Publications by authors named "Sabrina Buoro"

47 Publications

Complete Blood Count as point of care testing QBC STAR™: Preliminary evaluation.

Int J Lab Hematol 2021 Mar 22. Epub 2021 Mar 22.

Regional Reference Center for the Laboratories Quality, Hospital ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Introduction: Point of care testing (POCT) represents a valuable option when laboratory data shall be urgently available for timely clinical management, with a turnaround time (TAT) that is unfeasible using conventional laboratory instrumentation. This study was aimed to compare the performance of QBC STAR™ compared to Sysmex XN-module and the reference optical microscopy (OM) assessment.

Material And Methods: One hundred peripheral blood samples, collected in K EDTA tubes, and 50 capillary blood samples obtained by finger stick were analyzed with QBC STAR™, Sysmex XN-module, and OM. Data were compared with Passing-Bablok regression and Bland-Altman plots.

Results: The Passing-Bablok regression analysis (QBC STAR™ capillary sample vs XN-module) yielded slopes comprised between 0.30 and 1.37, while the intercepts ranged between -17.57 and 232.6. Bland-Altman plots yielded relative bias comprised between -4.87% (for MN QBC STAR™ capillary sample vs XN-module) and 27% (PLT QBC STAR™ capillary sample vs XN-module). A significant bias was found for all parameters except MN and WBC, RBC in all and pediatric samples, and HB in adults samples.

Conclusion: The results of this analytical evaluation suggest that QBC STAR™ may not be the ideal tool for performing complete blood count analysis for diagnostic purposes, while it could be more useful in urgent/emergent conditions, such as for rapid monitoring of some hematological parameters (eg, WBC and HB).
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http://dx.doi.org/10.1111/ijlh.13515DOI Listing
March 2021

Covid-19 and gender: lower rate but same mortality of severe disease in women-an observational study.

BMC Pulm Med 2021 Mar 20;21(1):96. Epub 2021 Mar 20.

Department of Health and Social Care Professions, ASST Papa Giovanni XXIII, Bergamo, Italy.

Background: Gender-related factors might affect vulnerability to Covid-19. The aim of this study was to describe the role of gender on clinical features and 28-day mortality in Covid-19 patients.

Methods: Observational study of Covid-19 patients hospitalized in Bergamo, Italy, during the first three weeks of the outbreak. Medical records, clinical, radiological and laboratory findings upon admission and treatment have been collected. Primary outcome was 28-day mortality since hospitalization.

Results: 431 consecutive adult patients were admitted. Female patients were 119 (27.6%) with a mean age of 67.0 ± 14.5 years (vs 67.8 ± 12.5 for males, p = 0.54). Previous history of myocardial infarction, vasculopathy and former smoking habits were more common for males. At the time of admission PaO/FiO was similar between men and women (228 [IQR, 134-273] vs 238 mmHg [150-281], p = 0.28). Continuous Positive Airway Pressure (CPAP) assistance was needed in the first 24 h more frequently in male patients (25.7% vs 13.0%; p = 0.006). Overall 28-day mortality was 26.1% in women and 38.1% in men (p = 0.018). Gender did not result an independent predictor of death once the parameters related to disease severity at presentation were included in the multivariable analysis (p = 0.898). Accordingly, the Kaplan-Meier survival analysis in female and male patients requiring CPAP or non-invasive ventilation in the first 24 h did not find a significant difference (p = 0.687).

Conclusion: Hospitalized women are less likely to die from Covid-19; however, once severe disease occurs, the risk of dying is similar to men. Further studies are needed to better investigate the role of gender in clinical course and outcome of Covid-19.
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http://dx.doi.org/10.1186/s12890-021-01455-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980742PMC
March 2021

At the peak of COVID-19 age and disease severity but not comorbidities are predictors of mortality: COVID-19 burden in Bergamo, Italy.

Panminerva Med 2021 Mar 27;63(1):51-61. Epub 2020 Nov 27.

Unit of Quality Management, ASST Papa Giovanni XXIII, Bergamo, Italy.

Background: Findings from February 2020, indicate that the clinical spectrum of COVID-19 can be heterogeneous, probably due to the infectious dose and viral load of SARS-CoV-2 within the first weeks of the outbreak. The aim of this study was to investigate predictors of overall 28-day mortality at the peak of the Italian outbreak.

Methods: Retrospective observational study of all COVID-19 patients admitted to the main hospital of Bergamo, from February 23 to March 14, 2020.

