Verification of a Benchtop Hematology Analyzer with a 5-Part Differential Count: There is Nothing Wrong with Being Small.

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.

Performance evaluation of the Sysmex XN-1000V in side-by-side comparison with the Siemens ADVIA 120 and manual methods for healthy CD Sprague-Dawley rats and CD-1 mice.

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.

The fully automated Sysmex XN-31 hematology analyzer can detect bloodstream form Trypanosoma brucei.

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.

Clinical evaluation of a fully electronic microfluidic white blood cell analyzer.

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.

Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer.

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.

Performance evaluation the new automated Atellica Hema 580 hematology analyzer.

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.

Performance evaluation of alternate ESR measurement method using BC-780 automated hematology analyzer: a comparison study with the Westergren reference method.

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.

Validation of a hematology analyzer in donkey medicine.

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.

Personalized and Population-Based Reference Intervals for 48 Common Clinical Chemistry and Hematology Measurands: A Comparative Study.

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.

Reference intervals for reticulocyte indices, immature reticulocyte fraction, and the percentage of hypochromic red blood cells in adult large breed dogs using the ADVIA 2120 hematology analyzer.

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.

White blood cell differentials performance of a new automated digital cell morphology analyzer: Mindray MC-80.

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.

Performance of digital morphology analyzer Medica EasyCell assistant.

OBJECTIVES: The EasyCell assistant (Medica, Bedford, MA, USA) is one of the state-of-the-art digital morphology analyzers. We explored the performance of EasyCell assistant in comparison with manual microscopic review and Pentra DX Nexus (Horiba ABX Diagnostics, Montpellier, France). METHODS: In a total of 225 samples (100 normal and 125 abnormal samples), white blood cell (WBC) differentials and platelet (PLT) count estimation by EasyCell assistant were compared with the results by manual microscopic review and Pentra DX Nexus. The manual microscopic review was performed according to the Clinical and Laboratory Standards Institute guidelines (H20-A2). RESULTS: WBC differentials between pre-classification by EasyCell assistant and manual counting showed moderate correlations for neutrophils (r=0.58), lymphocytes (r=0.69), and eosinophils (r=0.51) in all samples. After user verification, they showed mostly high to very high correlations for neutrophils (r=0.74), lymphocytes (r=0.78), eosinophils (r=0.88), and other cells (r=0.91). PLT count by EasyCell assistant highly correlated with that by Pentra DX Nexus (r=0.82). CONCLUSIONS: The performance of EasyCell assistant for WBC differentials and PLT count seems to be acceptable even in abnormal samples with improvement after user verification. The EasyCell assistant, with its reliable performance on WBC differentials and PLT count, would help optimize the workflow of hematology laboratories with reduced workload of manual microscopic review.

Effective and Practical Complete Blood Count Delta Check Method and Criteria for the Quality Control of Automated Hematology Analyzers.

Background: Delta checks increase patient safety by identifying automated hematology analyzer errors. International standards and guidelines for the complete blood count (CBC) delta check method have not been established. We established an effective, practical CBC delta check method and criteria. Methods: We assessed five delta check methods for nine CBC items (Hb, mean corpuscular volume, platelet count, white blood cell [WBC] count, and five-part WBC differential counts) using 219,804 blood samples from outpatients and inpatients collected over nine months. We adopted the best method and criteria and evaluated them using 42,652 CBC samples collected over two weeks with a new workflow algorithm for identifying test errors and corrections for Hb and platelet count. Results: The median delta check time interval was 1 and 21 days for inpatients and outpatients (range, 1-20 and 1-222 days), respectively. We used delta values at 99.5% as delta check criteria; the criteria varied among the five methods and between outpatients and inpatients. The delta percent change (DPC)/reference range (RR) rate performed best as the delta check for CBC items. Using the new DPC/RR rate method, 1.7% of total test results exceeded the delta check criteria; the retesting and resampling rates were 0.5% and 0.001%, respectively. Conclusions: We developed an effective, practical delta check method, including RRs and delta check time intervals, and delta check criteria for nine CBC items. The criteria differ between outpatients and inpatients. Using the new workflow algorithm, we can identify the causes of criterion exceedance and report correct test results.

Clinical application of a new method for determination of the erythrocyte sedimentation rate using the BC-720 automated hematology analyzer.

