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1.
PLoS One ; 19(9): e0296766, 2024.
Article in English | MEDLINE | ID: mdl-39240990

ABSTRACT

BACKGROUND: Malaria control depends primarily on rapid and accurate diagnosis followed by successful treatment. Light microscopy is still used as a gold standard method for the diagnosis of malaria. The Sysmex hematology analyzer is a novel method for malaria detection. Therefore, the aim of this review was to investigate the diagnostic accuracy of the Sysmex hematology analyzer for malaria diagnosis. METHODS: Electronic databases like PubMed, PubMed Central, Science Direct databases, Google Scholar, and Scopus were used to find relevant articles from April to June 14, 2023. The studies' methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Using Review Manager 5.4.1, the estimates of sensitivity and specificity, as well as their 95% confidence intervals, were shown in forest plots. Midas software in Stata 14.0 was utilized to calculate the summary estimates of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio. Heterogeneity was assessed by using I2 statistics. In addition, publication bias was assessed using a funnel plot and Deeks' test. Sub-group and meta- regression analysis were also performed. RESULTS: A total of 15 studies were assessed for diagnostic accuracy. The sensitivity and specificity of Sysmex hematology analyzer for studies ranged from 46% to 100% and 81% to 100%, respectively. The summary estimate of sensitivity and specificity of Sysmex hematology analyzer were 95% (95% CI: 85%-99%) and 99% (95% CI: 97%-100%), respectively. It had excellent diagnostic accuracy. There were significant heterogeneity among the studies included in this meta-analysis. The summary estimate of sensitivity and specificity of Sysmex hematology analyzer using polymerase chain reaction as the gold standard was 97.6% (95% CI: 83.2, 99.7) and 99.4% (98.5, 99.8), respectively. CONCLUSION: In this review, Sysmex hematology analyzer had excellent diagnostic accuracy. Therefore, it could be used as an alternate diagnostic tool for malaria diagnosis in the hospital and health center. TRIAL REGISTRATION: Systematic review registration PROSPERO (2023: CRD42023427713). https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023427713.


Subject(s)
Malaria , Humans , Hematologic Tests/instrumentation , Hematologic Tests/methods , Hematology/instrumentation , Hematology/methods , Malaria/diagnosis , Malaria/blood , Sensitivity and Specificity
2.
Clin Lab ; 70(7)2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38965963

ABSTRACT

BACKGROUND: Immunohematology skill education is an important part of the transfusion medicine professional training. We tried to solve the difficulty of obtaining suitable and sufficient positive samples in the immunohematology education. METHODS: Different identification panels and panel cells were created by RhD-positive red blood cells (RBCs) and RhD-negative RBCs, according to the underlying antibodies. Diluted anti-D reagent was used as simulated plasma for identification. RESULTS: The antibody identification of single antibody with dose-effect and two antibodies present at the same time were successfully simulated. CONCLUSIONS: It is a practical and cheap method for antibody identification training to use RhD blood group, especially when positive samples are short.


Subject(s)
Blood Grouping and Crossmatching , Rh-Hr Blood-Group System , Humans , Rh-Hr Blood-Group System/immunology , Rh-Hr Blood-Group System/blood , Blood Grouping and Crossmatching/methods , Erythrocytes/immunology , Isoantibodies/blood , Isoantibodies/immunology , Hematology/methods , Rho(D) Immune Globulin/immunology , Rho(D) Immune Globulin/blood , Transfusion Medicine/methods
3.
J Thromb Haemost ; 22(9): 2629-2652, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39043543

