Limitations of the MTB/RIF Assay: An Xpert Review of 4 Clinical Cases

Current U.S. Centers for Disease Control and Prevention tuberculosis (TB) guidelines recommend molecular testing for initial diagnosis of TB and detection of rifampin resistance to expedite initiation of proper treatment. The Cepheid Xpert MTB/RIF assay can detect members of the <i>Mycobacterium tuberculosis</i> complex and rifampin resistance by evaluating for mutations in the <i>rpoB</i> gene. However, false-positive and false-negative detection of <i>M tuberculosis</i> and rifampin resistance results can lead to incorrect treatment of patients, including overuse of second-line anti-TB drugs, and may result in patient harm and increased healthcare cost. We present a series of 4 cases to demonstrate the limitations of the Xpert MTB/RIF assay in the diagnosis of TB, emphasizing the importance of follow-up confirmatory testing and laboratory oversight in reporting accurate results.

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Publication Details

Journal
Open Forum Infectious Diseases
Published
2025-03-05
DOI
https://doi.org/10.1093/ofid/ofaf132
Citations
6
Primary Topic
Lung Cancer Treatments and Mutations
Type
article
Field-Weighted Citation Impact
9.11
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article

Limitations of the MTB/RIF Assay: An Xpert Review of 4 Clinical Cases

Masahiro Narita, Vincent Escuyer, Angela Ma, Elizabeth Church et al.
6 citations
Open Forum Infectious Diseases
Lung Cancer Treatments and Mutations
9.11
article

Limitations of the MTB/RIF Assay: An Xpert Review of 4 Clinical Cases

Masahiro Narita, Vincent Escuyer, Angela Ma, Elizabeth Church, Salika M. Shakir, Allison L Haas, Uma Malhotra, Jonathan Pham, Punam Verma
article en
6 citations

Abstract

Current U.S. Centers for Disease Control and Prevention tuberculosis (TB) guidelines recommend molecular testing for initial diagnosis of TB and detection of rifampin resistance to expedite initiation of proper treatment. The Cepheid Xpert MTB/RIF assay can detect members of the <i>Mycobacterium tuberculosis</i> complex and rifampin resistance by evaluating for mutations in the <i>rpoB</i> gene. However, false-positive and false-negative detection of <i>M tuberculosis</i> and rifampin resistance results can lead to incorrect treatment of patients, including overuse of second-line anti-TB drugs, and may result in patient harm and increased healthcare cost. We present a series of 4 cases to demonstrate the limitations of the Xpert MTB/RIF assay in the diagnosis of TB, emphasizing the importance of follow-up confirmatory testing and laboratory oversight in reporting accurate results.

Open Forum Infectious DiseasesVol. 12(4)
New York State Department of Health (US), Virginia Mason Medical Center (US), Wadsworth Center (US), Public Health – Seattle & King County (US), University of Washington (US), University of Utah (US), Franciscan Health (US), ARUP Laboratories (United States) (US), Fred Hutch Cancer Center (US), ARUP Laboratories (United States) (US)
Good health and well-being
Openalex Percentile: Top 2%
Lung Cancer Treatments and Mutations
9.11
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