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The most widespread healthcare reimbursement models, including diagnostic laboratory services, are Fee-for-Service, Reference Pricing and Diagnosis-Related Groups. Within these models healthcare providers are remunerated for each specific service or procedure they operate. Healthcare payers are increasingly exploring alternative models, such as bundled payments or value-based reimbursement to encourage value of patient care rather than the simple amount of delivered services. These alternative models are advised, as they are more efficient in promoting cost-effective, high-quality laboratory testing, thereby improving patient health outcomes. If outcomes-based evaluation is a pillar in a new vision of "Value-Based Healthcare", an active policy of Value-Based Reimbursement in laboratory medicine will assure both an efficiency-based sustainability and a high-quality effectiveness-based diagnostic activity. This review aims to evaluate current and alternative reimbursement models, to support a wider agenda in encouraging more Value-Based Healthcare and Value-Based Reimbursement in laboratory medicine. [ABSTRACT FROM AUTHOR]

In accordance with all the most recent international guidelines, the variation of circulating levels of cardiac troponins I and T, measured with high-sensitivity methods (hs-cTnI and hs-cTnT), should be used for the detection of acute myocardial injury. Recent experimental and clinical evidences have demonstrated that the evaluation of hs-cTnI and hs-cTnT variations is particularly relevant: a) for the differential diagnosis of Acute Coronary Syndromes (ACS) in patients admitted to the Emergency Department (ED); b) for the evaluation of cardiovascular risk in patients undergoing major cardiac or non-cardiac surgery, and in asymptomatic subjects of the general population aged >55 years and with co-morbidities; c) for the evaluation of cardiotoxicity caused by administration of some chemotherapy drugs in patients with malignant tumors. The aim of this document is to discuss the fundamental statistical and biological considerations on the intraindividual variability of hs-cTnI and hs-cTnT over time in the same individual. Firstly, it will be discussed in detail as the variations of circulating levels strictly depend not only on the analytical error of the method used but also on the intra-individual variability of the biomarker. Afterwards, the pathophysiological interpretation and the clinical relevance of the determination of the variability of the hs-cTnI and hs-cTnT values ​​ in patients with specific clinical conditions are discussed. Finally, the evaluation over time of the variation in circulating levels of hs-cTnI and hs-cTnT is proposed for a more accurate estimation of cardiovascular risk in asymptomatic subjects from the general population. [ABSTRACT FROM AUTHOR]

Cryofibrinogen (CF) is an abnormal protein in plasma that precipitates at 4 °C and dissolves at 37 °C. Whilst serum cryoglobulins (CGs) analysis is common practice, CF investigation is rarely performed. This study aims to describe the testing methodology developed at our laboratory, potential pitfalls for all analytical phases, the distribution among hospital wards and clinical conditions underlying test requests and clinical conditions in which to order CF analysis is useful. Retrospective analysis of laboratory samples received between January 2019 and June 2021 with CF testing requests. A complete protocol for CF pre-analytical, analytical and post-analytical phases are supplied. Most test requests were received from the rheumatology department for systemic sclerosis or liver transplant screening. Among the 103 in-patients included, CF+ was confirmed in 68 patients (66%). Of observed CF+ patients (n=68) most cases were CGs− (n=44, 67%). Isolated CF was found in 43% of the cases. Among CF− patients (n=35; 34%) only 2 patients had positive CGs (CGs+). Among rheumatology patients (n=66), isolated CF+ was observed in 45% (n=30/66), whilst among patients with systemic sclerosis with CF+ (n=19), isolated CF+ was detected in 79% (n=15/19). Described analytical procedures may be used for the creation of harmonized recommendations and indications for CF analysis. Isolated CF positivity among hospitalized patients, predominantly rheumatology and systemic sclerosis patients, appears higher than rates previously reported in literature. We propose CF test recommendations should be included in investigation protocols for diseases where cryofibrinogenemia may occur. [ABSTRACT FROM AUTHOR]