ABSTRACT

BACKGROUND: Hemophilia is a rare congenital bleeding disorder that results from complete or partial deficiency of blood coagulation factor (F)VIII (hemophilia A) or FIX (hemophilia B) due to pathogenic variants in their coding genes. Hemophilia requires complex management. To date, there is no evidence-based clinical practice guideline on hemophilia treatment based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. OBJECTIVES: This evidence-based clinical practice guideline from the International Society on Thrombosis and Haemostasis aims to provide an overview of evidence and support patients, caregivers, hematologists, pediatricians, other clinicians, researchers, and stakeholders in treatment decisions about congenital hemophilia A and B. METHODS: The International Society on Thrombosis and Haemostasis formed a multidisciplinary guideline panel of physicians and patients with global representation, balanced to minimize potential bias from conflicts of interest. The panel prioritized a set of clinical questions and outcomes according to their importance for clinicians and patients. A methodological team supported the guideline development process, including searching for evidence and performing systematic reviews. The GRADE approach was used, including GRADE Evidence to Decision frameworks. The recommendations were subject to public comment. RESULTS: The panel selected 13 questions, of which 11 addressed the treatment of hemophilia A and 2 the treatment of hemophilia B. Specifically, the panel addressed questions on prophylactic and episodic treatment with FVIII concentrates, bypassing agents, and nonfactor therapy (emicizumab) for hemophilia A (with and without inhibitors) as well as immune tolerance induction for hemophilia A. For hemophilia B, the panel addressed questions on prophylactic and episodic treatment of bleeding events with FIX concentrates. Agreement was reached for all 13 recommendations, of which 7 (54%) were based on evidence from randomized clinical trials, 3 (23%) on observational studies, and 3 (23%) on indirect comparisons. CONCLUSION: Strong recommendations were issued for prophylactic over episodic treatment for severe and moderately severe hemophilia A and B. Only conditional recommendations were issued for the remaining questions. Future research should focus on direct treatment comparisons and the treatment of hemophilia B with and without inhibitors. Future updates of this guideline will provide an updated evidence synthesis on the current questions and focus on new FVIII and FIX concentrates, novel nonfactor therapies, and gene therapy for severe and nonsevere hemophilia A and B.


Subject(s)
Evidence-Based Medicine , Hemophilia A , Hemophilia B , Humans , Coagulants/therapeutic use , Consensus , Evidence-Based Medicine/standards , Factor VIII/therapeutic use , Factor VIII/genetics , Hemophilia A/blood , Hemophilia A/genetics , Hemophilia A/therapy , Hemophilia A/diagnosis , Hemophilia B/blood , Hemophilia B/therapy , Hemophilia B/diagnosis , Hemophilia B/genetics , Hemorrhage/blood , Hemostasis , Societies, Medical , Treatment Outcome , Hematology/methods , Hematology/standards
4.
J Nanobiotechnology ; 22(1): 363, 2024 Jun 24.
Article in English | MEDLINE | ID: mdl-38910248

ABSTRACT

Fluorescence nanoscopy, also known as super-resolution microscopy, has transcended the conventional resolution barriers and enabled visualization of biological samples at nanometric resolutions. A series of super-resolution techniques have been developed and applied to investigate the molecular distribution, organization, and interactions in blood cells, as well as the underlying mechanisms of blood-cell-associated diseases. In this review, we provide an overview of various fluorescence nanoscopy technologies, outlining their current development stage and the challenges they are facing in terms of functionality and practicality. We specifically explore how these innovations have propelled forward the analysis of thrombocytes (platelets), erythrocytes (red blood cells) and leukocytes (white blood cells), shedding light on the nanoscale arrangement of subcellular components and molecular interactions. We spotlight novel biomarkers uncovered by fluorescence nanoscopy for disease diagnosis, such as thrombocytopathies, malignancies, and infectious diseases. Furthermore, we discuss the technological hurdles and chart out prospective avenues for future research directions. This review aims to underscore the significant contributions of fluorescence nanoscopy to the field of blood cell analysis and disease diagnosis, poised to revolutionize our approach to exploring, understanding, and managing disease at the molecular level.


Subject(s)
Blood Cells , Microscopy, Fluorescence , Animals , Humans , Blood Cells/ultrastructure , Blood Platelets/metabolism , Erythrocytes , Hematology/methods , Leukocytes/metabolism , Microscopy, Fluorescence/methods , Nanotechnology/methods
5.
Clin Lymphoma Myeloma Leuk ; 24(9): e293-e300, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38839449

