MR Imaging-Histology Correlation by Tailored 3D-Printed Slicer in Oncological Assessment.

3D printing and reverse engineering are innovative technologies that are revolutionizing scientific research in the health sciences and related clinical practice. Such technologies are able to improve the development of various custom-made medical devices while also lowering design and production costs. Recent advances allow the printing of particularly complex prototypes whose geometry is drawn from precise computer models designed on in vivo imaging data. This review summarizes a new method for histological sample processing (applicable to e.g., the brain, prostate, liver, and renal mass) which employs a personalized mold developed from diagnostic images through computer-aided design software and 3D printing. Through positioning the custom mold in a coherent manner with respect to the organ of interest (as delineated by in vivo imaging data), the cutting instrument can be precisely guided in order to obtain blocks of tissue which correspond with high accuracy to the slices imaged. This approach appeared crucial for validation of new quantitative imaging tools, for an accurate imaging-histopathological correlation and for the assessment of radiogenomic features extracted from oncological lesions. The aim of this review is to define and describe 3D printing technologies which are applicable to oncological assessment and slicer design, highlighting the radiological and pathological perspective as well as recent applications of this approach for the histological validation of and correlation with MR images.

Clinical metagenomics.

Clinical metagenomic next-generation sequencing (mNGS), the comprehensive analysis of microbial and host genetic material (DNA and RNA) in samples from patients, is rapidly moving from research to clinical laboratories. This emerging approach is changing how physicians diagnose and treat infectious disease, with applications spanning a wide range of areas, including antimicrobial resistance, the microbiome, human host gene expression (transcriptomics) and oncology. Here, we focus on the challenges of implementing mNGS in the clinical laboratory and address potential solutions for maximizing its impact on patient care and public health.

Driving the route of laboratory medicine: a manifesto for the future.

The role of laboratory medicine is essential in healthcare, since in vitro diagnostic testing represents now an unavoidable part of reasoning and clinical decision making. Laboratory tests are an essential part of most care pathways, aimed at optimizing resource utilization and improving patient outcome. The activity of laboratory professionals is interconnected with all medical disciplines, and provides a crucial support for ordering the right test, for the right patient and at the right time, but also helps interpreting and using laboratory data. Although recent advancement in laboratory medicine, catalyzed by technical innovations and development of innovative tests, have promoted a substantial revolution in the organization of clinical laboratories, the future of this profession seems still ambiguous. We have hence developed a "manifesto" of laboratory medicine, meant to promote an innovative prospect of our discipline and encouraging the establishment of a new generation of laboratory professionals and managers.

Quo Vadis Point-of-Care Diagnostics? Report II of the SWISS SYMPOSIUM in Point-of-Care Diagnostics 2017.

U.S. studies show that the global point-of-care (POC) diagnostics market will reach $40.5 bn by 2022, with a compound annual growth rate (CAGR) of 10%. This is one of the reasons why HES-SO Valais-Wallis and CSEM, acting on behalf of the NTN Swiss Biotech thematic platform in vitro Diagnostics (TP IVD), invited interested parties on October 26, 2017 to the SWISS SYMPOSIUM in Point-of-Care Diagnostics (see CHIMIA No. 12/2017). We now bring the second report on the future prospects of POC diagnostics.

Development and Evaluation of Up-Converting Phosphor Technology-Based Lateral Flow Assay for Quantitative Detection of NT-proBNP in Blood.

A newly assay, up-converting phosphor technology-based lateral flow (UPT-LF) assay, was developed for rapid and quantitative detection of N-terminal fragment of B-type natriuretic peptide precursor (NT-proBNP), one of the most important serum molecular maker of heat failure, in plasma samples as a point of care testing (POCT) method for diagnosis of acute heart failure. Human plasma from 197 patients with acute heart failure and 200 healthy controls was assessed using the UPT-LF assay, in a comparison with a Roche Elecsys assay. The limit of detection of the UPT-LF assay, with a coefficient of variation (CV) of less than 15%, was 116 ng/L, which is lower than the clinical diagnosis cutoff (150 ng/mL). The linear range was 50-35,000 ng/L. The CVs were less than 10% for both UPT-LF and Roche Elecsys assays for plasma samples under different storages, demonstrating the good stability and reproducibility. There are certain linear correlations between the results of UPT-LF and Roche Elecsys assay for EDTA-K2 and heparin-anticoagulated plasma, as well as for serum samples. For UPT-LF assay, there is a significant correlation between the values derived from analysis of EDTA-K2 and heparin-anticoagulated plasma samples (R = 0.995). No statistically significant difference was found between serum and plasma samples for UPT-LF assay. Our results demonstrate that NT-proBNP levels in healthy adults are elevated with age and had a relationship with sex, and with the age increase the NT-proBNP levels of females are significantly higher than those of males (p<0.01). The UPT-LF assay has a high reproducibility, stability, sensitivity, specificity, and is consistent with Roche Elecsys assay, and therefore it could be used as a POCT method for the quantitative detection of NT-proBNP in blood for clinical diagnosis and research of acute heart failure.

Plasma-Treated Microplates with Enhanced Protein Recoveries and Minimized Extractables.

SiO2 Medical Products, Inc. (SiO) has developed a proprietary technology that greatly enhances protein recoveries and reduces extractables from commercial microplates used for bioanalytical assays and storage of biologics. SiO technology is based on plasma treatment that chemically modifies the surface of polypropylene with predominantly hydrogen-bond-acceptor uncharged polar groups. The resultant surface resists nonspecific protein adsorption over a wide range of protein concentrations, thereby eliminating the need to passivate (and hence potentially contaminate) the microplates with blocking proteins. High shelf-life stability and cleanliness of the plasma-treated microplates have been demonstrated using five different proteins for two common microplate formats. The protein recovery performance of plasma-treated microplates is found to be higher compared with commercial low-protein-binding microplates.

