Total quality in laboratory diagnostics: the role of commercial companies

Quality is a key focus for clinical laboratories, since it is viewed as a prerequisite for patient safety. It permeates all three phases of the total testing process (preanalytical, analytical and postanalytical), and relies heavily on the quality of diagnostic products, such as in vitro (IVD) devices (instruments, assays, reagents and specimen collection tubes) and medical devices (blood collection needles and sets). The diagnostic industry has implemented strict criteria to assure that the quality of their products throughout their life cycle meets the needs of their customers. This is accomplished through established processes to develop products that meet customer needs, as well as regulatory requirements needed to assure their safety and efficacy while adhering to good clinical practices and maintaining high level of safety of human subjects that participate in clinical trials. At the same time, the commercial companies follow good manufacturing practices to reduce variability within their manufacturing processes and deliver products that are within established specifications. However, the highest level of quality can only be achieved when instrument/assay manufacturers work closely with specimen containment manufacturers to assure total system performance.