ABSTRACT

Breast implant insertion for breast reconstruction or breast augmentation is a developing procedure, with high demand worldwide-being the second most common plastic surgery in the US as of 2022. Breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL) is T-cell, non-Hodgkin lymphoma, typically CD30+, ALK-, presenting with fluid collection in the inner aspect of the peri-implant capsule in most patients, with the onset exceeding 1-year after implantation. The mean time between breast implant insertion and BIA-ALCL development is 7-10 years. The main risk factor is the use of textured implants because of their susceptibility to triggering local inflammation and immune stimulation finally leading to lymphoproliferation. Genetic predispositions to hereditary breast cancer increase the risk of disease development as well. BIA-ALCL seems to be underestimated in many countries and the initial symptom-seroma might be overlooked and misdiagnosed. Despite its rarity, the awareness of the disease should be improved among patients and medical professionals. This paper summarizes epidemiology, etiopathogenesis, differential diagnosis, and treatment-both surgical and hematological approaches.


Subject(s)
Breast Implants , Lymphoma, Large-Cell, Anaplastic , Humans , Lymphoma, Large-Cell, Anaplastic/etiology , Breast Implants/adverse effects , Female , Breast Neoplasms/etiology , Surgery, Plastic , Breast Implantation/adverse effects , Hematology/methods , Risk Factors
6.
Curr Oncol ; 31(5): 2867-2873, 2024 05 16.
Article in English | MEDLINE | ID: mdl-38785499

ABSTRACT

Investigational drug services need to be organised in a structured approach, especially for sites with a large number of ongoing clinical trials. The aim of this study was to develop a tool to assess the complexity of pharmacy involvement in a sponsored oncology clinical trial. Categorisation into ordinal complexity categories was used to assess the complexity of the clinical trials for consistent pharmacy grant applications. The 15 items of the tool were divided into three sections, and individual item scores were agreed upon among four pharmacists with experience in the conduct of clinical trials at two different centres. A final version of the tool, named Pharm-CAT, was approved. The pharmacists were instructed to use Pharm-CAT to assign a score to each new sponsored trial. To determine the cut-offs for the complexity categories, the scores were sorted in ascending order and the cut-offs corresponding to the first and third tertiles of the score distribution were selected. To verify the reproducibility of the results, Pharm-CAT was applied by two pharmacists independently for each trial. Pharm-CAT proved to be user-friendly. Sixty clinical trials were evaluated and a total of 120 scores were recorded. Low-complexity scores ranged from 0 to 19, medium-complexity scores ranged from 20 to 25, and high-complexity scores were 26 or higher. The average score recorded was 22.88 points. Prospective multicentre validation of Pharm-CAT is needed to confirm its applicability.


Subject(s)
Clinical Trials as Topic , Humans , Clinical Trials as Topic/methods , Workload , Pharmacists , Medical Oncology/methods , Neoplasms/drug therapy , Hematology/methods
7.
PLoS One ; 19(5): e0301845, 2024.
Article in English | MEDLINE | ID: mdl-38787860

ABSTRACT

Differential white blood cell counts are frequently used in diagnosis, patient stratification, and treatment selection to optimize therapy responses. Referral laboratories are often used but challenged with use of different hematology platforms, variable blood shipping times and storage conditions, and the different sensitivities of specific cell types. To extend the scientific literature and knowledge on the temporal commutability of blood samples between hematology analyzers, we performed a comparative ex-vivo study using four of the most utilized commercial platforms, focusing on the assessment of eosinophils given its importance in asthma management. Whole blood from healthy volunteers with and without atopy (n = 6+6) and participants with eosinophilic asthma (n = 6) were stored under different conditions (at 4, 20, 30, and 37°C, with or without agitation) and analyzed at different time points (3, 6, 24, 48 and 72h post-sampling) in parallel on the Abbott CELL-DYN Sapphire, Beckman Coulter DxH900, Siemens ADVIA 2120i and Sysmex XN-1000V. In the same blood samples, eosinophil-derived neurotoxin (EDN), eosinophil activation and death markers were analyzed. All platforms gave comparable measurements of cell differentials on fresh blood within the same day of sampling. However, by 24 hours, significant temporal and temperature-dependent differences were observed, most markedly for eosinophils. None of the platforms performed perfectly across all temperatures tested during the 72 hours, showing that handling conditions should be optimized depending on the cell type of interest and the hematology analyzer. Neither disease status (healthy vs. asthma) nor agitation of the sample affected the cell quantification result or EDN release. The eosinophil activation markers measured by flow cytometry increased with time, were influenced by temperature, and were higher in those with asthma versus healthy participants. In conclusion, hematology analyzer, time window from sampling until analysis, and temperature conditions must be considered when analyzing blood cell differentials, particularly for eosinophils, via central labs to obtain counts comparable to the values obtained in freshly sampled blood.


