LAMP Versus Traditional Diagnosis of Malaria to Treat Pregnant Mothers in NW Ethiopia

Diagnosis of malaria in pregnancy is inadequate. Current testing modalities lack the sensitivity to detect low level infections in expectant mothers. The National Strategy to eliminate malaria in Ethiopia and other sub-Saharan countries in the next 10 years will demand highly sensitive diagnostics in patients with such low level infections. Our group has validated a DNA based test for malaria called "LAMP" and shown 30% greater detection of malaria in some cases. In pregnant mothers, LAMP detects close to 4% more cases than microscopy in a pilot study. Here, we propose to look at measurable outcomes in terms of lives saved at birth and reduction in morbidity with LAMP versus traditional testing. The target population is the rural poor and specifically pregnant mothers. We will take the LAMP test to 10 rural health centers and prospectively evaluate its impact. Focusing on women is in line with the Ethiopian governments focus on affirmative action for women in the workforce. We have approached the Ministry of Health, Ministry of Science and Technology, and Public Health Institute in Ethiopia and all stakeholders are supportive. The Ethiopian Biotechnology Institute Director General has personally supported the idea of LAMP commercialization and we will work together on this initiative to produce kits at a fraction of the cost of competitors. Since the test is designed by our group there are no intellectual property impediments to its commercialization.