GeneXpert Testing: Applications for Clinical Microbiology, Part I^*

The impact of rapid polymerase chain reaction (PCR) technology on infectious disease testing is continuing to evolve outside the realm of a centralized laboratory. The GeneXpert Dx system is the first unit dose, near-point-of-care molecular device commercially available. To date, there are five FDA-cleared assays available for the GeneXpert System: group B Streptococcus (GBS) from vaginal-rectal swabs, enterovirus from cerebrospinal fluid, methicillin-resistant Staphylococcus aureus (MRSA) from nares swabs, MRSA and methicillin-susceptible S. aureus (MSSA) from skin and soft tissue infection swabs, and MRSA and MSSA from positive blood cultures. Advantages of the GeneXpert assays include ease of use, random access, rapid results, and the ability to run the assay without the need for pre- and post-analytical rooms. Limitations include a currently limited menu with few specimen types and potential delay of results due to indeterminate results. Part I of this article presents a review of this technology and its application for the detection of GBS, enterovirus, and MRSA from various clinical specimens.