Evidence map›Paper›PMID 20825313›Full record

Trial reportThe New England journal of medicine2010

Rapid molecular detection of tuberculosis and rifampin resistance.

Catharina C Boehme, Pamela Nabeta, Doris Hillemann, Mark P Nicol, Shubhada Shenai, Fiorella Krapp, Jenny Allen, Rasim Tahirli, Robert Blakemore, Roxana Rustomjee and 9 more

11 registry-linked trialsAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 11 registered trials, which are not on this map. Cited by 1,064 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,064citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01433796 completednot on this mapstarted 2011, after this paper: background citation

Tuberculosis in HIV-infected Patients Managed in Health Centres in Ethiopia - Identification of a Screening Algorithm for Active Tuberculosis and Determination of Outcome of Combined Antituberculosis and Antiretroviral Treatment

TypeobservationalSponsorLund UniversityRan2011 to 2015Enrolled812ConditionsHIV Infection, Tuberculosis
NCT02043067 completednot on this mapstarted 2011, after this paper: background citation

Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2011 to 2013Enrolled400ConditionsTuberculosisArmsComprehensive TB screening
NCT02043080 nacompletednot on this mapstarted 2012, after this paper: background citation

CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2012 to 2017Enrolled1,436ConditionsTuberculosis Diagnosis, HIVArmsXpert MTB/RIF Tuberculosis diagnostic tool
NCT02729532 completednot on this mapstarted 2016, after this paper: background citation

Z 31411 - The Effect of Xpert MTB/RIF on Patient Health Outcomes and Empirical TB Treatment Among Persons Living With HIV/AIDS: A Parallel-Group Prospective Cohort Study Under Real-World Conditions in Lusaka, Zambia

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2016 to 2018Enrolled776ConditionsTuberculosisArmsXpert
NCT02776150 unknown statusnot on this mapstarted 2016, after this paper: background citation

Multi Center Clinical Research and Evaluation of Melting Technology for Rapid Detection of Drug Resistant Tuberculosis

TypeobservationalSponsorBeijing HospitalRan2016 to 2019Enrolled3,100ConditionsTuberculosis, Pulmonary
NCT03173261 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Role of Genexpert in Extra Pulmonary Tuberculosis

TypeinterventionalSponsorAssiut UniversityRan2017 to 2018Enrolled2ConditionsExtra Pulmonary TuberculosisArmsGenexpert
NCT03303963 completednot on this mapstarted 2017, after this paper: background citation

Culture Free Diagnosis and Follow-up of Multidrug Resistant Tuberculosis Patients

TypeobservationalSponsorDissou AFFOLABIRan2017 to 2022Enrolled3,356ConditionsTuberculosis, Multidrug-ResistantArmsDeeplex test, MolBio TrueNat for 2nd line, GeneXpert 2nd line, Fluorescein DiAcetate (FDA) Microscopy,GeneXpert Ct value, pre-rRNA synthesis
NCT03356925 nacompletednot on this mapstarted 2018, after this paper: background citation

Feasibility, Accuracy, and Effect of Point-of-care Xpert MTB/RIF Ultra and Xpert MTB/RIF Ultra Testing in Patients Suspected of Having TB: a Randomised Controlled Trial

TypeinterventionalSponsorUniversity of StellenboschRan2018 to 2022Enrolled1,549ConditionsTuberculosisArmsXpert Ultra Point of Care testing
NCT04923958 narecruitingnot on this mapstarted 2021, after this paper: background citation

Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2031Enrolled26,436ConditionsTuberculosisArmsNovel mycobacterial culture techniques, Novel sputum smear microscopy techniques, Sputum-based molecular assays, Tongue swab-based molecular assays, Urine LAM assays
NCT04988984 unknown statusnot on this mapstarted 2020, after this paper: background citation

Development of Device Kit for Rapid and Sensitive Diagnostic Method for the Tuberculosis; Using Amine Groups Called HI(Homobifunctional Imidoesters),Negative Charge of the Pathogen and Formed Electrical Bonding to Isolate and Concentrate the Pathogen

TypeobservationalSponsorAsan Medical CenterRan2020 to 2023Enrolled400ConditionsTuberculosis Infection
NCT05941052 narecruitingnot on this mapstarted 2023, after this paper: background citation

Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2028Enrolled1,350ConditionsTuberculosisArmsTongue swab-based molecular assays
3 · Its place in the literature

Who cites it

1,064 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Diagnostic accuracy of Xpert MTB/RIF Ultra for detecting pulmonary tuberculosis and rifampicin resistance: a systematic review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
    Pooled it
  3. Trial
  4. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  5. Article
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  9. Review
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  11. Review
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  17. Article
  18. Predicting isoniazid resistance inJournal of clinical microbiology · 2026
    Article
  19. Article
  20. Article

1,004 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Catharina C BoehmeFoundation for Innovative New Diagnostics, Geneva, Switzerland. catharina.boehme@finddiagnostics.org
Pamela Nabeta
Doris Hillemann
Mark P Nicol
Shubhada Shenai
Fiorella Krapp
Jenny Allen
Rasim Tahirli
Robert Blakemore
Roxana Rustomjee
Ana Milovic
Martin Jones
Sean M O'Brien
David H Persing
Sabine Ruesch-Gerdes
Eduardo Gotuzzo
Camilla Rodrigues
David Alland
Mark D Perkins

Funding

Sample Processing Cartridges for Rapid PCR TB DetectionR42AI052523 · NIAID · CEPHEID · PI ALLAND, DAVID · 2006 to 2008
$4.0M
Rapid Diagnosis of XDR TuberculosisR01AI080653 · NIAID · UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL · PI ALLAND, DAVID · 2009 to 2013
$2.8M
Sample Processing Cartridges for Rapid PCR TB DetectionR41AI052523 · NIAID · CEPHEID · PI ALLAND, DAVID · 2002 to 2002
$376k
NIAID NIH HHS AI52523NIAID NIH HHS R01 AI080653NIAID NIH HHS R41 AI052523NIAID NIH HHS R42 AI052523
6 · The paper itself

Abstract

backgroundGlobal control of tuberculosis is hampered by slow, insensitive diagnostic methods, particularly for the detection of drug-resistant forms and in patients with human immunodeficiency virus infection. Early detection is essential to reduce the death rate and interrupt transmission, but the complexity and infrastructure needs of sensitive methods limit their accessibility and effect.

methodsWe assessed the performance of Xpert MTB/RIF, an automated molecular test for Mycobacterium tuberculosis (MTB) and resistance to rifampin (RIF), with fully integrated sample processing in 1730 patients with suspected drug-sensitive or multidrug-resistant pulmonary tuberculosis. Eligible patients in Peru, Azerbaijan, South Africa, and India provided three sputum specimens each. Two specimens were processed with N-acetyl-L-cysteine and sodium hydroxide before microscopy, solid and liquid culture, and the MTB/RIF test, and one specimen was used for direct testing with microscopy and the MTB/RIF test.

resultsAmong culture-positive patients, a single, direct MTB/RIF test identified 551 of 561 patients with smear-positive tuberculosis (98.2%) and 124 of 171 with smear-negative tuberculosis (72.5%). The test was specific in 604 of 609 patients without tuberculosis (99.2%). Among patients with smear-negative, culture-positive tuberculosis, the addition of a second MTB/RIF test increased sensitivity by 12.6 percentage points and a third by 5.1 percentage points, to a total of 90.2%. As compared with phenotypic drug-susceptibility testing, MTB/RIF testing correctly identified 200 of 205 patients (97.6%) with rifampin-resistant bacteria and 504 of 514 (98.1%) with rifampin-sensitive bacteria. Sequencing resolved all but two cases in favor of the MTB/RIF assay.

conclusionsThe MTB/RIF test provided sensitive detection of tuberculosis and rifampin resistance directly from untreated sputum in less than 2 hours with minimal hands-on time. (Funded by the Foundation for Innovative New Diagnostics.)

Indexed as

Drug Resistance, BacterialAdolescentAdultAgedAged, 80 and overAntitubercular AgentsBacterial ProteinsDNA-Directed RNA PolymerasesFemaleHumansMaleMicrobial Sensitivity TestsMiddle AgedMycobacterium tuberculosisPolymerase Chain ReactionProspective StudiesAntitubercular AgentsBacterial ProteinsDNA-Directed RNA PolymerasesRifampinrpoB protein, Mycobacterium tuberculosis

Identifiers

PMID20825313
PMCPMC2947799

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.