Results: Five hundred and eight patients were hospitalized, predominantly male (72.4%), mean age of 66±15 years; 49.2% were older than 70 years. Most of patients presented with severe respiratory failure (median value [IQR] of PaO2/FiO2: 233 [149-281]). Mortality rate at 28 days resulted of 33.7% (N.=171). Thirty-nine percent of patients were treated with continuous positive airway pressure (CPAP), 9.5% with noninvasive ventilation (NIV) and 13.6% with endotracheal intubation. 9.5% were admitted to Semi-Intensive Respiratory Care Unit, and 18.9% to Intensive Care Unit. Risk factors independently associated with 28-day mortality were advanced age (≥78 years: odds ratio [OR], 95% confidence interval [CI]: 38.91 [10.67-141.93], P<0.001; 70-77 years: 17.30 [5.40-55.38], P<0.001; 60-69 years: 3.20 [1.00-10.20], P=0.049), PaO2/FiO2<200 at presentation (3.50 [1.70-7.20], P=0.001), need for CPAP/NIV in the first 24 hours (8.38 [3.63-19.35], P<0.001), and blood urea value at admission (1.01 [1.00-1.02], P=0.015).

Conclusions: At the peak of the outbreak, with a probable high infectious dose and viral load, older age, the severity of respiratory failure and renal impairment at presentation, but not comorbidities, are predictors of 28-day mortality in COVID-19.
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http://dx.doi.org/10.23736/S0031-0808.20.04063-XDOI Listing
March 2021

What is the normal composition of pericardial fluid?

Heart 2020 Nov 11. Epub 2020 Nov 11.

Department of Biomedical and Clinical Sciences, University of Milano and ASST Fatebenefratelli-Sacco, Milano, Italy.

Objective: Biochemical and cytological pericardial fluid (PF) analysis is essentially based on the knowledge of pleural fluid composition. The aim of the present study is to identify reference intervals (RIs) for PF according to state-of-art methodological standards.

Methods: We prospectively collected and analysed the PF and venous blood of consecutive subjects undergoing elective open-heart surgery from July 2017 to October 2018. Exclusion criteria for study enrolment were evidence of pericardial diseases at preoperatory workup or at intraoperatory assessment, or any other condition that could affect PF analysis.

Results: The final study sample included 120 patients (median age 69 years, 83 men, 69.1%). The main findings were (1) High levels of proteins, albumin and lactate dehydrogenase (LDH), but not of glucose and cholesterol (2) High cellularity, mainly represented by mesothelial cells. RIs for pericardial biochemistry were: protein content 1.7-4.6 g/dL PF/serum protein ratio 0.29-0.83, albumin 1.19-3.06 g/dL, pericardium-to-serum albumin gradient 0.18-2.37 g/dL, LDH 141-2613 U/L, PF/serum LDH ratio 0.40-2.99, glucose 80-134 mg/dL, total cholesterol 12-69 mg/dL, PF/serum cholesterol ratio 0.07-0.51. RIs for pericardial cells by optic microscopy were: 278-5608 × 10 nucleated cells/L, 40-3790 × 10 mesothelial cells/L, 35-2210 × 10 leucocytes/L, 19-1634 × 10 lymphocytes/L.

Conclusions: PF is rich in nucleated cells, protein, albumin, LDH, at levels consistent with inflammatory exudates in other biological fluids. Physicians should stop to interpret PF as exudate or transudate according to tools not validated for this setting.
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http://dx.doi.org/10.1136/heartjnl-2020-317966DOI Listing
November 2020

Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability issue.

Int J Lab Hematol 2021 Jun 10;43(3):364-371. Epub 2020 Nov 10.

Clinical Chemistry Laboratory, Hospital Papa Giovanni XXIII, Bergamo, Italy.

Introduction: In the hub and spoke laboratory network, the number of hematology analyzers (HAs) within each core center has increased, and the control of HAs alignment is becoming necessary requirement to ensure analytical quality. In this scenario, HA alignment can be assessed by analyzing the same control material used for internal quality control on multiple HAs, assuming its commutability. The aim of the study was to verify the applicability of a protocol for the alignment of HAs based on control material rather than on fresh whole-blood samples.

Methods: The alignment of five HAs was evaluated for red (RBC, Hb, MCV, RET), white (WBC, NE, LY, MO, EO, BA, IG), and platelet (PLT) series parameters, following a protocol by SIBioC, using human sample (HS) and quality control material (QC), after the verification of commutability, according to the IFCC protocol. Maximum bias was derived from biological variation data.

Results: A complete alignment between instruments was confirmed for the majority of the parameters investigated both for HS and QC material. Partial misalignments or inconcludent results were instead evident for MCV, MO, EO, BA, and IG. Interestingly, QC material was found to be not commutable for LY, MO, and BA.

Conclusion: The alignment of hematologic analyzers for main cell population parameters may be verified with both QC and HS, displaying consistent results and interpretation. The evaluation for some white series parameters (EO, BA, and IG) is critical, and particular attention must be paid to the values of the material used for the alignment.
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http://dx.doi.org/10.1111/ijlh.13379DOI Listing
June 2021

Multicentric evaluation of analytical performances digital morphology with respect to the reference methods by manual optical microscopy.

J Clin Pathol 2020 Sep 14. Epub 2020 Sep 14.

