PCR Detection of TB and Extended Drug-resistant TB <90 Minutes

Xpert® MTB/RIF Ultra & Xpert® MTB/XDR

 
 

Tuberculosis (TB) remains one of the most common infectious diseases, with around a quarter of the global population estimated to have been infected with TB.1 In 2024 over 5,400 people were notified with TB in England, an increase of 13.0% in numbers and notification rate compared with 2023 (the largest year-on-year increase).2

 

A major concern for TB is the multidrug-resistant form that can emerge when the frontline antibiotic treatment, rifampicin, is inappropriately used. When this occurs, the antibiotic treatment options are very limited.

 

Precise and early detection of TB is needed to improve case management and significantly enhance the prevention of TB transmission.3

 

 

Who Should be Tested?

It is recommended that asymptomatic people who are at high risk of infection should be screened for TB through active case-finding, including:4

  • People who have been in contact with an infected person
  • People who are immunocompromised
  • People travelling from a high TB prevalence country
  • People who have not completed treatment
 

Why Test with Fast PCR?

Fast and accurate PCR diagnostics with Cepheid’s GeneXpert® system and Xpert® MTB/RIF Ultra and Xpert® MTB/XDR tests provide standardised, on-demand, and actionable results in <90 minutes, enabling healthcare systems to streamline complex and timely TB testing algorithms and support improved active case finding and patient outcomes.

 

Given the increase in TB incidence and rates in England, diverging further from the trajectory needed to meet the WHO End TB target by 2035, limiting transmission has now become even more important.2 National guidance includes the use of rapid diagnostics tests if there is a clinical suspicion of TB, and the WHO specifically recommends the use of rapid molecular diagnostic tests such as Xpert® MTB/RIF Ultra.5,6 

 

Xpert® MTB/RIF Ultra

Detection of Mycobacterium tuberculosis (MTB) complex and rifampin-resistance associated mutations in less than 80 minutes. As a frontline test over smear microscopy or line probe assay, Xpert® MTB/RIF Ultra provides: 

  • Faster diagnostics access to support optimised treatment and outcomes7
  • Improved active case finding to limit community transmission8
  • Enhanced sensitivity versus smear microscopy in pulmonary samples7
  • Enhanced performance in HIV-positive patients9
  • Potential to be more cost-effective10

Xpert® MTB/XDR

Detection of Mycobacterium tuberculosis complex and mutations associated with drug resistance towards  isoniazid (INH), fluoroquinolones (FLQ), second-line injectable drug (SLID) (amikacin, kanamycin, capreomycin), and ethionamide (ETH) in a single test in less than 90 minutes. Combined with the frontline test Xpert® MTB/RIF Ultra, the Xpert® MTB/XDR reflex test enables fast molecular drug susceptibility testing (DST) to provide:

  • Increased diagnostic access and upfront molecular DST for all TB-positive cases to support optimised treatment in a single visit11
  • Increased access to fast molecular DST to help notify more patients affected by multidrug-resistant TB11
  • Capability to differentiate between high and low-level resistance to INH and FLQ, important for determining therapeutic options and individualized treatment regimens12

GeneXpert® Systems

Our GeneXpert® family of systems have set a new standard in workflow flexibility, 24/7 accuracy, and user-friendly design.

 

Our engaging platform delivers:

  • On-demand and random-access walkway testing
  • Unique scalability and flexible design from 2-80 modules
  • Simplified workflow
  • Easy to maintain
  • Full connectivity

 

>30 CE-IVD Tests, One GeneXpert System for Consolidated Infectious Disease PCR Testing

 

COVID-19, Flu & RSV

Results in 36 minutes

Carbapenem-resistant Bacteria

Results in 50 minutes

C. difficile

Results in 43 minutes

Group B Streptoccoccus

Results in 56 minutes

MRSA

Results in 47 minutes*

TB & Resistance

Results in <90 minutes

Norovirus

Results in 60 minutes^

Vancomycin-resistant Bacteria

Results in 48 minutes

 

Choose Cepheid as your Trusted Diagnostics NHS Partner Today

Over the last 28 years, Cepheid has partnered with many hospitals, clinics, and laboratories around the world with more than 50,000 systems installed and millions of tests performed, including ~2 million PCR tests delivered to NHS hospitals each year13, changing the lives of patients.

 

With our solutions, your healthcare organisation can potentially reduce costs, streamline operations, and maximise productivity while prioritising patient health.

 

Download TB Infographic

Speak to our experts about your TB active case finding and stewardship plan

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

* For positive MRSA results with early assay termination. Otherwise, full runtime is 70 minutes.
^ For positive Norovirus results with early assay termination. Otherwise, full runtime is 90 minutes.
1. WHO Tuberculosis Report. 2023. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023

2. UK Government. National quarterly report of tuberculosis in England: quarter 4, 2024, provisional data. 2025. https://www.gov.uk/government/statistics/tuberculosis-in-england-national-quarterly-reports/national-quarterly-report-of-tuberculosis-in-england-quarter-4-2024-provisional-data

3. CDC. Guidelines for Preventing the Transmission of TB. https://www.cdc.gov/mmwr/preview/mmwrhtml/00001897.htm

4. NICE. Who should be screened for Tuberculosis? https://cks.nice.org.uk/topics/tuberculosis/diagnosis/screening/

5. NICE. Guidance [NG 33]. Published 13 January 2016. Updated on 16 February 2024. https://www.nice.org.uk/guidance/ng33/chapter/Recommendations#active-tb

6. WHO. Tuberculosis Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/tuberculosis

7. Charkravorty S, et al. The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing - https://journals.asm.org/doi/10.1128/mbio.00812-17

8. Saavedra B, et al. Performance of Xpert MTB/RIF Ultra for tuberculosis diagnosis in the context of passive and active case finding. European Respiratory Journal 2021 58(6): 2100257

9. Aliasgar E, et al, Comparison of Xpert MTB/RIF (G4) and Xpert Ultra, including trace readouts, for the diagnosis of pulmonary tuberculosis in a TB and HIV endemicsetting. International Journal of Infectious Diseases 95 (2020) 246–252.

10. Diel R, et al. Cost-benefit analysis of Xpert MTB/RIF for tuberculosis suspects in German hospitals. Eur Respir J. 2016 Feb;47(2):575-87.

11. Penn-Nicholson A, et al. Clinical evaluation of the Xpert MTB/XDR assay for rapid detection of isoniazid, fluoroquinolone, ethionamide and second-line drug resistance: A cross-sectional multicentre diagnostic accuracy study. medRxiv 2021.05.06.21256505; doi: https://doi.org/10.1101/2021.05.06.21256505.

12. Saderi L, et al. Rapid Diagnosis of XDR and Pre-XDR TB: A Systematic Review of Available Tools. Arch Bronconeumol. Vol. 58. Issue 12.

13. 2023 Internal data analysis actual 1.9.

About Cepheid

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company's solutions deliver actionable results where they are needed most from central laboratories and hospitals to near patient settings.

For more information, visit www.cepheid.com

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