Over the last two decades, tuberculosis (TB) infection rates have doubled across Africa, fueled by the HIV epidemic, and overwhelmed health systems that have been unable to address the emergence of multi-drug resistant TB (MDR-TB). Globally one third of the world is infected with TB, and 9 million people develop active disease each year, resulting in 1.4 million deaths. As one of the 22 high-burden TB countries, Mozambique continues to struggle with this epidemic, and TB remains the leading cause of death for patients with HIV. The WHO estimates a TB incidence rate in Mozambique of 552/100,000 —about 130,000 cases in total, and 3-4% of these are multi-drug resistant TB (MDR-TB). The ability to diagnose and treat patients with TB, called the case detection rate, is one of the lowest in the world in Mozambique at only 34%, compared to 86% in the USA. As a result, many patients with TB in Mozambique are not diagnosed and appropriately treated which further fuels the TB epidemic. Very few patients are tested for MDR-TB and even fewer are started on appropriate treatment. An estimated 58% of patients with TB in Mozambique are also co-infected with HIV.
In December 2011, HAI was awarded a grant through the Stop TB Partnership/WHO called TB REACH. The project’s main objective was to increase the overall number and detection rate of patients with confirmed pulmonary TB and MDR-TB by utilizing new laboratory methods.
To achieve this project’s objective, HAI partnered with the Mozambique Ministry of Health to introduce two new, rapid, and highly sensitive diagnostic technologies: GeneXpert (Xpert) and LED Microscopy initially in the Sofala and Manica Provinces. In late 2015 we extended Xpert testing to the Maputo and Gaza Provinces. Traditional sputum smears (what is currently being used to diagnose pulmonary TB in Mozambique) only detect an estimated 45% of pulmonary TB cases in Mozambique, making diagnosis a significant challenge. The Xpert platform, developed by Cepheid, is a new rapid and fully automated molecular test that uses real-time polymerase chain reactions (PCR) on sputum samples to simultaneously detect TB and to screen for rifampin resistance, a strong marker for MDR-TB. LED microscopy utilizes a more sensitive sputum staining and analysis technique. These new technologies can detect more cases of TB, so that patients can be treated earlier, and the spread of TB throughout their communities can be stopped. Since February 2012, we have implemented 10 Xpert machines and 10 LED microscopes across 4 provinces. We’ve trained laboratory technicians in all these public sectors facilities on the appropriate utilization and maintenance of these machines.
To date, we have tested more than 30,000 patients with LED microscopy for TB. Relative to the less sensitive test that was the previous standard of care, we estimate that this has helped diagnose more than 1,000 additional patients with confirmed TB. We have also analyzed more than 30,000 patients who had negative smear microscopy tests with Xpert, and 12%, (about 3,800 individuals) tested positive for TB. Of these 3,800 additional patients diagnosed with TB by Xpert, almost 7%, (260 individuals) tested positive for rifampin resistance and presumed MDR-TB.
This grant is supported by the WHO, the TB Partnership, and UNITAID.