Major adverse cardiovascular events are frequently observed in patients undergoing major non-cardiac surgery during the peri-operative period. At this time, the possibility to predict cardiovascular events remains limited, despite the introduction of several algorithms to calculate the risk of adverse events, mainly death and major adverse cardiovascular events (MACE) based on the clinical history, risk factors (sex, age, lipid profile, serum creatinine) and non-invasive cardiac exams (electrocardiogram, echocardiogram, stress tests). The cardiac-specific biomarkers natriuretic peptides (NPs) and cardiac troponins (cTn) have been proposed as additional tools for risk prediction in the peri-operative period, particularly for the identification of myocardial injury in patients undergoing major non-cardiac surgery. The prognostic information from the measurement of BNP/NT-proBNP and hs-cTn is independent and complementary to other important indicators of risk, also including ECG and imaging techniques. Elevated levels of cardiac-specific biomarkers before surgery are associated with a markedly higher risk of MACE during the peri-operative period. BNP/NT-proBNP and hs-cTn should be measured in all patients during the clinical evaluation before surgery, particularly during intermediate- or high-risk surgery, in patients aged >65 years and/or with comorbidities. Several questions remain to be assessed in dedicated clinical studies, such as how to optimize the management of patients with raised cardiac specific biomarkers before surgery, and whether a strategy based on biomarker measurement improves patient outcomes and is cost-effective. [ABSTRACT FROM AUTHOR]

Keywords: clinical genomics; genetic testing; hereditary cancer; laboratory automation; Next Generation Sequencing EN clinical genomics genetic testing hereditary cancer laboratory automation Next Generation Sequencing 115 122 8 02/07/22 20220201 NES 220201 Introduction Several omics approaches have been described so far with the potential to lead information and improvement in many aspects of human life, particularly in the healthcare system, for prevention, diagnosis, clinical knowledge and, of course, treatment of diseases. Discussion Diagnostic laboratories are commonly part of a wider clinical frame, where the inflow of samples to be tested with the NGS is not generally made of large, constant and fixed samples' cohorts, but of a dynamic and even intermittent rate of smaller number of samples. After processing, sequencing and analyzing more than 1,000 genomic DNA samples, we compared the NGS results carried out with this automated protocol with the ones carried out manually on 240 samples, collected in the SOPHiA HCS performance evaluation study (https://www.sophiagenetics.com/fileadmin/documents/Solutions/HCS/HCSbySG%5fApplicationNote.pdf) and we get some conclusions about of NGS data robustness and essential benefits of automation. [Extracted from the article]

Serial measurements of cardiac troponin are recommended by international guidelines to diagnose myocardial infarction (MI) since 2000. However, some relevant differences exist between the three different international guidelines published between 2020 and 2021 for the management of patients with chest pain and no ST-segment elevation. In particular, there is no agreement on the cut-offs or absolute change values to diagnose non-ST-segment elevation MI (NSTEMI). Other controversial issues concern the diagnostic accuracy and cost-effectiveness of cut-off values for the most rapid algorithms (0 h/1 h or 0 h/2 h) to rule-in and rule-out NSTEMI. Finally, another important point is the possible differences between demographic and clinical characteristics of patients enrolled in multicenter trials compared to those routinely admitted to the Emergency Department in Italy. The Study Group of Cardiac Biomarkers, supported by the Italian Scientific Societies Società Italiana di Biochimica Clinica, Italian Society of the European Ligand Assay Society, and Società Italiana di Patolgia Clinica e Medicina di Laboratorio decided to revise the document previously published in 2013 about the management of patients with suspected NSTEMI, and to provide some suggestions for the use of these biomarkers in clinical practice, with a particular focus on the Italian setting. [ABSTRACT FROM AUTHOR]

Keywords: biomarkers; Covid-19 vulnerability; homocysteine (Hcy); MTHFR677C>T mutations; MTHFR gene; predictor parameters EN biomarkers Covid-19 vulnerability homocysteine (Hcy) MTHFR677C>T mutations MTHFR gene predictor parameters e354 e357 4 08/06/21 20210815 NES 210815 To the Editor, The Covid-19 pandemic is a global challenge, with rapidly increasing cases from the high infective aetiological agent, the Covid-19 virus. For both infected patients and/or those awaiting diagnostic confirmation of Covid-19 disease, these biomarkers may predict risk stratification and determine patient management. [Extracted from the article]

