Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis

doi:10.1001/jama.2009.148

Cited by 70 publications

(1 citation statement)

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“…Although the GeneXpert platform (Cepheid, Sunnyvale, California, United States) was available as early as the 1990s, it was originally only used to detect anthrax. 3 From 2006, the platform was more widely used to diagnose tuberculosis 4 , 5 and, in 2010, received an endorsement from the WHO as a first-line tuberculosis diagnostic test among people living with HIV and those presumed to have MDR-TB. 1 The Xpert MTB/RIF assay (Cepheid, Sunnyvale, California, United States) is an automated molecular (nucleic acid amplification) test for the diagnosis of tuberculosis with comparable accuracy to culture.…”

Section: Introductionmentioning

confidence: 99%

GeneXpert rollout in three high-burden tuberculosis countries in Africa: A review of pulmonary tuberculosis diagnosis and outcomes from 2001 to 2019

et al. 2022

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Background: The rollout of GeneXpert aimed at increasing early diagnosis of tuberculosis to improve treatment outcomes and global tuberculosis targets.Objective: This study evaluated trends in tuberculosis diagnosis and outcomes pre- and post-introduction of GeneXpert in three African countries – the Democratic Republic of the Congo (DRC), Nigeria and South Africa.Methods: Data from 2001 to 2019 were extracted from the World Health Organization’s data repository. Descriptive analysis, paired t-tests and interrupted time series models were used.Results: Estimated tuberculosis incidence decreased from 327/100 000 to 324/100 000 in the DRC, and from 1220/100 000 to 988/100 000 in South Africa. Incidence remained at 219/100 000 in Nigeria. The tuberculosis case notification rate did not change significantly. Increases in the new case treatment success rates were statistically significant (DRC: p = 0.0201; Nigeria: p = 0.0001; South Africa: p = 0.0017); decreases in mortality were also statistically significant (DRC: p = 0.0264; Nigeria: p = 0.0001; South Africa: p 0.0001). Time series models showed insignificant increases in new tuberculosis cases in DRC (n = 1856, p = 0.085) and Nigeria (n = 785, p = 0.555) from 2011 to 2019; and a statistically significant decrease in South Africa (n = 15 269, p = 0.006).Conclusion: Improvements in tuberculosis treatment outcomes were achieved, but little progress has been made in new case notification due to varied implementation and scale-up of GeneXpert across the three countries. Implementation barriers need to be addressed to achieve the required tuberculosis targets.

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Section: Introductionmentioning

confidence: 99%

GeneXpert rollout in three high-burden tuberculosis countries in Africa: A review of pulmonary tuberculosis diagnosis and outcomes from 2001 to 2019

et al. 2022

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Association of Rapid Molecular Testing With Duration of Respiratory Isolation for Patients With Possible Tuberculosis in a US Hospital

et al. 2018

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Importance New guidelines recommend that molecular testing replace sputum-smear microscopy to guide discontinuation of respiratory isolation in patients undergoing evaluation for active tuberculosis(TB) in health-care settings. Objective To evaluate the implementation and impact of a molecular-testing strategy to guide discontinuation of isolation. Design Prospective cohort study with a pragmatic, before-and-after-implementation design. Setting Zuckerberg San Francisco General Hospital and Trauma Center. Participants 621 consecutive hospitalized patients undergoing sputum examination for evaluation for active pulmonary TB from January 2014—January 2016. Intervention Implementation of a sputum molecular-testing algorithm using GeneXpert MTB/RIF(Xpert) to guide discontinuation of isolation. Main Outcomes and Measures We measured the proportion of patients with molecular testing ordered and completed; the accuracy of the molecular-testing algorithm in reference to mycobacterial culture; the duration of each component of the testing and isolation processes; length of stay; mean days in isolation and in hospital; and mean cost. We extracted data from hospital records and compared measures before and after implementation. Results Among 320 patients evaluated in the post-implementation period, clinicians ordered molecular testing for 234(73%) patients and received results for 295/302(98%) tests ordered. Median age was 54(interquartile range 44–63), and 161(26%) were women. The molecular-testing algorithm accurately diagnosed all seven patients with culture-confirmed TB and excluded TB in all 251 Mtb-culture-negative patients. Compared to the pre-implementation period, there were significant decreases in median times to final rapid-test result(39.1 vs. 22.4 hours, p<0.001), discontinuation of isolation(2.9 vs. 2.5 days, p=0.001), and hospital discharge(6.0 vs 4.9 days, p=0.003), on average saving $13,347 per isolated non-TB patient. Conclusions and Relevance A sputum molecular-testing algorithm to guide discontinuation of respiratory isolation for patients undergoing evaluation for active TB was safe, feasible, widely and sustainably adopted, and provided substantial clinical and economic benefits. Molecular testing may facilitate more efficient, patient-centered evaluation for possible TB in U.S. hospitals.

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Molecular Diagnostics in Pulmonary Infections

Gao

Huston

Toro

et al. 2020

Precision in Pulmonary, Critical Care, and Sleep Medicine

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Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis

Abstract: underlying cause coded as J65 (pneumoconiosis associated with tuberculosis) or J92.0 (pleural plaque with presence of asbestos) also were included in the underlying cause-of-death tabulation for asbestosis if code J61 also was listed on the death certificate. ‡Alaska,

Cited by 70 publications

References 6 publications

GeneXpert rollout in three high-burden tuberculosis countries in Africa: A review of pulmonary tuberculosis diagnosis and outcomes from 2001 to 2019

GeneXpert rollout in three high-burden tuberculosis countries in Africa: A review of pulmonary tuberculosis diagnosis and outcomes from 2001 to 2019

Association of Rapid Molecular Testing With Duration of Respiratory Isolation for Patients With Possible Tuberculosis in a US Hospital

Molecular Diagnostics in Pulmonary Infections

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