ASST Papa Giovanni XXIII, Bergamo, Italy

Aims: Optical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of the laboratory haematological workflow. The morphological cell analysis is time-consuming and expensive and it requires skilled operator. To address these challenges, automated image-processing systems, as digital morphology (DM), were developed in the last few years. The aim of this multicentre study, performed according to international guidelines, is to verify the analytical performance of DM compared with manual OM, the reference method.

Methods: Four hundred and ninety PB samples were evaluated. For each sample, two May Grunwald-stained and Giemsa-stained smears were performed and the morphological evaluation of cells was analysed with both DM and OM. In addition, the assessment times of both methods were recorded.

Results: Comparison of DM versus OM methods was assessed with Passing-Bablok and Deming fit regression analysis: slopes ranged between 0.17 for atypical, reactive lymphocytes and plasma cells (LY(AT)) and 1.24 for basophils, and the intercepts ranged between -0.09 for blasts and 0.40 for LY(AT). The Bland-Altman bias ranged between -6.5% for eosinophils and 21.8% for meta-myemielocytes. The diagnostic agreement between the two methods was 0.98. The mean of assessment times were 150 s and 250 s for DM and OM, respectively.

Conclusion: DM shows excellent performance. Approximately only 1.6% of PB smears need the OM revision, giving advantages in terms of efficiency, standardisation and assessment time of morphological analysis of the cells. The findings of this study may provide useful information regarding the use of DM to improve the haematological workflow.
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http://dx.doi.org/10.1136/jclinpath-2020-206857DOI Listing
September 2020

Age-specific SARS-CoV-2 infection fatality ratio and associated risk factors, Italy, February to April 2020.

Euro Surveill 2020 08;25(31)

Bruno Kessler Foundation, Trento, Italy.

We analysed 5,484 close contacts of coronavirus disease (COVID-19) cases in Italy, all tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Infection fatality ratio was 0.43% (95% confidence interval (CI): 0.21-0.79) for individuals younger than 70 years and 10.5% (95% CI: 8.0-13.6) for older individuals. Risk of death after infection was 62% lower (95% CI: 31-80) in clusters identified after 16 March 2020 and 1.8-fold higher for males (95% CI: 1.03-3.16).
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http://dx.doi.org/10.2807/1560-7917.ES.2020.25.31.2001383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459272PMC
August 2020

A very uncommon haemoglobin value resulting from a severe acute malnutrition in a 16-month-old child in Ethiopia.

Clin Chem Lab Med 2021 Feb 29;59(3):e103-e105. Epub 2020 Apr 29.

Laboratory Medicine, Kidane Mehret Maternity and Surgical Wards, Adwa, Tigray Region, Ethiopia.

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http://dx.doi.org/10.1515/cclm-2020-0364DOI Listing
February 2021

Multicenter evaluation of analytical performances of platelet counts and platelet parameters: Carryover, precision, and stability.

Int J Lab Hematol 2020 Oct 18;42(5):552-564. Epub 2020 Apr 18.

Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.

Introduction: The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis.

Methods: Four hundred eighty-six peripheral blood samples (PB), collected in K EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC-6800, BC-6800 Plus, Cell-DYN Sapphire, DxH800, XE-2100, XE-5000, XN-20 with PLT-F App. Within-run imprecision and between-run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated.

Results: The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell-Dyn Sapphire) and 25.0 × 10 /L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN-20) and 12.0 × 10 /L (XE-5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CV for PLT counts less than 50.0 × 10 /L, with the exception of Cell-DYN Sapphire (CV 3.0% with PLT-O mean value of 26.7 × 10 /L), XN-20 (CV 2.4% with PLT-F mean value of 21.5 × 10 /L), and BC-6800 Plus (CV 1.9% with PLT-O mean value of 26.5 × 10 /L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs.

Conclusion: The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.
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http://dx.doi.org/10.1111/ijlh.13204DOI Listing
October 2020

Papa Giovanni XXIII Bergamo Hospital at the time of the COVID-19 outbreak: Letter from the warfront….

Int J Lab Hematol 2020 06;42 Suppl 1:8-10

Gastroenterology, Hepatology and Liver Transplantation, Department of Medicine, Papa Giovanni XXIII Hospital, Bergamo, Italy.

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http://dx.doi.org/10.1111/ijlh.13207DOI Listing
June 2020

A specific abnormal scattergram of peripheral blood leukocytes suggestive for the presence of proerythroblast.

Scand J Clin Lab Invest 2020 02 22;80(1):55-58. Epub 2019 Nov 22.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

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http://dx.doi.org/10.1080/00365513.2019.1692230DOI Listing
February 2020

Platelet Transfusion Thresholds: How Low Can We Go in Respect to Platelet Counting?

Semin Thromb Hemost 2020 Apr 28;46(3):238-244. Epub 2019 Sep 28.

Clinical Chemistry Laboratory, Hospital Papa Giovanni XXIII, Bergamo, Italy.