Important advances achieved in pharmacological cancer treatment have led progressively to a reduction in mortality from many forms of cancer, and increasing numbers of previously incurable patients can now hope to become cancer-free. Yet, to achieve these improved outcomes a high price has been paid in terms of untoward side effects associated with treatment, cardio-toxicity in particular. Several recent studies have reported that cardiac troponin assay using high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have recently suggested that changes in hs-cTn values enable the early diagnosis of cardiac injury from chemotherapy, thus potentially benefitting cancer patients with increased troponin values by initiating early cardioprotective therapy. However, large randomised clinical trials are needed in order to evaluate the cost/benefit ratio of standardised protocols for the early detection of cardiotoxicity using the hs-cTn assay in patients treated with chemotherapy. [ABSTRACT FROM AUTHOR]

Background: The comparability of thyroid-stimulating hormone (TSH) results cannot be easily obtained using SI-traceable reference measurement procedures (RPMs) or reference materials, whilst harmonization is more feasible. The aim of this study was to identify and validate a new approach for the harmonization of TSH results. Methods: Percentile normalization was applied to 125,419 TSH results, obtained from seven laboratories using three immunoassays (Access 3rd IS Thyrotropin, Beckman Coulter Diagnostics; Architect System, Abbott Diagnostics and Elecsys, Roche Diagnostics). Recalibration equations (RCAL) were derived by robust regressions using bootstrapped distribution. Two datasets, the first of 119 EQAs, the second of 610, 638 and 639 results from Access, Architect and Elecsys TSH results, respectively, were used to validate RCAL. A dataset of 142,821 TSH values was used to derive reference intervals (RIs) after applying RCAL. Results: Access, Abbott and Elecsys TSH distributions were significantly different (p < 0.001). RCAL intercepts and slopes were −0.003 and 0.984 for Access, 0.032 and 1.041 for Architect, −0.031 and 1.003 for Elecsys, respectively. Validation using EQAs showed that before and after RCAL, the coefficients of variation (CVs) or among-assay results decreased from 10.72% to 8.16%. The second validation dataset was used to test RCALs. The median of between-assay differences ranged from −0.0053 to 0.1955 mIU/L of TSH. Elecsys recalibrated to Access (and vice-versa) showed non-significant difference. TSH RI after RCAL resulted in 0.37–5.11 mIU/L overall, 0.49–4.96 mIU/L for females and 0.40–4.92 mIU/L for males. A significant difference across age classes was identified. Conclusions: Percentile normalization and robust regression are valuable tools for deriving RCALs and harmonizing TSH values. [ABSTRACT FROM AUTHOR]

Serum or plasma? An old question looking for new answers. There is a continual debate on what type of sample a clinical laboratory should use. While serum is still considered the gold standard and remains the required sample for some assays, laboratories must consider turn-around time, which is an important metric for laboratory performance and, more importantly, plays a critical role in patient care. In addition, a body of evidence emphasise the choice of plasma in order to prevent modifications of some analytes due to the coagulation process and related interferences. Advantages and disadvantages of serum and plasma are discussed on the basis of current literature and evidence. In addition, data are provided on the current utilisation of the samples (serum or plasma) in Italy and in other countries. Finally, a rationale for a possible switch from serum to plasma is provided. [ABSTRACT FROM AUTHOR]

Keywords: antibodies; coronavirus; COVID-19; vaccine EN antibodies coronavirus COVID-19 vaccine 1333 1335 3 07/01/21 20210801 NES 210801 With the ongoing coronavirus disease 2019 (COVID-19) pandemic outbreak unremittingly spreading all around the world, and a plausible future characterized by a condition of endemic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection [[1]], widespread vaccination against this new coronavirus is currently regarded as one of the most effective strategies for mitigating the paramount adverse consequences of COVID-19 on people, healthcare, societies and economies [[2]]. The CDC also state that viral testing aimed at diagnosing an acute SARS-CoV-2 infection, along with serologic testing for defining presence of anti-SARS-CoV-2 antibodies titer, are not recommended before vaccination. [Extracted from the article]