BACKGROUND: The erythrocyte sedimentation rate (ESR) is a nonspecific inflammatory indicator and is widely used in clinical diagnosis. Westergren is the gold standard method recommended by the International Committee for Standardization of Hematology (ICSH), but it is time-consuming and inconvenient and has biosafety risks. A new alternate method for ESR (Easy-W ESR) measurement was designed and integrated into the Mindray BC-720 series automated hematology analyzer to meet the clinical needs of hematology laboratories for efficiency, safety, and automation. In this study, the performance of the new ESR method was evaluated based on the ICSH recommendations on modified and alternate ESR methods. METHODS: Methodological comparisons using the BC-720 analyzer, TEST 1, and the Westergren method were performed to assess repeatability, carryover, sample stability, reference range validation, factors influencing the ESR, and clinical applicability in rheumatology and orthopedics. RESULTS: The correlation between the BC-720 analyzer and the Westergren method was good (Y = 2.082 + 0.9869X, r = 0.9657, P > 0.0001, n = 342), carryover was <1%, the repeatability standard deviation was ≤1 mm/h, and the coefficient of variation (CV) was ≤5%. The reference range meets the manufacturer's claim. For rheumatology patients, the BC-720 analyzer showed a good correlation with the Westergren method (Y = 1.021X-1.941, r = 0.9467, n = 149). For orthopedic patients, the BC-720 analyzer also showed a good correlation with the Westergren method (Y = 1.037X + 0.981, r = 0.978, n = 97). CONCLUSION: This study verified the clinical and analytical performance of the new ESR method, indicating that the results are very similar to those obtained using the Westergren method.

Developing and validating a highly sensitive platelet clump detection model for the Sysmex haematology analyser.

BACKGROUND: Mainstream haematology analysers (HAs) are reported to have low detection sensitivity for platelet clumps. In this study, a deep learning (DL) algorithm, convolutional neural network (CNN), was implemented to detect platelet clumps. METHODS: Adenosine diphosphate (ADP) was used to induce platelet aggregation to mimic platelet clumps detected (PCD) samples. Six types of leukocyte scattergrams were collected from the Sysmex XN-10. Then, multiple CNNs were trained and validated by scattergrams in a fivefold cross-validation (CV) method. Finally, the CNN model with the best CV accuracy was tested with practical routine work samples. RESULTS: A total of 386 samples (190 PCD and 196 negative samples) and 4253 samples (150 PCD and 4103 negative samples) were eligible for CNN training and practical test, respectively. The CNN with the highest CV accuracy was trained by using scattergrams of side scatter (SSC) vs. forward scatter (FSC) from the white count and nucleated red blood cells (WNR) channel, whose mean area under the curve (AUC), accuracy, specificity and sensitivity were 0.968, 0.940, 0.937 and 0.942, respectively, in the CV. In the practical test, the AUC, accuracy, specificity and sensitivity of the CNN were 0.916, 0.961, 0.860 and 0.965, respectively. The dispersed spots presenting around the leucocytes in the WNR channel may be a sign of platelet clumping. CONCLUSIONS: This study demonstrates that the CNN algorithms can identify platelet clumps based on optical information from dedicated leukocyte channels and has a higher ability to detect platelet clumps than the XN-10 device's internal algorithm under practical circumstances.

Comparative retrospective study on the validity of point-of-care testing device for massive obstetrical hemorrhage: dry hematology vs thromboelastography.

BACKGROUND: Early recognition of hypofibrinogenemia and prompt initiation of transfusion therapy in patients with massive obstetrical hemorrhage can improve prognosis. There are reports on the usefulness of point-of-care testing, which provides quicker test results compared with fibrinogen measurements using the conventional Clauss method. OBJECTIVE: This study aimed to compare and investigate the diagnostic accuracy of dry hematology and thromboelastography in point-of-care testing for the diagnosis of hypofibrinogenemia. STUDY DESIGN: A single-center, retrospective study of 126 massive obstetrical hemorrhage cases with point-of-care testing before treatment was initiated. The correlation of fibrinogen values with the Clauss method and the diagnostic accuracy for hypofibrinogenemia were compared between dry hematology and thromboelastography. RESULTS: Fibrinogen value in dry hematology showed a strong positive correlation with values measured by the Clauss method, and the diagnostic accuracy for hypofibrinogenemia was high, but there were many residuals above 100 mg/dL, and the distribution of these residuals was not uniform. Although thromboelastography cannot be used to directly measure fibrinogen values, maximum amplitude citrated functional fibrinogen, amplitude-10 citrated rapid thromboelastography, and amplitude-10 citrated functional fibrinogen showed a strong positive correlation with fibrinogen values using the Clauss method, and no significant difference in correlation or diagnostic accuracy was observed relative to dry hematology. CONCLUSION: Dry hematology and thromboelastography were equally accurate in diagnosing hypofibrinogenemia, with results correlating well with fibrinogen values measured by the Clauss method.

Evaluation of the ESR fast detector and Improve® ESR analyzer as modified Westergren methods for erythrocyte sedimentation rate.

The erythrocyte sedimentation rate (ESR) has been commonly ordered in hematology laboratories and used to screen for monitoring responses to therapy and identifying inflammatory conditions. To overcome the limitations of traditional ESR measurements, various methods have been developed and compared to the established reference method. This study evaluates the analytical performance of ESR fast detector and Improve® ESR analyzer compared to the reference method. Method validation and comparison were performed in 189 volunteer blood samples according to the International Council for Standardization in Hematology recommendations. The analytical efficacy of ESR fast detector and Improve® ESR analyzer was also assessed and compared with the reference method and C-reactive protein (CRP) levels. The results demonstrated that the precision of ESR fast detector and Improve® ESR analyzer was considered as the acceptance criterion for the ESR measurement. The method comparison analysis between the two modified Westergren methods and reference method demonstrated a strong correlation with the Spearman's rank correlation coefficient of 0.94, with a mean difference of -2.1 and -7.7 mm/h in the ESR fast detector and Improve® ESR analyzer, respectively. Analysis of the area under the receiver operating curve illustrated a high analytical performance compared to the reference method and CRP level. The measurement of ESR level using the ESR fast detector and Improve® ESR analyzer is a reliable method and has a high analytical performance, which can be used instead of the reference method for screening inflammatory conditions.