Platelet transfusion is conventionally used to prevent or treat bleeding in patients with low platelet counts or impaired platelet function. The identification of accurate thresholds of platelet count for guiding platelet transfusion practices is a crucial aspect in health care to prevent adverse events, side effects, unwarranted costs for the health care service, and deprivation of supplies. This article is therefore aimed at providing a narrative overview on current guidelines and recommendations for platelet transfusion across many clinical settings, including platelet function disorders, and critically analyzing the available platelet transfusion thresholds according to the current analytical performance of platelet counting with automated hematological analyzers. Overall, universal agreement on the definition of platelet transfusion thresholds has not been reached. The degree of accuracy and imprecision of many fully automated hematological analyzers appears also unsatisfactory, especially at the lower thrombocytopenic range, and this may thus jeopardize the managed care of patients who are candidates for platelet transfusions. Potential solutions to overcome the current shortcomings of automated platelet counting are also discussed, encompassing the use of alternative tests for guiding platelet transfusion (e.g., thrombin generation assays or thromboelastography) along with innovative approaches for platelet enumeration (e.g., fluorescent labeling and flow cytometry).
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http://dx.doi.org/10.1055/s-0039-1696943DOI Listing
April 2020

Preliminary evaluation of a new flow cytometry method for the routine hematology workflow.

Clin Chem Lab Med 2019 Sep;57(10):1608-1622

Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Piazza OMS, 1, 24127 Bergamo, Italy, Phone: (+039) 0352674550, Fax: (+039) 0352674939.

Background In a generalist laboratory, the integration of the data obtained from hematology analyzers (HAs) with those from multiparametric flow cytometry (FMC) could increase the specificity and sensitivity of first level screening to identify the pathological samples. The aim of this study was to perform a preliminary evaluation of a new simple hybrid method (HM). The method was obtained by integration between HAs reagents into FCM, with a basic monoclonal antibodies panel for the leukocytes differential count. Methods Eighty-one peripheral blood samples, collected in K3EDTA tubes, were analyzed by XN-module, and CyFlow Space System, using both standard MoAbs and HM method analysis, and with the optical microscopy (OM). Within-run imprecision was carried out using normal samples, the carryover was evaluated, data comparison was performed with Passing-Bablok regression and Bland-Altman plots. Results The within-run imprecision of HM methods ranged between 1.4% for neutrophils (NE) and 10.1% for monocytes (MO) always equal or lower to the OM. The comparison between HM methods vs. OM shows Passing-Bablok regression slopes comprised between 0.83 for lymphocyte (LY) and 1.14 for MO, whilst the intercepts ranged between -0.18 for NE and 0.25 for LY. Bland-Altman relative bias was comprised between -12.43% for NE, and 19.77% for eosinophils. In all 11 pathological samples the agreement between the methods was 100%. Conclusions The new hybrid method generates a leukocytes differential count suitable for routine clinical use and it is also useful for identifying morphological abnormalities with a reduction in cost and improvement of screening for first level hematology workflow.
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http://dx.doi.org/10.1515/cclm-2018-1356DOI Listing
September 2019

Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series.

Clin Chem Lab Med 2019 Nov;57(12):e324-e327

Clinical Chemistry Laboratory - Hospital Papa Giovanni XXIII, Piazza OMS 1, 24127 Bergamo, Italy, Phone: (+0039) 0352674550, Fax (+0039) 0352674939.

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http://dx.doi.org/10.1515/cclm-2019-0373DOI Listing
November 2019

Comparison between optical microscopy and automation for cytometric analysis of pericardial fluids in a cohort of adult subjects undergoing cardiac surgery.

J Clin Pathol 2019 Jul 29;72(7):493-500. Epub 2019 Apr 29.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Aims: Limited information is available on number and type of cells present in the pericardial fluid (PF). Current evidence and has been garnered with inaccurate application of guidelines for analysis of body fluids. This study was aimed at investigating the performance of automate cytometric analysis of PF in adult subjects.

Methods: Seventy-four consecutive PF samples were analysed with Sysmex XN with a module for body fluid analysis (XN-BF) and optical microscopy (OM). The study also encompassed the assessment of limit of blank, limit of detection and limit of quantitation (LoQ), imprecision, carryover and linearity of XN-BF module.

Results: XN-BF parameters were compared with OM for the following cell classes: total cells (TC), leucocytes (white blood cell [WBC]), polymorphonuclear (PMN) and mononuclear (MN) cells. The relative bias were -4.5%, 71.2%, 108.2% and -47.7%, respectively. Passing and Bablok regression yielded slope comprised between 0.06 for MN and 5.8 for PMN, and intercept between 0.7 for PMN and 220.3 for MN. LoQ was comprised between 3.8×10 and 6.0×10 cells/L for WBC and PMN. Linearity was acceptable and carryover negligible.