Subject(s)
Asthma , Eosinophils , Humans , Asthma/blood , Asthma/diagnosis , Eosinophils/cytology , Female , Male , Adult , Blood Cell Count/instrumentation , Blood Cell Count/methods , Leukocyte Count/instrumentation , Leukocyte Count/methods , Middle Aged , Hematology/instrumentation , Hematology/methods
8.
Sci Rep ; 14(1): 11176, 2024 05 15.
Article in English | MEDLINE | ID: mdl-38750071

ABSTRACT

Multiple Myeloma (MM) is a hematological malignancy characterized by the clonal proliferation of plasma cells within the bone marrow. Diagnosing MM presents considerable challenges, involving the identification of plasma cells in cytology examinations on hematological slides. At present, this is still a time-consuming manual task and has high labor costs. These challenges have adverse implications, which rely heavily on medical professionals' expertise and experience. To tackle these challenges, we present an investigation using Artificial Intelligence, specifically a Machine Learning analysis of hematological slides with a Deep Neural Network (DNN), to support specialists during the process of diagnosing MM. In this sense, the contribution of this study is twofold: in addition to the trained model to diagnose MM, we also make available to the community a fully-curated hematological slide dataset with thousands of images of plasma cells. Taken together, the setup we established here is a framework that researchers and hospitals with limited resources can promptly use. Our contributions provide practical results that have been directly applied in the public health system in Brazil. Given the open-source nature of the project, we anticipate it will be used and extended to diagnose other malignancies.


Subject(s)
Multiple Myeloma , Humans , Bone Marrow/pathology , Brazil , Hematology/methods , Machine Learning , Multiple Myeloma/diagnosis , Multiple Myeloma/pathology , Neural Networks, Computer , Plasma Cells/pathology
10.
Clin Lab ; 70(2)2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38345977

ABSTRACT

BACKGROUND: The benchtop ADVIA 560 AL hematology analyzer (Siemens Healthineers Tarrytown, NY, USA) offers a small footprint and ease of operation making it suitable for satellite laboratories and intensive care units. A verification study of this analyzer was performed. METHODS: Between- and intra-run precision, carry-over, linearity, and throughput were evaluated on the ADVIA 560 AL. Accuracy was assessed on 94 patient samples by comparing the results obtained on the ADVIA 560 AL to the results on the reference Sysmex XN1000 analyzer (Sysmex Corporation, Kobe, Japan). RESULTS: The ADVIA 560 AL showed acceptable imprecision on control material and minimal bias in comparison to the XN 1000 on patient samples with a throughput of 60 samples per hour. The percentage carryover was not significant and the linearity was within acceptable limits. CONCLUSIONS: The ADVIA 560 AL bench-top analyzer is suitable for acute care centers and satellite laboratories owing to its small footprint, ease of use, and reproducible and accurate results.


Subject(s)
Hematology , Humans , Blood Cell Count/methods , Reproducibility of Results , Hematology/methods , Laboratories , Japan , Leukocyte Count
11.
PLoS One ; 19(1): e0296344, 2024.
Article in English | MEDLINE | ID: mdl-38236796

ABSTRACT

The White Blood Cell (WBC) count is one of the key parameters signaling the health of the immune system. Abnormal WBC counts often signal a systemic insult to the body such as an underlying infection or an adverse side effect to medication. Typically, the blood collected is sent to a central lab for testing, and results come back within hours, which is often inconvenient and may delay time-sensitive diagnosis or treatment. Here, we present the CytoTracker, a fully electronic, microfluidic based instant WBC analyzer with the potential to be used at point-of-care. The CytoTracker is a lightweight, portable, affordable platform capable of quantifying WBCs within minutes using only 50 µl of blood (approximately one drop of blood). In this study, we clinically evaluated the accuracy and performance of CytoTracker in measuring WBC and granulocyte counts. A total of 210 adult patients were recruited in the study. We validated the CytoTracker against a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros 60). Linear dynamic ranges of 2.5 k/µl- 35 k/µl and 0.6 k/µl- 26 k/µl were achieved for total WBC count and granulocyte count with correlation coefficients of 0.97 and 0.98. In addition, we verified CytoTracker's capability of identifying abnormal blood counts with above 90% sensitivity and specificity. The promising results of this clinical validation study demonstrate the potential for the use of the CytoTracker as a reliable and accurate point-of-care WBC analyzer.


