title: False-negative results obtained with the Gen-Probe Amplified Mycobacterium tuberculosis direct test caused by unrecognized inhibition of the amplification reaction.
abstract: 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.
authors: Department of Pathology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.
authors: Ji Yeon
authors: JY
authors: Kim
authors: Mary Jane
authors: MJ
authors: Ferraro
authors: John A
authors: JA
authors: Branda
mesh_terms: D005188:False Negative Reactions; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D014376:Tuberculosis / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic