Search Results (69)

Background: Reliable platelet (PLT) measurement is crucial for the accurate diagnosis of thrombocytopenia. Several methods exist for automated PLT counting, including the impedance method (PLT-I), as well as optical and fluorescence methods (PLT-F). The impedance method is cost-effective but susceptible to interference from small red blood cells and schistocytes. In contrast, fluorescent assessment offers higher specificity but is more expensive, as it requires additional dyes and detectors. Hybrid platelet counting (PLT-H) combines impedance with measurements from the leukocyte differentiation channel and is available without additional cost. Aim: The aim of this study was to evaluate the accuracy of hybrid PLT counting in anemic samples. Methods: In this retrospective study, PLT counts from 583 unselected anemic samples were analyzed using two different analyzers: the Sysmex XN3500, equipped with fluorescent PLT-F technology, and the Mindray BC6200, which uses both impedance (PLT-I) and hybrid (PLT-H) technologies. Agreement between PLT-I and PLT-F, as well as between PLT-H and PLT-F, was assessed using Bland–Altman plots. Correlation between the methods was evaluated using the Pearson correlation coefficient. Results: The hybrid method demonstrated better accuracy in PLT counting compared to the impedance method. Correlation between PLT-H and PLT-F was excellent, ranging from 0.991 to 0.999. In thrombocytopenic samples (PLT < 50 G/L), the hybrid method also provided more reliable PLT counts than the impedance method, reducing the number of falsely elevated PLT results by nearly fivefold. Conclusions: Hybrid platelet counting yields more accurate results than the impedance method in anemic samples and shows excellent correlation with the fluorescence method. Full article

Background: We evaluated the Sysmex Highly Integrated Single-Cartridge Luminescence Immunoassay System (HISCL) hs-cTnT assay, and compared its performance to the Roche assay, with derivation of 99th-percentile upper reference limits (99% URLs) for healthy subjects. We assessed the effect of increasing age/decreasing eGFR on the HISCL hs-cTnT. Methods: We verified assay limits of blank/detection, precision and the functional sensitivity. Samples were analyzed on both the Sysmex HISCL and Roche Elecsys analyzers for method comparison. Results: The HISCL assay limit of blank/detection was 1.3/1.9 ng/L, and concentrations corresponding to 20/10% CVs were 1.8/3.3 ng/L. Assay precision of kit controls at 3253 ng/L was 2.2% and at 106 ng/L was 2.5%. Linear regression analysis (n = 2151) showed good agreement (r = 0.95) with the Roche hs-cTnT. Bland–Altman (Roche/HISCL) analysis for samples with hs-cTnT ≤ 52 ng/L showed a mean absolute difference of 3.5 ng/L; for hs-cTnT > 52 ng/L, the mean difference was 2.8%. In a cardio-renal healthy population (n = 1004), the 99% URLs were 14.4/17.0/13.9 ng/L for overall/male/female, respectively; assay CV% was below 10% at these levels. More than 50% of the hs-cTnT in the healthy male and female subjects were measurable above the limit of detection. Hs-cTnT increased with increasing age and decreasing eGFR. Conclusions: In conclusion, the Sysmex HISCL hs-cTnT fulfils the criteria for a high-sensitivity assay, with specific 99th URLs for males and females. Expectedly, the baseline Sysmex hs-cTnT increases with age and decreasing eGFR. Full article

Background/Objectives: The gold standard for cerebrospinal fluid leukocyte counting is manual counting in a Fuchs–Rosenthal chamber. Recent advances in automated body-fluid-counting systems, offering a time- and labor-saving solution, are challenging this dogma. Yet, the equivalence of diagnostic accuracy is still debated in the community. Methods: We compared manual and automated cell counting of cerebrospinal fluid samples of lumbar punctures and extraventricular drains with both low and high leukocyte counts, shedding light on the variability of results between man and machine. Results: Automated and manual cell counting showed a strong correlation across all samples, particularly in the subgroup of patients with fewer than 20 cells/µl, where outliers could become especially clinically relevant. Conclusions: We found the automated counting system to be highly accurate and not lacking in diagnostic sensitivity even at low cell counts, making it a powerful tool when used in the right clinical setting. Full article