Subject(s)
Hematology , Microfluidics , Adult , Humans , Leukocyte Count , Leukocytes , Hematology/methods , Blood Cell Count
12.
Vet Clin Pathol ; 53(1): 8-39, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38164989

ABSTRACT

BACKGROUND: The Sysmex XN-1000V automated hematology analyzer with multispecies software was released in June 2017 for use in research laboratories. Laser light, impedance, fluorescent staining, and fluorescent flow cytometry are used to analyze whole blood for CBC, reticulocyte counts, and WBC counts, including a 5-part differential leukocyte analysis. OBJECTIVES: A side-by-side comparison of the Sysmex XN-1000V with the Siemens ADVIA 120 in analyzing blood from healthy mice and rats will provide insight into the performance of the new analyzer and its capabilities for use in drug development studies. Method correlation analyses on normal mouse and rat hematology data collected with both analyzers and manual reference methods will help determine the reliability of the data produced using the Sysmex XN-1000V analyzer. METHODS: Whole blood samples collected in K2 EDTA from healthy CD-1 mice and CD Sprague-Dawley rats were analyzed in parallel with the XN-1000V and ADVIA 120 analyzers. Male and female mice, approximately 6-9 weeks old, and male and female rats, approximately 7-9 weeks old, were included in this study. Manual reference methods for WBC differential leukocyte analysis and packed cell volume (PCV) measurements were also performed. EP Evaluator version 11.2 (Data Innovations LLC, South Burlington, VT, USA) was used for method comparison statistical analysis. RESULTS: Most hematologic parameters for naïve mice and rats achieved correlation in the fair to excellent range, with the majority showing very good to excellent correlation with low biases (<11.0%) for cohorts analyzed separately and when cohort data were combined. CONCLUSIONS: The Sysmex XN-1000V Hematology Analyzer provided comparable results to those obtained from the Siemens ADVIA 120. We found the Sysmex XN-1000V Hematology Analyzer to be acceptable for use in drug development studies for rats and mice.


Subject(s)
Hematology , Humans , Male , Female , Mice , Rats , Animals , Rats, Sprague-Dawley , Reproducibility of Results , Leukocyte Count/veterinary , Reticulocyte Count/veterinary , Hematology/methods
13.
Diagn Microbiol Infect Dis ; 108(4): 116193, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38295683

ABSTRACT

BACKGROUND: For fully automated detection and quantification of Plasmodium parasites, Sysmex developed the XN-31 hemocytometer. This study investigated whether the XN-31 can also detect and quantify bloodstream form trypanosomes (trypomastigotes). METHODS: Axenic cultures of Trypanosoma brucei brucei were used to prepare two dilution series of trypomastigotes in the whole blood of a healthy donor, which were subsequently examined by the XN-31 as well as by microscopic examination of thin and thick blood films. Trypomastigote intactness during the procedures was evaluated by microscopy. RESULTS: The XN-31 hemocytometer detected trypomastigotes with a detection limit of 26 trypomastigotes/µL. Scattergram patterns of Trypanosoma and Plasmodium parasites were clearly distinct, but current interpretation settings do not allow the identification of trypomastigotes yet, and therefore, need future refinement. CONCLUSION: Proof of concept was provided for an automated fluorescent flow cytometry method that can detect and quantify Plasmodium spp., as well as Trypanosoma brucei trypomastigotes.


