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Background: Molecular testing is considered the gold standard for the detection of SARS-CoV-2. This study aimed to compare the performance of the P742H SARS-CoV-2 Nucleic Acid Multiplex Detection Kit in salivary samples, with respect to the 732HF Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit and the TaqPath COVID-19 CEIVD RT-PCR Kit, used at University-Hospital of Padova, Italy. Methods: One hundred twenty-four salivary samples selfcollected by healthcare workers (HCW) during the screening program at University-Hospital of Padova, Italy, from Oct to Nov 2022, were included in the study. RNA extraction was performed by Viral DNA and RNA Extraction Kit (Technogenetics, Lodi, Italy) and amplification by P742H and 732HF (Technogenetics, Lodi, Italy). RNA was extracted using MagNa Pure 96 DNA and Viral NA Small Volume Kit (Roche, Switzerland) for TaqPath analysis (Thermo Fisher Scientific, USA). Results: 94 samples were positive at P742H, while 30 were negative; for 732HF, 96 samples were positive, while 28 were negative, with an overall agreement of 97.5% (Cohen's = 0.930, p < 0.001). TaqPath gave 95 positive samples, and 29 negative results, with an overall agreement of 100% (Cohen's = 1.0, p < 0.001) with respect to P742H, and 97.5% (Cohen's = 0.931, p < 0.001) with respect to 732HF. Comparing cycle threshold (Ct) between the P742H and 732HF, no statistically significant differences were found (p = n.s.). Conclusion: The P742H method proved better performances than 732HF for salivary samples, both presenting the same amplification time. In addition, P742H results were comparable to those obtained through the highthroughput method TaqPath.

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]

Point-of-care testing (POCT), near-patient testing (NPT) and patient self-tests (PST) are diagnostic examinations performed at the time and place of patient care. While POCT and NPT are performed and analyzed by medical professionals, PST are based on samples and parameters directly collected and analyzed by lay users. These tests are spreading both in high income countries and in low to middle income countries as they are expected to improve healthcare efficiency and equity, by saving resources, releasing pressure from hospitals and reducing logistical barriers. However, accurate multidisciplinary assessment is mandatory to ensure that what they promise is real. We reviewed some important ethical aspects, international standards and regulations. The current risks associated with alternative ways of testing are explained by the principles of respect for patient autonomy and non-maleficence. Further evidence from multidisciplinary assessment is needed to evaluate pros and cons in light of the principles of beneficence and justice. Although POCT or NPT need common regulation and accurate provider training to ensure safe and appropriate interpretation of results, PST needs even more attention as they are subject to direct patient use. Randomized controlled trails including patient education should be conducted in order to provide reliable evidence on clinical outcomes, patient acceptance and cost-effectiveness. Mandatory regulation is needed to avoid harm and EU regulation should help different countries maintain a safe use of devices in a global population of producers and users. [ABSTRACT FROM AUTHOR]

In recent years, the integration of technological advancements and digitalization into healthcare has brought about a remarkable transformation in care delivery and patient management. Among these advancements, the concept of digital twins (DTs) has recently gained attention as a tool with substantial transformative potential in different clinical contexts. DTs are virtual representations of a physical entity (e.g., a patient or an organ) or systems (e.g., hospital wards, including laboratories), continuously updated with real-time data to mirror its real-world counterpart. DTs can be utilized to monitor and customize health care by simulating an individual's health status based on information from wearables, medical devices, diagnostic tests, and electronic health records. In addition, DTs can be used to define personalized treatment plans. In this study, we focused on some possible applications of DTs in laboratory medicine when used with AI and synthetic data obtained by generative AI. The first point discussed how biological variation (BV) application could be tailored to individuals, considering population-derived BV data on laboratory parameters and circadian or ultradian variations. Another application could be enhancing the interpretation of tumor markers in advanced cancer therapy and treatments. Furthermore, DTs applications might derive personalized reference intervals, also considering BV data or they can be used to improve test results interpretation. DT's widespread adoption in healthcare is not imminent, but it is not far off. This technology will likely offer innovative and definitive solutions for dynamically evaluating treatments and more precise diagnoses for personalized medicine. [ABSTRACT FROM AUTHOR]

