Evidence map›Paper›PMID 20504986›Full record

ArticleJournal of clinical microbiology2010

Evaluation of the analytical performance of the Xpert MTB/RIF assay.

Robert Blakemore, Elizabeth Story, Danica Helb, JoAnn Kop, Padmapriya Banada, Michelle R Owens, Soumitesh Chakravorty, Martin Jones, David Alland

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical microbiology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 234 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
234citing papers in PubMed, 13 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.

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
NCT06618573 phase2 / phase3recruitingnot on this mapstarted 2022, after this paper: background citation

Study on the Safety of Administering Isoniazid to Systemic Lupus Erythematosus Patients to Prevent Tuberculosis

TypeinterventionalSponsorUniversitas PadjadjaranRan2022 to 2025Enrolled60ConditionsTuberculosis, Systemic Lupus ErythematosusArmsIsoniazid/Pyridoxine, Saccharum Lactis
3 · Its place in the literature

Who cites it

234 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  10. XpertThe Cochrane database of systematic reviews · 2018
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174 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Robert BlakemoreDivision of Infectious Disease, University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark, NJ 07103, USA.
Elizabeth Story
Danica Helb
JoAnn Kop
Padmapriya Banada
Michelle R Owens
Soumitesh Chakravorty
Martin Jones
David Alland

Funding

Sample Processing Cartridges for Rapid PCR TB DetectionR42AI052523 · NIAID · CEPHEID · PI ALLAND, DAVID · 2006 to 2008
$4.0M
Sample Processing Cartridges for Rapid PCR TB DetectionR41AI052523 · NIAID · CEPHEID · PI ALLAND, DAVID · 2002 to 2002
$376k
NIAID NIH HHS R41 AI052523NIAID NIH HHS R41-AI52523NIAID NIH HHS R42 AI052523NIAID NIH HHS R42-AI52523
6 · The paper itself

Abstract

We performed the first studies of analytic sensitivity, analytic specificity, and dynamic range for the new Xpert MTB/RIF assay, a nucleic acid amplification-based diagnostic system that detects Mycobacterium tuberculosis and rifampin (RIF) resistance in under 2 h. The sensitivity of the assay was tested with 79 phylogenetically and geographically diverse M. tuberculosis isolates, including 42 drug-susceptible isolates and 37 RIF-resistant isolates containing 13 different rpoB mutations or mutation combinations. The specificity of the assay was tested with 89 nontuberculosis bacteria, fungi, and viruses. The Xpert MTB/RIF assay correctly identified all 79 M. tuberculosis isolates and correctly excluded all 89 nontuberculosis isolates. RIF resistance was correctly identified in all 37 resistant isolates and in none of the 42 susceptible isolates. Dynamic range was assessed by adding 10(2) to 10(7) CFU of M. tuberculosis into M. tuberculosis-negative sputum samples. The assay showed a log-linear relationship between cycle threshold and input CFU over the entire concentration range. Resistance detection in the presence of different mixtures of RIF-resistant and RIF-susceptible DNA was assessed. Resistance detection was dependent on the particular mutation and required between 65% and 100% mutant DNA to be present in the sample for 95% certainty of resistance detection. Finally, we studied whether assay specificity could be affected by cross-contaminating amplicons generated by the GenoType MTBDRplus assay. M. tuberculosis was not detected until at least 10(8) copies of an MTBDRplus amplicon were spiked into 1 ml of sputum, suggesting that false-positive results would be unlikely to occur.

Indexed as

Mycobacterium tuberculosisAntibiotics, AntitubercularBacterial ProteinsDNA, BacterialDNA-Directed RNA PolymerasesLinear ModelsMicrobial Sensitivity TestsMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesReproducibility of ResultsRifampinSensitivity and SpecificitySputumAntibiotics, AntitubercularBacterial ProteinsDNA, BacterialDNA-Directed RNA PolymerasesRifampinrpoB protein, Mycobacterium tuberculosis

Identifiers

PMID20504986
PMCPMC2897495

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.