Subject(s)
Hematology , Trypanosoma brucei brucei , Humans , Hematology/methods , Reproducibility of Results , Microscopy
14.
Int J Lab Hematol ; 46(1): 63-71, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37731006

ABSTRACT

INTRODUCTION: The Atellica Hema (Siemens Healthineers, Tarrytown, NY, USA) is a new generation multi-parameter analyzer for full blood count, 6-part differential and reticulocyte testing by impedance variation and fluorescence flow cytometry. In this study, we verified the whole blood and limited body fluid modes of the Atellica Hema 580. METHODS: We evaluated precision, linearity, carry-over, throughput and performed a method comparison to assess the performance of the Atellica Hema 580. For comparison of the Atellica Hema 580 with the Sysmex XN-1000 (Sysmex, Kobe, Japan), 140 samples from adult and pediatric patients including both normal and abnormal hematology profiles were analyzed in parallel. RESULTS: The Atellica Hema 580 demonstrated acceptable imprecision within the manufacturer's specifications for whole blood and body fluid modes, good linearity for high and low ranges and no significant carryover. The full blood count, differential and reticulocyte correlated well with the Sysmex XN-1000, except for mean cell hemoglobin concentration, basophil and large immature cells. The optical platelet count, reflexed in 34 samples with a platelet count <150 × 109 /l, showed a strong correlation with the fluorescent platelet count on the Sysmex XN-1000. The morphology flagging efficiency was 92% for white blood cells, 95% for red blood cells and 87% for platelets. CONCLUSION: The Atellica Hema 580 showed good analytical performance and workflow efficiency for a wide range of patient samples.


Subject(s)
Hematology , Adult , Humans , Child , Blood Cell Count/methods , Hematology/methods , Platelet Count/methods , Leukocytes , Blood Platelets , Reproducibility of Results
15.
J Equine Vet Sci ; 132: 104984, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38081332

ABSTRACT

Asinina de Miranda is a protected donkey sub-species from the Mirandês plateau in northeastern of Portugal. Donkeys are animals that have substantially lost their place as working animals in modern society, this had led to a decrease in their population numbers. A need to preserve native species has led to the foundation of organizations like Associação para o Estudo e Proteção do Gado Asinino (AEPGA) and the development of studies regarding breed welfare, such as hematology. The IDEXX ProCyte Dx is a veterinary hematology analyzer validated for several species, but not for donkeys. The aim of this study was to validate the ProCyte Dx for Asinina de Miranda donkeys. The validation requires a controlled study of precision, carryover, linearity and comparison between the equipment and the manually obtained values for the leukocyte differential count and hematocrit. Results indicated coefficient of variation was good (below 5 %) for both the intra-assay and the inter-assay precision, except for basophils. Carryover was 0 % for all the parameters except platelets (5.88 %). Linearity showed a very high Pearson correlation coefficient, above 0.99, for erythrocytes, hematocrit, hemoglobin, leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, platelets and plateletcrit. Comparison demonstrated excellent agreement for hematocrit (rs=0.96) and good Spearman rank correlation for neutrophils (rs=0.84) and lymphocytes (rs=0.90). Accuracy for total leukocyte count and platelets could not be determined. In conclusion, the ProCyte Dx seems appropriate to be used in Asinina de Miranda hematology.


Subject(s)
Equidae , Hematology , Animals , Blood Cell Count/methods , Blood Cell Count/veterinary , Reproducibility of Results , Leukocyte Count/veterinary , Hematology/methods
16.
Clin Chem Lab Med ; 62(4): 690-697, 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-37855253

ABSTRACT

OBJECTIVES: Automated hematology analysis is expected to improve the performance of platelet counting. We evaluated the performance of a new platelet counting, hybrid (PLT-H) and also impedance (PLT-I) and optical (PLT-O) on the BC-780 automated hematology analyzer compared to the international reference method (IRM) in blood samples with thrombocytopenic and platelet interference. METHODS: The basic platelet count performance of the BC-780 automated hematology analyzer was evaluated according to the requirements of the Clinical Laboratory and Standards Institute (CLSI) Document H26-A2. Additionally, the thrombocytopenic (low PLT count) blood samples and the platelet interference blood samples including fragmented red blood cells (RBCs), microcytes or small RBCs, and giant platelets were determined with the BC-780 hematology analyzer compared to the IRM. RESULTS: Blank counting and the carry-over contamination rate of platelet count using the BC-780 both met the manufacturers' claim. For both 123 thrombocytopenic and 232 platelet interference blood samples (72 fragmented RBCs, 91 microcytes and 51 giant platelets), all three platelet counting methods exhibited high comparability with the IRM (the lowest correlation (r)=0.916). Interestingly, the comparability of PLT-H (r=0.928-0.986) with the IRM was better than that of PLT-I (r=0.916-0.979). CONCLUSIONS: The performance of PLT-H in the BC-780 met the manufacturer's specifications. PLT-H exhibits better reproducibility than did PLT-I, correlates well with the PLT-O for thrombocytopenic samples and demonstrates good anti-interference ability. PLT-H counting is therefore recommended as a zero-cost alternative platelet counting method for platelet interference samples in clinical settings.


