Global Laboratory Initiative

Mission and Strategic priorities

To serve as a platform of coordination and communication, providing the required infrastructure, focused on TB laboratory strengthening, in the areas of:

• Global policy guidance on appropriate laboratory technology and best practices
• Laboratory capacity development
• Interface with other laboratory networks to ensure appropriate integration
• Standardized laboratory quality assurance
• Coordination of technical assistance
• Effective knowledge sharing
• Advocacy and resource mobilization

GLI strategic priorities 2009 - 2011:

Development of laboratory norms and standards, including specifications for TB laboratory equipment, laboratory biosafety, standard operating procedures for TB laboratories, policy guidance and technical manuals for first- and second-line drug susceptibility testing, and assessment of evidence for WHO policy recommendations on the use of new diagnostics for rapid screening of patients at risk of MDR-TB.

Acceleration of country laboratory strengthening, guided by a Roadmap for country specific strategic plans on TB laboratory strengthening. This generic Roadmap or template for TB laboratory strengthening is required for developing and implementing a national TB laboratory strategy to be able to meet the needs of DOTS expansion, HIV-associated and drug-resistant TB, within national strategic plans for laboratory strengthening. It also aims to provide a structured framework for TB laboratory strengthening based on WHO-recommended norms and standards, documented country best-practices and growing lessons learnt from field experiences that can be used to develop a strategic plan for providing reliable TB laboratory services as part of the National TB Programme. It is expected that countries will adapt the generic Roadmap to suit country-specific needs, within the context of their own epidemiological situation and resource availability.

Prioritization of human resource development and training, including development of a comprehensive training and retention strategy, and proposals to train a cadre of laboratory consultants from developing countries. The training will focus on:

- Senior TB laboratory consultants who will assist countries with development of the National Laboratory Strengthening plans and support development of the TB laboratory component of the Global Fund proposals

- TB laboratory consultants who can ensure a long term assistance to countries in strengthening laboratory capacity

- TB laboratory technicians who will perform day to day routine activities

Partner organizations with an active interest and involvement include the Association of Public Health Laboratories (APHL), the Netherlands Tuberculosis Foundation (KNCV), the US Centers for Disease Control and Prevention (CDC), the International Union Against Tuberculosis and Lung Disease (Union), MSH and WHO.

Laboratory accreditation, involving a task force lead by the International Organization for Migration (IOM) and consisting of international experts and key partners, to develop a consensus strategy and proposal for a voluntary laboratory accreditation programme for national TB reference laboratories and selected country level regional laboratories.

Laboratory biosafety, involving an Expert consultations under joint WHO and CDC leadership to achieve consensus on appropriate biosafety standards for laboratories in resource-constrained settings, develop appropriate biosafety manuals, and design a comprehensive training plan and training materials.

Expansion of the Supranational Reference Laboratory Network, to fill existing geographical gaps, to enable SRLs to assume broader laboratory strengthening responsibilities and to meet the demand for expanded global drug resistance surveillance capacity.

Gaps and needs

Assuming universal access to TB culture and drug susceptibility testing (DST), as called for by the World Health Assembly in May 2007, estimates based on epidemiological modelling indicate that 60 million culture investigations and five million DST investigations are required annually to meet the diagnostic goals of drug-resistant and HIV-associated TB by 2015, resulting in a current gap of 50 million cultures and 4.5 million DSTs per annum in addition to the almost 120 million microscopy investigations needed annually. Meeting the estimated gap will therefore require at least 5 000 new microscopy laboratories, 2,000 new culture and DST laboratories to be established and more than 9 000 and 20,000 new laboratory technicians to be trained in smear microscopy, culture and DST respectively and deployed, at an estimated minimum investment of USD 2.5 billion for infrastructure and capital expenditure between 2007 and 2015.

The associated business model and strategic plan depends on a flexible and responsive approach involving comprehensive resource mapping and multi-sectoral partnerships.