Background: The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods: The TSH values stored in the laboratory information system of clinical laboratories of four Italian city hospitals, including 146,801 TSH measurements (with the respective age and sex data of individuals) were taken in consideration. Assuming a log-normal distribution, to log-transformed TSH values were applied the Dixon's iterative principle in order to exclude the outliers. At the end of this iterative process 142,821 log-transformed TSH results remained. The four clinical laboratories measured serum TSH concentrations using the same TSH immunoassay method (Access TSH 3rd IS, using UniCel DxI platform). Results: The TSH reference interval calculated in the present study (0.362–5.280 mIU/L) is similar to that suggested by the manufacturer for the Access TSH 3rd IS assay (0.45–5.33 mIU/L). TSH values in females were significantly higher than in males (females: mean=2.06 mIU/L; standard deviation [SD]=1.26 mIU/L; n=101,243; males: mean=1.92 mIU/L; SD=1.19 mIU/L; n=41,578; p<0.0001). Moreover, a negative linear relationship was observed between TSH throughout all interval age values (from 0 to 105 years). Conclusions: The results of the present multicenter study confirm that data mining techniques can be used to calculate clinically useful reference intervals for TSH. From a pathophysiological point of view, our results suggest that some Northern populations of Italy might still suffer some harmful effects on the thyroid gland due to mild to moderate iodine intake deficiency. Specific clinical trials are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Background: Diagnostic studies usually provide important information about the analytical and diagnostic performances. We investigated the clinical utility of (-2) proPSA in identifying patients with prostate cancer (PCa). Methods: We performed electronic searches in five databases as well as a list of reference literature. Studies were included if they evaluated the diagnostic accuracy of (-2)proPSA in men with PSA value ranged from 2.0 to 10 µg/L. We also analyzed data about total PSA (tPSA), %(-2)proPSa, freePSA (fPSA), its percentage (%fPSA) and the prostate health index (phi). The selection of the studies, the screening of the full texts and the data extraction, as well as the assessment of risk of bias using the QUADAS-2 tool were conducted independently by two authors. Grading the quality of the evidence was carried out according to the GRADE method. The random effects model was used for the meta-analyses. Results: We included 17 studies, including 6912 patients. The pooled sensitivity of (-2)proPSA was 90% and the summary specificity was 13%. The tPSA sensitivity and specificity were 89% and 25%, respectively. Considering (-2)proPSA, 225 men out of 1000 have been identified having PCa true positives (TP). However, 652 persons have been incorrectly identified and undergo biopsy. The majority of studies were judged to carry a moderate risk of bias. Therefore, the overall quality of evidences was deemed to be low. Conclusions: The (-2)proPSA could be useful to identify men at risk of PCa, but its accuracy still remains uncertain and the level of evidence does not support an improved clinical utility. [ABSTRACT FROM AUTHOR]

Harmonisation and risk management policies represent key-issues in modern laboratory medicine as they focus on a more patient-centred delivery of laboratory information based on the recognition of the importance of all steps of the total testing process (TTP) for assuring quality and patient safety. However, a further essential step in project aiming to improve the value of laboratory medicine becomes the assessment of the impact of testing on patient-important outcomes. The grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks may provide a systematic and transparent approach for translating the best clinical evidence available into healthcare decisions and recommendations. GRADE is a tool appropriate not only for evaluating test accuracy but also for clinical impact, such as mortality, morbidity, symptoms, and quality of life and therefore it should be applied to the outcome research in laboratory medicine. The application of GRADE requires the recognition that a recommendation about the use of test results should result from a balance between the desirable and the undesirable consequences, including non-health related consequences such as resource utilisation, feasibility, acceptability, equity and other factors. GRADE EtDs, represents a fundamental step in projects designed to improve care quality. Patient-physician-laboratory feedback can be assured through the GRADE process, where the team developing the recommendations should include the "three-parties" representatives; clinicians, laboratorians and patient/consumers. This ensures that the laboratory-patient interaction should not be a one-way process only (information from laboratory to patient) but a two-way process, incorporating patient expectations and feedback. [ABSTRACT FROM AUTHOR]

Background: Cerebrospinal fluid (CSF) levels assessment of Aβ1-42 and Tau proteins may be accurate diagnostic biomarkers for the differentiation of preclinical Alzheimer’s disease (AD) from age-associated memory impairment, depression and other forms of dementia in patients with mild cognitive impairment (MCI). The aim of our study was to explore the utility of CSF biomarkers in combination with common cognitive markers as predictors for the risk of AD development, and other forms of dementia, and the time to conversion in community patients with MCI. Methods: A group of 71 MCI patients underwent neurological assessment, extended neuropsychological evaluation, routine blood tests, ApoE determination, and lumbar puncture to dose t-tau, p-tau181, Aβ1-42. We investigated baseline CSF and neuropsychological biomarker patterns according to groups stratified with later diagnoses of AD conversion (MCI-AD), other dementia (MCI-NAD) conversion, or clinical stability (sMCI). Results: Baseline Aβ1-42 CSF levels were significantly lower in MCI-AD patients compared to both sMCI and MCI-NAD. Additionally, p-tau181 was higher in the MCI-AD group compared to sMCI. The MCI-AD subgroup analysis confirmed the role of Aβ1-42 in its predictive role of time to conversion: rapid converters had lower Aβ1-42 levels compared slow converters. Logistic regression and survival analysis further supported the key predictive role of baseline Aβ1-42 for incipient AD and dementia-free survival. Conclusions: Our results confirm the key role of CSF biomarkers in predicting patient conversion from MCI to dementia. The study suggests that CSF biomarkers may also be reliable in a real world clinical setting. [ABSTRACT FROM AUTHOR]

