Cardiometabolic Devices Accuracy Study

Independent performance evaluation of POC devices have shown that many devices, regardless of their intended use, do not perform as well as the manufacturers' claims may suggest. There are a variety of reasons for this, including difference in skills levels of personnel who were involved in generating the data for the manufacturer's claims and who actually perform the test in a clinic, limited evaluation of samples from different geographical locations and thus potential interfering substances or less controlled environmental conditions (e.g. dust, heat and humidity). Independent performance evaluations to assess clinical accuracy, as well as system usability are important to drive adoption of any technology, and even more so, if the technology is intended to move testing outside of the traditional setting, i.e. away from the central laboratory to the point-of-care. Many devices appear ideally suited for certain settings, however when it comes to actual implementation, the users often discover that the device and workflow do not meet their needs. The choice of a suboptimal device means badly invested resources and may lead to inappropriate use, resulting in fewer reliable tests for patients in the absence of alternatives. Data from real-world evaluations in settings of the intended use can support decision makers to select the right device. The setting for this study will be a primary healthcare facility and a health post in Nepal, where study participants attend the facility in the context of the "Early detection and management of Chronic Kidney Diseases, Hypertension, Diabetes and Cardiovascular disease in Community in Nepal (KHDC-Nepal) program", conducted by the University Hospital of Geneva and the BP Koirala Institute of Health Science in Nepal.