Conclusions: PF has a specific cellular composition. Overall, automated cell counting can only be suggested for total number of cells, whereas OM seems still the most reliable option for cell differentiation.
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http://dx.doi.org/10.1136/jclinpath-2019-205788DOI Listing
July 2019

Lack of harmonization in high fluorescent cell automated counts with body fluids mode in ascitic, pleural, synovial, and cerebrospinal fluids.

Int J Lab Hematol 2019 Apr 13;41(2):277-286. Epub 2019 Feb 13.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Introduction: Cellular analysis in body fluids (BFs) provides important diagnostic information in various pathological settings. This study was hence aimed at comparing automated cell count obtained with Mindray BC-6800 (BC-BF) vs Sysmex XN-series (XN-BF) and evaluating other quantitative and qualitative information provided by these analyzers in ascitic (AF), pleural (PF), synovial (SF), and cerebrospinal (CSF) fluids.

Methods: Three hundred and fifty-one samples (99 AFs, 45 PFs, 75 SFs, and 132 CSFs) were analyzed in parallel with BC-BF, XN-BF, and optical microscopy (OM). The study also included the assessment of diagnostic agreement among BC-BF, XN-BF, and OM.

Results: The comparison of BC-BF vs XN-BF yielded slopes of Passing and Bablok regression always comprised between 0.9 and 1.0 except for EO-BF and HF-BF, whilst the intercepts ranged from -0.4 for MN-BF and 12.0 for PMN-BF. The bias was comprised between -103.3% and 67.1% for HF-BF and EO-BF, respectively. A significant bias was found for TC-BF, WBC-BF, HF-BF (negative bias) and for PMN-BF and EO-BF (positive bias). The agreement (Cohen's kappa) between XN-BF and BC-BF was always ≥0.7, ranging between 0.87 in CSFs and 0.94 in AFs, and that with OM was similar (ie, 0.85 and 0.96).

Conclusion: The cytometric analysis of BF samples using BC-BF and XN-BF is clinically favorable when appropriately combined with OM. Quantitative and qualitative parameters displayed optimal agreement, whilst instrument-specific cut-offs should be defined and implemented for HF-BF and EO-BF. Further efforts should be made for achieving better harmonization in cytometric analysis of BF samples.
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http://dx.doi.org/10.1111/ijlh.12968DOI Listing
April 2019

A Preliminary Proposal for Quality Control Assessment and Harmonization of Leukocytes Morphology-structural Parameters (cell Population Data Parameters).

J Med Biochem 2018 Dec 1;37(4):486-498. Epub 2018 Dec 1.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Background: The cell population data (CPD) measured by Sysmex XN-9000 can be used for screening many hematological and non-hematological disorders. Since little information is available on harmonization of CPD among different instrumentation and clinical laboratories, this study aimed at assessing the current degree of CPD harmonization between separate Sysmex XN modules allocated to the same laboratory.

Methods: A total number of 78291 data were used for verification of within-run imprecision, analyzers harmonization, reference ranges and assessment of blood sample stability of CPD parameters, including results of daily quality control testing and those generated in samples collected from blood donors and healthy volunteers.

Results: Within-run imprecision of CPD parameters ranged between 0.4 and 14.1%. Good agreement was found among five different XN-modules, especially when values were adjusted after calculation of instrument-specific alignment factors. The bias of all parameters remained always lower than the reference change values in samples stored for up to 8 hours, regardless of storage temperature.

Conclusions: The imprecision of CPD parameters was acceptable, except for those reflecting the dispersion of cellular clusters. Due to the lack of reference control materials, we showed that the use of data generated on a large number of normal routine samples (i.e., a Moving Average population) may be a reliable approach for testing analyzers harmonization. Nevertheless, availability of both calibration and quality control materials for these parameters is highly advisable in the future. We finally showed that whole blood samples may be stable for up to 2-4 hours for most CPD parameters.
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http://dx.doi.org/10.2478/jomb-2018-0005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6298477PMC
December 2018

Lymphocyte morphology supports early diagnosis of Bordetella pertussis infection in neonates.

Intensive Care Med 2019 06 28;45(6):894-895. Epub 2018 Sep 28.

Department of Anesthesia and Intensive Care, Pediatric Intensive Care Unit, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.

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http://dx.doi.org/10.1007/s00134-018-5385-4DOI Listing
June 2019

Megakaryoblasts in a newborn with Down syndrome.

Blood Res 2018 Jun 25;53(2):102. Epub 2018 Jun 25.

Clinical Chemistry Laboratory, ASST PAPA Giovanni XXIII Bergamo, Bergamo, Italy.

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http://dx.doi.org/10.5045/br.2018.53.2.102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6021559PMC
June 2018

Harmonization of laboratory hematology: a long and winding journey.

Clin Chem Lab Med 2018 09;56(10):1575-1578

Section of Clinical Biochemistry, University Hospital of Verona, Piazzale LA Scuro, 37100 Verona, Italy.

