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Cited by 162Tuberculosis Research and EpidemiologyMycobacterium research and diagnosisInfectious Diseases and Tuberculosis

Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis

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Greco, S, Girardi, E, Navarra, A, Saltini, C·2006·Thorax
DOI 10.1136/thx.2005.054908PMC PMC2117107
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Abstract

BACKGROUND: Even though commercial nucleic acid amplification tests (NAATs) have become the most frequently used molecular tests for laboratory diagnosis of pulmonary tuberculosis (TB), published studies report variable estimates of their diagnostic accuracy. We analysed the accuracy of commercial NAATs for the diagnosis of pulmonary TB in smear positive and smear negative respiratory samples using culture as a reference standard. METHODS: English language studies reporting data sufficient for calculating sensitivity and specificity of commercial NAATs on smear positive and/or smear negative respiratory samples were included. Meta-regression was used to analyse associations with reference test quality, the prevalence of TB, sample and test type. Predictive values for different levels of pre-test probability were quantified using Bayes' approach. RESULTS: Sixty three journal articles published between 1995 and 2004 met the inclusion criteria. Pooled sensitivity and specificity were 0.96 and 0.85 among smear positive samples and 0.66 and 0.98 among smear negative samples. The number of culture media used as reference test, the inclusion of bronchial samples, and the TB prevalence were found to influence the reported accuracy. The test type had no effect on the diagnostic odds ratio but seemed to be correlated with sensitivity or specificity, probably via a threshold effect. CONCLUSIONS: Commercial NAATs can be confidently used to exclude TB in patients with smear positive samples in which environmental mycobacteria infection is suspected and to confirm TB in a proportion of smear negative cases. The methodological characteristics of primary studies have a considerable effect on the reported diagnostic accuracy.

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  • FNA is increasingly being used worldwide as a first diagnostic step because of its ease and safety profile, although sensitivity is very variable depending on the study, with positive mycobacterial culture ranging from 10% to 80%.

    “FNA is increasingly being used worldwide as a first diagnostic step because of its ease and safety profile, although sensitivity is very variable depending on the study, with positive mycobacterial culture ranging from 10% to 80%.3,4,13–16”

    From Epidemiology and Diagnosis of Tuberculous Lymphadenitis in a Tuberculosis Low-Burden Country (2015) · cites this paper as [14]

    The Discussion reports variable culture yield in bronchial samples (12%–87%) and variable accuracy of commercial nucleic acid amplification tests, not fine-needle aspiration (FNA). Searches for FNA, its use as a first diagnostic step, and the claimed 10%–80% culture-positive range found no passage addressing those points in our copy. (LLM, conf=0.78)

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  1. Greco, Girardi, Navarra, et al www.thoraxjnl.com on July 29, 2023 by guest. Protected by copyright. http://thorax.bmj.com/ Thorax: first published as 10.1136/thx.2005.054908 on 31 May 2006. Downloaded from REFERENCES

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Authors
Greco, S., Girardi, E., Navarra, A., & Saltini, C.
Affiliations
  • Azienda Ospedaliera San Camillo-Forlanini (IT)
  • Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani (IT)
  • University of Rome Tor Vergata (IT)
Corresponding author
Greco, S
ORCID
Venue
Thorax
Publisher
BMJ
Published
2006-09-01
Volume
61
Issue
9
Pages
783-790
ISSN
0040-6376 (ISSN-L)
DOI
10.1136/thx.2005.054908
PMC
PMC2117107
OpenAlex
W2122348642
Cited by
162
References
97
Citations by year
2025: 5 · 2024: 2 · 2023: 2 · 2022: 5 · 2021: 5 · 2019: 7 · 2018: 5 · 2017: 7 · 2016: 9 · 2015: 13 · 2014: 12 · 2013: 15 · 2012: 12
FWCI
5.34
Type
journal article
Language
en
Open access
Locations
  • Thorax (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
  • Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
  • Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
Keywords
pulmonary tuberculosis, nucleic acid amplification tests, diagnostic accuracy, sensitivity and specificity, tuberculosis prevalence
MeSH terms
Humans, Predictive Value of Tests, Sensitivity and Specificity, Tuberculosis, Pulmonary, Nucleic Acid Amplification Techniques

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