Subject(s)
Agmatine/analogs & derivatives , Hematology , Oxamic Acid/analogs & derivatives , Humans , Platelet Count/methods , Reproducibility of Results , Hematology/methods , Blood Platelets
17.
Clin Chem Lab Med ; 62(2): 303-311, 2024 Jan 26.
Article in English | MEDLINE | ID: mdl-37732424

ABSTRACT

OBJECTIVES: Implementation of alternate erythrocyte sedimentation rate (ESR) measurement method is increasing worldwide due to its various advantages. In this study, we aim to evaluate the analytical performance of the BC-780 automated hematology analyzer in measurement of ESR value. METHODS: Analyzer performance including precision study, carryover, sample stability and potential interferences are examined. Samples with ESR values spanning the whole analytical ESR range are included for method comparison study. Samples with different hematocrit (Hct) and mean corpuscular volume (MCV) values are also analyzed and compared with the results obtained from the Westergren reference method. RESULTS: Precisions and carryover results are consistent with the manufacturers' claim. ESR values do not change significantly in the samples stored at 2-8 °C for 24 h (h) or at room temperature (RT) for 8 h, but significantly decreased (p<0.001) when stored at RT for 24 h. Significant increase in ESR value is documented in samples that are hemolyzed (hemoglobin concentration ranged from 1.28-6.01 g/L) (p=0.010) or lipemic (triglyceride above 4.75 mmol/L) (p=0.001). Method comparison study yields a proportional difference with a regression equation=3.08+ 0.98x. Bland-Altman analysis shows a mean absolute bias of 3.12 mm. The obtained absolute mean biases are below 5 mm in all analytical categories except for the group where MCV>100 fL. CONCLUSIONS: Most tested parameters met the manufacturer's specifications and were comparable to the reference method. Despite the presence of positive bias, it falls within acceptable criteria. Extensive validation against potential interferences such as hemolysis/lipemia is still necessary in future.


Subject(s)
Hematology , Humans , Blood Sedimentation , Hematology/methods , Research Design , Hemolysis , Hematocrit
18.
Clin Chem ; 69(9): 1009-1030, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37525518

ABSTRACT

BACKGROUND: Personalized reference intervals (prRIs) have the potential to improve individual patient follow-up as compared to population-based reference intervals (popRI). In this study, we estimated popRI and prRIs for 48 clinical chemistry and hematology measurands using samples from the same reference individuals and explored the effect of using group-based and individually based biological variation (BV) estimates to derive prRIs. METHODS: 143 individuals (median age 28 years) were included in the study and had fasting blood samples collected once. From this population, 41 randomly selected subjects had samples collected weekly for 5 weeks. PopRIs were estimated according to Clinical Laboratory Standards Institute EP28 and within-subject BV (CVI) were estimated by CV-ANOVA. Data were assessed for trends and outliers prior to calculation of individual prRIs, based on estimates of (a) within-person BV (CVP), (b) CVI derived in this study, and (c) publically available CVI estimates. RESULTS: For most measurands, the individual prRI ranges were smaller than the popRI range, but overall about half the study participants had a prRI wider than the popRI for 5 or more out of 48 measurands. The dispersion of prRIs based on CVP was wider than that of prRIs based on CVI. CONCLUSION: The prRIs derived in our study varied significantly between different individuals, especially if based on CVP. Our results highlight the limitations of popRIs in interpreting test results of individual patients. If sufficient data from a steady-state situation are available, using prRI based on CVP estimates will provide a RI most specific for an individual patient.