Objective: Accurate total hemoglobin concentration (ctHb) measurement is critical for clinical decision-making, particularly in acute care, where immediate therapeutic decisions are required. This study evaluated previously established laboratory-based accuracy criteria for ctHb measurements in routine clinical practice at an interdisciplinary operative intensive care unit (IO-ICU), and with particular attention to significantly reduced hemoglobin concentrations. Method: Remaining blood from blood gas analysis (BGA) cuvettes was collected directly at the ICU bedside. From these initial samples, three clinically relevant measurement scenarios were established: direct bedside measurement (Group 01), elevated ctHb levels (Group 02), and lowered ctHb concentrations below 9 g/dl (Group 03). The samples were analyzed using the GEM 4000, GEM 5000 (Werfen GmbH, Muenchen, Germany), ABL90 Flex plus (Radiometer GmbH, Krefeld, Germany), HemoCue Hb 201+, and XN 9000/9100 (Sysmex Deutschland GmbH, Norderstedt, Germany) automatic hematology analyzers. Since each measurement device inherently possesses systematic deviations, no single analyzer was defined as an absolute reference. Instead, the mean value across all tested measurement systems was utilized as a best-fit reference (REF) value. Results: A total of 120 data pairs from 40 ICU patients were analyzed using regression analyses, Bland and Altman (B&A) methods, and tolerance level analysis (TLA). The results demonstrated strong concordance among the evaluated measurement devices across the examined ctHb spectrum (~1–18 g/dL). Moderate systematic deviations identified by B&A analysis were most pronounced at critically low ctHb levels (<6 g/dL). A key outcome was the determination of 95% prediction intervals (PIs), representing a quantifiable range of uncertainties for future bedside measurements. The PIs for Group 03 “low” were in the range of ±7% (relative difference) or ±0.38 g/dL (absolute difference). Conclusion: This study effectively translates previous laboratory findings into clinical practice, highlighting the practical utility of PIs to guide the accurate interpretation of bedside ctHb measurements under acute care conditions. Full article

Background: The significance of cell population data (CPD) and leukocyte scattergrams in COVID-19 has not been fully established, partly due to the absence of serial leukocyte monitoring before and after SARS-CoV-2 infection. This study first examined changes in these parameters in non-immunosuppressed subjects over the course of infection. Subsequently, these findings were compared with those observed in patients who were immunosuppressed to assess the impact of immunosuppression. Methods: In total, 48 patients with COVID-19 were analyzed. Complete blood count (CBC) results and CPD were assessed using a Sysmex XN-9000 hematological analyzer. Results: The control and IST groups had similar clinical characteristics regarding COVID-19 severity and baseline CBC and CPD. WBC and neutrophil counts showed no significant changes immediately post onset; however, they decreased in the control group and increased in the IST group. Platelet counts decreased transiently on days 3–5 in both groups. The control group’s lymphocyte counts significantly dropped, but their lymphocyte-related CPD remained unchanged. The IST group experienced delayed lymphocyte recovery and showed reduced DNA/RNA content and cell size diversity. Scattergrams immediately after onset showed an increase in lymphocyte clusters, particularly juvenile lymphocytes, in the control group, while they decreased in the IST group. In the control group, mature neutrophils decreased while immature neutrophils increased. Conversely, the percentage of mature neutrophils increased in the IST group. Both groups showed minimal plasmacytoid lymphocyte clusters after onset. Conclusions: Immunosuppression impairs juvenile cell mobilization, which may increase susceptibility to viral impacts and potentially worsen prognosis by increasing the risk of infection. Full article

Hematological studies provide essential information about the health of animals, which is crucial for veterinary medicine, scientific research, and aquaculture. Automatic hematological analyzers are an alternative to manual methods, offering faster and more reliable results. The objective of this study was to validate the Sysmex XN-1000V automatic hematology analyzer for blood samples from rainbow trout (Oncorhynchus mykiss), examine the effects of two anticoagulants (K₂EDTA and lithium heparin), and establish normal blood reference values for this fish species. Additionally, comparative studies were conducted between the Sysmex XN-1000V and manual methods (hemocytometer cell count and blood smear estimation), and reference intervals were established. Ninety-nine heparinized blood samples were analyzed for validation and sample stability tests. The results showed extremely good precision, with a coefficient of variation (CV) below 3% for RBCs, HGB, and HCT and less than 5% for non-RBC cells (leukocytes plus thrombocytes). However, heterophils (%) exhibited higher variability, with a CV of 15.08%. Linearity was excellent, and the carry-over was below 1% for all parameters. The sample stability test indicated that samples could be analyzed for up to 48 h when stored at 4 °C and up to 24 h at room temperature. Non-RBC cells were the first to degrade over time. The automated and manual methods demonstrated good correlation and agreement, validating the analyzer’s accuracy. The effects of two anticoagulants, K₂EDTA and lithium heparin, on the blood samples were also studied. Heparin was the preferred anticoagulant for routine hematological analysis of rainbow trout blood with the Sysmex XN-1000V analyzer. In conclusion, the Sysmex XN-1000V enables complete hemogram analyses to be performed quickly and accurately, standardizing techniques, harmonizing results, and providing reliable reference intervals with O mykiss blood. Full article

