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Journal of Clinical Microbiology, September 2009, p. 2995-2997, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.00966-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

False-Negative Results Obtained with the Gen-Probe Amplified Mycobacterium tuberculosis Direct Test Caused by Unrecognized Inhibition of the Amplification Reaction{triangledown}

Ji Yeon Kim,1 Mary Jane Ferraro,1,2 and John A. Branda1*

Departments of Pathology,1 Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts2

Received 14 May 2009/ Returned for modification 14 June 2009/ Accepted 1 July 2009

The Gen-Probe Amplified Mycobacterium tuberculosis direct test is widely used in the diagnosis of tuberculosis. Specimens may contain amplification inhibitors, potentially leading to false-negative results if unrecognized. We report a failure to detect inhibition, despite adherence to the inhibition testing guidelines provided on the label, and recommend changes.

* Corresponding author. Mailing address: GRB-526 Microbiology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114. Phone: (617) 726-3611. Fax: (617) 726-5957. E-mail: Branda.John{at}mgh.harvard.edu

{triangledown} Published ahead of print on 8 July 2009.

Journal of Clinical Microbiology, September 2009, p. 2995-2997, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.00966-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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