Using standards and controls in molecular assays for infectious diseases.

Ten years ago, laboratory directors introducing molecular infectious disease diagnostics in the routine clinical setting had few resources to assist in their implementation and quality assurance programs. In the past 10 years, several organizations have recognized this need and have established standard reference materials, controls, external quality assessment programs, and written guidelines. It is a challenge for the clinical laboratory scientist to evaluate and incorporate these new programs and services in the context of traditional good laboratory practice and current laboratory regulations. This article presents many of the options available for control materials, proficiency programs, standard reference materials, and written guidelines. It shows where harmonization of new practice with long-standing convention and regulation is progressing and where questions remain.