Background/Objectives: Mac-2 binding protein glycosylation isomer (M2BPGi) is a novel biomarker for liver fibrosis, and its prognostic role has never been explored in coronavirus disease 2019 (COVID-19). We compared the M2BPGi level simultaneously with age, severe/critical disease, the sequential organ failure assessment (SOFA) score, and the National Early Warning Score 2 (NEWS2) in a total of 53 hospitalized patients with COVID-19 (mild/moderate [n = 15] and severe/critical [n = 38]). Methods: M2BPGi levels were measured using the HISCL M2BPGi assay (Sysmex, Kobe, Japan) in an HISCL-5000 analyzer (Sysmex), and clinical outcomes were analyzed according to M2BPGi and the clinical variables, using the receiver operating characteristic (ROC) curve, Kaplan–Meier survival, and Cox proportional hazards regression analyses. Results: M2BPGi levels differed significantly according to disease severity, 30-day mortality, and 60-day mortality (p = 0.045, 0.011, and 0.002, respectively). In the ROC curve analysis, the M2BPGi, age, SOFA score, and NEWS2, except for severe/critical disease, significantly predicted clinical outcomes (all p < 0.01). In the survival analysis, the hazard ratios of M2BPGi added to each clinical variable were higher than that of each clinical variable alone, and M2BPGi was the only independent prognostic factor for the mortality. Conclusions: This study demonstrated that M2BPGi may be a useful biomarker for assessing disease severity and clinical outcomes in hospitalized COVID-19 patients. Combined with conventional clinical assessment, M2BPGi would provide objective and valuable information for prognosis prediction in these critically ill patients. Further studies are warranted to extend its utility in other clinical settings. Full article

The objective of this study was to assess the performance characteristics of the new automated haematology analyser from Sysmex Corporation, the Sysmex XR-Series, compare its performance to the Sysmex XN-Series through method comparison, and compare our results to previously published literature. Analytical performance of the new Sysmex XR-20 consisting of precision, bias, and total error, a method comparison with the Sysmex XN-2000, and the flagging performance evaluation were conducted on a Sysmex XR-20 analyser in the AZ Sint-Lucas Hospital (Bruges, Belgium) several months before its launch in Europe. We conclude that the Sysmex XR-Series is an excellent successor to the Sysmex XN-Series for routine haematology analysis. Analytical performance and flagging efficiency are comparable to the Sysmex XN-analyser. Full article

Background/Objectives: Liquid biopsy methods have gained prominence as minimally invasive tools to improve cancer treatment outcomes. Circulating tumor cells (CTCs) offer valuable insights into both primary and metastatic lesions. However, validating the CTC test results requires confirmation that the detected cells originate from cancer tissue. While studies have identified CTCs in colorectal cancer (CRC) patients using molecular markers, simultaneous validation of their cancer tissue origin remains unexplored. Methods: This study introduces a simple approach to detect adenomatous polyposis coli (APC) gene abnormalities alongside established CTC markers using a molecular imaging flow cytometer (MI-FCM). Given that APC gene abnormalities occur in 60–70% of CRC patients, their detection serves as strong evidence of cancer origin. Results: Our method achieved 92% concordance with DNA sequence analysis of tumor-derived cells. In a proof-of-concept study using 5 mL of whole blood from CRC patients, we observed a high frequency of cells exhibiting APC abnormalities, cytokeratin (CK), and vimentin (Vim) expression. Extending the study to 80 CRC patients across pathological stages I–IV confirmed CK and Vim as valid CTC markers. Three distinct cell populations were identified in blood: CK+/Vim−, CK+/Vim+, and CK−/Vim+. CTC number and frequency increased progressively with cancer stage. Conclusions: This is the first report demonstrating CK and Vim as effective markers for direct CTC detection in CRC patients. Our findings provide evidence-based validation of CTC markers, offering new insights and advancing approaches for patient care. Full article