The article examines the quality of reporting of diagnostic test accuracy (DTA) studies in medical laboratory journals pulished between January 2013 and September 2015. The adherence of each study to the 25 Standards for Reporting of Diagnostic Accuracy (STARD) items were documented. The study reveals that only three journals adopted the STARD guidelines.

A letter to the editor on long-term stability of serum samples positive for carbohydrate deficient transferrin (CDT) routinely stored at -20-degree centigrade is presented.

Background: The neutrophil gelatinase associated lipocalin (NGAL) has been identified as the most promising biomarker of acute kidney injury (AKI). This study was aimed to evaluate a NGAL immunoassay on Beckman Coulter AU 5822. Methods: NGAL Test™ (BioPorto Diagnostics A/S) is a particle-enhanced turbidimetric immunoassay. The within-and between-run imprecision were assessed on three urine samples. The linearity was assessed by serially diluting two urine samples with low and high NGAL concentration. The comparison study was performed with Abbott ARCHITECT NGAL, on 70 urine samples. Results: The within-run imprecision was comprised between 1.0% and 2.3%, whereas the between-run imprecision was between 1.2% and 2.0%. The linearity was excellent in the range between 18 ng/mL and 790 ng/mL (r=1.000; p<0.001). A highly significant agreement was observed between NGAL Test™ on Beckman Coulter AU5822 and Abbott ARCHITECT NGAL (r=0.925; p<0.001), although the method exhibited a bias of +65%. Excellent sensitivity and specificity against the ARCHITECT values were found at 200 ng/mL. Conclusions: This analytical evaluation attests that the NGAL Test™ has several technical and analytical advantages, including no manual pretreatment, low volume of sample (i.e., 3 μL), fast turnaround time (approx. 10 min), low imprecision, wide dynamic range, optimal linearity. [ABSTRACT FROM AUTHOR]

Background: Aution Max AX-4030, a test strip analyzer recently introduced to the market, represents an upgrade of the Aution Max AX-4280 widely employed for urinalysis. This new instrument model can allocate two different test strips at the same time. In the present study the two instruments have been compared together with the usage of Uriflet 9UB and the recently produced Aution Sticks 10PA urine strips, the latter presenting an additional test area for the measurement of urinary creatinine. Methods: Imprecision and correlation between instruments and strips have been evaluated for chemical-physical parameters. Accuracy was evaluated for protein, glucose and creatinine by comparing the semi-quantitative results to those obtained by quantitative methods. The well-known interference effect of high ascorbic acid levels on urine glucose test strip determination was evaluated, ascorbic acid influence was also evaluated on protein and creatinine determination. Results: The two instruments have demonstrated comparable performances: precision and correlation between instruments and strips, evaluated for chemical-physical parameters, were always good. Furthermore, accuracy was always very good: results of protein and glucose semi-quantitative measurements resulted to be highly correlated with those obtained by quantitative methods. Moreover, the semi-quantitative measurements of creatinine, employing Aution Sticks 10PA urine strips, were highly comparable with quantitative results. Conclusions: 10PA urine strips are eligible for urine creatinine determination with the possibility of correcting urin-alysis results for urinary creatinine concentration, whenever necessary and calculating the protein creatinine ratio. Further studies should be carried out to evaluate effectiveness and appropriateness of the usage of creatinine semi-quantitative analysis. [ABSTRACT FROM AUTHOR]

