Assays based on polymerase chain reaction (PCR) have been developed to
identify a variety of infectious agents. To date, these assays have b
een routinely applied only in academic or highly sophisticated testing
laboratories. With the 1993 introduction in the United States of the
first PCR-based in vitro diagnostic kit, the stage is set for rapid co
mmercial entry of other kit assays and eventual automation of the vers
atile technology. The availability of PCR methodology in simple, relia
ble kit formats should fulfill the promise of some years ago of DNA pr
obe-based diagnostics and extend their diagnostic potential to DNA and
RNA pathogens, multiple target detection, and quantitation of pathoge
n load.