Low Sensitivity of a Whole-Blood Interferon-γ Release Assay for Detection of Active Tuberculosis

International Research and Programs Branch, Division of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Clinical Infectious Diseases (Impact Factor: 8.89). 02/2007; 44(1):69-73. DOI: 10.1086/509928
Source: PubMed

ABSTRACT The sensitivity of an interferon-gamma assay (Quantiferon-TB Gold; Cellestis) was evaluated for the detection of tuberculosis among 242 persons with suspected tuberculosis in San Francisco, California. Thirty-seven subjects had culture-confirmed tuberculosis. Excluding 1 indeterminate result, 23 (64%; 95% confidence interval, 48%-78%) of 36 subjects had positive results using the QuantiFERON-TB Gold assay. The 64% sensitivity suggests that the QuantiFERON-TB Gold assay should not be used alone to exclude active tuberculosis.

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    • "Our IGRA results showed modest sensitivity of 81.9% and specificity of 62.3% when compared with previous studies in sputum smear negative PTB suspects.10,11,16,20,21 Similar findings were observed in the analysis of all PTB suspects (Supplementary Table 3, only online). "
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    ABSTRACT: We investigated the value of an interferon-γ release assay (IGRA) for the diagnosis of active pulmonary tuberculosis (PTB) among sputum smear negative PTB suspects in an environment with intermediate burden of PTB and high Bacillus Calmette-Guerin (BCG) vaccination rate. We retrospectively reviewed IGRA, medical records, chest PA and CT scan of PTB suspects seen at Gangnam Severance Hospital, Seoul, Korea from Oct. 2007 to Apr. 2013. "Active PTB" was diagnosed when 1) M. tuberculosis culture positive, 2) confirmation by pathologic examination; or 3) clinical findings compatible with TB. Of 224 sputum smear negative PTB suspects, 94 were confirmed as having active PTB. There were no statistically significant differences in the diagnostic yield of IGRA between immunocompromised and immunocompetent sputum smear negative PTB suspects. IGRA did show superior sensitivity [81.9%, 95% confidence interval (CI); 74.13-89.70%] in the diagnosis of sputum smear negative PTB when compared with chest high-resolution computed tomography (HRCT), tuberculin skin test (TST), and chest X-ray (p<0.001). Also, IGRA showed highest negative predictive value (82.7%, 95% CI; 75.16-90.15%) when compared with HRCT, TST and chest X-ray (p=0.023). However, combining the results of IGRA with those of HRCT, TST, or both did not increase any diagnostic parameters. Failure to increase diagnostic yields by combination with other diagnostic modalities suggests that additional enforcement with IGRA may be insufficient to exclude other diagnoses in sputum smear negative PTB suspects and to screen active PTB in an environment with intermediate TB prevalence and a high BCG vaccination rate.
    Yonsei medical journal 05/2014; 55(3):725-31. DOI:10.3349/ymj.2014.55.3.725 · 1.29 Impact Factor
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    • "Several studies using the previous generation of the QFT assay reported that age and extrapulmonary TB may also cause false-negative QFT results [25, 32]. "
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    ABSTRACT: The risk of active tuberculosis is increased in psoriasis patients receiving biologic drug therapy. The QuantiFERON-TB Gold In-Tube assay (QFT) is used for latent tuberculosis screening in these patients. This study presents a retrospective analysis on repeated QFT assays, investigating the influence of biologic drugs and isoniazid therapy on the outcome of the assay. Serial QFTs of 58 psoriasis patients, who received biologic drug therapy, were evaluated at baseline and after 12 months of treatment. Patients were retrospectively divided in four groups according to QFT results at baseline and at follow-up: patients having a QFT reversion (from positive to negative results); patients with a conversion (from negative to positive); patients confirming the baseline results, either positive or negative. At the end of the 12-months period, 11.1% of patients with a negative QFT result at baseline presented a conversion, showing low interferon (IFN)-gamma values, whereas 6.9% of positive patients presented a QFT reversion. When the test was repeated after 2-3 months without isoniazid chemoprophylaxis, patients with QFT conversion showed negative results. No patient developed active tuberculosis. In patients undergoing biologic therapy, a positive QFT assay needs to be further confirmed, as false-positive results may occur after long-term therapy. Repeating QFT tests in patients with low IFN-gamma values could reduce the incidence of false-positive latent tuberculosis infection diagnosis, thus preventing unnecessary tuberculosis chemoprophylaxis. In conclusion, a dynamic QFT response is possible in psoriasis patients undergoing biologic therapy.
    06/2013; 3(1):73-81. DOI:10.1007/s13555-013-0020-3
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    • "This may be the reason for the low QTF positivity in this group. However, QTF positivity rates of as low as 64% have previously been reported among patients with active tuberculosis [34]. "
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    ABSTRACT: The usefulness of interferon-gamma (IFN-γ) release assays for tuberculosis screening before tumor necrosis factor-alpha (TNF-α) antagonists and for monitoring during treatment is a contraversial issue. The aims of this study were to determine whether TNF-α antagonists affect the results of the Quantiferon-TB Gold in-tube assay (QTF); to assess how QTF performs in comparison with the tuberculin skin test (TST) in rheumatoid arthritis (RA) patients who are about to start treatment with TNF-α antagonists, RA patients who are not candidates for treatment with TNF-α antagonists, rheumatology patients with confirmed current or past tuberculosis infection, and healthy controls, and to determine the specificity of the QTF test to differentiate leprosy patients, another group of patients infected with mycobacteria. The 38 RA patients who were prescribed TNF-α antagonists, 40 RA patients who were not considered for TNF-α antagonist use, 30 rheumatology patients with a history or new diagnosis of tuberculosis, 23 leprosy patients, and 41 healthy controls were studied. QTF and TST were done on the same day, and both were repeated after a mean of 3.6 ± 0.2 months in patients who used TNF-α antagonists. Treatment with TNF-α antagonists did not cause a significant change in the QTF or TST positivity rate (34% versus 42%; P = 0.64; and 24% versus 37%; P = 0.22). Patients with leprosy had a trend for a higher mean IFN-γ level (7.3 ± 8.0) and QTF positivity (61%) than did the other groups; however, the difference was not significant (P = 0.09 and P = 0.43). Treatment with TNF-α antagonists does not seem to affect the QTF test to an appreciable degree. The higher IFN-γ levels in leprosy patients deserves further attention.
    Arthritis research & therapy 06/2012; 14(3):R147. DOI:10.1186/ar3882 · 3.75 Impact Factor
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