The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Bone Marker Standards (WG-BMS) has evaluated the clinical potential of bone turnover markers (BTMs) in the prediction of fracture risk and for monitoring treatment. Research evidence suggests that BTMs may provide information on fracture risk independently from BMD, so that fracture risk prediction might be enhanced by their inclusion in assessment algorithms. The potential use of BTMs to predict the response to treatments for osteoporosis in the individual patient is also of great interest. Treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. However, there is still a need for stronger evidence on which to base practice in both situations. IOF/IFCC recommends one bone formation marker (serum procollagen type I N propeptide, s-PINP) and one bone resorption marker (serum C-terminal cross-linking telopeptide of type I collagen, s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to enlarge the international experience of the application of markers to clinical medicine and to help resolve uncertainties over their clinical use. [ABSTRACT FROM AUTHOR]

Hepatitis C virus (HCV) infection is frequently characterized by evolution to chronicity and by a variable clinical course of the disease. The clinical heterogeneities of HCV infection and the imperfect predictability of the response to interferon (IFN) have suggested the need to search for a genetic basis of clinical features. This led to the discovery of genetic polymorphisms playing a major role in the evolution of infection, as well as on treatment response and adverse effects. This review will cover recent reports on the subject, focusing on the potential use of the new genetic markers in the diagnostic algorithm for the stratification of patients for personalized antiviral regimens. [ABSTRACT FROM AUTHOR]

Laboratory data play a pivotal role in the clinical decision-making process. Major transformations have occurred in laboratory medicine in recent decades. To face the economic pressures, hospital laboratories are forced to enhance efficiency. Decisions on policy and practice take place at many levels. However, decision-making often does not follow Evidence Based Laboratory Medicine principles. Also, the literature shows limited influence of economic evaluations on health care decisions and diagnostic processes. Several barriers to the use of economic evaluation in decision-making process have been identified, and guidelines tend to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. As an example, we analyzed recommendations on the use of brain natriuretic peptide (BNP) or N-terminal fragment of the prohormone BNP (NT-proBNP) in patients with chronic heart failure. All guidelines recommend the use of BNP if available. Nevertheless, none included economic data explicitly, even if economic information exists in the literature. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, propose using a balance sheet approach, one way of helping decision makers to explicitly consider resource use along with other outcomes when making recommendations. Key aspects of GRADE, such as the explicit presentation of information and the quality evaluation of the economic data can help overcome barriers in the use of economic evaluations in the decision-making in process. This approach can help to give health decision makers, clinical guideline panels and patients, a better appreciation of the overall health benefits, harms and costs of laboratory tests. [ABSTRACT FROM AUTHOR]

Point-of-care testing (POCT) is traditionally defined as laboratory diagnostics performed at or near the site where clinical care is delivered. POCT thereby combines sample collection, analysis, and reporting of results into a robust integrated testing structure, with a simple user interface. The availability of reliable devices and consolidated tests for patient screening, diagnosis and monitoring has allowed broad diffusion of POCT to the patient's bedside, physician offices, pharmacies, other healthcare facilities, supermarkets, and even into the patient's home. However, current evidence clearly shows that POCT can be subjective, and might even amplify the traditional problems encountered in the preanalytical, analytical and postanalytical phases of the total testing process. This may especially be seen in inappropriateness of the test request, collection of unsuitable biological materials, inaccurate test performances, larger analytical imprecision, unsuitable report formatting, delayed reporting of critical value, and report recording/retrieval. POCT patient care service in the pharmacy can be regarded as a valuable option for the present and future since it might be beneficial for all parties. However, several economic, clinical and regulatory issues should also be addressed before this opportunity can turn into a real advantage for patients and the entire healthcare system. The most appropriate allocation of POCT within the diagnostic pathway, as well as its adjuvant role in screening, diagnosis and monitoring of diseases should also be clearly established in order to prevent widespread and deregulated implementation. Clin Chem Lab Med 2010;48:943–53. [ABSTRACT FROM AUTHOR]

