SBIR Topic 133: Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections

Measles and rubella are diseases that can lead to serious health complications, or even death. Globally, over 100,000 deaths are still attributed to measles infection each year. Reported worldwide measles cases increased by 79% in the first 2 months of 2022, compared to the same period in 2021. Rubella infection during pregnancy can lead to miscarriage, stillbirth, or multiple birth defects that together are called congenital rubella syndrome (CRS). Over 100,000 infants worldwide are born with CRS annually, and 33% of them die before one year of age. Rubella was declared eliminated from the US in 2004, but cases can occur when unvaccinated individuals are exposed to infected individuals, mostly through international travel. Strong surveillance systems are thus necessary for detecting sporadic cases of disease, preventing disease outbreaks, and maintaining disease elimination status. Based on our company’s prior experience of detecting serological responses against SARS-CoV-2, we propose in this SBIR to develop a similar IgG/IgM lateral flow immunoassay (LFIA) for rapid differentiation of measles vs rubella infection to help guide the public health response. Such rapid diagnostic tests (RDTs) will find usefulness not only within the U.S, but also on the global market.