Current approaches to scale-up of TB diagnostics do not sufficiently focus on the primary goal of diagnosis, which is to treat and cure people with TB and relieve the economic and physical burden of suffering that TB imposes. National TB Programs in high-burden countries, in-country program staff, technical assistance agencies, academic institutions, supranational and non-governmental organizations, came together to discuss this issue at the World Lung Conference in Paris, France in November 2013. That meeting resulted in the following statement, which highlights the importance of TB diagnosis as a continuum of care, and outlines the 5 key elements of a patient-centered agenda for TB diagnostic testing: focus on cure, access to care, systems of care, empowered patients and sustainability.

Call for a Patient-Centered Agenda for TB Diagnosis

The field of TB diagnostics has witnessed unprecedented technological advances over the past decade, but three million patients with TB remain undiagnosed every year. Many more seek care for similar symptoms but suffer from other conditions. To “reach the three million,” we must not only implement new tools, but also strengthen the broader continuum of care, placing priority on relieving the physical and economic burdens borne by patients and ensuring that patients are rapidly diagnosed and cured.

We call on global policymakers and funders to prioritize an agenda for implementing TB diagnostics that centers upon the patient with TB symptoms and highlights patient well-being and cure. This agenda should reduce barriers to accessing care and strengthen the diverse health systems in which patients are evaluated and treated. Timely and accurate diagnosis should be part of a continuum of carethat also offers pre- and post-test counseling; health education; access to quality-assured drugs; relief of symptoms; support in overcoming psychosocial barriers, economic constraints, and challenges to treatment adherence; and follow-up until cure is achieved. This continuum of care will only succeed if patients being evaluated for TB receive more than just a test result.

This patient-centered diagnostic agenda must include:

1. Focus on cure: Patients deserve diagnosis that is not only accurate, but that also leads to rapid treatment, active management of co-morbidities and symptoms, follow-up to ensure adherence, and cure. All policies for TB diagnosis must help to achieve the goal of cure.

2. Access to care: Patients often live and work far from established health centers. The development and scale-up of new diagnostics should be accompanied by infrastructure and other innovations (e.g. in patient support structures, specimen transport systems, and communication of results) to reduce the economic and logistical burdens of accessing care.

3. Systems of care: Patients are diagnosed not by assays but by complex systems. All weaknesses in those systems must be considered, not only the accuracy of diagnostic tests. Systems of care must particularly address the burdens faced by key populations including children, the poor and vulnerable, those living in congregate settings, and those affected by HIV and drug-resistant TB.

4. Empowered patients: Patients will achieve successful diagnosis and cure only if they can trust and collaborate with their providers and healthcare systems as full partners in their care. They must receive counseling, health information, and support to speak up about obstacles to care, establish trust, and make appropriate decisions about their personal courses of diagnosis and treatment. The continuum of care must be implemented in a way that improves, rather than worsens, their economic circumstances.

5. Sustainability: Patients need systems that they can rely on. TB diagnostics must be implemented in a way that guarantees high quality from year to year with optimum cost, maintains accountability through scientifically rigorous evaluation and monitoring, sustains itself with local rather than with donor support, and adapts to the changing needs of communities over time.