Background: The International Normalized Ratio (INR) monitors anticoagulant treatment but relies on laboratory-based services. This could limit access to rapid monitoring and increase the diagnostic delay, both of which may be addressed by point-of-care testing (POCT). This study investigated the LumiraDx POC platform for INR monitoring. Methods: INR was measured on recalcified residual venous (n = 94) specimens from Chris Hani Baragwanath Hospital and capillary blood specimens (n = 254) from consenting enrolled participants at Charlotte Maxeke Johannesburg Academic Hospital Anticoagulation clinic, Johannesburg, South Africa. Standard-of-care (SOC) INR was measured on sodium-citrated venous blood using the Sysmex-CS2500 platform (Siemens Healthcare) and Neoplastin-R (Roche Diagnostics and Diagnostica Stago, Paris, France) within 2 h post-venipuncture. Within run, precision was measured using 2 LumiraDx control levels. The statistical agreement of paired INR measurements was also stratified by dosing decision. Results: The precision was within the manufacturer’s claim for controls (level 1%CV: 3.63, level 2%CV: 2.24). Accuracy analysis showed a moderate overall agreement compared to the SOC INR results with a correlation coefficient of 0.94 (95% Cl, (0.9267 to 0.9497)). The overall precision (ρ > 0.9) and accuracy (C_b = 0.9842) were good with an absolute bias of 0.07. The 95% confidence intervals for the slope and intercept did not include 1.00 and 0.00, respectively; however, the total calculated error was within the minimal acceptable limits. Conclusion: The LumiraDx INR Test showed a good performance compared to laboratory-based testing and provided opportunity for rapid and patient-centric care. Owing to an increasing positive bias for INR > 3.5, confirmation with laboratory INR measurements may be required. Full article

The Sysmex XN-1000V provides a percentage and concentration of basophils from the WNR scattergram, as for human samples, but this method has been shown to be irrelevant in cats. This study aimed to characterize the feline basophil distribution on the WDF channel and to preliminarily evaluate the performance of a new basophil gate on the WDF channel. Cases of feline basophilia were retrospectively retrieved and the scattergram from the WDF and WNR channels were evaluated for any consistent pattern. A new gating setting for the WDF channel was created to include the suspected basophil region. This new gating was applied retrospectively to identified basophilia cases and prospectively to randomly selected feline cases. Manual, WNR, and new WDF methods for basophil identification were compared. Nine cases of feline basophilia were identified. A characteristic WDF scattergram was identified in seven of the nine cases. A new gate was created on the WDF channel and applied to these and 34 additional cases. The comparison study showed that the new method of basophil quantification using the WDF scattergram correlated better with the manual method than the Sysmex XN-1000V method using the WNR scattergram. Basophil concentration in feline peripheral blood can be determined using a new gate on the WDF channel of the Sysmex XN-1000V, which provides better performance than the WNR channel and is comparable to the manual method. Full article

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led the medical and scientific community to explore the pathogenesis and clinical manifestations of coronaviruses. In felines, a widespread coronavirus known as feline coronavirus (FCoV) can lead to feline infectious peritonitis (FIP), a highly fatal disease characterised by severe systemic inflammation. Diagnosing FCoV remains challenging due to the limited accuracy of the available methods. The present study introduces the FIP Effusion Index, a novel diagnostic method that combines the albumin-to-globulin (ALB/GLOB) ratio with the delta total nucleated cell (∆TNC) count obtained via flow cytometry using the Sysmex XN-1000V^® analyser in effusions. Samples from cats (n = 50) with suspected FIP were analysed for ∆TNC, with findings showing that a ∆TNC ≥ 2.1 is highly indicative of FIP and a ∆TNC ≥ 4.9 can be considered diagnostic. The FIP Effusion Index enhanced diagnostic precision in our group of samples, achieving 96.3% sensitivity and 95.7% specificity for values ≥ 5.06, and reaching perfect specificity (100%) with 96.3% sensitivity for values ≥ 7.54. This combined approach surpasses the accuracy of individual parameters, establishing the FIP Effusion Index as a superior diagnostic tool for FIP, with potential applications in both veterinary and human medicine for related coronavirus diseases. Full article

