Purpose This prospective comparative study aims to evaluate the accuracy and validity of CoaguChek XS point-of-care system (Roche Diagnostics GmbH, Mannheim, Germany), compared with the standard central laboratory international normalized ratio (INR) results, in a vascular surgery ward. Methods Data based on 54 INR pairs, measured by the central laboratory analyzer and CoaguChek XS, were compared using the intraclass correlation coefficient. Other outcomes included the time and cost of the service from the patient's perspectives. Correlation was assessed using Pearson correlation test. Bland-Altman analysis was done to determine mean difference and 95% limits of agreement. Cohen κ test was done to assess agreement between the 2 methods. Results The mean INR values for CoaguChek XS and standard laboratory (Sysmex Ca-1500 system; Siemens Healthcare Diagnostics, Erlangen, Germany) were 1.21 ± 0.28 and 1.24 ± 0.43, respectively. The Pearson correlation coefficient in all 108 measurements was (r) = 0.591 (95% confidence interval, 0.38–0.74; P < 0.0001), indicating a moderately positive correlation. Overall intraclass correlation coefficient was 0.803 (95% confidence interval, 0.324–0.707) indicating good reliability. Bland-Altman analysis showed a bias of 0.035 and a 95% limits of agreement ranging from −0.63 to 0.70. There was substantial agreement between the 2 methods (κ = 0.694; SE, 0.108; 95% confidence interval, 0.481–0.907). CoaguChek XS results were obtained, on average, 213 minutes faster than the standard laboratory. Conclusions CoaguChek XS appears to have positive correlation, substantial agreement, and good reliability when compared with the standard laboratory. Thus, it is recommended to be used in hospital settings.
The ISO 22870:2016 standard requires validation of point-of-care testing (POCT) instruments before routine use. Although it is a relatively easy task for blood gas analyzers, it is much more involved in connected blood glucose monitoring (BGM) devices because they are used ubiquitously and in large numbers throughout hospital departments. Here we present the model used in order to validate efficiently and effectively compliance of 116 glucose/ketone BGM devices to ISO 22870. In a first step, a "reference" BGM was established and fully evaluated in comparison to our criterion-standard laboratory method. The 115 remaining connected and hospital-wide distributed BGM devices were then correlated against the "reference" BGM. We spiked donated blood samples with increasing amounts of glucose derived from a diluted oral glucose solution and tested it with the reference StatStrip BGM device and with a cobas 8000 glucose laboratory comparison method. Every connected BGM device was then compared with the BGM reference device using the same sample preparation methodology. The ISO 15197, POCT 12-A3, and Food and Drug Administration performance acceptance criteria were used for comparing the BGM reference results with the laboratory criterion-standard results and for comparing BGM reference results with the connected hospital BGM devices. Repeatability and interassay precision were assessed with aqueous controls. We show that it is possible to validate compliance of a large number of connected POCT BGM devices to ISO 22870 efficiently and effectively using only 1 operator. The StatStrip BGM device performances were excellent and met the ISO 15197, POCT 12-A3, and Food and Drug Administration criteria.
The main users of point-of-care testing devices placed outside the central laboratory are clinicians, predominantly nurses. Understanding the factors influencing sample accuracy is important to ensure appropriate clinical decision making. Previous studies focus on the analysis process; however, errors can also occur during the preanalytical phase, linked to user knowledge, skills, and other factors associated with the wider context of care. This study explored adult critical care nurses' views about point-of-care testing, the challenges they experience, and their suggestions on how the preanalytical phase might be improved. Using a qualitative design, 4 focus group discussions took place with 60 critical care nurses studying at 2 London-based universities between April and July 2019. Anonymized and verbatim-transcribed focus group data were uploaded into NVivo(11) and underwent a standard process of inductive thematic analysis. Findings suggest that nurses' concerns focus on 3 key areas: training and competence; sample frequency and volume; and impacts on patients, relatives, and staff. Critical care nurses view point-of-care testing as a necessary task, which aids timely patient management. However, the process can detract nurses from performing other care duties. Being able to draw less blood was identified as an important way to increase patient comfort and to reduce risks. Collaborative working is key to ensure that improvements made to the preanalytical process reflect users' needs. Ensuring best use of nurses' time by streamlining preanalytical processes and ensuring equipment is readily available for use are important to ensure other clinical priorities can be achieved.
From the Quidel Corporation, Athens, OH. Reprints: Molly Winters, BS, MHA, CCRP, Quidel Corporation, 2005 E State St, Suite 100, Athens, OH 45701. E-mail: [email protected]. The author declares no conflict of interest.
Major technical challenges often prevent developers from producing new point-of-care technologies that deliver the required clinical performance in the intended settings of use. However, even when devices meet clinical requirements, they can fail to be adopted and successfully implemented. Adoption barriers occur when decision makers do not understand the "value proposition" of new technologies. Current discussions of value in the context of point-of-care testing focus predominantly on the intended use and performance of the device from the manufacturer's point of view. However, the perspective of potential adopters in determining whether new devices provide value is also important, as is the opinion of all stakeholders who will be impacted. Incorporating value concepts into decisions made across the full development-to-adoption continuum can increase the likelihood that point-of-care testing will have the desired impact on health care delivery and patient outcomes. This article discusses how various approaches to technology development impact adoption and compares the characteristics of these approaches to emerging value concepts. It also provides an overview of value initiatives and tools that are being developed to support the evaluation of value propositions. These are presented for a range of technology adoption decision contexts, with particular applicability to point-of-care testing. Expanding the focus of research to address gaps in both the creation and evaluation of value propositions is imperative in order for value concepts to positively influence the adoption of point-of-care testing.
