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Xpert® MTB/RIF
Accurate Detection of MTB and Rifampin Resistance Mutations
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10 Tests
GXMTB/RIF-US-10
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The Need
- Each day, more than 3,400 people lose their lives to TB and nearly 30,000 people fall ill with this preventable and curable disease1
- In the United States, 22% of people affected by TB are still not diagnosed by the WHO-recommended rapid diagnostic test1
- Precise and early detection of TB is needed to improve case management and significantly enhance the prevention of TB transmission2
1 Global Tuberculosis Report 2023. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023. Accessed Jan 2024.
2 Centers for Disease Control and Prevention—Guidelines for preventing the transmission of TB-- https://www.cdc.gov/mmwr/preview/mmwrhtml/00001897.htm. Accessed Jan 2024.
2 Centers for Disease Control and Prevention—Guidelines for preventing the transmission of TB-- https://www.cdc.gov/mmwr/preview/mmwrhtml/00001897.htm. Accessed Jan 2024.
The Solution
The Xpert MTB/RIF test provides fast and accurate detection of Mycobacterium Tuberculosis (MTB) and Rifampicin (RIF) resistance simultaneously from patient samples
- Simple three-step process with results in less than 2 hours
- Designed to provide the most accurate MTB and Rifampicin detection
- On-demand capability that empowers physicians to manage patients effectively
The Impact
- Early detection of MTB and resistance to Rifampicin enables faster access to the most appropriate treatment for better patient outcomes3
- Significantly reduces AII (airborne infection isolation) duration compared to the smear microscopy3
- Implementation is highly cost-effective for diagnosing pulmonary TB in the United States4
3 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): 186–19
4 H. W. Choi, et al, Cost-effectiveness of Xpert® MTB/RIF for diagnosing pulmonary tuberculosis in the United States Int J Tuberc Lung Dis. 2013 October ; 17(10): 1328–1335
4 H. W. Choi, et al, Cost-effectiveness of Xpert® MTB/RIF for diagnosing pulmonary tuberculosis in the United States Int J Tuberc Lung Dis. 2013 October ; 17(10): 1328–1335
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Product Resources
Product Information
Package Inserts & MSDS
ADF Files
Frequently Asked Questions
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
References:
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