Diagnostic developers are invited to submit concept sheets to the CDRC to request evaluation of a technology at clinical study sites in TB-endemic countries.
Despite UN Secretary-General Ban Ki-moon’s statement in March 2010 that “in this day and age, no one should be dying from TB,” fatal cases of TB remain a reality.1
In 2009, an estimated 1.7 million people died of TB-380,000 of whom were co-infected with HIV.2
Roughly one-third of the world’s population is infected with TB, and 10 percent of infected people are likely to develop active TB at some point in their lives.2
Development of more-effective TB tests is critical. It depends not only on the identification of new technologies and improved engineering of diagnostic devices, but also on the integration of these technologies into existing clinical algorithms to simplify and expedite diagnosis or exclusion of TB in TB-endemic countries.
With these objectives in mind, in 2009 the National Institute of Allergy and Infectious Diseases (NIAID) established the Tuberculosis Clinical Diagnostics Research Consortium (CDRC; www.tbcdrc.org
) under a contract with Johns Hopkins University to promote the development of improved diagnostics. The goal of the CDRC is to determine, early in the development process, whether investigational diagnostics have the potential to impact the current clinical and laboratory diagnostic algorithm in TB-endemic countries.
Diagnostic developers are invited to submit concept sheets to the CDRC to request evaluation of a technology at clinical study sites in such countries. Data from these studies can be used to inform developers on the next steps for improving a technology and where the diagnostic can be most appropriately positioned (for instance, in a reference hospital or at the point of care) to improve speed and accuracy of TB diagnosis or the determination of drug resistance.
The CDRC evaluates experimental diagnostics not solely in comparison to stand-alone “gold standard” diagnostics tests; it also evaluates how these diagnostics perform within a clinical algorithm. This is particularly important since the gold standard currently used for TB diagnosis (the acid fast stain) is an antiquated test with limited specificity and sensitivity. Through evaluation of new diagnostic tests in combination with a clinical algorithm, it is expected that the CDRC will demonstrate that even diagnostic tests with limited sensitivity and specificity may nevertheless show great utility when evaluated in the context of a diagnostic process.
Technology holders with diagnostic platforms that have performed well for diagnosis of other pathogens are encouraged to consider developing these platforms for use in TB diagnosis in collaboration with the CDRC. In general, technologies that are well suited for CDRC studies are those that have the potential to impact TB diagnostic algorithms in endemic settings and also have existing proof-of-principle data but have not undergone extensive field testing.
The consortium conducts feasibility studies of new or experimental diagnostics at four established clinical-study sites in TB-endemic countries: Cape Town, South Africa; Kampala, Uganda; Vitoria, Brazil; and Masan, South Korea. The CDRC does not perform interventional studies, nor does it support the development of diagnostics. It does not provide funds to support research at sites unaffiliated with the consortium.
More information about the CDRC program and application information is available at www.tbcdrc.org
1. UN Secretary-General Ban Ki-moon’s message for World Tuberculosis Day, 24 March 2010.
2. The World Health Organization/Stop TB Partnership “Global Plan to Stop TB 2006-2015.”
Jerrold Ellner, MD is Principal Investigator of theTB CDRC, Professor of Medicine, and Chief of Infectious Diseases at Boston University School of Medicine and Boston Medical Center. He can be reached via David Hom, Director of the TB Clinical Diagnostics Research Consortium Coordinating Center, at David.Hom@bmc.org.
to post comments