TBoss: TB Operation Support SolutionQuantiFERON®-TB GoldYour support in TB contact investigations

2 Changing the way the world looks at TB

Tuberculosis control investigations: U.S. trendsIn 2015, a total of 9,563 active tuberculosis (TB) cases were reported in the United States (US), bringing the case rate to 3.0 cases per 100,000 population (1). After years of decline, the 2015 CDC TB surveillance report announced an increase of 150 active TB cases – the first increase in almost 25 years. These US changes are also reflected in global trends. The rate of decline in TB cases is not nearly enough to meet the World Health Organization (WHO) and Stop TB Partnership’s goal of halving active TB cases globally by 2025 (2). Ongoing surveillance and improved TB control and prevention activities are needed to catch up and eventually eliminate TB. In the US, this means considerable focus and resources for TB contact and outbreak investigations.

“The best way to reduce active TB cases is to identify latent TB infection in those who

are exposed“ (3)

Key statistics on US contact investigations

• Close contacts of those with infectious pulmonary TB have high prevalences of TB disease and infection, with >2% of contacts in one study having developed active TB (4).

• Of the approximate 12,000 infectious active TB cases in the US, 85% require an investigation. Each case typically involves 10 contacts (5).

• An estimated 90 TB contact investigations occur each month in the US (based on above figures).

Theoretical graph of how treating latent and active TB together can overcome global TB burden. Model supported by data from Dye & Williams, 2008 (3).

Importance of treating TB infection

Changing the way the world looks at TB 3

Typical TB contact investigation logisticsWith numerous logistical complexities and time-sensitive issues, evaluating and diagnosing TB contacts can be challenging (4, 6). The choice of TB test is critical for the effective management of contact investigations.

TBoss: TB Operation Support SolutionQIAGEN is proud to offer TBoss – TB Operation Support Solution for customers in the US. TBoss is a comprehensive support service to help the Public Health sector manage contact investigations using QuantiFERON-TB Gold (QFT®).

Pre-work and initiation ofcontact investigations

Investigating index caseand transmission sites

Prioritizing follow-upwith contacts

Evaluation and diagnosisof contacts

Treating contacts withlatent TB infection

Expansion of investigation

Communications and media

Data management andprogram evaluation

Confidentiality and consent

Conducting investigations inspecial circumstances

Key tasks for evaluation and diagnosis of TB contacts

• Organizing and mobilizing staff

• Locating, communicating with, and educating contacts

• Organizing and performing testing for contacts

• Ensuring availability of testing materials and supplies

• Processing and analysing results

• Ensuring thoroughness and accuracy of information

• Collating all information to determine contacts’ true risk of TB

The dedicated TBoss program coordinator will:

• Work with Public Health officials to determine which resources are required

• Organize QFT blood collection and handling, if required

• Facilitate an experienced QFT laboratory for results generation

Conducted summary of NTAC/CDC recommendation (4)

4 Changing the way the world looks at TB

QFT is approved by the US FDA as an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection. It uses a peptidecocktail simulating ESAT-6, CFP-10 and TB7.7(p4) proteins to stimulate cells in heparinized whole blood. Detection of IFN-γ byELISA is used to identify in vitro responses to these peptide antigens that are associated with M. tuberculosis infection. FDA approvalnotes that QFT is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with riskassessment, radiography and other medical and diagnostic evaluations. QFT results alone cannot distinguish active TB from infection.QFT Package Inserts, available in multiple languages, as well as up-to-date licensing information and product-specific disclaimerscan be found at www.QuantiFERON.com.

References: 1. Salinas, J.L., et al. (2016) Leveling of tuberculosis incidence – United States, 2013–2015. MMWR 65, 273–278. 2. WHO End TB Strategy – Global strategy and targets for tuberculosis prevention, care and control after 2015. A67/11 – 14 March 2014. 3. Dye, C. and Williams, B.G. (2008) Eliminating human tuberculosis in the twenty-first century. J. R. Soc. Interface.5, 653–662. 4. Marks, S.M., et al. (2000) Outcomes of contact investigations of infectious tuberculosis patients. Am. J. Respir. Crit. Care Med. 162, 2033-2038. 5. Centers for Disease Control and Prevention. (2005) Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR 54(RR-15). 6. Erkens, C.G., et al. (2010) Tuberculosis contact investigations in low prevalence countries: a European consensus. Eur. Respir. J. 36, 925–949. 7. Diel, R., Loddenkemper, R., Niemann, S., Meywald-Walter, K., and Nienhause, A. (2011) Negative and positive predictive value of a whole-blood interferon-γ release assay for developing active tuberculosis: an update. Am. J. Respir. Crit. Care. Med. 183, 88–95. 8. Diel, R., Chealberg, T., Loddenkemper, R., Welte, T., Nienhause, A. (2009) Enhanced cost-benefit analysis of strategies for LTBI screening and INH chemoprevention in Germany. Respir. Med. 103, 1838–1853.

Trademarks: QIAGEN®, Sample to Insight®, QuantiFERON®, QFT® (QIAGEN Group)PROM-9857-001 2901057 09/16 SAP © 2016 QIAGEN, all rights reserved.

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TBoss: TB Operation Support SolutionYour support in TB contact investigations

TBoss utilizes QuantiFERON-TB Gold to:

• Provide quick definitive testing

• Identify those truly infected for follow-up medical treatment (7)

• Reduce overall contact investigation costs (8)

TBoss@qiagen.com www.quantiferon.com 1-855-QFT-TBoss