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Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections


(Direct to Phase II proposals will not be accepted) (Fast-Track proposals will be accepted) Number of anticipated awards: 1-2 Budget (total costs): Phase I: $300,000 for up to 1 year; Phase II: $1,500,000 for up to 3 years Page 118 Background Over 60 million people in the U.S. have genital herpes which is caused by infection with herpes simplex virus type 1 or 2 (HSV-1, HSV-2). The WHO’s 2021 global progress report indicates that more than 500 million people are infected with HSV globally. Currently, genital herpes can be diagnosed based on clinical manifestations of the disease combined with very accurate nucleic acid tests to detect the virus in lesions or on mucosal surfaces. However, many patients with genital herpes are asymptomatic and do not shed virus and therefore a serological test is used to confirm HSV infection. Most available serologic tests, based on the enzyme-linked immunosorbent assay, are efficient but have very high false positive rates with positive predictive values (PPV) of about 50% or lower. Serologic tests for HSV infection using the Western blot have been shown to have high PPV and can readily distinguish HSV-1 and HSV-2. However, the Western blot is not suitable for wide-scale use in clinical settings.
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