Evidence map›Paper›PMID 21298001›Full record

ArticlePloS one2011

Nucleic acid amplification tests for diagnosis of smear-negative TB in a high HIV-prevalence setting: a prospective cohort study.

J Lucian Davis, Laurence Huang, William Worodria, Henry Masur, Adithya Cattamanchi, Charles Huber, Cecily Miller, Patricia S Conville, Patrick Murray, Joseph A Kovacs

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in PloS one, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 34 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Mycobacteriosis and Tuberculosis: Laboratory Diagnosis.The open microbiology journal · 2018
    Review
  5. Biographical Feature: Patrick R. Murray, Ph.D.Journal of clinical microbiology · 2016
    Article
  6. Tuberculous Pleural Effusion.Turkish thoracic journal · 2015
    Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
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

10 authors at 5 institutions in 2 countries.

J Lucian DavisDivision of Pulmonary & Critical Care Medicine, Department of Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, United States of America. Lucian.Davis@ucsf.edu
Laurence Huang
William Worodria
Henry Masur
Adithya Cattamanchi
Charles Huber
Cecily Miller
Patricia S Conville
Patrick Murray
Joseph A Kovacs
National Institutes of Health Clinical Center · USUniversity of California, San Francisco · USMUJHU Research Collaboration · UGMulago Hospital · UGSan Francisco General Hospital · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 1988 to 2026
$93.6M
MUTIDISCIPLINARY TRAINING PROGRAM IN LUNG DISEASEST32HL007185 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI David J Erle, LAURENCE HUANG · 1985 to 2026
$24.6M
CTSA: K12 COMPONENTKL2RR024130 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$19.3M
International HIV-associated Opportunistic Pneumonias (IHOP) StudyR01HL090335 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HUANG, LAURENCE · 2007 to 2011
$4.0M
Patient-Oriented Research and Mentoring in PneumocystisK24HL087713 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI HUANG, LAURENCE · 2006 to 2018
$1.8M
Immunodiagnosis of Active Tuberculosis in HIV-infected PatientsK23HL094141 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CATTAMANCHI, ADITHYA · 2009 to 2013
$760k
Oral Wash for Nucleic Acid Diagnosis and Prognosis of TB in HIV-Infected UgandansK23AI080147 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DAVIS, JOHN LUCIAN · 2008 to 2012
$711k
Intramural NIH HHSNCRR NIH HHS KL2 RR024130NCRR NIH HHS KL2RR024130NHLBI NIH HHS K23 HL094141NHLBI NIH HHS K23HL094141NHLBI NIH HHS K24 HL087713NHLBI NIH HHS K24HL087713NHLBI NIH HHS R01 HL090335NHLBI NIH HHS R01HL090335NHLBI NIH HHS T32 HL007185NHLBI NIH HHS T32HL007185NIAID NIH HHS K23 AI080147NIAID NIH HHS K23AI080147NIAID NIH HHS P30 AI027763NIAID NIH HHS P30AI027763
6 · The paper itself

Abstract

backgroundNucleic acid amplification tests are sensitive for identifying Mycobacterium tuberculosis in populations with positive sputum smears for acid-fast bacilli, but less sensitive in sputum-smear-negative populations. Few studies have evaluated the clinical impact of these tests in low-income countries with high burdens of TB and HIV.

methodsWe prospectively enrolled 211 consecutive adults with cough ≥2 weeks and negative sputum smears at Mulago Hospital in Kampala, Uganda. We tested a single early-morning sputum specimen for Mycobacterium tuberculosis DNA using two nucleic acid amplification tests: a novel in-house polymerase chain reaction targeting the mycobacterial secA1 gene, and the commercial Amplified® Mycobacterium tuberculosis Direct (MTD) test (Gen-Probe Inc, San Diego, CA). We calculated the diagnostic accuracy of these index tests in reference to a primary microbiologic gold standard (positive mycobacterial culture of sputum or bronchoalveolar lavage fluid), and measured their likely clinical impact on additional tuberculosis cases detected among those not prescribed initial TB treatment.

resultsOf 211 patients enrolled, 170 (81%) were HIV-seropositive, with median CD4+ T-cell count 78 cells/µL (interquartile range 29-203). Among HIV-seropositive patients, 94 (55%) reported taking co-trimoxazole prophylaxis and 29 (17%) reported taking antiretroviral therapy. Seventy-five patients (36%) had culture-confirmed TB. Sensitivity of MTD was 39% (95% CI 28-51) and that of secA1 was 24% (95% CI 15-35). Both tests had specificities of 95% (95% CI 90-98). The MTD test correctly identified 18 (24%) TB patients not treated at discharge and led to a 72% relative increase in the smear-negative case detection rate.

conclusionsThe secA1 and MTD nucleic acid amplification tests had moderate sensitivity and high specificity for TB in a predominantly HIV-seropositive population with negative sputum smears. Although newer, more sensitive nucleic acid assays may enhance detection of Mycobacterium tuberculosis in sputum, even currently available tests can provide substantial clinical impact in smear-negative populations.

Indexed as

AdultCohort StudiesComorbidityHIV InfectionsHumansMycobacterium tuberculosisNucleic Acid Amplification TechniquesPolymerase Chain ReactionPrevalenceProspective StudiesSensitivity and SpecificityTuberculosis

Identifiers

PMID21298001
PMCPMC3029312
OpenAlexW2141111214

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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.