AC-09 To PCR or Not to PCR: Role of Nucleic Acid Amplification Testing for the Laboratory Diagnosis of Select Community Acquired Infections
Date: October 10, 2007
Speaker: Mario J. Marcon, Ph.D., Children’s Hosp., Columbus, OH.

Summary of Session: PCR and other nucleic acid amplification methods have been shown to be important in diagnosis and management of a number of categories of infections including STDs, viral hepatitis, and AIDS. To this end, commercial companies have developed and obtained FDA-clearance to market products designed to diagnose infections of these types. On the other hand, there are currently no FDA-cleared tests for the diagnosis of many community acquired infections including respiratory tract and central nervous systems infections. Thus "home-brew" methods are increasingly being developed and offered by a number of institutions and reference laboratories for these types of infection. It is difficult for many laboratories to decide what role home-brew amplification testing vs. testing by traditional methods of culture, serology, and antigen detection should play for these infections in their institutions. With the use of select clinical cases, this presentation is designed to illustrate the important role that nucleic acid amplification tests may play in the diagnosis of community acquired infections with emphasis on clinical utility and appropriate utilization.

Objectives: Upon completion of this Teleconference, participants should be able to:

• List important types of community-acquired infections for which nucleic acid amplification testing is available and should be considered;
• Recognize the diagnostic limits of both traditional and nucleic acid amplification testing for such infections; and
• Evaluate the relative clinical importance of making a specific laboratory diagnosis in terms of the infectious agent, severity of disease, patient population being served, and public health significance.

Intended Audience: Medical technologists, laboratory supervisors, microbiologists, and pathologists.

CME Disclosures: Dr. Mario Marcon has dislcosed the following financial relationship:

Prodesse Inc., Quidel Corp., Meridian Biosciences; Grants/research support

In accordance with the ACCME Essential Areas and Policies relating to commercial support, the audience is advised that Dr. Marcon will discuss the following off-label usage of various home-brew PCR tests, commercial analyte-specific reagents for PCR and DFA testing from Prodesse, Inc. (PCR ProFlue) and Diagnostic Hybrids, Inc. (DFA for hMVN).

Termination of CME Credit: This program will not be eligible for CME credit after October 10, 2008