Literature DB >> 24869625

Impact of GeneXpert MTB/RIF on patients and tuberculosis programs in a low-burden setting. a hypothetical trial.

J Lucian Davis1, L Masae Kawamura, Lelia H Chaisson, Jennifer Grinsdale, Jihane Benhammou, Christine Ho, Anna Babst, Houmpheng Banouvong, John Z Metcalfe, Mark Pandori, Philip C Hopewell, Adithya Cattamanchi.   

Abstract

RATIONALE: Guidelines recommend routine nucleic-acid amplification testing in patients with presumed tuberculosis (TB), but these tests have not been widely adopted. GeneXpert MTB/RIF (Xpert), a novel, semiautomated TB nucleic-acid amplification test, has renewed interest in this technology, but data from low-burden countries are limited.
OBJECTIVES: We sought to estimate Xpert's potential clinical and public health impact on empiric treatment, contact investigation, and housing in patients undergoing TB evaluation.
METHODS: We performed a prospective, cross-sectional study with 2-month follow-up comparing Xpert with standard strategies for evaluating outpatients for active pulmonary TB at the San Francisco Department of Public Health TB Clinic between May 2010 and June 2011. We calculated the diagnostic accuracy of standard algorithms for initial empiric TB treatment, contact investigation, and housing in reference to three Mycobacterium tuberculosis sputum cultures, as compared with that of a single sputum Xpert test. We estimated the incremental diagnostic value of Xpert, and the hypothetical reductions in unnecessary treatment, contact investigation, and housing if Xpert were adopted to guide management decisions.
MEASUREMENTS AND MAIN RESULTS: A total of 156 patients underwent Xpert testing. Fifty-nine (38%) received empiric TB treatment. Thirteen (8%) had culture-positive TB. Xpert-guided management would have hypothetically decreased overtreatment by 94%, eliminating a median of 44 overtreatment days (interquartile range, 43-47) per patient and 2,169 total overtreatment days (95% confidence interval, 1,938-2,400) annually, without reducing early detection of TB patients. We projected similar benefits for contact investigation and housing.
CONCLUSIONS: Xpert could greatly reduce the frequency and impact of unnecessary empiric treatment, contact investigation, and housing, providing substantial patient and programmatic benefits if used in management decisions.

Entities:  

Keywords:  diagnosis; health care quality assurance; operations research; public health; tuberculosis

Mesh:

Substances:

Year:  2014        PMID: 24869625      PMCID: PMC4226012          DOI: 10.1164/rccm.201311-1974OC

Source DB:  PubMed          Journal:  Am J Respir Crit Care Med        ISSN: 1073-449X            Impact factor:   21.405


  45 in total

1.  Reporting statistical information in medical journal articles.

Authors:  Peter Cummings; Frederick P Rivara
Journal:  Arch Pediatr Adolesc Med       Date:  2003-04

2.  When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?

Authors:  Sarah J Lord; Les Irwig; R John Simes
Journal:  Ann Intern Med       Date:  2006-06-06       Impact factor: 25.391

3.  Nucleic acid amplification tests for tuberculosis.

Authors: 
Journal:  MMWR Morb Mortal Wkly Rep       Date:  1996-11-01       Impact factor: 17.586

4.  Cost-effectiveness analysis of the gen-probe amplified mycobacterium tuberculosis direct test as used routinely on smear-positive respiratory specimens.

Authors:  David W Dowdy; Amelia Maters; Nicole Parrish; Christopher Beyrer; Susan E Dorman
Journal:  J Clin Microbiol       Date:  2003-03       Impact factor: 5.948

5.  From the Food and Drug Administration.

Authors:  S L Nightingale
Journal:  JAMA       Date:  1996-02-28       Impact factor: 56.272

6.  The interpretation of nucleic acid amplification tests for tuberculosis: do rapid tests change treatment decisions?

Authors:  S J Conaty; A P Claxton; D A Enoch; A C Hayward; M C I Lipman; S H Gillespie
Journal:  J Infect       Date:  2005-04       Impact factor: 6.072

7.  Guidelines for the investigation of contacts of persons with infectious tuberculosis. Recommendations from the National Tuberculosis Controllers Association and CDC.

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Journal:  MMWR Recomm Rep       Date:  2005-12-16

8.  Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005.

