SCOPE

Nucleic acid-based assays are used in a variety of settings, the most common of which include the detection of infectious agents (viruses, bacteria, etc.), and cellular materials, as well as disease profiling. More recently such assays have also been used for forensic purposes and for the detection of trace contamination in biological materials. The latter include pharmaceutical development applications, such as viral clearance and adventitious agent testing in vaccine seed lots and tissue culture cell banks. This chapter introduces a series of general information chapters that provide techniques that support procedures for the detection and analysis of nucleic acids (see Figure 1). The assays using these techniques may be presented in a USP general chapter or in a private specification.