The TBXpert Project will scale up access to a ground-breaking diagnostic test for tuberculosis, Xpert MTB/RIF and reduce the cost of its use. An innovative private-public partnership is a part of this project and two external implementers will roll out the activities via the non-governmental and private sector. While UNITAID funding will allow Xpert to be rolled out in 21 recipient countries, a novel financing collaboration led by UNITAID and other partners has achieved a 40 percent price reduction for this rapid TB test. The project will assist in timely procurement of 225 GeneXpert instruments in project sites in 21 low- and middle-income countries, utilising 1,444,960 Xpert MTB/RIF tests in 2013-2015
The Xpert assay represents a major advance for TB diagnosis. Most current TB testing involves a century-old technique where sputum samples are examined under a microscope to check for the tuberculosis bacillus. The gold standard diagnostic test for TB diagnosis is the laboratory culture of Mycobacterium tuberculosis but it can take up to two months to provide results. Xpert provides dependable results directly from sputum samples in less than two hours and also detects resistance to rifampicin, one of the most commonly used first-line drug for the treatment of TB.
Under the leadership of Global TB Programme of the World Health Organization (WHO), and the Stop TB Partnership’s Global Drug Facility (GDF), the TBXpert Project will provide approximately 1.4 million Xpert MTB/RIF test cartridges and over 225 Xpert instruments instruments for the rapid detection of TB and rifampicin resistance in 21 recipient countries (see map by clicking “data visualization” on the right-hand column). Currently all 21 countries have agreements with the Project for the roll out. All countries placed orders and all 21 countries received their supplies. Number of cases detected with TB and with Rifampicin resistant TB has steadily increased with programme roll out.
Through an agreement led by UNITAID, the United States Government and the Bill & Melinda Gates Foundation, the manufacturer of Xpert, Cepheid, had significantly reduced the price of diagnostic cartridges from $17 to less than $10. This price reduction allowed an accelerated roll-out of the test. UNITAID’s investment applies to more than 145 eligible countries and public sector purchasers in low- and middle-income countries, including those with a high-burden of MDR-TB and coinfection of HIV and TB. In the first year after the 40% price reduction about 3 million cartridges were ordered in countries eligible to access the reduced price option. This number rose to 4.8 million cartridges during 2014.
Interactive Research and Design, UAE under TB REACH of the Stop TB Partnership is implementing a special private sector Social-Business model in the three countries: Bangladesh, Indonesia and Pakistan where at the respective urban centres in Dhaka, Jakarta and Karachi, patients accessing private providers will be tested using TBXpert. African Society for Laboratory Medicine, Ethiopia is providing Technical Assistance to Laboratory capacity building and uptake of TBXpert Technology in 5 African countries.
The Project had rolled out the “Unified Forecasting Initiative” with other manufacturing partners and the manufacturer of this test, to prepare quarterly forecasts in a co-ordinated fashion so as to prevent supply chain problems and stock-outs. Besides the forecast for cartridges, updates on monitoring and maintenance of products are also discussed with implementing partners in the Forecasting Initiative meetings. The Global TB Program of the WHO is monitoring the roll-out of the new diagnostic test actively and provides quarterly updates on their website. New guidance and norms on the use of this test in pulmonary and non-pulmonary drug susceptible and drug resistant TB have been updated by WHO to assist in uptake in countries. The manufacturer plans to roll out a system for calibration and checking of modules remotely via internet, so as to enable easy functioning and less downtime. Remote data collection mechanism is feasible at sites using TBXpert, but would only be implemented based on country agreement and on needs of the country.