RESUMO
Recent advances in areas such as biomarker discovery and microfluidic device fabrication have allowed clinical testing to be moved ever closer to the site of patient care. The development of a range of point-of-care testing (POCT) devices that seek to provide the clinician with diagnostic test results more rapidly offer the opportunity to enhance the quality of care for the individual patient and the population at large. However, there are indications that, notwithstanding advances in the technologies that underpin the utility of POCT, their clinical uptake and utilization is less than might be expected. Moreover, the nature and relative importance of the barriers identified as being impediments to their more widespread adoption are not well understood. This article reports the findings from a systematic narrative review of published literature sources over the period 2000 to January 2014 to identify and categorize the various barriers to adoption of POCT devices within the clinical environment. Data from a total of six electronic bibliographic databases were accessed and these searches were supplemented by scrutinizing the reference lists within the key articles identified. A set of 49 key articles were assessed in detail and from these four specific categories of barrier to adoption of POCT were identified. Identification and categorization of these barriers, along with an assessment of their significance to clinical practice, is seen as necessary for developing real solutions to ensure appropriate and effective POCT uptake. The most prevalent categories were those associated with the economics of adoption and quality assurance and regulatory issues, each which were reflected in 65% of the literature articles reviewed. Device performance and data management issues were cited in 51% of the publications. Staff and operational issues were found within 35% of articles. The most significant barriers identified concerned higher cost per test of POCT in comparison to centralized testing; difficulties in gauging the cost-effectiveness of a POCT system and the complexities in making cost comparisons with centralized systems; quality assurance issues relating to the operation of devices by untrained/non-competent staff; reduced analytical performance of POCT devices in comparison to centralized methods; and connectivity and data management issues. Complex regulatory requirements for accreditation, staff satisfaction levels and friction between clinical groups and the effect on existing clinical pathways by alternative testing methods were also identified as being significant concerns.