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http://dx.doi.org/10.1515/cclm-2018-0161DOI Listing
September 2018

Validation of an immunoturbidimetric assay for assessment of C reactive protein in synovial fluid.

J Immunol Methods 2018 06 6;457:22-25. Epub 2018 Mar 6.

Sezione di Biochimica Clinica, Università degli Studi di Verona, Verona, Italy.

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http://dx.doi.org/10.1016/j.jim.2018.03.001DOI Listing
June 2018

Harmonization of interpretative comments in laboratory hematology reporting: the recommendations of the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH-SIBioC).

Clin Chem Lab Med 2018 12;57(1):66-77

Section of Clinical Biochemistry, University Hospital of Verona, Verona, Italy.

The goal of harmonizing laboratory testing is contributing to improving the quality of patient care and ultimately ameliorating patient outcome. The complete blood and leukocyte differential counts are among the most frequently requested clinical laboratory tests. The morphological assessment of peripheral blood cells (PB) through microscopic examination of properly stained blood smears is still considered a hallmark of laboratory hematology. Nevertheless, a variable inter-observer experience and the different terminology used for characterizing cellular abnormalities both contribute to the current lack of harmonization in blood smear revision. In 2014, the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH-SIBioC) conducted a national survey, collecting responses from 78 different Italian laboratories. The results of this survey highlighted a lack of harmonization of interpretative comments in hematology, which prompted the WGDH-SIBioC to develop a project on "Harmonization of interpretative comments in the laboratory hematology report", aimed at identifying appropriate comments and proposing a standardized reporting system. The comments were then revised and updated according to the 2016 revision of the World Health Organization classification of hematologic malignancies. In 2016, the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH SIBioC) published its first consensus based recommendation for interpretative comments in laboratory hematology reporting whit the purpose of evaluating comments and the aim to (a) reducing their overall number, (b) standardizing the language, (c) providing information that could be easily comprehended by clinicians and patients, (d) increasing the quality of the clinical information, and (e) suggesting additional diagnostic tests when necessary. This paper represents a review of the recommendations of the former document.
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http://dx.doi.org/10.1515/cclm-2017-0972DOI Listing
December 2018

Short- and medium-term biological variation estimates of red blood cell and reticulocyte parameters in healthy subjects.

Clin Chem Lab Med 2018 05;56(6):954-963

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Background: The integrated evaluation of traditional and innovative red blood cell (RBC) and reticulocyte parameters is a rapid, inexpensive and non-invasive diagnostic tools for differential diagnosis and follow-up of anemia and other pathological conditions needing bone marrow erythropoiesis assessment. Therefore, estimating the biological variation (BV) of these parameters is essential for evaluating the analytical performance of hematological analyzers, and for enabling accurate data interpretation and appropriate clinical management. This study aims to define short- and medium-term BV estimates and reference change value (RCV) of RBC and reticulocyte parameters.

Methods: Twenty-one healthy volunteers participated in the assessment of medium-term BV (blood sampling once/week, five consecutive weeks) and 22 volunteers in the assessment of short-term BV (blood sampling once/day, five consecutive days) using Sysmex XN. Outlier analysis was performed before CV-ANOVA, to determine BV estimates with confidence intervals (CI).

Results: Medium- and short-term within-subject BV were between 0.3% and 16.4% and 0.2%-10.4% (MCH and IRF), respectively, whereas medium and short-term between-subjects BV ranged between 0.9% and 66.6% (MCHC and Micro-R) and 1.4%-43.6% (MCHC and IRF), respectively. The RCVs were similar for all parameters in both arms of the study, except for hemoglobin, RDW-CV and MCV.

Conclusions: This study allowed for estimating the BV of many RBC and reticulocyte parameters, some of which have not been currently explored. For RBC, hemoglobin, RDW-CV and MCV it seems advisable to use RCV calculated according to monitoring time and/or differentiated by sex. As regards analytical goals, we suggest using the most stringent targets found in the short-term arm of this study.
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http://dx.doi.org/10.1515/cclm-2017-0902DOI Listing
May 2018

A specific abnormal scattergram of peripheral blood leukocytes that may suggest hairy cell leukemia.

Clin Chem Lab Med 2018 04;56(5):e108-e111

Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.

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http://dx.doi.org/10.1515/cclm-2017-0763DOI Listing
April 2018

Preliminary evaluation of UF-5000 Body Fluid Mode for automated cerebrospinal fluid cell counting.

Clin Chim Acta 2017 Oct 24;473:133-138. Epub 2017 Aug 24.

Clinical Chemistry Laboratory, Hospital Papa Giovanni XXIII, Bergamo, Italy. Electronic address:

Background: Cellular analysis of cerebrospinal fluid (CSF) provides important diagnostic information in various medical conditions. The aim of this study was to evaluate the application of Sysmex UF-5000 body fluid mode in cytometric analysis of CSF compared to Light Microscopic (LM).

