Point-of-Care Nucleic Acid Testing: User Requirements, Regulatory Affairs, and Quality Assurance
Angelika Niemz, Tanya M. Ferguson and David S. Boyle
from: Molecular Diagnostics: Current Research and Applications (Edited by: Jim Huggett and Justin O'Grady). Caister Academic Press, U.K. (2014)
Nucleic acid testing (NAT) for in vitro diagnostic (IVD) use has moved beyond high-complexity reference laboratories to moderate complexity centralised laboratories, and to certain professional point of care (POC) settings in developed and developing countries. To develop, launch, and sustainably implement a POC NAT system requires compliance with regulatory affairs and quality assurance requirements, and long term demonstration of the system's clinical utility. This report discusses the pros and cons of POC versus centralised laboratory testing, general clinical utility considerations, use environment, and user requirements in developed versus developing countries. The report further provides an overview of the applicable regulatory requirements in different regions around the globe, and describes quality assurance considerations during test execution by the end user, which can be especially challenging for POC testing read more ...