False-negative results obtained with the Gen-Probe Amplified Mycobacterium tuberculosis direct test caused by unrecognized inhibition of the amplification reaction.
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.
Kim
Ji Yeon
JY
Department of Pathology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.
Ferraro
Mary Jane
MJ
Branda
John A
JA
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
D011933:Reagent Kits, Diagnostic