![]() ![]() Scores higher than that are deemed high-complexity ( 2015a). Diagnostic tests with scores of 12 or less are in the moderate-complexity category. These scores are then summed to determine the risk associated with the test. ![]() As outlined in Table 1, diagnostic tests are scored by the FDA using seven independent criteria. The resulting CLIA requirements are more stringent for more complicated tests. This lab classification is determined by the complexity and clinical significance of the testing to be performed. The process of registration is based on the type of testing that is to be performed, and a set of compliance standards are required for the given lab classification. Since its enactment, CLIA has required that all labs performing diagnostic tests of human samples must register with the Centers for Medicare and Medicaid Services (CMS). This was, specifically, in response to an alarmingly high number of false negative results from in-house laboratories. This regulation was primarily enforced by the Clinical Laboratory Improvement Amendment (CLIA) of 1988, which established regulatory standards for all human-related laboratories testing for diagnostic purposes (1988). However, the variability in quality of these tests ultimately led to regulation that mandated how these tests were to be performed ( Berger, 1999a, b). When these tests were first being used in diagnosis, most of these tests were performed at the side of the patient, and the individual practitioner had a significant amount of autonomy ( Moore, 2005). Prior to these advances, decision making was primarily based on patient history and physical examination ( Burke, 2000). This impact has been driven by the advances in science and technology of the 20 th century. Healthcare-related diagnostic tests are an integral component of healthcare delivery in the US as they currently have a direct impact on up to 70% of healthcare-related decisions ( 2005). Our goal here is not to exhaustively cover all possible applications within each area, but rather to increase the general awareness of the opportunities available and to focus on selected examples that have the greatest impact. A couple of these areas (e.g., veterinary medicine or emergency care) contain a vast number of potentially useful biomarkers that could be tested-enough to warrant a dedicated review article for each. Then we review POC diagnostics for veterinary medicine, space travel, sports medicine, emergency care, and operating room applications. In this review, we focus on some of these niche areas that have not been covered extensively in the literature and which have a small market size compared to health diagnostics in developed nations, or where the clinical benefit is still being actively investigated.įirst, we briefly review the regulations governing POC diagnostics for human health, as they dictate how the diagnostics are used. In addition to global health, other areas where portability and low cost are key drivers have benefitted from improvements in POC diagnostic technology. Excellent reviews of POC diagnostic tests for global health have been published recently and thus are not included here ( Chin et al., 2011, Yager et al., 2008). ![]() ![]() For example, these advances have made possible the burgeoning field of POC diagnostics for resource-limited settings, such as developing nations. However, recent advances in microfluidics combined with the decreasing cost and size of advanced electrochemical and optical sensors ( Vashist et al., 2015) have broadened the range of applications for POC diagnostics. The blood glucose meter, used for the management of diabetes, and the home pregnancy test (dipstick) are the most popular examples. Point-of-care (POC) diagnostic tests provide clinically relevant information at the point-of-use, without the need for sample processing or analysis from a remote clinical chemistry laboratory. ![]()
0 Comments
Leave a Reply. |