Microsystems represent an alternative but proficient approach of analysis outside the laboratory, and their use could help in reducing the impact of pre-analytical errors, in particular in challenging newborn samples. The study purpose is to compare the Horiba Microsemi CRP LC-767G system for rapid 3-part complete blood count (CBC) and C-reactive protein (CRP) determination with the laboratory reference systems (respectively Sysmex XN-9100™ and Roche Cobas® c702) in samples of adult patients and newborns hospitalized in the neonatal intensive care unit (NICU) samples. The comparison between the analyzers was performed through Passing-Bablok regression analysis and Bland-Altman plot. One hundred eighty-three blood samples were analyzed. The regression analysis results, performed in the newborn (n = 70) and in adult (n = 113) populations, showed a good agreement between the instruments. The evaluation of the Bland-Altman plots showed comparable values of bias < 10% for most of the parameters, but not for MPV, lymphocyte, and monocyte count.
CONCLUSIONS: The comparison between the Microsemi CRP LC-767G system and the laboratory instrumentations demonstrated comparable results. The Microsemi CRP LC-767G system provides reliable analytical data and faster turnaround time, particularly useful in NICU.
BACKGROUND: • Microsystems for point-of-care testing (POCT) represent an alternative but proficient approach of analysis outside the laboratory, in order to perform a rapid, safe, and exhaustive evaluation for critical patients\' management, acting as a valid support for treatment in acute care.
BACKGROUND: • The Microsemi CRP LC-767G system can represent an alternative but effective testing approach outside the laboratory, particularly in NICU, to reduce the impact of pre-analytical errors on newborn samples.

OBJECTIVE: Even in the current era of hematology analyzer automation and peripheral equipment, quality control sample measurement remains a manual task, leading to variability in quality control data and increased workload. In this study, we evaluated the performance of quality control measurement using the BT-50 Transportation Unit (BT-50, Sysmex, Kobe, Japan), equipped with a scheduled automatic quality control function, to ensure measurement accuracy and streamline the workflow of hematology testing.
METHODS: We evaluated the automatic measurement performance of quality control samples using the BT-50 for six representative blood test parameters: WBC (white blood cell), RBC (red blood cell), HGB (hemoglobin), HCT (hematocrit), PLT (platelet), and RET% (reticulocyte percent). We evaluated the equivalence and compared measurement accuracy between the BT-50 and the manual method. We then compared the variability to other laboratories and confirmed the stability of quality control samples. We also evaluated changes in workflow and staff resources before and after the introduction of the BT-50.
RESULTS: The quality control measurement results for the BT-50 and the manual method were found to be equivalent for all six parameters. The variability measured by the BT-50 was lower for some parameters compared to the manual method. Furthermore, the workflow was streamlined by reducing manual processes, resulting in increased efficiency.
CONCLUSIONS: We confirmed the performance of quality control measurements using the schedule function of the BT-50. Introducing the BT-50 reduced the operator\'s workload, improved operational efficiency, and promoted the standardization of quality control measurements.

Immature granulocytes (IGs) have significance for the diagnosis of myeloid neoplasms (MNs). The current study aims to use a hematology analyzer to evaluate the accuracy of IG parameters in MNs. Blood specimens from 388 patients with MN, 524 with non-hematological neoplasms (non-HNs), including 109 patients with inflammation and 68 undergoing G-CSF administration, and 500 healthy control subjects were analyzed. IG parameters was assayed by Sysmex XN-9000 (XN) and compared with manual assessments. A high level of agreement between IG% derived from XN and manual measurements for MN patients (r = 0.828, p < 0.0001) was revealed but only a moderate correlation for acute myeloid leukemia patients (AML; r = 0.597; p < 0.0001). Bland-Altman bias analysis was conducted, and the results showed that differences in IG% from XN and manual analysis for MN patients were considered clinically insignificant. ROC analysis demonstrated a good performance of IG# (AUC = 0.842) and IG% (AUC = 0.885) assessed by XN for MN patients with cut-off values of 0.200 × 109/L and 1.95%, respectively. IG parameters from Sysmex XN analyzer are helpful for screening of MNs even though granulocyte morphological abnormalities may interfere with IG parameter accuracy.

BACKGROUND: 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.
CONCLUSIONS: The Atellica Hema 580 showed good analytical performance and workflow efficiency for a wide range of patient samples.

BACKGROUND: Hemoglobin-based oxygen carriers, for example HBOC-201 (Hemopure), are aimed to bridge acute anemia when blood transfusion is not available or refused by the patient. However, since HBOC-201 appears free in plasma, it interferes with laboratory tests. This study presents an overview of HBOC-201 interference on four commonly used hematology analyzers and suggests treatment monitoring possibilities.
METHODS: Blood samples were spiked with therapeutic doses of HBOC-201 and nine hematology parameters were measured with the Sysmex XN-20, Siemens Advia 2120i, Abbott Alinity Hq and Abbot Cell Dyn Sapphire hematology analyzers. The results were compared to control samples and the bias was determined.
RESULTS: Most parameters, including all cell counts, hematocrit and MCV, showed a non-significant bias compared to control. However, the standard, total hemoglobin (Hb) measurement as well as MCH and MCHC showed poor agreement with control, as HBOC-201 was included in this measurement. Yet, the flow cytometry-based Hb method quantified intracellular Hb in spiked samples, excluding HBOC-201.
CONCLUSIONS: Of all included hematology parameters, only total Hb and the associated MCH and MCHC suffered from interference. In contrast, the flow cytometry-based Hb measurement provided an accurate measure of intracellular Hb. The difference between total Hb and cellular Hb represents the HBOC-201 concentration and can be used to monitor HBOC-201 treatment.