Background/Objectives: Chronic kidney disease and mineral bone disorders (CKD-MBD) are frequently associated with an increased risk of both vascular calcifications (VCs) and bone fractures (BFs). The complex pathogenesis of VCs and BFs involves various factors such as calcium overload, phosphate imbalance, and secondary hyperparathyroidism. Key players, such as the vitamin K-dependent proteins (VKDPs) matrix Gla protein (MGP) and bone Gla protein (BGP), have pivotal roles both for VCs and BFs. The VIKI study highlighted that hemodialysis patients treated with calcimimetics had higher levels of total BGP and MGP compared to those untreated, suggesting a potential protective effect of these drugs on BFs and VCs beyond the beneficial effect of reducing PTH levels. Methods: ETERNITY-ITA is a multi-center, comparative effectiveness, observational, longitudinal study that will enroll 160 hemodialysis patients (80 patients treated with Etelcalcetide and 80 age- and sex-matched patients treated with calcitriol or vitamin D analogs). Nephrologists will tailor the target dose of Etelcalcetide on an individual level to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). Conclusions: This study will evaluate the real-world effect of Etelcalcetide on VKDP levels, such as BGP and MGP, at 3, 9, and 18 months from baseline. The resulting preservation of vascular and bone health will be assessed for the first time by examining aortic and iliac artery calcifications and vertebral fractures, respectively. [ABSTRACT FROM AUTHOR]

Over the last decades, in addition to the improvement of pathophysiological knowledge regarding the role and mechanisms of action of vitamin D, there has been a progressive advancement in analytical technologies for its measurement, as well as in methodological standardization. A significant number of scientific works, meta-analyses, and guidelines have been published on the importance of vitamin D and the need for supplementation in deficient individuals. However, it appears necessary to clarify the fundamental elements related to the measurement of vitamin D (both at the strictly analytical and post-analytical levels) and the scientific evidence related to the efficacy/safety of supplementation. In particular, there is a need to discuss current recommended levels for deficiency, insufficiency and possible toxicity in the light of evidence from standardization projects. Additionally, given the important interrelations between vitamin D, parathyroid hormone (PTH), and fibroblast growth factor-23 (FGF23), the analytical issues and clinical utility of these biomarkers will be discussed. [ABSTRACT FROM AUTHOR]

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]

Following the COVID-19 pandemic, the concepts of value-based medicine (VBM) and value-based laboratory medicine (VBLM) are receiving increasing interest to improve the quality, sustainability and safety of healthcare. Laboratory medicine is well positioned to support the transition to value-based healthcare as it helps to improve clinical outcomes and healthcare sustainability by reducing the time to diagnosis, improving diagnostic accuracy, providing effective guidance for tailored therapies and monitoring, and supporting screening and wellness care. However, the perception of the value of laboratory medicine is still limited, to the extent that it has been defined a “profession without a face”, often lacking visibility to patients and the public. In addition, in recent decades, clinical laboratories have sought to improve the ration between outcomes and costs by increasing efficiency and reducing the cost per test rather than improving clinical outcomes. The aim of this paper is to propose a 10-point manifesto for implementing value-based laboratory medicine in clinical practice. [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]

Elevated plasma concentration of cholesterol bound to LDL (LDL-C) is the predominant risk factor for cardiovascular (CV) diseases. An important number of clinical trials demonstrated that the use of statins to reduce LDL-C is beneficial in terms of prevention of CV events in the entire population. Over time, specific LDL-C targets to be achieved have been established to guarantee the best outcome for the patient from the therapeutic intervention. The fundamental role of the clinical laboratory in diagnosis and treatment monitoring of dyslipidemias, requires that harmonization in the different phases of the laboratory process be pursued and achieved in order to allow the correct management of patients. The harmonization process has been the subject of national and international recommendations over time; however, a further recommendation is essential, considering that some recent evidences testify to a sub-optimal adoption of the indications by a non-negligible number of laboratories, confirming the need to repeat training and information activities. Aim of this joint document is to analyze the importance of the therapeutic targets to be achieved and the critical elements of laboratory diagnostic related to dyslipidemia, in order to provide indications for the harmonization of the reporting of the lipid profile. According to these recommendations, the lipid parameters should be reported accompanied by the therapeutic goals differentiated by the risk categories for LDL-C and non-HDL-C and by the threshold values for the other parameters. The use of comparison terms like Reference values or Normal values in the laboratory report must be definitely abandoned. [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]