identified relevant reports published through August 2008 by searching PubMed for articles written in English that listed "tuberculosis" as the major MeSH topic and included "QuantiFERON" or "T-Spot" in the title or abstract. The agency identified additional published reports by contacting test manufacturers and examining references listed in retrieved articles. These methods identified 152 potentially rel evant articles. The CDC reviewed methods in each study to select 96 primary reports that provided data related to:
1) sensitivity or specificity of QFT-GIT or T-Spot,
2) agreement of QFT-GIT and T-Spot results with each other or with TST results,
3) association of QFT-GIT or T-Spot results with risk for M. tuberculosis infection or subsequent active tuberculosis and
4) evaluation of QFT-GIT or T-Spot use in contact investigations, immunocompromised persons or children.
The CDC used the published reports, data submitted to the FDA, product package inserts and expert opinion related to QFT-GIT and T-Spot to prepare its guidelines. It coordinated development of these guidelines with the American Academy of Pediatrics, the American Thoracic Society and the Infectious Disease Society of America.
