrombosis progression. PV patients had higher NLR, MLR, PLR, SII, SIRI, and AISI than controls. NLR, MLR, SIRI, and AISI were associated with an increased risk of thrombosis compared to the low-risk group. In the progression group, high monocytes, NLR, MLR, SIRI, AISI, and previous thrombosis were notably correlated. ROC analysis showed that MLR (AUC = 0.739), SIRI (AUC = 0.714), AISI (AUC = 0.670), and NLR (AUC = 0.649) had the highest predictive ability for thrombosis progression. Multivariate analysis identified MLR (HR = 6.979) and previous thrombosis (HR = 4.494) as independent risk factors.

Conclusion: These findings support recent reports linking systemic inflammation to thrombosis risk in PV patients and highlight for the first time that MLR may serve as a valuable prognostic biomarker for thrombotic events.

Introduction: Numerous algorithms based on recent developments of additional parameters on last generation haematology analysers have opened new perspectives for hereditary spherocytosis (HS) screening. Although some studies have demonstrated significant age-related variation for reticulocyte-derived parameters, these algorithms did not consider patients' age. Moreover, the apparent lack of short-term stability of some parameters could represent an obstacle to their use if not performed as first-line testing. This study aimed to identify robust and discriminating parameters that could be used for HS screening at any patients' age.

Methods: After an evaluation of the reference values and stability of the additional parameters offered by the Sysmex XN-9000, we retrospectively collected and analysed the haematological parameters of 103 confirmed HS patients and 124 controls. The HS group was also compared to 116 samples from patients affected with other red blood cell or iron disorders.

Results: Our findings confirm that the reticulocyte count (Ret) and its ratio to the immature reticulocyte fraction (Ret/IRF) are the most effective and robust parameters for HS screening, with stability up to 48 and 96 h at room temperature (RT) and 4°C, respectively. The Ret/IRF ratio was mostly affected by patients' age rather than haemoglobin levels. We therefore proposed different algorithms that can be adapted to the laboratory's needs and that incorporate age-specific thresholds for Ret/IRF. The combination of Ret and Ret/IRF allowed a sensitivity between 91.3% and 100% and a specificity between 77.1% and 94.2%.

Conclusions: This new age-dependent algorithm using Sysmex's most stable parameters offers an easy-to-use tool for HS screening, even in cases of delayed or residual blood analysis.

Chronic lymphocytic leukemia (CLL) is the most common low-grade B-cell neoplasm worldwide. While diagnostic criteria are well established, prognostication and management of this disease are an evolving field, owing to the biological and clinical heterogeneity of CLL. Molecular, cytogenetic, and immunogenetic workup are key in the management of CLL, and include evaluation for specific gene variants, copy number variants (CNVs), and detailed analysis of the immunoglobulin heavy chain variable region (IGHV) with respect to somatic hypermutation (SHM) status and the presence of recurrent stereotyped IGHV subsets. IGHV status has significant prognostic, predictive, and therapeutic implications in CLL and has been incorporated into multiple risk stratification systems. The advent of both next-generation sequencing (NGS) and novel targeted therapies has added further complexity to immunogenetic analysis in CLL. Owing to the necessity and growing complexity of IGHV analysis, the European Research Initiative on CLL (ERIC) developed guidelines to standardize methods for immunogenetic analysis and provide recommendations for interpretation of challenging cases (including multiple productive IGHV clones and discordant SHM status) and has published multiple updates, revising recommendations and raising new questions. This review discusses the biology and clinical significance of IGHV status in CLL as well as laboratory methodology in immunogenetic analysis, the evolution of the ERIC recommendations leading into the era of NGS, and recent advances and emerging strategies in this field.

Introduction: Coagulation tests are crucial for diagnosing hemostatic disorders. However, preanalytical errors, particularly sample clotting, may compromise test accuracy and lead to clinical misinterpretation. As not all clots are detectable by visual inspection, this study characterized clotted citrated samples to establish objective criteria for clot identification.

Methods: Routine coagulation assays-including PT, APTT, fibrinogen, D-dimer, FDP, fibrin monomer complex (FMC), plasmin-α2 plasmin inhibitor complex (PIC), and thrombin-antithrombin complex (TAT)-were performed, and 101 paired specimens from 101 patients who required blood recollection were analyzed. Among the 77 specimens with visible clots, coagulation profiles were analyzed to identify cut-off values and develop logistic regression models. The models were subsequently validated using an additional 24 abnormal but clot-free specimens.

Results: Clotted samples showed significantly shortened APTT and elevated FDP, FMC, PIC, and TAT levels. Shortening of APTT by ≥ 3.1 s relative to the reference was a reliable indicator of clotting. Combining APTT with TAT or FMC provided high diagnostic accuracy (AUC: 0.969 and 1.000, respectively). We established a "Clotting Score" to assess sample viability even without visible clots. FDP and PIC increased progressively with time in clotted samples.

Conclusion: Sample clotting substantially affects the accuracy of coagulation tests. Shortened APTT and elevated FMC and TAT serve as reliable indicators, with FDP and PIC offering time-sensitive supplementary clues. This multimodal approach could help standardize criteria for sample rejection and recollection, thereby improving test reliability and supporting clinical decisions.

With the advent of effective multikinase and selective tyrosine kinase inhibitors in systemic mastocytosis, diagnosing this rare disease has been critical to improving patient morbidity and mortality. This state-of-the-art review interprets the international diagnostic criteria, including differences between the WHO 5th edition classification and the International Consensus Classification. Subclassification of systemic mastocytosis is critical for correct therapeutic strategies, and diagnostic difficulties are described for the practicing pathologist. Morphologic mimics, which require alternative treatment, are discussed.