Quantiferon-TB Gold: performance for ruling out active tuberculosis in HIV-infected adults with high CD4 count in Côte d'Ivoire, West Africa

PLoS One. 2014 Oct 16;9(10):e107245. doi: 10.1371/journal.pone.0107245. eCollection 2014.

Abstract

Objective: To assess the performance of QuantiFERON-TB Gold In-Tube (QFT-GIT) test for active tuberculosis (TB) in HIV adults, and its variation over time in patients on antiretroviral therapy (ART) and/or isoniazide preventive therapy (IPT).

Methods: Transversal study and cohort nested in the Temprano ANRS 12136 randomized controlled trial assessing benefits of initiating ART earlier than currently recommended by World Health Organization, with or without a 6-month IPT. Performance of QFT-GIT for detecting active TB at baseline in the first 50% participants, and 12-month incidence of conversion/reversion in the first 25% participants were assessed. QFT-GIT threshold for positivity was 0.35 IU/ml.

Results: Among the 975 first participants (median baseline CD4 count 383/mm3, positive QFT-GIT test 35%), 2.7% had active TB at baseline. QFT-GIT sensitivity, specificity, positive and negative predictive value for active TB were 88.0%, 66.6%, 6.5% and 99.5%. For the 444 patients with a second test at 12 months, rates for conversion and reversion were 9.3% and 14%. Reversion was more frequent in patients without ART and younger patients. IPT and early ART were not associated with reversion/conversion.

Conclusion: A negative QFT-GIT could rule out active TB in HIV-infected adults not severely immunosuppressed, thus avoiding repeated TB testing and accelerating diagnosis and care for other diseases.

Trial registration: ClinicalTrials.gov NCT00495651.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / pharmacology
  • Anti-HIV Agents / therapeutic use
  • CD4 Lymphocyte Count*
  • Cote d'Ivoire
  • Enzyme-Linked Immunosorbent Assay*
  • Female
  • Follow-Up Studies
  • HIV Infections / complications*
  • HIV Infections / drug therapy
  • HIV Infections / immunology*
  • Humans
  • Interferon-gamma / analysis*
  • Isoniazid / pharmacology
  • Male
  • Tuberculosis / complications*
  • Tuberculosis / diagnosis*
  • Tuberculosis / prevention & control

Substances

  • Anti-HIV Agents
  • Interferon-gamma
  • Isoniazid

Associated data

  • ClinicalTrials.gov/NCT00495651

Grants and funding

Funding provided by Agence Nationale de Recherches sur le SIDA et les hépatites virales (ANRS, Paris, France) (Grant ANRS 12136 and ANRS 12224). Trial conducted with the support of Gilead Sciences and in part by Merck. The opinions expressed in this paper are those of authors and do not necessarily represent those of Merck. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.