Performance of whole blood IFN-γ test for tuberculosis diagnosis based on PPD or the specific antigens ESAT-6 and CFP-10
Source: The International Journal of Tuberculosis and Lung Disease, Volume 5, Number 5, May 2001 , pp. 462-467(6)
Abstract:OBJECTIVE: To evaluate the QuantiFERON-TB® test in BCG-vaccinated, non-BCG-vaccinated and tuberculosis (TB) patient donor groups, and to compare its diagnostic performance with that of a blood test based on the Mycobacterium tuberculosis specific antigens ESAT-6 and CFP-10.
DESIGN: Analysis of the IFN-γ responses of whole blood cells from BCG-vaccinated or non-BCG-vaccinated donors or patients with tuberculosis, stimulated with PPD, ESAT-6 or CFP-10 antigens, and evaluation of the specificity and sensitivity of the test.
RESULTS: None of the non-vaccinated donors showed positive responses to M. tuberculosis-PPD, ESAT-6 or CFP-10. In BCG-vaccinated donors, 9/19 (47%) donors responded to the QuantiFERON-TB® test based on M. tuberculosis-PPD, whereas 2/19 (10.5%) responded to either ESAT-6 or CFP-10. Comparable levels of sensitivity were obtained with the QuantiFERON-TB® test based on M. tuberculosis-PPD (79%) and ESAT-6 or CFP-10 antigens (72%).
CONCLUSION: Our results demonstrate that the whole blood test based on M. tuberculosis-PPD did not efficiently distinguish BCG-vaccinated donors from individuals with disease due to M. tuberculosis. The introduction of new recombinant antigens specific for M. tuberculosis, such as ESAT-6 or CFP-10, should increase the specificity of the whole blood test and enable discrimination between TB infection, atypical mycobacterial reactivity and reactivity due to BCG vaccination. Such a test would provide a quantum improvement over the current practice of using the tuberculin skin test for TB control and elimination.
Document Type: Regular Paper
Publication date: May 1, 2001
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