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Test Information


Situation Today

Tuberculosis (TB) is the second leading cause of infectious disease-related death behind COVID-19.1 It is estimated that 1/3 to 1/4 of the world’s population is infected with TB, with the greatest burden falling on low- and middle-income countries and poor and marginalized populations.2 The reservoir of latent disease continues to fuel around 10 million cases of active TB disease – 30% of which go undiagnosed – and 1.5 million deaths per year.2

The opportunity to end TB by 2030 stands before the global community. Together, governments, NGOs, donors, and others have made incredible strides against the disease, but the COVID-19 pandemic has set the fight against TB back nearly a decade.3 To regain progress and drive toward disease eradication, TB programs need accurate and timely diagnostics, effective and easy-to-take treatments, strong health care infrastructure, and innovative partnerships.


Developing innovative solutions to fight TB is in our company DNA. In 2006, we started collaborations to develop a test that could simultaneously detect Mycobacterium tuberculosis and mutations associated with Rifampicin resistance in an easy-to-use workflow. From this, Xpert® MTB/RIF was born. Since then, we have been continuously innovating to stay ahead of the disease and evolving patient needs.

The true impact comes from our partnerships with global organizations, Ministries of Health, leading scientists, affected communities, and donors to realize the full potential of Cepheid’s diagnostic solutions.

Rapid molecular tests like Xpert MTB/RIF Ultra are WHO-recommended first-line diagnostic tests for patients with signs and symptoms of TB4


Reduction in the number of people with TB who do not get diagnosed since the introduction of Xpert MTB/RIF in 20105

8 Million

Number of people who have had TB detected with Cepheid's TB tests since 2015, when data collection began5


Testing with Xpert has been found to get patients started on TB treatment 2.5X faster than traditional diagnostic methods6

Stories from the Field


Cepheid’s tests, coupled with its diagnostic instrument systems, are designed to enable easy and fast TB diagnosis and detection of drug resistance to reduce barriers to diagnosis for everyone in any location, even in remote community settings.


Xpert MTB/RIF Ultra


System Compatibility

GeneXpert®-II, IV, XVI; GeneXpert® Infinity-48 and -80; GeneXpert® Edge

GeneXpert-II, IV, XVI

Operating Requirement

6-color or 10-color


Regulatory and WHO Status

CE marked

WHO endorsed

CE marked

WHO endorsed

Shelf Life

18 months

18 months

Pricing for Customers Eligible for Global Access Program

FIND website

FIND website

For More Information

Xpert MTB/RIF Ultra product page

Xpert MTB/XDR product page

For any questions, please contact your local Cepheid Sales Executive or Technical Support team in your respective country. Please see complete pricing and eligibility details here.


Global Access Homepage

Learn More

CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

IVD. In Vitro Diagnostic Medical Device. May not be available in all countries

1.  NPR. Before COVID, TB was the world’s worst pathogen. It’s still a ‘monster’ killer. 13 Feb 2022. Accessed Jun 2022.

2.  WHO. 10 facts on tuberculosis. 12 Oct 2021. Accessed Jun 2022.

3.  WHO. Tuberculosis deaths rise for the first time in more than a decade due to the COVID-19 pandemic. 14 Oct 2021. Accessed Jun 2022.

4.  WHO. WHO consolidated guidelines on tuberculosis, Module 3: Diagnosis, Rapid diagnostics for tuberculosis detection. 2021.

5.  WHO. Global Tuberculosis Programme. Accessed Jun 2022.

6.  Kwak N, et al. Diagnostic Accuracy and Turnaround Time of the Xpert MTB/RIF Assay in Routine Clinical Practice. PLoS One, 2013; 8(10): e77456.

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