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Xpert® MTB/RIF
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Ans: The Xpert® MTB/RIF Assay, performed on the GeneXpert® Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis complex DNA. In specimens where Mycobacterium tuberculosis complex (MTB-complex) is detected, the Xpert MTB/RIF Assay also detects the rifampin-resistance associated mutations of the rpoB gene1
Ans: Raw sputum or concentrated sputum sediment prepared from induced or expectorated sputum can be used as an initial sample type for the Xpert MTB/RIF test1
Ans: Sputum specimens that are AFB smear-negative but subsequently TB culture-positive have lower MTB-complex organism loads than specimens that are AFB smear-positive. Because of the greater sensitivity of the Xpert MTB/RIF Assay for the detection of MTB-complex than that of acid-fast microscopy, MTB-complex may be detected by the Xpert MTB/RIF Assay in AFB smear-negative samples1
Ans: The Xpert MTB/RIF Assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than three days of therapy1
Ans: Xpert MTB/RIF-based strategies can significantly reduce AII (airborne infection isolation) duration compared with the smear-based strategy2
Ans: A Sample Processing Control (SPC) and a Probe Check Control (PCC) are included in the cartridge. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the PCR reaction. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability1
Referências:
1. Xpert MTB/RIF Package Insert 301-1404, Rev. G July 2020
2. Christopher K. Lippincott et al, Xpert MTB/RIF Assay Shortens Airborne Isolation for Hospitalized Patients with Presumptive Tuberculosis in the United States Clin Infect Dis. 2014 Jul 15; 59(2): 186–192