The role of molecular diagnostics in the clinical microbiology laboratory

With the exquisite sensitivity, inherent specificity, and versatility of polymerase chain reaction (PCR) and other amplification techniques, it is clear that infectious disease diagnostic tests based on these methods will assume a niche quickly in many clinical microbiology laboratories. Routine implementation, however, requires that many issues be addressed, including control of amplicon contamination, specimen treatment to avoid inhibitors, interpretation of positive results when clinical significance is unclear, and cost. Laboratory experience with the Chlamydia Amplicor product (Roche Molecular Systems, Branchburg, NJ) is discussed to illustrate these issues. Commercial kit products using nucleic acid amplification techniques can be introduced into a routine laboratory easily and with a high degree of accuracy.