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Abstract Background One objective of the Belgian Rare Diseases plan is to improve patients’ management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories. Methods A feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories’ scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019. Results In 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium. Conclusions In the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients’ management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests.

Background: Valproic acid (VPA) is a broad-spectrum anticonvulsant drug. Under normal conditions, this drug is highly protein bound. However, in patients with hypoalbuminemia, the free fraction can increase substantially while the total VPA levels remain in therapeutic range. The neurologic activity and toxicity of the drug are directly related to free drug levels. Methods: Our in-house free VPA assay was validated using 20 patient samples obtained from a reference laboratory (RL1). It was further evaluated by parallel testing with RL1 using samples collected from our patients. Subsequently, sample handling effects were investigated by comparing free VPA levels measured in our laboratory to 3 selected RLs with different sample transportation conditions. Results: No significant bias was observed between the in-house assay (y) and RL1 (x) assay in free VPA measurement (y = 1.12x + 0.072, r = 0.994). However, patient samples collected in our institution and sent to RL1 revealed significant negative bias (y = 0.776x − 3.861, r = 0.954). A large discrepancy in free VPA levels was further observed from identical aliquots of the same samples transported to 3 RLs in different conditions. Conclusions: Our study demonstrated that sample handling has significant impact on free VPA levels. The observed magnitude of variation exceeds a clinically acceptable limit and could alter clinical decisions. [ABSTRACT FROM AUTHOR]

Background: One objective of the Belgian Rare Diseases plan is to improve patients' management using phenotypic tests and, more specifically, the access to those tests by identifying the biochemical analyses used for rare diseases, developing new financing conditions and establishing reference laboratories.Methods: A feasibility study was performed from May 2015 until August 2016 in order to select the financeable biochemical analyses, and, among them, those that should be performed by reference laboratories. This selection was based on an inventory of analyses used for rare diseases and a survey addressed to the Belgian laboratories of clinical pathology (investigating the annual analytical costs, volumes, turnaround times and the tests unavailable in Belgium and outsourced abroad). A proposal of financeable analyses, financing modalities, reference laboratories' scope and budget estimation was developed and submitted to the Belgian healthcare authorities. After its approval in December 2016, the implementation phase took place from January 2017 until December 2019.Results: In 2019, new reimbursement conditions have been published for 46 analyses and eighteen reference laboratories have been recognized. Collaborations have also been developed with 5 foreign laboratories in order to organize the outsourcing and financing of 9 analyses unavailable in Belgium.Conclusions: In the context of clinical pathology and rare diseases, this initiative enabled to identify unreimbursed analyses and to meet the most crucial financial needs. It also contributed to improve patients' management by establishing Belgian reference laboratories and foreign referral laboratories for highly-specific analyses and a permanent surveillance, quality and financing framework for those tests. [ABSTRACT FROM AUTHOR]

Electronic data reporting from public health laboratories to a central site provides a mechanism for public health officials to rapidly identify problems and take action to prevent further spread of disease. However, implementation of reference laboratory systems is much more complex than simply adopting new technology, especially in international settings. We describe three major areas to be considered by international organizations for successful implementation of electronic reporting systems from public health reference laboratories: benefits of electronic reporting, planning for system implementation (e.g., support, resources, data analysis, country sovereignty), and components of system initiation (e.g., authority, disease definition, feedback, site selection, assessing readiness, problem resolution). Our experience with implementation of electronic public health laboratory data management and reporting systems in the United States and working with international organizations to initiate similar efforts demonstrates that successful reference laboratory reporting can be implemented if surveillance issues and components are planned.

This study was designed to evaluate the effect of different conditions of collection, transport and storage on the quality of blood samples from normal individuals in terms of the activity of the enzymes ß-glucuronidase, total hexosaminidase, hexosaminidase A, arylsulfatase A and ß-galactosidase. The enzyme activities were not affected by the different materials used for collection (plastic syringes or vacuum glass tubes). In the evaluation of different heparin concentrations (10% heparin, 5% heparin, and heparinized syringe) in the syringes, it was observed that higher doses resulted in an increase of at least 1-fold in the activities of ß-galactosidase, total hexosaminidase and hexosaminidase A in leukocytes, and ß-glucuronidase in plasma. When the effects of time and means of transportation were studied, samples that had been kept at room temperature showed higher deterioration with time (72 and 96 h) before processing, and in this case it was impossible to isolate leukocytes from most samples. Comparison of heparin and acid citrate-dextrose (ACD) as anticoagulants revealed that ß-glucuronidase and hexosaminidase activities in plasma reached levels near the lower normal limits when ACD was used. In conclusion, we observed that heparin should be used as the preferable anticoagulant when measuring these lysosomal enzyme activities, and we recommend that, when transport time is more than 24 h, samples should be shipped by air in a styrofoam box containing wet ice.

