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Introduction: recently the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) Big Data and Artificial Intelligence Working Group (BAI-WG) conducted a survey to examine technological and information technology readiness for developing BAI applications and to investigate laboratory professionals' knowledge and skills. This article examines specific survey questions related to supporting data. These data are visible only by laboratory professionals for the purpose of supporting all laboratory processes and, ultimately for the validation of results and they can be generally ascribed under the quality management system (QMS). Methods: the questionnaire, designed by the BAI-WG, was sent to 1351 SIBioC members. The responses were evaluated using Survey-Monkey software and Google Sheets. Results: over 90% of respondents work in laboratories with a QMS in place. The participants consider digitisation of QMS as highly advantageous (93%). Nevertheless, computerisation of the QMS is actually often incomplete, and the connection between QMS and Laboratory Information Systems (LIS) is usually lacking or missing. Consequently, alternative systems, separate from the LIS, have been developed to record various QMS data essential for monitoring processes. Discussion: the integration of medical data sources is crucial for developing BAI applications. The issue of integration is relevant and strongly linked to digitisation. However, algorithms may often consider only reported data, but integration should also be extended to supporting data, which could be correlated with clinical and process outcomes. Current LIS lack the necessary features for BAI applications and QMS digitisation is still too far behind to allow for real-time control. Software vendors should move towards the total integration of health data. [ABSTRACT FROM AUTHOR]

Introduction: the increase of Mean Corpuscolar Hemoglobin Concentration (MCHC) in the Complete Blood Count (CBC) test is a complex issue, deserving great attention. Erytrocytes (RBC) count by impedance and the photometric hemoglobin (HGB) measurement can be influenced by both biological variables (cold agglutinins, lipemia, icterus, hemolysis, RBC alterations) and pre-analytical factors (collection, storage and transport of the sample). In this paper, the Complete Blood Count-Optical (CBC-O) algorithm is evaluated for the identification of the cause of the MCHC increase and for the suggested corrective action to correctly report the CBC parameters. Methods: 255 samples, collected with K2-EDTA anticoagulant, for the CBC test were used. The algorithm was triggered after the reticulocytes reflex testing (XN-RET) using the XN hematology analyzer (Sysmex), when MCHC was >365 g/L. The CBC-O tool uses a number of RBC and HGB measures and indices. Results: the samples were classified by the CBC-O algorithm into 5 groups according to the causes of the MCHC increase: cold agglutinins (n=70), cold agglutinins and HGB interferences (n=10), HGB interferences (n=6), RBC pathologies or hemolysis (n=32) and unclear situations with normal RBC profile (n=137). Discussion: MCHC elevation is a rare occurrence in routine daily practice, but it needs to be managed properly. The CBC-O algorithm is a useful tool since, in a short time, it allows to give indications on the probable causes of the increase and to report correct erythrocyte indices, without the need to treat the sample, which would otherwise lengthen the turn around time. [ABSTRACT FROM AUTHOR]

Introduction: kappa index (ratio between cerebrospinal fluid (CSF)/serum kappa free light chains and CSF/serum albumin) is an emerging CSF biomarker, easily and quickly evaluable using a complete automatic technique that offers a quantitative result, to integrate the qualitative assessment of oligoclonal bands (OCB). These parameters can be further supplemented with the central vein sign (CVS), an imaging parameter indicative of inflammatory injury in the white matter in patients with Multiple Sclerosis (MS). Methods: we analyzed CSF biomarkers, OCB and kappa index in patients who underwent on CSF examination in our MS Center in Firenze (Italy) during 2020-2022. The patients were divided in MS and not MS (nMS) groups and further divided in OCB+ or OCB-, kappa index+ or kappa index-, and CVS+ or CVS-patients. Results: the study population is composed by 114 patients (77 women and 37 men) with an average age of 42.2 years. Among the 114 participants, 68 (59.6%) were MS and 46 (40.4%) nMS. We also analyzed a subgroup of 49 patients with 3T Magnetic Resonance (n=31 MS and n=18 nMS). When the kappa index was compared between the two groups, it showed higher sensitivity, Positive Predictive Value and Negative Predictive Value than OCB; the combination of CVS and kappa index showed the best ratio of sensitivity to specificity compared with the other groups analyzed. Discussion: these results also suggest that kappa index can be used as a screening test in MS even before performing OCB, in a reflex approach that can improve MS diagnosis. Using both MRI and CSF biomarkers ameliorate remarkably the MS diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: the use of antioxidant supplements in athletes is frequent but rarely the choice is based on preliminary biochemical tests. Aim of our work was to verify the usefulness of some blood and urinary markers of oxidative and inflammatory balance in a case of antioxidant supplementation involving athletes of an elite women's football team. Methods: in preparation for an increased workload, 22 players took a food supplement containing N-acetylcysteine (NAC) for 30 days. At the beginning and at the end of this period, some biomarkers of muscle physiology, inflammation, redox balance and oxidative damage were measured. Results: after supplementation, total antioxidant barrier remained unchanged and anti-inflammatory capacity increased despite the higher workload. However, the measurement of oxidative damage markers did not allow us to reach useful conclusions. Discussion: redox balance, glutathione, IL-6 and IL-10 measurements before supplementation showed an initial oxidative-inflammatory balance, and have proven useful for evaluating the effects of the antioxidant treatment. The maintenance of oxidative balance and the increase in anti-inflammatory capacity seem to indicate its effectiveness. Unfortunately, the lack of a control group prevented us from attributing the beneficial effects to the treatment alone. Supplementation with antioxidants in sport should be a thoughtful choice based on a preliminar assessment of the athlete's real needs. The role of the laboratory is crucial to evaluate the oxidative balance of athletes, to plan the integration and subsequently to measure the effects of supplementation. [ABSTRACT FROM AUTHOR]