Methods: Eighty-one consecutive CSF samples were analyzed by UF-5000 body fluid mode and by LM. The study also included the evaluation of: limit of Blank (LoB), limit of Detection (LoD), limit of Quantitation (LoQ), carryover and linearity.

Results: For total nucleated cells (TNC-UF) and white blood cells (WBC-UF) LoB, LoD and LoQ were 1×10cells/L, 1.8×10cells/L and 1.9×10cells/L respectively. For red blood cells (RBC) LoB was 2×10cells/L, LoD was 3.5×10cells/L and LoQ was 14×10cells/L respectively. Linearity was excellent, carryover was negligible. The agreement between UF-5000 body fluid mode parameters and manual cell counts was good in all CSF samples with bias ranged between -0.5 and 25.1×10cells/L. The ROC curve analysis showed an area under curve of 0.99 for both TNC-UF and WBC-UF parameters.

Conclusions: The UF-5000 body fluid mode offers rapid and accurate counts in clinically relevant concentration ranges, replacing the LM for most samples. However, in samples with abnormal cell counts or with abnormal scattergram the need for microscopic review remains.
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http://dx.doi.org/10.1016/j.cca.2017.08.026DOI Listing
October 2017

Innovative haematological parameters for early diagnosis of sepsis in adult patients admitted in intensive care unit.

J Clin Pathol 2018 Apr 20;71(4):330-335. Epub 2017 Aug 20.

Department of Clinical Biochemistry, University of Verona, Verona, Italy.

Aims: This study was aimed to investigate the role of erythrocyte, platelet and reticulocyte (RET) parameters, measured by new haematological analyser Sysmex XN and C reactive protein (CRP), for early diagnosis of sepsis during intensive care unit (ICU) stay.

Methods: The study population consisted of 62 ICU patients, 21 of whom developed sepsis during ICU stay and 41 who did not. The performance for early diagnosing of sepsis was calculated as area under the curve (AUC) of receiver operating characteristics curves analysis.

Results: Compared with CRP (AUC 0.81), immature platelet fraction (IPF) (AUC 0.82) showed comparable efficiency for identifying the onset of sepsis. The association with the risk of developing sepsis during ICU stay was also assessed. One day before the onset of sepsis, a decreased of RET% was significantly associated with the risk of developing sepsis (OR=0.35, 95% CI 0.14 to 0.87), whereas an increased of IPF absolute value (IPF#) was significantly associated with the risk of developing sepsis (OR=1.13, 95% CI 1.03 to 1.24) 2 days before the onset of sepsis. The value of CRP was not predictive of sepsis at either time points.

Conclusions: IPF# and RET% may provide valuable clinical information for predicting the risk of developing sepsis, thus allowing early management of patients before the onset of clinically evident systemic infections.
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http://dx.doi.org/10.1136/jclinpath-2017-204643DOI Listing
April 2018

Performance evaluation of the new fully automated urine particle analyser UF-5000 compared to the reference method of the Fuchs-Rosenthal chamber.

Clin Chim Acta 2017 Sep 29;472:123-130. Epub 2017 Jul 29.

Clinical Chemistry Laboratory, Department of Laboratory Medicine, Papa Giovanni XXIII Hospital, Piazza OMS 1, Bergamo, Italy.

Background: UF-5000 is the new fully automated urine particle analyser. We validated its performance.

Methods: 736 urines were analysed and results were compared by two pathologists on uncentrifuged samples, using Fuchs-Rosenthal chamber.

Results: AUC of ROC curve ranged between 0.86 and 0.99. Sensitivity was >0.90 for all the elements and similar for RBC and yeasts. Specificity ranged between 0.74 and 0.89 for total cast, epithelial/non-squamous/renal-tubular cells and RBC. For all the other parameters specificity was >0.90. Comparison with Fuchs-Rosenthal chamber was very good for all the parameters; r ranged between 0.52 and 0.99 except for pathological cast because of the lack of the pathological samples in medium and higher ranges. Linearity performance (R) was 1.00, 1.00 and 0.99 respectively for RBC, WBC and epithelial cells (EC). No carry-over was observed. The within-run imprecision was 25.42%,13.81%,1.36% for RBC; 37.50%,10.16%,1.41% for WBC and 35.25%, 17.85%,6.30% for EC at low, near the cut off level and high concentrations, respectively. The between-run imprecision was 6.90%,1.60% for RBC, 4.10%,1.90% for WBC and 7.60%,7.30% for EC, using low and high positive quality controls, respectively.

Conclusion: UF-5000 is an analyser of great interest to detect urine particle related to pathological process of kidney and urinary tract.
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http://dx.doi.org/10.1016/j.cca.2017.07.028DOI Listing
September 2017

Short- and medium-term biological variation estimates of leukocytes extended to differential count and morphology-structural parameters (cell population data) in blood samples obtained from healthy people.