Clinical applications of MS-based protein quantification.

Mass spectrometry-based assays are increasingly important in clinical laboratory medicine and nowadays are already commonly used in several areas of routine diagnostics. These include therapeutic drug monitoring, toxicology, endocrinology, pediatrics, and microbiology. Accordingly, some of the most common analyses are therapeutic drug monitoring of immunosuppressants, vitamin D, steroids, newborn screening, and bacterial identification. However, MS-based quantification of peptides and proteins for routine diagnostic use is rather rare up to now despite excellent analytical specificity and good sensitivity. Here, we want to give an overview over current fit-for-purpose assays for MS-based protein quantification. Advantages as well as challenges of this approach will be discussed with focus on feasibility for routine diagnostic use.

[Management of POCT Devices and Reagents].

In order to ensure the accuracy of POCT devices and reagents, it is necessary to appropriately manage and store them. There are various points to be considered for these items, such as management before and environments when using them; it is more complex than when using conventional analysis apparatuses in clinical laboratories. In addition, staff using such devices should be provided with opportunities to obtain sufficient knowledge and skills. These approaches are indispensable to ensure POCT accuracy and provide reliable data, and, in this respect, support for staff with expertise in clinical examination is crucial.

[Internal Quality Control and External Quality Assessment on POCT].

The quality management (QM) of POCT summarizes its internal quality control (IQC) and external quality assessment (EQA). For QM requirements in POCT, ISO 22870-Point-of-care testing (POCT) -Requirements for quality and competence and ISO 15189-Medical laboratories-Requirements for quality and competence, it is performed under the guidance of the QM committee. The role of the POC coordinator and/or medical technologist of the clinical laboratory is important. On measurement performance of POCT devices, it is necessary to confirm data on measurement performance from the manufacturer other than those in the inserted document. In the IQC program, the checking and control of measurement performance are the targets. On measurements of QC samples by the manufacturer, it is essential to check the function of devices. In addition, regarding the EQA program, in 2 neighboring facilities, there is an effect to confirm the current status of measurement and commutability assessment in these laboratories using whole blood along with residual blood samples from daily examinations in the clinical laboratory.

[Effective IT-Based Quality Management of Clinical Laboratories--Using POCT Apparatus].

Clinical laboratories are beneficial for users with difficulty in participating in a regular health examination to conveniently undergo it and directly and promptly receive the results. As some users possibly make their own judgments on such results, and submit them to clinics or hospitals, it is necessary for clinical laboratories analyzing patients' samples to provide accurate results based on quality management. For rapid result-reporting, POCT apparatus and kits may be more appropriate examination devices, rather than those for analysis, which are large and used in general examination rooms. Effective IT-based data management systems combined with such devices may enable users to obtain reliable examination results.

Papel del laboratorio clínico en la gestión de la demanda: un nuevo horizonte / The role of clinical laboratories in the management of the demand for analyses: a new horizon

Introducción. Es necesario establecer estrategias en el laboratorio clínico para adecuar la demanda analítica a las necesidades clínicas (gestión de la demanda analítica). Material y métodos. Se definieron una serie de indicadores de «sobreutilización de pruebas de laboratorio», según criterios de medicina basada en la evidencia durante los años 2012 y 2013, para medir el uso excesivo del laboratorio y se procedió a cuantificar, en términos de eficiencia (costes), el ahorro que suponía a la organización no realizar este grupo de pruebas innecesarias y, en algunos casos, redundantes. Resultados. El porcentaje de sobreutilización del laboratorio en las distintas magnitudes estudiadas osciló de 9,2 al 95,6%, según distintas áreas de conocimiento en el laboratorio, en el año 2012; y entre 4,6 al 96% en 2013. Esto ha generado un ahorro total de 90.954,84 euros en 2012 y de 121.749,26 euros en el año 2013. Destaca que el 8% de los estudios genéticos solicitados correspondían a pacientes a los que ya se le había realizado dicha prueba; sin embargo sus resultados no habían sido consultados por los clínicos peticionarios. Conclusiones. Nuestra estrategia ha supuesto un importante ahorro económico para la organización y para el área sanitaria. El papel del facultativo del laboratorio clínico en la gestión de la demanda analítica para adecuar las solicitudes a la evidencia científica es hoy clave en el ámbito sanitario, que busca más que nunca la optimización de los recursos y la eficiencia (AU)

Introduction. Strategies need to be established in clinical laboratories in order to cope with the continuous demand for analyses to be carried out (analytical demand management). Materials and methods. A group of quality indicators, defined as «laboratory tests overuse indicators», were introduced according to evidence-based medical criteria during a two-year period, 2012 and 2013, to assist in the management of the constant demand for analyses and to quantify, by employing efficiency terms (costs), the accumulated savings after the removal of unnecessary and, sometimes, redundant tests. Results. The percentage of rejected clinical tests, based on taking into account the newly introduced overuse quality indicators, and according to the various clinical laboratory areas, ranged between 9.2 and 95.6% in 2012, and between 4.6 and 96% in 2013. This has resulted in a total saving of 90,954.84 euros and 121,749.26 euros in each year, respectively. It should be emphasized that 8% of the requested genetic studies corresponded to patients who had already undergone such laboratory tests. However, the medical staff had not reviewed their results. Conclusions. Our strategy has resulted in important savings for the organization and the health system overall. The role of clinical laboratory professionals in the management of the demand for analyses, according to evidence-based medical criteria, has become crucial in healthcare and seeks, more than ever, efficiency and optimization of the available resources (AU)