Introduction: the analysis of cerebrospinal fluid (CSF) and the determination of free light chains (FLC) are routinely used in the clinical laboratory. We investigated the utility of kappa index (Qkappa FLC/Qalb) as a specific biomarker for the differential diagnosis of multiple sclerosis and inflammatory neurological disorders in a pediatric population. Methods: among 978 patients enrolled from January 2019 to May 2022, we analyzed 53 pediatric samples (0-17 years old). Albumin, IgG and kappa FLC in serum and CSF were measured by turbidimetric method, while isoelectrofocusing was performed to check for the presence of oligoclonal bands. The related CSF/serum indices (kappa index and IgG index) are also calculated. Results: according to the clinical diagnosis, four groups of patients have been identified: multiple sclerosis, inflammatory neurological disorders, non-inflammatory diseases, negative controls. The kappa index cut-off of 6.2, obtained from our previous study, yielded 83.3% sensitivity and 85.7% specificity in the comparison between multiple sclerosis patients and the other groups. The IgG index (showing 50% sensitivity and 45.5% specificity at a threshold of 0.50) confirmed its poor diagnostic performance. In the comparison between inflammatory and non-inflammatory disorders a kappa index cut-off of 3.3 was associated with 80.6% sensitivity and 76.5% specificity. Conclusion: the kappa index cut off (6.2) in use in our laboratory for multiple sclerosis diagnosis in the adult population can be confirmed in a pediatric cohort. Moreover, a lower kappa index cut-off (3.3) seems useful to discriminate pediatric inflammatory diseases, as recently reported by other Authors, and can be applied in the differential diagnosis of inflammatory processes of the central nervous system. [ABSTRACT FROM AUTHOR]

Background: the poor adherence to guidelines approved by scientific societies are widely described as a possible cause of criticisms in the management of several diseases. In the setting of dyslipidemia, a lack of compliance with clinical and biochemical recommendations defining the informations that should be included in the laboratory report, could be a relevant issue. Methods: in order to verify the state-of-the art of this specific topic, a survey containing 8 questions spanning from the pre-analitycal phase (panel of tests, nonfasting testing), to analytical (types of methods and equations) and to post-analytical phase (reference interval, desirable values, therapeutic goals) was sent to the laboratory professionals registered in the Italian Society of Clinical Biochemistry and Molecular Biology (SIBioC). Results: the most interesting results demonstrate that: about 40% of the laboratories add to the traditional lipid panels (total, LDL and HDL cholesterol, tryglicerides) the recommended measurement of apolipoproteins (Apo-A1, Apo-B and Lpa); 89% adopt the fasting testing; 73.6% use direct methods to measure HDL-C and 29% calculate LDL-C using Friedewald equation; 87.3% of the values are reported using the traditional (mg/dL) units; 64.5% use the reference interval as comparator, inadequate for the most part of lipid tests, 51.4% desirable levels, only 5.61% the recommended therapeutic goals. Discussion: on the basis of the obtained data, a shared improvement in the adoption and application of the recommendations published by SIBioC but poorly adopted until now, seems to be a fundamental activity that should be undertaken in the near future. [ABSTRACT FROM AUTHOR]