Air pollution contributes significantly to morbidity and mortality globally. The Niger Delta Region of Nigeria flares the second largest amount of natural gas in the world, with residents of oil-producing communities bearing the burden of outdoor pollution that may have adverse effects on their health and well-being. Our study aimed to investigate the haematological indices of residents of a selected gas-flaring site. We conducted a cross-sectional study, wherein a total of eighty adults aged 24 to 73 years were recruited from communities located within a radius of approximately 5 to 10 km from the gas-flaring facility. Blood specimens were collected from consenting participants and analysed for various haematological parameters, including Red Blood Cell (RBC) count, Packed Cell Volume (PCV), Haemoglobin (HB), Mean Cell Haemoglobin (MCH), platelet count (PLT), White Blood Cell (WBC) count, neutrophil (NEU), lymphocytes (LYMs), and Monocyte + Basophil + Eosinophil (MXD). The analysis was performed using an automated Sysmex KX21N haematological analyser. Overall, there was a significant decrease in RBC counts (p < 0.001) and a significant elevation in WBCs (p < 0.001) among people residing within a 5 km radius compared to those residing within a 10 km radius. About 42.5% of males residing within a 5 Km radius exhibited low RBC counts in contrast to only 15% of males residing within a 10 km radius. The WBC levels were found to be significantly higher (p < 0.001) than the reference range among both males and females residing within a 5 km radius compared to those residing at a distance of 10 km. In the female population, 15% of individuals residing within a 5 km and 10 Km radius exhibited RBC levels below the reference category, while 7.5% showed RBC levels above the reference range. Exposure to gas flaring may alter haematological indices. It is, therefore, recommended that a comprehensive longitudinal study be conducted among residents of oil-producing communities and workers at gas-flaring facilities in the Niger Delta region of Nigeria to assess the potential environmental and health implications of their exposure to chemical pollutants. Full article

Chronic hemorrhagic anemia (CHA) and anemia of chronic inflammation (ACI) are difficult to differentiate in small animals using hematology. Advanced hematological parameters (RET-He, Delta-He and %Hypo-He) are used in humans to discriminate between types of non-regenerative anemia. Whether they could be useful in the diagnosis of CHA and ACI in small animals is unknown. We evaluated these parameters in the Sysmex XN-1000V analyzer in a population of non-anemic and anemic dogs and cats. Delta-He was significantly different between dogs with CHA and ACI. Moreover, Delta-He and RET-He were different between healthy and non-anemic dogs with inflammation. Neither of these two statements was true for cats. We also report the reference ranges for these parameters using the Sysmex XN-1000V. Although additional clinical and laboratory information should always be considered, the measurement of these parameters using this analyzer can help clinicians to classify type of anemia. Full article

Background: Aging is characterized by a decline in the cardiovascular hemodynamic response, which may be aggravated by undernutrition. However, no study has evaluated whether low caloric intake may affect cardiovascular hemodynamics and its possible relation with functional capacity and immune response in older adults. Methods: Sixty-one older adults of both genders were enrolled in this study and were classified as normocaloric (n = 18) and hypocaloric (n = 43). All volunteers were evaluated for cardiovascular hemodynamics using impedance cardiography (PhysioFlow^®); functional capacity by the 1′ sit-to-stand test with SpO₂ monitoring; whole-blood analysis using an automated hematocytometer (Sysmex^®); and levels of IL-6, TNF-alpha, IL-10, and Klotho by ELISA. Results: The hypocaloric group presented impaired functional capacity, measured by a reduced number of sit-to-stand repetitions (p < 0.0251) and impaired delta of SpO₂ (p < 0.0307). In contrast, the hypocaloric group presented an improved stroke volume (p < 0.0352), systemic vascular resistance (p < 0.0075), and systemic vascular resistance index (p < 0.0184). In addition, no changes were observed in the whole-blood analysis (p > 0.05) or for IL-6 (p > 0.05), TNF-alpha (p < 0.05), IL-10 (p < 0.05), and Klotho (p > 0.05). Conclusions: A long-term hypocaloric diet in eutrophic older adults’ resulted in an enhanced cardiovascular hemodynamic response but was associated with reduced functional capacity without changes in the immune response. Full article