Clin Chim Acta 2017 Oct 10;473:147-156. Epub 2017 Jul 10.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Background: Recent studies showed that some cell population data (CPD) parameters of neutrophils may be useful for diagnosing myelodysplastic syndromes and sepsis, for the differential diagnosis of acute promyelocytic leukemia, and some CPD parameters of lymphocytes may be a valuable tool for preliminary screening of B cell lymphoproliferative disease. Notwithstanding the knowledge, no information has been made available about their analytical quality specification. This study was aimed to define short- and medium-term biological variation (BV) estimates and reference change value (RCV) of leukocyte count, extended leukocyte differential and CPD.

Methods: The study population consisted of 43 healthy volunteers, who participated in the assessment of medium-term (21 volunteers; blood sampling once a week for 5 consecutive weeks) and short-term (22 volunteers; blood sampling once a day for 5 consecutive days) BV, using Sysmex XN. Outlier analysis was carried out before CV-ANOVA, to determine BV estimates and their confidence intervals.

Results: The medium-term and short-term within-subject BV (CV) was comprised between 0.6-19.7% and 0.2-21.9%, whereas the medium-term and short-term between-subjects BV (CV) was comprised between 1.2-61.5% and 1.1-58.5%. The RCVs were found to be similar for all the parameters, in both arms of the study, except for some CPD parameters.

Conclusion: This study allowed accurately estimating the BV of many leukocyte parameters, some of which have not been currently explored. The kinetics of some leukocyte turnover suggests the use of short-term BV data for calculating analytical goals and RCV.
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http://dx.doi.org/10.1016/j.cca.2017.07.009DOI Listing
October 2017

Biological variation of platelet parameters determined by the Sysmex XN hematology analyzer.

Clin Chim Acta 2017 Jul 4;470:125-132. Epub 2017 May 4.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Background: This study was aimed to define the short- and medium-term biological variation (BV) estimates, the index of individuality and the reference change value (RCV) of platelet count, platelet distribution width, mean platelet volume, platelet larger cell ratio, plateletcrit and immature platelet fraction.

Methods: The study population consisted of 43 health subjects, who participated to the assessment of medium-term (21 subjects; blood sampling once a week for 5 consecutive weeks) and short-term (22 subjects; blood sampling once a day for 5 consecutive days) BV study, using Sysmex XN-module. Eight subjects were also scheduled to participate to both phases. The data were subject to outlier analysis prior to CV-ANOVA, to determine the BV estimates with the relative confidence intervals.

Results: The medium-term and short-term within-subject BV (CV) was comprised between 2.3 and 7.0% and 1.1-8.6%, whereas the medium-term and short-term between-subjects BV (CV) was comprised between 7.1 and 20.7% and 6.8-48.6%. The index of individuality and index of heterogeneity were always respectively <0.6 and >0.63 for all the parameters, in both arms of the study. The RCVs were similar for all parameters, in both arms of the study.

Conclusion: This study allowed to define the BV estimates of many platelet parameters, some of them unavailable in literature. The kinetics of platelet turnover suggests the use of short-term BV data for calculating analytical goals and RCV. The correct clinical interpretation of platelet parameters also necessitates that each laboratory estimates local RCV values.
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http://dx.doi.org/10.1016/j.cca.2017.05.004DOI Listing
July 2017

Clinical significance of cell population data (CPD) on Sysmex XN-9000 in septic patients with our without liver impairment.

Ann Transl Med 2016 Nov;4(21):418

Department of Clinical Biochemistry, University of Verona, Verona, Italy.

Background: This study evaluated the clinical significance of cell population data (CPD) parameters obtained on Sysmex XN-9000 in septic patients admitted to intensive care unit (ICU) and stratified according to liver function.

Methods: The study population consisted in 84 patients, 44 of whom did not develop sepsis (NS), whereas the remaining 40 developed sepsis (SE) (n=24) or septic shock (SS) (n=16). Two hundred ostensibly healthy blood donors [healthy subjects (HS)], undergoing routine blood testing before a regular blood donation, were studied.

Results: Except for neutrophils and lymphocytes cell size (NE-FCS and LY-Z), all other CPD values were significantly different in ICU patients compared to HS. Neutrophils and monocytes fluorescence intensity (NE-SFL and MO-X) values were significantly higher in SS compared to sepsis and not develop sepsis patients. The value of many parameters was also different according to liver function. Overall, MO-X and neutrophils fluorescence intensity (NE-SFL) exhibited the best performance for diagnosing sepsis in all patients (AUC, 0.75 and 0.72), as well as in those with (AUC, 0.95 and 0.89) or without (AUC, 0.72 for both) liver impairment. These parameters were also significantly correlated with Sequential Organ Failure Assessment (SOFA) score.

Conclusions: This study suggested that some novel CPD parameters (namely NE-SFL and MO-X) may provide useful information for diagnosis and management of sepsis.
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http://dx.doi.org/10.21037/atm.2016.10.73DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124619PMC
November 2016