Specificity of QuantiFERON-TB plus, a new-generation interferon gamma release assay

S. A.R. Siegel, M. Cavanaugh, J. H. Ku, L. M. Kawamura, Kevin Winthrop

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Interferon gamma release assays (IGRAs) are important tools in identifying prior tuberculosis exposure. The new-generation QuantiFERON-TB Gold Plus (QFT-Plus) assay, recently approved for use in the United States, differs from the current-generation QFT Gold-In-Tube (QFT-GIT) assay with the addition of a second antigen tube that also contains novel CD8 T-cell-stimulating peptides. The QFT-Plus assay has increased sensitivity in immunocompromised populations, and we sought to assess the specificity of QFT-Plus compared to that of QFT-GIT in low-risk individuals. We enrolled adults without tuberculosis risk factors, including a subgroup with pulmonary nontuberculous mycobacterial (NTM) disease due to Mycobacterium avium complex (MAC) or Mycobacterium abscessus. The primary outcome measures included specificity, interassay concordance, and agreement between the QFT-Plus and QFT-GIT assays. Of 262 participants enrolled, 51 had pulmonary NTM. The median age was 39 years (age range, 18 to 78 years); 73% were female. Among the 262 individuals who were enrolled, 5 (1.9%) individuals had positive QFT-Plus results, and 3 of these individuals also had positive QFT-GIT results. The two individuals with discordant results (QFT-Plus positive/QFT-GIT negative) had only one tube positive in the QFT-Plus assay. The overall specificity of QFT-Plus and QFT-GIT was 98.1% (95% confidence interval [CI], 95.6, 99.4%) and 98.9% (95% CI, 96.7, 99.8%), respectively. The QFT-Plus specificity was similar in both the NTM (98.0% [95% CI, 89.4, 99.9%]) and non-NTM (98.1% [95% CI, 95.2, 99.5%]) groups. QFT-Plus has a high specificity, similar to that of the QFT-GIT assay, including in patients with pulmonary MAC or M. abscessus disease.

Original languageEnglish (US)
Article numbere00629-18
JournalJournal of Clinical Microbiology
Volume56
Issue number12
DOIs
StatePublished - Dec 1 2018

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Interferon-gamma Release Tests
Gold
Confidence Intervals
Mycobacterium avium Complex
Lung
Tuberculosis

Keywords

  • Diagnostic
  • Latent tuberculosis infection
  • Nontuberculous mycobacterial infection

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Specificity of QuantiFERON-TB plus, a new-generation interferon gamma release assay. / Siegel, S. A.R.; Cavanaugh, M.; Ku, J. H.; Kawamura, L. M.; Winthrop, Kevin.

In: Journal of Clinical Microbiology, Vol. 56, No. 12, e00629-18, 01.12.2018.

Research output: Contribution to journalArticle

Siegel, S. A.R. ; Cavanaugh, M. ; Ku, J. H. ; Kawamura, L. M. ; Winthrop, Kevin. / Specificity of QuantiFERON-TB plus, a new-generation interferon gamma release assay. In: Journal of Clinical Microbiology. 2018 ; Vol. 56, No. 12.
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