L2 DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

ABSTRACT Zika virus ZIKV has rapidly emerged and spread through South and Central America the Caribbean and Puerto Rico since its last outbreak in Micronesia in Transmitted by the mosquito Aedes sp its forecasted spread will have a major impact on the Southeast U S Most ZIKV infections remain asymptomatic or present with non specific rash and fever therefore they have been difficult to diagnose and report However two major health consequences appear to be associated with the ZIKV outbreak which sets it apart from other flaviviruses such as West Nile Virus and Dengue namely a transmission from an infected mother to fetus resulting in reports of microcephaly in fetuses and b Guillain Barre syndrome GBS in adults Several teams have now developed qRT PCR assays to detect ZIKV However such tests are relatively expensive require well equipped laboratories with specialized equipment and the procedure takes at least hours to finish There is an urgent need for a rapid sensitive specific and economical diagnostic test for ZIKV Such an assay could be routinely used in resource poor settings as well as in doctorsandapos offices including as part of regular prenatal care Therefore the goal of the SBIR Phase I project is to use loop mediated isothermal nucleic acid amplification LAMP to develop a rapid sensitive point of care diagnostic for ZIKV This technology is of low complexity requiring only a water bath Colorimetric results are visible to the naked eye in one hour or less We will use serial dilutions of ZIKV and other viruses including West Nile virus Dengue viruses and Chikungunya virus spiked in human blood saliva and urine to determine the assayandapos s sensitivity and specificity Based on our laboratoryandapos s extensive previous experience with LAMP assay development we forecast a lower limit of detection of viral genomes with very high specificity In addition to rapid colorimetric ZIKV detection we will also develop a rapid lateral flow assay to facilitate the differential analysis with other flaviviruses The development of rapid point of care assays will reduce the dependence on central laboratory testing facilities for epidemiologic surveillance and clinical diagnosis a key advantage in the resource poor areas where the epidemic is currently prevalent Further we anticipate that the availability of a rapid test will result in the incorporation of ZIKV testing into the sustainable routine evaluation of women who are pregnant or anticipating pregnancy as well as their partners NARRATIVE The goal of this project is to develop a rapid low cost point of care diagnostic for the detection of Zika virus from patient samples of blood urine and saliva to answer the unmet diagnostic testing needs as a result of the current Zika epidemic A successful project would provide a new assay for sustainable routine use in resource poor settings including in doctorsandapos offices as part of regular prenatal care and general disease surveillance