Background: Clinical Governance is described as “a framework through which the NHS organisations are accountable to continue to improve the quality of the service and safeguarding high standards of care by creating an environment in which excellence in clinical care would flourish”; it is aimed to ensure continuous improvement in the overall standard of clinical care, ensuring that clinical decisions are based on the most up-to-date evidence in terms of effectiveness. Methods: If Clinical Governance is a framework through which NHS organisations are accountable to continuously improve the quality of their services and safeguarding high standards of care, Clinical Effectiveness is a vital part of Clinical Governance. Clinical Effectiveness is a term that refers to measuring and monitoring the quality of care, and comprises various activities, including: Evidence-Based Practice, Research and Development, Clinical Audit, Clinical Guidelines, Integrated Care Pathways, and Total Quality Management. Results: The application of evidence-based medicine (EBM) in laboratory medicine or evidence-based laboratory medicine (EBLM) aims to advance clinical diagnosis by researching and spreading new knowledge, combining methods from clinical epidemiology, statistics and social science with the traditional pathophysiological molecular approach. EBLM, by evaluating the role of diagnostic investigations in the clinical decision-making process, can help in translating the results of good quality research into everyday practice. Conclusions: If Clinical Governance is a framework through which organisations are accountable to improve the quality of care, health professionals should identify high quality standards, and systematically and rigorously monitor against them the process and outcomes that represent the diagnostic process. Within such a policy framework, practice guidelines are expected to play a major role, providing the basis to access the quality of care and guidance where clinical practice is found not in line with professional standards. [ABSTRACT FROM AUTHOR]

The ultimate goal of value-based laboratory medicine is maximizing the effectiveness of laboratory tests in improving patient outcomes, optimizing resources and minimizing unnecessary costs. This approach abandons the oversimplified notion of test volume and cost, in favor of emphasizing the clinical utility and quality of diagnostic tests in the clinical decision-making. Several key elements characterize value-based laboratory medicine, which can be summarized in some basic concepts, such as organization of in vitro diagnostics (including appropriateness, integrated diagnostics, networking, remote patient monitoring, disruptive innovations), translation of laboratory data into clinical information and measurable outcomes, sustainability, reimbursement, ethics (e.g., patient empowerment and safety, data protection, analysis of big data, scientific publishing). Education and training are also crucial, along with considerations for the future of the profession, which will be largely influenced by advances in automation, information technology, artificial intelligence, and regulations concerning in vitro diagnostics. This collective opinion paper, composed of summaries from presentations given at the two-day European Federation of Laboratory Medicine (EFLM) Strategic Conference “A vision to the future: value-based laboratory medicine” (Padova, Italy; September 23–24, 2024), aims to provide a comprehensive overview of value-based laboratory medicine, projecting the profession into a more clinically effective and sustainable future. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which focuses on a study that analyzed the possible differences and seasonal variations of serum vitamin D levels in atopic patients compared to healthy controls.

In recent years, the formulation of some immunoassays with high-sensitivity analytical performance allowed the accurate measurement of cardiac troponin I (cTnI) and T (cTnT) levels in reference subjects. Several studies have demonstrated the association between the risk of major cardiovascular events and cardiac troponin concentrations even for biomarker values within the reference intervals. High-sensitivity cTnI and cTnT methods (hs-cTn) enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk ofheart failure. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Specific clinical trials should be carried out to demonstrate the efficacy and efficiency of the general population screening by means of cost-benefit analysis, in order to better identify individuals at higher risk for heart failure (HF) progression with hs-cTn methods. [ABSTRACT FROM AUTHOR]

Objectives: The Next Generation Sequencing (NGS) based mutational study of hereditary cancer genes is crucial to design tailored prevention strategies in subjects with different hereditary cancer risk. The ease of amplicon-based NGS library construction protocols contrasts with the greater uniformity of enrichment provided by capture-based protocols and so with greater chances for detecting larger genomic rearrangements and copy-number variations. Capture-based protocols, however, are characterized by a higher level of complexity of sample handling, extremely susceptible to human bias. Robotics platforms may definitely help dealing with these limits, reducing hands-on time, limiting random errors and guaranteeing process standardization., Methods: We implemented the automation of the CE-IVD SOPHiA Hereditary Cancer Solution™ (HCS) libraries preparation workflow by SOPHiA GENETICS on the Hamilton's STARlet platform. We present the comparison of results between this automated approach, used for more than 1,000 DNA patients' samples, and the performances of the manual protocol evaluated by SOPHiA GENETICS onto 240 samples summarized in their HCS evaluation study., Results: We demonstrate that this automated workflow achieved the same expected goals of manual setup in terms of coverages and reads uniformity, with extremely lower standard deviations among samples considering the sequencing reads mapped onto the regions of interest., Conclusions: This automated solution offers same reliable and affordable NGS data, but with the essential advantages of a flexible, automated and integrated framework, minimizing possible human errors and depicting a laboratory's walk-away scenario., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)