The sensitivity of the QuantiFERON®-TB Gold Plus assay in Zambian adults with active tuberculosis.

L Telisinghe; M Amofa-Sekyi; K Maluzi; D Kaluba-Milimo; M Cheeba-Lengwe; K Chiwele; B Kosloff; S Floyd ORCID logo; S-L Bailey; H Ayles ORCID logo; (2017) The sensitivity of the QuantiFERON®-TB Gold Plus assay in Zambian adults with active tuberculosis. The international journal of tuberculosis and lung disease, 21 (6). pp. 690-696. ISSN 1027-3719 DOI: 10.5588/ijtld.16.0764
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SETTING AND OBJECTIVE: To investigate the sensitivity of the new interferon-gamma release assay (IGRA), QuantiFERON®-TB Gold Plus (QFT-Plus), for active TB (used as a surrogate for latent tuberculous infection) in a Zambian TB clinic. DESIGN: Consecutive smear or Xpert® MTB/RIF-positive adult (age 18 years) pulmonary TB patients were recruited between June 2015 and March 2016. Venous blood was tested using QFT-Plus. The sensitivity was defined as the number positive divided by the total number tested. Using logistic regression, factors associated with positive QFT-Plus results were explored. RESULTS: Of 108 patients (median age 32 years, interquartile range 27-38; 73% male; 63% human immunodeficiency virus [HIV] positive), 90 were QFT-Plus-positive, 11 were negative and seven had indeterminate results; sensitivity was 83% (95%CI 75-90). There was no difference in sensitivity by HIV status (HIV-positive 85%, 95%CI 75-93; n = 68 vs. HIV-negative 80%, 95%CI 64-91; n = 40; P = 0.59). In models adjusted for age alone, CD4 cell count <100 cells/μl (OR 0.15, 95%CI 0.02-0.96; P = 0.05) and body mass index <18.5 kg/m2 (OR 0.27, 95%CI 0.08-0.91; P = 0.02) were associated with decreased odds of positive QFT-Plus results. CONCLUSION: Overall, the sensitivity of QFT-Plus is similar to that of the tuberculin skin test and other IGRAs. While overall sensitivity is not affected by HIV status, QFT-Plus sensitivity was lower among people living with HIV/acquired immune-deficiency syndrome with severe immunosuppression.


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