@article {Shanaube:2010:1027-3719:828, title = "Intra-assay reliability and robustness of QuantiFERON extregistered-TB Gold In-Tube test in Zambia", journal = "The International Journal of Tuberculosis and Lung Disease", parent_itemid = "infobike://iuatld/ijtld", publishercode ="iuatld", year = "2010", volume = "14", number = "7", publication date ="2010-07-01T00:00:00", pages = "828-833", itemtype = "ARTICLE", issn = "1027-3719", eissn = "1815-7920", url = "https://www.ingentaconnect.com/content/iuatld/ijtld/2010/00000014/00000007/art00007", keyword = "QuantiFERON-TB Gold In-Tube, tuberculosis, Zambia, reliability, HIV", author = "Shanaube, K. and De Haas, P. and Schaap, A. and Moyo, M. and Kosloff, B. and Devendra, A. and Raby, E. and Godfrey-Faussett, P. and Ayles, H.", abstract = "BACKGROUND: Interferon-gamma (IFN-) release assays (IGRAs), such as the QuantiFERON extregistered-TB Gold In-Tube test (QFT-GIT), are becoming a preferred method for diagnosis of tuberculosis (TB) infection in many industrialised countries. However, data on the effectiveness of IGRAs in high TB-HIV (human immunodeficiency virus) endemic and resource-limited settings, such as Zambia, are limited.OBJECTIVE: To determine the intra-assay reliability and robustness of QFT-GIT in a field setting in Zambia.DESIGN: During JulyOctober 2007, 109 adult smear-positive TB patients were recruited to determine QFT-GIT reliability and the effect of a 24-h delay in incubation. Two simulated laboratory experiments were also performed using 914 volunteers, to explore the effect of power outages during incubation and storage temperature of collection tubes on IFN- responses.RESULTS: QFT-GIT intra-assay concordance was 91.7% ( = 0.8). Discordance was observed for nine patients, of whom six were HIV-positive. There was evidence of an association between HIV status and discordant results (OR 1.98, 95%CI 1.063.67, P = 0.03). A 24-h delay in incubation changed results for 25 of the 109 (22.9%) patients. Power outages that altered incubation time reduced IFN- responses.CONCLUSION: Although QFT-GIT seems reliable in this setting, we have identified operational factors that affect its robustness. These factors may influence the effectiveness of this test in similar resource-limited settings.", }