Introduction: this study was designed to measure ethyl alcohol concentrations in blood samples of different matrices (Li-He plasma, K2-EDTA plasma and serum) with the DRI® method on the ILab Taurus analyzer. The aim of the protocol was to compare the values between the matrices K2-EDTA and serum with Li-He plasma. Furthermore, 18 real samples from the emergency room were used to compare the results obtained with the enzymatic method on both Li-He and K2-EDTA plasma in comparison with the GC/HS reference method. Methods: serum, Li-He and K2-EDTA samples were obtained from left-over routine samples to obtain different pools (serum, Li-He plasma and K2-EDTA plasma pools). Samples with different expected concentrations of ethanol (range 0.00-2.22 g/L) were prepared in situ (60 samples for each matrix) by precise additions of a 10% ethanol solution. All these samples were stored at -20°C until use. Results: in the expected concentration range between 0.42 and 0.85 g/L and around 0.8 and 1.5 g/L [which incorporates most of the legally permitted levels of BAC (Blood Alcohol Concentration) in Europe including Italy] the CV% obtained are all <5.0%. The GC/HS correlation with ILab Taurus for both plasma matrices, LI-He and K2-EDTA evaluated in 18 genuine samples was excellent. Discussion: all the obtained results show that for all the matrices evaluated in the study, the analytical performances are highly satisfactory. [ABSTRACT FROM AUTHOR]

Introduction: the Failure Mode Effects And Criticality Analysis (FMECA) is a proactive risk management tool that involves the analysis of a predefined process and the multidisciplinary identification of preventable defects/errors in order to prioritise the changes to be implemented. The Regional Centre for Health Risk Management and Patient Safety of Regione Lombardia (Italy) has drawn up together with the Regional Reference Centre for the Quality of Laboratory Medicine Services, an FMECA model for the management of the process of swabs for the detection of the SARS-CoV-2 virus during the recent pandemic. Methods: the application of FMECA involves several procedural steps, the first of which is the establishment of a multi-disciplinary and multi-professional team. For each process in the FMECA model, the working group identified, by means of a qualitative analysis, the frequency of occurrence, the severity of the effects and their detectability as well. Results: the working group found 118 different possible criticalities (items) in the entire process: 9 belonged to the Request Generation Phase, 35 to the pre-Analytical phase, 46 to the Analytical phase and 28 to the post-Analytical phase. The analysis of the Risk Index (RI), revealed that 81% of the items presented an acceptable risk, subject only to periodic monitoring, while 19% presented a low RI for which planned corrective measures were developed. Discussion: the working group considered the proactive approach useful in intercepting errors before they occur by identifying potentially dangerous situations. The FMECA model made it possible to act proactively on the threats inherent in laboratory processes, stimulating reflection in the identification of improvement actions, ensuring awareness of daily processes and increasing the spread of a preventive risk culture. [ABSTRACT FROM AUTHOR]

Introduction: light chain (AL) amyloidosis complexity requires specialized laboratories and use of highly sensitive methods for disease monitoring. During COVID-19 outbreak, access to our diagnostic facility was limited and a telemedicine (TM) program was established to maintain patients' management. Methods: patients were asked to perform specific blood and urine tests at a local laboratory. Biopsy samples were shipped to Pavia for amyloid typing. Results: in 2020, 369 TM were performed. For 102 (27%) patients, this was the first contact with our center, 73 (71%) of them received a final diagnosis and the specific therapeutic treatment, whereas in 29 (28%) the diagnostic suspicion was not confirmed. A TM was done in 276 (72%) patients previously evaluated, 214 (80%) of them had systemic AL with 99 (46%) receiving chemotherapy [89 (41%) proceeded with therapy, 10 (4%) suspended due to sustained hematologic response]. Seven (3%) started a new treatment due to loss of hematologic response. In all other cases, hematologic response was confirmed, and treatment free interval was prolonged. In 2021, 109 patients previously evaluated in our Center performed TM, of them 54 (50%) had a systemic AL. In 11 (19%) patients ongoing chemotherapy was proceeded and in one case a new therapy was suggested due to disease progression. Discussion: through this TM based-approach we reached a final diagnosis in 71% of cases and we assessed hematologic and organ response in local laboratories making clinical decisions. Despite being a response to pandemic, this hub and spoke TM model proved effective in a complex disease. [ABSTRACT FROM AUTHOR]

