THE POLYMERASE CHAIN-REACTION - CLINICAL-APPLICATIONS

This chapter discusses the clinical applications of polymerase chain reaction (PCR). The chapter identifies those diseases for which the PCR offers an advantage over conventional diagnostic methods—for example, it may be the preferred method for detecting pathogens that are difficult, slow, or impossible to culture. Another objective is to address the issues and technical challenges that must be solved before the method is widely available in the form of Food and Drug Administration (FDA) approved standardized kits suitable for the clinical laboratory. Examples of these challenges include procedures for simplifying specimen preparation, eliminating false positives, and colorimetric detection. The chapter addresses various questions regarding the sensitivity of PCR, the necessity of more than one gene target, and confirmation of positive results if the method is more sensitive than culture. The chapter tabulates various PCR applications in detecting bacterial pathogens. Most of these studies concern simple detection of the organism rather than diagnosis and await standardized procedures, simplified sample preparation methods, and colorimetric detection formats before they may be used for practical purposes in clinical laboratories. © 1992 Academic Press Inc.