Authors:  Paul A Jensen; Lauren A Lambert; Michael F Iademarco; Renee Ridzon
Journal:  MMWR Recomm Rep       Date:  2005-12-30

9.  Assessment by meta-analysis of PCR for diagnosis of smear-negative pulmonary tuberculosis.

Authors:  Olga L Sarmiento; Kristen A Weigle; Janet Alexander; David J Weber; William C Miller
Journal:  J Clin Microbiol       Date:  2003-07       Impact factor: 5.948

10.  Presumptive diagnosis and treatment of pulmonary tuberculosis based on radiographic findings.

Authors:  F M Gordin; G Slutkin; G Schecter; P C Goodman; P C Hopewell
Journal:  Am Rev Respir Dis       Date:  1989-05
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  14 in total

Review 1.  Update in Mycobacterium tuberculosis lung disease 2014.

Authors:  Paul Elkington; Alimuddin Zumla
Journal:  Am J Respir Crit Care Med       Date:  2015-10-01       Impact factor: 21.405

Review 2.  Emerging technologies for the clinical microbiology laboratory.

Authors:  Blake W Buchan; Nathan A Ledeboer
Journal:  Clin Microbiol Rev       Date:  2014-10       Impact factor: 26.132

3.  Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults.

Authors:  David J Horne; Mikashmi Kohli; Jerry S Zifodya; Ian Schiller; Nandini Dendukuri; Deanna Tollefson; Samuel G Schumacher; Eleanor A Ochodo; Madhukar Pai; Karen R Steingart
Journal:  Cochrane Database Syst Rev       Date:  2019-06-07

4.  Clinical Impact and Cost-effectiveness of Xpert MTB/RIF Testing in Hospitalized Patients With Presumptive Pulmonary Tuberculosis in the United States.

Authors:  James F Cowan; Aldine S Chandler; Elizabeth Kracen; David R Park; Carolyn K Wallis; Emelline Liu; Chao Song; David H Persing; Ferric C Fang
Journal:  Clin Infect Dis       Date:  2017-02-15       Impact factor: 9.079

5.  Impact of nucleic acid amplification test on pulmonary tuberculosis notifications and treatments in Taiwan: a 7-year single-center cohort study.

Authors:  Chih-Wei Wu; Yao-Kuang Wu; Chou-Chin Lan; Mei-Chen Yang; Ting-Qian Dong; I-Shiang Tzeng; Shu-Shien Hsiao
Journal:  BMC Infect Dis       Date:  2019-08-16       Impact factor: 3.090

6.  Difficulties with the implemented xpert MTB/RIF for determining diagnosis of pulmonary and extrapulmonary tuberculosis in adults and children.

Authors:  Ni Made Mertaniasih; Tutik Kusmiati; Eko Budi Koendhori; Deby Kusumaningrum; Titiek Sulistyowati; Zakiyathun Nuha; Hatif Chanifah
Journal:  J Clin Tuberc Other Mycobact Dis       Date:  2020-03-13

7.  Characteristics Indicative of Tuberculosis/HIV Coinfection in a High-Burden Setting: Lessons from 13,802 Incident Tuberculosis Cases in Harare, Zimbabwe.

Authors:  Richard J Martino; Joconiah Chirenda; Hilda A Mujuru; Wen Ye; Zhenhua Yang
Journal:  Am J Trop Med Hyg       Date:  2020-05-14       Impact factor: 2.345

8.  Xpert®MTB/RIF for the Diagnosis of Tuberculosis in a Remote Arctic Setting: Impact on Cost and Time to Treatment Initiation.

Authors:  Olivia Oxlade; Jordan Sugarman; Gonzalo G Alvarez; Madhukar Pai; Kevin Schwartzman
Journal:  PLoS One       Date:  2016-03-18       Impact factor: 3.240

Review 9.  Impact of Molecular Diagnostics for Tuberculosis on Patient-Important Outcomes: A Systematic Review of Study Methodologies.

Authors:  Samuel G Schumacher; Hojoon Sohn; Zhi Zhen Qin; Genevieve Gore; J Lucian Davis; Claudia M Denkinger; Madhukar Pai
Journal:  PLoS One       Date:  2016-03-08       Impact factor: 3.240

10.  Use of Nucleic Acid Amplification Tests in Tuberculosis Patients in California, 2010-2013.

Authors:  Gianna Peralta; Pennan Barry; Lisa Pascopella
Journal:  Open Forum Infect Dis       Date:  2016-12-05       Impact factor: 3.835

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