Band 44, Heft 2 - Special Issue: POCT at the Interface of Emerging Technologies and New Clinical Applications / Issue Editor: Peter B. Luppa

Background For a long time, self-monitoring of blood glucose (SMBG) was widely viewed as the essential glucose measurement procedure in the therapy of insulin-treated people with diabetes. With increasing accuracy and simplified handling of continuous glucose monitoring (CGM) systems, this evolving technology challenges and at least partly replaces SMBG systems. Content Sensors of all currently available CGM systems measure glucose levels in the subcutaneous interstitial fluid for 6–14 days. The only available implantable sensor facilitates a measurement span of up to 6 months. Depending on the used system, glucose levels are either shown in real time (rtCGM systems) or after scanning (iscCGM systems). Functions such as alerts, alarms and trend arrows and data presentation encourage independent self-management of diabetes therapy. The high frequency of glucose data and the multitude of existing functions require an extensive training of people with diabetes and their caregivers. Summary CGM systems provide a much more detailed picture of glycemia in people with diabetes. Educated patients can use these data to react adequately to their glucose levels and therefore avoid hypoglycemic and hyperglycemic events. Studies showed that glycated hemoglobin (HbA 1c ) levels and hypoglycemic events can be significantly reduced by frequent use of CGM systems.

Chronic disease poses a major burden to patients and health care systems. This review considers how patient self-testing can contribute to the management of chronic disease. Self-testing can only confer benefit if it occurs in the context of an empowered patient who has the skills and training to translate test results into meaningful actions. The benefits may include improved clinical outcomes, greater patient convenience and improved psychological well-being; separately and together these may contribute to reduced costs of care. As self-testing may be expensive and burdensome to patients, it is important that its use in chronic disease is supported by a robust evidence base confirming its utility and efficacy. The design of studies to assess the impact of self-testing poses challenges for the researcher and the quality of evidence presented is often variable. Randomised controlled trials (RCTs) provide more robust evidence than observational studies; the intervention under study is not just self-testing but includes the educational support to allow patients to use results effectively. This review discusses the evidence base relating to patient self-testing in diabetes, anticoagulant monitoring and in renal transplant patients and in particular highlights the impact of new technology developments such as flash glucose monitoring in diabetes.

The measurement of the cardiac troponins (cTn), cardiac troponin T (cTnT) and cardiac troponin I (cTnI) are integral to the management of patients with suspected acute coronary syndromes (ACS). Patients without clear electrocardiographic evidence of myocardial infarction require measurement of cTnT or cTnI. It therefore follows that a rapid turnaround time (TAT) combined with the immediacy of results return which is achieved by point-of-care testing (POCT) offers a substantial clinical benefit. Rapid results return plus immediate decision-making should translate into improved patient flow and improved therapeutic decision-making. The development of high sensitivity troponin assays offer significant clinical advantages. Diagnostic algorithms have been devised utilising very low cut-offs at first presentation and rapid sequential measurements based on admission and 3 h sampling, most recently with admission and 1 h sampling. Such troponin algorithms would be even more ideally suited to point-of-care testing as the TAT achieved by the diagnostic laboratory of typically 60 min corresponds to the sampling interval required by the clinician using the algorithm. However, the limits of detection and analytical imprecision required to utilise these algorithms is not yet met by any easy-to-use POCT systems.

Background Quality assurance (QA) in point-of-care testing (POCT) is an important issue for organizing POCT structures within the healthcare sector. In Germany, only one device needs to participate in an external QA program, if the responsible core laboratory is supervising internal quality controls of all other identical POCT devices. This flexible definition of quality control (QC) testing is in line with the fundamentals of ISO 22870 and the ISO 15189, but can only be regarded as a minimum requirement. Methods We present a pilot study for an inexpensive new approach for additional POCT QC measurement similar to the external QA program within the medical laboratory using capillary glucose measurement as an example. This new system, referred to as “extended internal QC (eIQC)”, uses in-house generated QC material from leftover full blood from routine diagnostics. We provide information on calculation of target values and acceptance ranges and preliminary data on stability and comparison between POCT and core laboratory testing (COBAS 8000). Additionally, we simulated the approach using three devices within the laboratory as surrogate for three POCT sites. In this pilot study, measurements of QC material beyond the mandatory QA plan are structured and optimized through the use of the POCTopus Software solution. Results QC material was easily generated including specification of target values. The software aided in automatized processing of the samples. The software showed limitations in evaluation and monitoring without relevant use of resources. We found a significant bias between measurements on POCT and COBAS 8000 instruments. Conclusions The presented new approach for additional QAs for POCT enables POCT coordinators to establish an additional safety and QC level. Further software improvements are required. Further studies are needed for validation and comparison measurements between methods. Overall, this approach offers great potential for POCT structures seeking higher quality standards.

This text is a synopsis of the “Seminar on Organizational Aspects of POCT Management” which was part of the 4 th Munich POCT symposium 2019. The session was chaired in part 1 by Christiane Maschek (Berlin) and Anke Urban (Ludwigshafen), and in part 2 by Barbara Oschwald-Häg (Offenburg) and Marco Kachler (Klagenfurt/AT). The seminar was held in German in order to allow non-English-speaking medical technicians the full understanding of the presented contents. Part 1: Nice to Know – Challenges for networking POCT systems (Michaela Markhoff, Hamburg). Best Practice – Implementation of POCT in a hospital without central lab services (Jennifer Planz, Essen). Best Practice – Benefits of the POCT commission demonstrated using the example of implementing glucose POCT devices (Barbara Oschwald-Häg, Offenburg). Part 2: Best Practice – Challenges of a group-wide implementation of a POCT competence management (Sandra Mütze, Berlin). Nice to Know – Learning from mistakes in preanalytics (Reno Konzack, Berlin). New IFCC recommendation for checking reference intervals (Harald Maier, Altötting).

Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling. Hospital information technology (IT) security regulations, however, have not yet been adapted to the specificities of POCT. Following the POCT Symposium in Munich, the “1 st Round Table POCT-IT-Security Meeting” held in October 2019 in Cologne addressed these issues and managed to establish first consensus results in the essential fields of user, data and update management, as well as network connections and user-friendliness. First practical steps include optimizing the user management by connection to a directory service and definition of access control (including emergency authorization). Patient data economy on analyzers in combination with data and data transmission encryption as well as technically secure communication protocols are relevant steps in the fields of data management and network connections. An update management needs to be contractually defined for remote services and generally includes testing in a protocol-based scenario. Providing an organizational structure for POCT-IT security is a necessary prerequisite, as are continuous training and awareness for this topic with a strong focus on usability.