GeneXpert Testing: Applications for Clinical Microbiology, Part I*
Abstract
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.
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*Editor's Note: Part II of this article will be published in the December 15, 2008 issue of CMN (Vol. 30, No. 24).NOTE: No responsibility is assumed by the Publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. No suggested test or procedure should be carried out unless, in the reader's judgment, its risk is justified. Because of rapid advances in the medical sciences, we recommend that the independent verification of diagnoses and drug doses should be made. Discussions, views and recommendations as to medical procedures, choice of drugs and drug dosages are the responsibility of the authors.SUBSCRIPTION INFORMATION: Access to full text online is included in the price of individual print subscriptions. Please visit www.cmnewsletter.com. Clinical Microbiology Newsletter (ISSN 0196-4399) is issued twice monthly in one indexed volume per year by Elsevier, 360 Park Avenue South, New York, NY 10010. Subscription price per year: Personal: U.S., $95; International, $101. Institutional: U.S., $559; Interational, $558. Periodical postage paid at New York, NY and at additional mailing offices. Postmaster: Send address changes to Clinical Microbiology Newsletter, Elsevier Science Inc., 360 Park Avenue South, New York, NY 10010. For customer service, phone (212) 633-3950; TOLL-FREE for customers in the United States and Canada: 1-888-4ES-INFO (1888-437-4636) or fax: (212) 633-3860.Reprints: For copies of 100 more of articles in this publication, please contact the Commercial Reprints Department, Elsevier Science, Inc., 360 Park Avenue South, New York, NY 10010-1710. Tel. (212) 633-3813, Fax: (212) 633-3820, e-mail: reprints@elsevier.com
PII: S0196-4399(08)00056-1
doi:10.1016/j.clinmicnews.2008.11.001
© 2008 Elsevier Inc. All rights reserved.