Myelodysplastic syndromes (MDS) are common malignant disorders with a poor prognosis. It is necessary to search for new rapid diagnostic methods to detect MDS patients with cytogenetic changes. The aim of the study was to assess new hematological neutrophil- and monocyte- related parameters I then bone marrow of MDS patient with and without cytogenetic changes. A total of 45 patients with MDS, including 17 patients with cytogenetic changes, were examined. The study was conducted using the Sysmex XN-Series hematological analyzer. New neutrophil and monocyte parameters, such as immature granulocytes (IG), neutrophil reactivity intensity (NEUT-RI), neutrophil granularity intensity (NEUT-GI), neutrophil size (NE-FSC) and neutrophil/monocyte data relating to granularity, activity and volume (NE-WX/MO-WX, NE-WY/MO-WY, NE-WZ/MO-WZ, MO-X, MO-Y, MO-Z) were evaluated. We observed higher median proportions of NE-WX, NE-WY, NE-WZ, and IG counts in MDS patients with cytogenetic changes than in patients without cytogenetic changes. The NE-FSC parameter was lower in MDS patients with cytogenetic changes than in patients without cytogenetic changes. The combination of new neutrophil parameters was found to be a new successful approach in distinguishing MDS patients with cytogenetic changes from patients without cytogenetic changes. It appears that there may be unique neutrophil parameter signatures associated with an underlying mutation.

暂无摘要。

We compared a point-of-care HemoScreen hematology analyzer to an automated Sysmex XN analyzer for complete blood count (CBC) and white blood cell (WBC) differential, and evaluated its capacity to detect leukocyte abnormalities. A total of 100 K2-EDTA whole blood samples, median age 56 years (2 months to 92 years), were compared. For CBC and WBC differential we compared 74 samples with no confirmed abnormal leukocytes. For 26 samples both analyzers gave flagging regarding leukocytes and the accuracy of the flagging was compared. Abnormal leukocytes were confirmed with manual microscopy (200 cells). HemoScreen CBC and WBC differential were highly comparable to Sysmex XN for most of the essential parameters (r = 0.909-0.975). More variation was seen for basophil and monocyte counts (r = 0.452 and 0.753, respectively). Sysmex XN gave more false WBC abnormal flagging (n = 15 altogether) compared to HemoScreen. In addition, Sysmex XN, as well as HemoScreen, gave false WBC flagging for eight samples confirmed normal. The samples verified by microscopy review to truly contain leukocyte abnormalities (n = 18) were flagged abnormal with both analyzers. The specificity for analyzer flagging was 72% and 88% for Sysmex XN and HemoScreen, respectively. HemoScreen hematology analyzer is essentially comparable to Sysmex XN for CBC and WBC differential analysis. Most importantly, HemoScreen detected all the samples confirmed to include abnormal leukocytes. HemoScreen was less prone for false WBC flagging compared to Sysmex XN, thereafter requiring less microscopy review. These abilities increase its utility in small health care units. Studies with a larger number of abnormal leukocyte samples are needed to confirm HemoScreen performance.

BACKGROUND: Assessing the percentage of reticulocytes (%Retic) is useful for diagnosing and treating blood diseases that present with anaemia. The Celltac G+™ hematology analyzer (HA) uses a novel reticulocyte identification method that involves metachromatic nucleic acid staining with acridine orange and crossover analysis of emission light of DNA/RNA (determination of red cells, nucleic acid-containing cells, and platelets, RNP Determination™). The red and green fluorescence generated by stained single-stranded RNA and double-stranded DNA express immaturity and morphological abnormality of erythrocytes by detecting erythrocyte RNA and DNA content.
METHODS: The basic performance of the test automated analyzer (TAA) Celltac G+ was evaluated and compared with the flow cytometry reference method and the comparative automated analyzer (CAA) XN-1000/2000™. In addition, its precision, limit of quantity (LoQ), linearity, analytical measurement interval (AMI), accuracy, and comparability and the effects of interfering substances were evaluated.
RESULTS: Evaluation of %Retic by the TAA demonstrated good precision and linearity. The AMI was confirmed from 0.02 to 8.23, and the LoQ in %Retic as the coefficient of variation within an 11% limit (SD, within a 0.01 limit) was 0.14. TAA correlated well with the reference method and routine HA (CAA). Some deviations were found between TAA and CAA in DNA measurements of erythrocytes from abnormal samples.
CONCLUSIONS: Celltac G+ uses a novel measurement principle and can assess erythrocyte immaturity independent of DNA contents. It represents a new HA that provides novel, useful information on immaturity and morphological abnormality of erythrocytes.

Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson’s correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal−Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson’s coefficients indicated a strong correlation and positive relationship between all variables. The Bland−Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal−Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device.