Cepheid | MTB/RIF Molecular Test

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The Need

  • Globally in 2019, an estimated 10.0 million people fell ill with TB. There were 1.4 million TB deaths (14% among HIV-positive people).1
  • Today, the challenge to the global TB community is to ‘End TB’. The reliance on microscopy, with a sensitivity of only 46%–78%,2 is a severe limitation. Between 36%–59% of pulmonary TB cases are smear-negative/culture-positive and the relative transmission rate (10-24%) of these patients has a strong impact on patient management in hospitals, as well as TB control programs in developed and developing countries.3,4
  • In order to support the goal of TB elimination, we must implement efficient active case finding. A precise and early detection of TB is needed to improve case management and significantly enhance prevention of TB transmission.

(1) World Health Organization. Global Tuberculosis Report 2020. https://www.who.int/publications/i/item/9789240013131
(2) Kox. Tests for detection and identification of mycobacteria. How should they be used? Respir Med. 1995 Jul;89(6):399-408.;
(3) Diel et al. Cost-benefit analysis of Xpert MTB/RIF for tuberculosis suspects in German hospitals. Eur Respir J. 2016 Feb;47(2):575-87.;
(4) Behr et al. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9.

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The Solution

  • Enhancing the Standard
  • Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries and counting.
  • Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical.

Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra will bring:

  • Improved performance and faster time to result
  • Higher sensitivity especially in smear-negative TB cases
  • Results in <80 minutes5
  • Increased accuracy of Rifampicin results
  • Improved detection of mixed infections
  • Same easy-to-use process

(5) Jones M, et al. Xpert® MTB/RIF Ultra – design and analytical performance of a second generation Xpert® MTB/RIF assay. Poster presented at ECCMID. 2016 April 9-12, Amsterdam, Netherlands

The Impact

  • Preventing the transmission of MTB by fast identification of contagious patients, placing them in airborne infection isolation and initiating the right antibiotic therapy as soon as possible are crucial to ‘END TB’. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing.7,8,9 Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient3 and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test.
  • Impact on Patient Management Pathway
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(7) Global Laboratory Initiative. GLI model TB diagnostic algorithms. Accessed Mar 2017. http://www.stoptb.org/wg/gli/assets/documents/GLI_algorithms.pdf;
(8) World Health Organization. European Tuberculosis Laboratory Initiative. Algorithm for laboratory diagnosis and treatment-monitoring of pulmonary tuberculosis and drug-resistant tuberculosis using state-of-the-art rapid molecular diagnostic technologies. Accessed Mar 2017. http://www.euro.who.int/__data/assets/pdf_file/0006/333960/ELI-Algorithm.pdf;
(9) Global Laboratory Initiative. Planning for country transition to Xpert® MTB/RIF Ultra cartridges. Accessed Apr 2017. http://www.stoptb.org/wg/gli/assets/documents/GLI_ultra.pdf

Making a Positive Impact, Together.

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