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Randomized Controlled Trial
. 2014 Oct 16;9(10):e107245.
doi: 10.1371/journal.pone.0107245. eCollection 2014.

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

Christine Danel  1 , Mathieu Kabran  2 , André Inwoley  3 , Anani Badje  1 , Jean Louis Herrmann  4 , Raoul Moh  5 , Jérôme Lecarrou  1 , Delphine Gabillard  1 , Jean Baptiste Ntakpe  1 , Nina Deschamps  6 , Eric Ouattara  1 , Christian Perronne  7 , Serge Eholie  5 , Xavier Anglaret  1
Affiliations
Randomized Controlled Trial

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

Christine Danel et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: The authors received support from Gilead Sciences and Merck in the form of ART to conduct the study. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Flow chart.
POS: Positive QuantiFERON TB Gold in-tube test; NEG: Positive QuantiFERON TB Gold in-tube test; INDET: Indeterminate QuantiFERON TB Gold in-tube test.
Figure 2
Figure 2. QuantiFERON TB Gold in-tube test results at Day-0, by CD4 count category.
a positive: Nil ≤8.0 IU/ml, TB Antigen minus Nil ≥0.35 IU/ml and ≥25% of Nil value; b negative: Nil ≤8.0 IU/ml, TB Antigen minus Nil <0.35 IU/ml and Mitogen minus Nil ≥0.45; or Nil ≤8.0 IU/ml, TB Antigen minus Nil ≥0.35 IU/ml and <25% of Nil value, and Mitogen minus Nil ≥0.45; c indeterminate: Nil tube >8.0 IU/ml, or Nil tube ≤8.0 IU/ml and TB Antigen minus Nil <0.35 IU/ml and Mitogen minus Nil <0.45; or Nil tube ≥8.0 IU/ml and TB Antigen minus Nil ≥0.35 IU/ml and <25% of Nil value, and Mitogen minus Nil <0.45.
Figure 3
Figure 3. Distribution of QuantiFERON TB Gold in-tube test results at Day-0, by CD4 count category in patients with positive tests and with or without active tuberculosis.
Box plots show median value, interquartile range, and range. p: Kruskal-Wallis test.
See this image and copyright information in PMC

References

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