Strengthening laboratory capacity in a developing country setting
A typical staining corner in Lesotho, pre renovation
Biosafety Level 3 cabinet, post renovation
Gathering evidence for scale-up
The Kingdom of Lesotho, a small landlocked country with limited natural resources and a population of approximately 2 million people, is severly affected by the HIV and TB epidemics. In order to meet the high health costs, both in terms of human suffering and economic setbacks associated with these diseases, a coalition of partners and the Lesotho Ministry of Health (MoH) determined that 1) significant renovation of the national TB reference laboratory was needed, 2) essential equipment for drug susceptibility testing was missing and that 3) a quality assurance programme for smear microscopy was only partially implemented.
Lesotho, which has a predominance of TB, MDR-TB and HIV per 100,000 population, invited a coalition made up of FIND, Partners in Health and the WHO, to renovate the National TB Reference Laboratory (NTRL) between 2006 and 2008. The improvements included reinforcing microscopy services, streamlining conventional culture and drug susceptibility testing (DST) and introducing modern TB diagnostic methods.
In 2007, in the short period of four months, a biosafety level three facility for solid culture and DST and an external quality assessment programme for smear microscopy were established. A month after completing the renovations, liquid culture and DST were introduced. Findings showed that the preliminary results were comparable to those found in laboratories in industrialized countries. A year later, the line-probe assay for the rapid detection of MDR-TB was introduced.
Laboratory capacity to properly diagnose and manage MDR-TB is an essential component of the complex response to the urgent challenges posed by MDR- and XDR-TB. In many developing countries with the highest burdens of TB and HIV, weaknesses in the delivery systems for diagnostic services include deficits in laboratory infrastructure, overreliance on light microscopy, outdated standard operating procedures, absence or lack of quality assurance, and a shortage of trained personnel. In other words, diagnostic services have been among the most neglected sectors of the health system.
Since the development of new diagnostic tools for TB and the demonstration of their effectiveness in the field offer great promise, it is indispensible that these tools be translated into national laboratory policy and implemented in laboratory services through strategic implementation plans if they are to play an effective role in the detection and management of disease.
Dr CN Paramasivan, Head of TB Laboratory Support at FIND, during his visit to Lesotho's Central TB Laboratory in 2008
In the case of Lesotho, the commitment of the MoH and partners to collaborate with complementary resources enabled TB diagnostic services in the country to rapidly be brought up to the standards of the developed world. It was determined that through strong political commitment and collaboration, it is possible to rapidly establish quality assured TB diagnostic capacity, including the latest laboratory methods, in a resource-limited setting. From a low baseline, TB culture throughput in the laboratory increased ten-fold and has been sustained.
This experience has served as a catalyst to translate policy into practice with new diagnostic technologies, and supports the global policy setting to enhance and modernize laboratory work in developing countries. New mechanisms for coordination of partners have been instituted, including the WHO Global Laboratory Initiative (GLI), which was established to bring partners together to address the challenges of upgrading laboratory services to meet the demands of the MDR- and XDR-TB epidemics and other infectious diseases. The US President's Emergency Plan for AIDS Relief (PEPFAR), through the CDC, has made a major commitment to supporting laboratory strengthening in many countries over the next 5 years. UNITAID has provided an initial grant to a coalition of partners, including FIND, GLI and the Global Drug Facility of the Stop TB Partnership, to implement new TB diagnostic technologies in up to 27 countries over the next three years. Currently, FIND and partners are in the process of evaluating the impact on MDR-TB management as a result of strengthening the NTRL in Maseru.
The experience in Lesotho has played a vital role in demonstrating that it is possible to improve health systems without long delays when concerted efforts unite new technologies and partners in a common cause.