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 m ethods will assume a niche quickly in many clinical microbiology labor atories. Routine implementation, however, requires that many issues be addressed, including control of amplicon coni amination, specimen tre atment to avoid inhibitors, interpretation of positive results when cl inical significance is unclear, and cost. Laboratory experience with t he Chlamydia Amplicor product (Roche Molecular Systems, Branchburg, NJ ) is discussed to illustrate these issues. Commercial kit products usi ng nucleic acid amplification techniques can be introduced into a rout ine laboratory easily and with a high degree of accuracy.