Antigen Mixtures for Serological Detection of HHV-8 Infection

This invention describes a highly specific and sensitive serological test for human herpesvirus 8 (HHV-8) infection that uses the Luciferase Immunoprecipitation System (LIPS). A mixture of four virus-specific antigens, including K8.1, v-cyclin, ORF65 and LANA, was shown to provide more robust detection of HHV-8 infection than traditional methods due its ability to detect very low viral loads. In addition, one of the antigens, v-cyclin, was identified as a new serological marker for HHV-8 infection, and its similarity to a known human oncogene, cyclin-D, raises the possibility of its use as a diagnostic tool for detecting cancer.

This test is more sensitive and amenable to a high-throughput format than other conventional tests for HHV-8 infection such as Immunofluorescent Assays, Western Blots, ELISAs and PCR based approaches. It simplifies data collection and analysis and allows for more rapid clinical output. Validation tests on patient sera samples using this 4-antigen mixture has shown 100% sensitivity and specificity compared to 94% for ELISAs.

The test can be incorporated into routine screening panels for rapid screening of HHV-8 infection, and may be potentially adapted for use as a diagnostic tool for detecting cancer. A successful embodiment of the test can be incorporated into routine blood screening panels, and may lead a reduced risk of transfusion-transmitted HHV-8 infection in patients. It may also be useful for detecting HHV-8 induced cancer in HIV infected patients.