Introduction: the diagnosis of periprosthetic joint infection (PJI) is a clinical challenge. Among other clinical and laboratory parameters, recent recommendations for the diagnosis of PJI advocate the assessment of leukocyte esterase in synovial fluid (SF), commonly performed with urine test strips, a method that is not validated for such a matrix. To challenge this practice, we evaluated the performance of a commercial urine test strip to assess leukocyte esterase in SF compared with leukocyte counting. Methods: between October 2017 and September 2019, SF samples were collected from patients scheduled for revision surgery for 6 painful total knee arthroplasties. International Consensus Meeting (ICM) criteria were used to classify PJI. Leukocyte esterase (visual assessment with Menarini Aution test strips) and automated leukocyte count (Sysmex 2000, XN- 8 Body Fluids Module) were assessed in 74 SF specimens. Results: the AUC of leukocyte esterase compared with automated leukocyte counting ranged from 0.88 to 0.94. Leukocyte esterase cutoff values of 500, 250, and 75 leukocytes/µL yielded sensitivity values ranging from 0.78-1.00, 0.87-1.00, and >0.96, respectively, whereas specificity ranged from 0.76-0.94, 0.61-0.78, and <0.37. The diagnostic performance of leukocyte esterase was higher when hemolyzed samples were excluded. Discussion: our results highlight the many limitations of using conventional urine test strips to visually assess leukocyte esterase in SF specimens, underscoring the need to develop specific assays or perform validation studies before implementing a diagnostic procedure. [ABSTRACT FROM AUTHOR]

Artificial Intelligence (AI) introduced a new era of possibilities into Medicine and promises considerable socio-economic benefits and improvements in individual and public health. Although lagging behind other medical specialties, laboratory medicine is beginning to invest in AI, particularly in machine learning and deep learning applications. Despite many encouraging results, the clinical impact of AI models in clinical medicine is hindered by incorrect study design, reduced sample size, wide heterogeneity of algorithms and performance metrics used, as well as weak validation strategies. This review aims to present a balanced vision of the potential applications of AI in Medicine, opportunities and benefits, without minimizing or neglecting limitations or risks. A range of possible solutions to deal with potential threats are also discussed. In order to be an actor and no longer a spectator, specialists in Laboratory Medicine are encouraged to experiment and practice with these new concepts and methods, being engaged in multidisciplinary teams and multicentric studies. [ABSTRACT FROM AUTHOR]

Vaccination against SARS-CoV-2 is an important preventive strategy against COVID-19 particularly in frail patients. Recent literature reports about suboptimal antibody response to COVID-19 vaccination in people with weakened immune system, including those with hematological malignancies and who are receiving or have received treatment for cancer. Here we report the case of a 63-year-old woman who was diagnosed a breast cancer and a stage 3 multiple myeloma with multiple bone lesions both in 2016. Following specific radio and chemotherapy and autologous stem cell transplantation, the diseases completely remitted. Currently, she presents serum hypogammaglobulinemia, a condition that usually prevents the immune system from producing circulating antibodies in adequate amounts. The immune response of the patient to the mRNA BNT162b2 vaccine against SARS-CoV-2 is presented and compared with that of a cohort of healthcare professionals. It was possible to conclude that the patient exhibits a good SARS-CoV-2 immune response comparable to that of the control population. [ABSTRACT FROM AUTHOR]

Allergic diseases are among the top chronic diseases in Europe and developing countries, and the World Health Organisation now considers allergy a 'non-communicable, out-of-control disease' with a possible increase in prevalence of up to 50% in the latest generation. Allergology transversally involves different medical specialities, affecting different organs and apparatuses and opening up to numerous varieties of clinical pictures. In parallel, the Allergy Diagnostic Laboratory is assuming a major role in helping to provide a personalised, targeted and accurate approach for the allergic patient, based on the preliminary detection of an individual sensitisation profile. The aim of this document is to illustrate the whole range of new resources that Laboratory Medicine can provide for initial diagnostic guidance for Allergy, directing selected patients into the appropriate pathway, and referring those who really need an accurate specialist examination to the allergist. In a following document (part 2), specific allergies will be considered: food allergies, allergies to hymenoptera venoms and professional allergies (i.e. latex). [ABSTRACT FROM AUTHOR]