Quality control validation for a veterinary laboratory network of six Sysmex XT-2000iV hematology analyzers.

BACKGROUND: Quality control (QC) validation is an important step in the laboratory harmonization process. This includes the application of statistical QC requirements, procedures, and control rules to identify and maintain ongoing stable analytical performance. This provides confidence in the production of patient results that are suitable for clinical interpretation across a network of veterinary laboratories. OBJECTIVES: To determine that a higher probability of error detection (Ped ) and lower probability of false rejection (Pfr ) using a simple control rule and one level of quality control material (QCM) could be achieved using observed analytical performance than by using the manufacturer's acceptable ranges for QCM on the Sysmex XT-2000iV hematology analyzers for veterinary use. We also determined whether Westgard Sigma Rules could be sufficient to monitor and maintain a sufficiently high level of analytical performance to support harmonization. METHODS: EZRules3 was used to investigate candidate QC rules and determine the Ped and Pfr of manufacturer's acceptable limits and also analyzer-specific observed analytical performance for each of the six Sysmex analyzers within our laboratory system using the American Society of Veterinary Clinical Pathology (ASVCP)-recommended or internal expert opinion quality goals (expressed as total allowable error, TEa ) as the quality requirement. The internal expert quality goals were generated by consensus of the Quality, Education, Planning, and Implementation (QEPI) group comprised of five clinical pathologists and seven laboratory technicians and managers. Sigma metrics, which are a useful monitoring tool and can be used in conjunction with Westgard Sigma Rules, were also calculated. RESULTS: The QC validation using the manufacturer's acceptable limits for analyzer 1 showed only 3/10 measurands reached acceptable Ped for veterinary laboratories (>0.85). For QC validation based on observed analyzer performance, the Ped was >0.94 using a 1-2.5s QC rule for the majority of observations (57/60) across the group of analyzers at the recommended TEa . We found little variation in Pfr between manufacturer acceptable limits and individual analyzer observed performance as this is a characteristic of the rule used, not the analyzer performance. CONCLUSIONS: An improved probability of error detection and probability of false rejection using a 1-2.5s QC rule for individual analyzer QC was achieved compared with the use of the manufacturers' acceptable limits for hematology in veterinary laboratories. A validated QC rule (1-2.5s) in conjunction with sigma metrics (>5.5), desirable bias, and desirable CV based on biologic variation was successful to evaluate stable analytical performance supporting continued harmonization across the network of analyzers.

Technological features of blast identification in the cerebrospinal fluid: A systematic review of flow cytometry and laboratory haematology methods.

BACKGROUND: Involvement of the central nervous system (CNS) by acute leukemias (ALs) has important implications for risk stratification and disease outcome. The clinical laboratory plays an essential role in assessment of cerebrospinal fluid (CSF) specimens from patients with ALs at initial diagnosis, at the end of treatment, and when CNS involvement is clinically suspected. The two challenges for the laboratory are 1) to accurately provide a cell count of the CSF and 2) to successfully distinguish blasts from other cell types. These tasks are classically performed using manual techniques, which suffer from suboptimal turnaround time, imprecision, and inconsistent inter-operator performance. Technological innovations in flow cytometry and hematology analyzer technology have provided useful complements and/or alternatives to conventional manual techniques. AIMS: We performed a PRISMA-compliant systematic review to address the medical literature regarding the development and current state of the art of CSF blast identification using flow cytometry and laboratory hematology technologies. MATERIALS AND METHODS: We searched the peer reviewed medical literature using MEDLINE (PubMed interface), Web of Science, and Embase using the keywords "CSF or cerebrospinal" AND "blasts(s)". RESULTS: 108 articles were suitable for inclusion in our systematic review. These articles covered 1) clinical rationale for CSF blast identification; 2) morphology-based CSF blast identification; 3) the role of flow cytometry; 4) use of hematology analyzers for CSF blast identification; and 5) quality issues. 9 /L, which is much lower than the original machine count and platelet transfusion was warranted. DISCUSSION: 1) Clinical laboratory testing plays a central role in risk stratification and clinical management of patients with acute leukemias, most clearly in pediatric ALs; 2) studies focused on other patient populations, including adults and patients with AML are less prevalent in the literature; 3) improvements in instrumentation may provide better performance for the classification of CSF specimens. CONCLUSION: Current challenges include: 1) more precisely characterizing the natural history of AL involvement of the CNS, 2) improvements in automated cell count technology of low cellularity specimens, 3) defining the role of flow MRD testing of CSF specimens and 4) improved recognition of specimen quality by clinicians and laboratory personnel.