TB Notes Newsletter
No. 1, 2012
More than 70 Tuberculosis Epidemiologic Studies Consortium-II (TBESC-II) principal investigators, project coordinators, and support personnel joined DTBE staff from SEOIB and several other branches at the 3rd TBESC-II Semiannual meeting February 6-7, 2013. The purpose of the meeting, which was held at the Crowne Plaza Ravinia Hotel in Atlanta, GA, was to share the outcomes of the recent TBESC-II pilot, as well as discuss the study’s overall direction and potential future sub-studies. This semiannual meeting also marked the first for the newly formed TBESC-II Board of Advisors, which is comprised of external experts in the areas of TB diagnostics, research and programming. Attendees were welcomed by Phil LoBue, MD, Associate Director for Science, DTBE.
On the first day of the meeting Sekai Chideya, MD, presented the findings from the TBESC-II pilot conducted from July through September 2012. The pilot, which was conducted using actual study forms and a newly developed, state-of-the-art electronic Data Management System (DMS), enrolled 447 participants aged 1-75 years from all 10 study sites. The most frequent eligibility criterion among participants was being foreign born (82%), but many (44%) participants met multiple eligibility criteria. Overall, 86% of participants were foreign born, predominantly from Asia and the Pacific Islands; 11% of all participants were HIV infected.
Nearly half (47%) of participants tested positive on one or more of the three diagnostic tests being studied (QFT-GIT, TSPOT.TB, and TST). Two thirds (67%) of participants who received all tests had full agreement between the three (i.e., either all three tests were negative or all three were positive).The TST was positive and both IGRAs negative for 73 (18%) of participants receiving the three tests. QFT and TSPOT were discordant 11% of the time, and most often with the QFT positive and the TSPOT negative. The three participant characteristics with the highest risk of being positive on one or more test were being foreign born, a member of a group with a local LTBI prevalence ≥25%, and BCG vaccinated. The pilot provided valuable experience and insight that were used to revise the protocol, forms, and DMS. CDC IRB approved the revised materials in September 2012; sites began the active study in October 2012.
Following discussion of the pilot, Joan Mangan, PhD (CEBSB) led a brainstorming session on possible sub-studies regarding enhancing adherence and completion of LTBI treatment. Niaz Banaei, MD, Medical Director of Stanford University’s Clinical Microbiology Laboratory, gave a comprehensive presentation on IGRA reproducibility that generated a lot of discussion. Madhu Pai, MD, and Sandra Kik, PhD of McGill University, presented on IGRA predictive value and TB point of care testing.
Highlights of the second day of the meeting included a presentation by Dr. David Holland, MD, of Duke University on cost-effectiveness related to TB prevention. Among talking points he encouraged TB programs to identify exactly what they want to achieve with funding, so as to best determine cost effectiveness. Suzanne Marks, MPH (CRB) also contributed to the discussion.
Northrup Gruman contractor Kumar Batra provided an overview of the DMS’s revised and new features for the active study. The second half of the day included an update by Sekai Chideya on the TBESC-II biobanking initiative; a summary by Justin May of University of Florida on the TBESC Laboratory Working Group’s recommendations to standardize and improve the quality of QFT testing; and a presentation by Dolly Katz, PhD, on CDC’s proposed data sharing agreement.
The 4th Semiannual TBESC-II meeting will be held in Atlanta in August 2013.
—Reported by Sekai Chideya, MD, MPH
Div of TB Elimination