Subject(s)
Chemistry, Clinical , Hematology , Humans , Adult , Chemistry, Clinical/methods , Reference Values , Hematology/methods , Reference Standards
19.
Vet Clin Pathol ; 52(4): 755-760, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37468943

ABSTRACT

Reticulocyte indices are used to characterize anemia, including the identification of regeneration. In people, the immature reticulocyte fraction (IRF), percentage of hypochromic red blood cells (%HYPO-RBC), and other reticulocyte indices have been used as earlier indicators of erythropoiesis and as valuable monitoring tools in the assessment of various therapies. The reference intervals (RI) of the IRF and %HYPO-RBC have not been reported in dogs. The objective of this study was to establish RIs for novel variables (IRF, %HYPO-RBC, and CH-delta) and assess RIs for more commonly reported reticulocyte indices in healthy dogs. RIs were calculated from blood results retrospectively collected from 106 client-owned healthy dogs at the time of induction into a blood donor program using the ADVIA 2120 hematology analyzer (Siemens Healthcare Diagnostics). For the calculation of RIs, appropriate tests were applied for outlier detection and normality assessment. For variables normally distributed, RIs and their respective 90% confidence intervals (CIs) were calculated using parametric methods, while for variables not normally distributed, robust methods were used and bootstrapping for calculating the 90% CIs. The following RIs were established: reticulocyte hemoglobin content (CHr) 24.5-28 pg, mean reticulocyte volume (MCVr) 85.9-99.3 fL, mean corpuscular hemoglobin concentration of reticulocytes (CHCMr) 271.0-306.3 g/L, IRF 10.4%-43.5%, CH-delta 0.5-4.3 pg, and percentage of hypochromic red blood cells (%HYPO-RBC) 0.10%-0.80%. The results of this study provide RIs for novel reticulocyte variables. Further studies are required to determine the clinical utility of IRF, %HYPO-RBC, and CH delta as early indicators of erythropoietic activity in canine patients.


Subject(s)
Anemia, Iron-Deficiency , Dog Diseases , Hematology , Humans , Dogs , Animals , Reticulocytes/chemistry , Retrospective Studies , Reticulocyte Count/veterinary , Hematology/methods , Erythrocyte Indices/veterinary , Hemoglobins/analysis , Anemia, Iron-Deficiency/veterinary , Dog Diseases/diagnosis
20.
Int J Lab Hematol ; 45(5): 691-699, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37338111

ABSTRACT

INTRODUCTION: The manual differential count has been recognized for its disadvantages, including large interobserver variability and labor intensiveness. In this light, automated digital cell morphology analyzers have been increasingly adopted in hematology laboratories for their robustness and convenience. This study aims to evaluate the white blood cell differential performance of the Mindray MC-80, the new automated digital cell morphology analyzer. METHODS: The cell identification performance of Mindray MC-80 was evaluated for sensitivity and specificity using pre-classification and post-classification of each cell class. The method comparison study used manual differentials as the gold standard for calculating Pearson correlation, Passing-Bablok regression, and Bland-Altman analysis. In addition, the precision study was performed and evaluated. RESULTS: The precision was within the acceptable limit for all cell classes. Overall, the specificity of cell identification was higher than 95% for all cell classes. The sensitivity was greater for 95% for most cell classes, except for myelocytes (94.9%), metamyelocytes (90.9%), reactive lymphocytes (89.7%), and plasma cells (60%). Pre-classification and post-classification results correlated well with the manual differential results for all the cell types investigated. The regression coefficients were greater than 0.9 for most cell classes except for promyelocytes, metamyelocytes, basophils, and reactive lymphocytes. CONCLUSION: The performance of Mindray MC-80 for white blood cell differentials is reliable and seems to be acceptable even in abnormal samples. However, the sensitivity is less than 95% for certain abnormal cell types, so the user should be aware of this limitation where such cells are suspected.


Subject(s)
Hematology , Leukocytes , Humans , Leukocyte Count , Reproducibility of Results , Blood Cell Count/methods , Hematology/methods , Plasma Cells
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