Abstract: The foreseen decline in antibiotic effectiveness explains the needs for data to inform the global public health agenda about the magnitude and evolution of antibiotic resistance as a serious threat to human health and development. Opportunistic bacterial pathogens are the cause of the majority of community and hospital-acquired infections worldwide. We provide an inventory of pre-existing regional surveillance programs in the six WHO regions which should form the underpinning for the consolidation of a global network infrastructure and we outline the structural components such as an international network of reference laboratories that need to be put in place to address the void of these crucial data. In addition we suggest to make use of existing Health and Demographic Surveillance Sites (HDSS) to obtain crucial information from communities in resource limited settings at household level in low- and middle-income countries in Asia and Africa. For optimising the use of surveillance data for public health action i.e. priority setting for new drug development, comparative quantification of antibiotic effectiveness at local, national, regional and global level and identification of the action gaps can be helpful. [Copyright &y& Elsevier]

Abstract: The standardization of measurements is of high priority in Laboratory Medicine, its purpose being to achieve closer comparability of results obtained using routine analytical systems. In order to achieve standardization, an approach is required that provides reliable transfer of the measurement values from the highest hierarchical level to methods which are routinely used in the clinical laboratories. Such a structure is presented by the reference measurement system (RS), based on the concepts of metrological traceability. Key elements of a comprehensive RS are the reference measurement procedure and reference materials. Other essential elements include the definition of the measurand in regards to the intended clinical use and the reference laboratories that may collaborate in a network. At present, there is international cooperation in developing RS for analytes of clinical significance. Thanks to the work of the Joint Committee on Traceability in Laboratory Medicine (JCTLM), a list of higher order reference materials and reference methods is now publicly available. JCTLM has also published the list of reference laboratories that are able to deliver a reference measurement service. As soon as a new RS is implemented, clinical validation of the correctly calibrated routine methods (the IVD products sold onto the market) should take place. Other important issues concerning the implementation of a metrologically-correct approach for result standardization are: 1) the clear definition of the clinically allowable error of measurements and 2) the post-market surveillance of the performance of IVD products. These are tasks of our profession through the organization of appropriate External Quality Assessment programs. [Copyright &y& Elsevier]

Abstract: Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available. [Copyright &y& Elsevier]

Background: Valproic acid (VPA) is a broad-spectrum anticonvulsant drug. Under normal conditions, this drug is highly protein bound. However, in patients with hypoalbuminemia, the free fraction can increase substantially while the total VPA levels remain in therapeutic range. The neurologic activity and toxicity of the drug are directly related to free drug levels., Methods: Our in-house free VPA assay was validated using 20 patient samples obtained from a reference laboratory (RL1). It was further evaluated by parallel testing with RL1 using samples collected from our patients. Subsequently, sample handling effects were investigated by comparing free VPA levels measured in our laboratory to 3 selected RLs with different sample transportation conditions., Results: No significant bias was observed between the in-house assay (y) and RL1 (x) assay in free VPA measurement (y = 1.12x + 0.072, r = 0.994). However, patient samples collected in our institution and sent to RL1 revealed significant negative bias (y = 0.776x - 3.861, r = 0.954). A large discrepancy in free VPA levels was further observed from identical aliquots of the same samples transported to 3 RLs in different conditions., Conclusions: Our study demonstrated that sample handling has significant impact on free VPA levels. The observed magnitude of variation exceeds a clinically acceptable limit and could alter clinical decisions., (© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Esoteric testing presents a broad range of opportunities to improve clinical decision making. To be effective, the knowledge support needs to be seamlessly embedded into clinical workflows. Reference laboratories are uniquely positioned to play an outsized role in laboratory decision support, in part because they are large repositories of esoteric testing knowledge and in part because of their resources and client relationships. To accomplish this, however, reference laboratories must develop strong capabilities to integrate content and logic into clinical software platforms, including but not limited to electronic health records., (Copyright © 2019 Elsevier Inc. All rights reserved.)