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PARTNERSHIPS FOR ENHANCED ENGAGEMENT IN RESEARCH (PEER)
Cycle 8 (2019 Deadline)


Evaluation of a novel SS-LAMP assay for rapid, low-cost diagnosis of tuberculosis in Morocco

PI: Hassan Ait Benhassou (h.aitbenhassou@mascir.com), Moroccan Foundation for Advanced Science Innovation and Research (MAScIR), in partnership with
Université Mohammed V
U.S. Partner: Adithya Cattamanchi, University of California, San Francisco
Project Dates: To be determined

Project Overview:
 
Tuberculosis (TB) is one of the deadliest infectious diseases worldwide. Each year, about 1% of the world’s population is newly infected, about 9 million develop the disease, and approximately 2 million of them die. In Morocco, as in most developing countries, where the timely and accurate diagnosis of TB remains a great challenge, the disease constitutes a major public health threat, with 30,000 new cases each year. Currently, the conventional methods used routinely to diagnose the disease, such as microscopy and culture, are complex, unreliable, labor-intensive, technically challenging, and time-consuming. Although semi-automated PCR (Xpert MTB/RIF) is now available, it has high device and consumable costs and requires stable electricity. The laboratory of the PI Dr. Ait Benhassou has developed a novel assay called SS-LAMP (Single Step Loop Mediated Isothermal Amplification) for the diagnosis of TB. SS-LAMP provides a number of advantages over microscopy, including superior sensitivity and significantly less operating time, and compared to GeneXpert it does not require expensive instrumentation or electricity. Furthermore, SS-LAMP has the advantage of being able to be directly used without the need of sputum processing steps and to be easily integrated into a portable, battery-powered Lab-on-Card device developed in the PI’s lab. Their SS-LAMP is proposed to provide a low-cost, more accurate, and more convenient alternative to sputum smear microscopy for the detection of pulmonary TB in limited resource settings. In this last mile pilot study supported by PEER, the researchers will evaluate on a large population the clinical accuracy and operational features of the SS-LAMP for the detection of pulmonary TB in clinical settings in Morocco. They will compare the performance of the SS-LAMP assay with sputum smear microscopy and XpertMTB/RIF. The project will involve the enrollment of 700 consenting individuals with TB typical symptoms in Casablanca and Tangier. Three sputum samples will be collected from each of these TB presumptive cases. The single SS-LAMP test will be compared with GeneXpert MTB/RIF, using mycobacterial culture as a reference standard.

Thanks to its simplicity, robustness, ease of use, and ability to be performed in simple laboratories, small-scale hospitals, and primary care facilities, SS-LAMP appears promising as a diagnostic tool for containing the spread of TB in Morocco and other high burden countries. The roll-out of the SS-LAMP assay can play a key role in strengthening access to quality care for the most vulnerable and underserved populations in overpopulated urban zones, as well as in remote rural villages. The PI and his team believe that this test will revolutionize TB diagnosis and control in Morocco, as patients will receive accurate and rapid results and can be placed on an appropriate drug regimen, saving households and health systems time and money. At the educational level, the project should also contribute to ensuring and improving access to knowledge, improving the quality of research, and stimulating innovation, in order to contribute to the country development.


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