Sedia Biosciences Announces Global Launch of New Research Assay to Detect Recent HIV-1 Infections
Release Date: 20-May-2013
The Sedia™ HIV-1 Limiting Antigen Avidity Enzyme Immunoassay, a powerful new tool in the global fight against HIV, measures the maturation of the immune response to identify recent HIV infections among those already identified as positive
PORTLAND, Ore. -- Sedia Biosciences Corporation of Portland Oregon, U.S.A., announced today the global launch of a new assay, the Sedia™ HIV-1 Limiting Antigen Avidity Enzyme Immunoassay (“Sedia™ HIV-1 LAg-Avidity EIA”) to epidemiologists, researchers and public health care scientists seeking an accurate laboratory tool to identify recent infections previously identified as HIV-1 positive on a population level. The assay works by measuring the maturation of the antibody response, measured as antibody avidity or “binding strength”, as the HIV-1 infection progresses. Recently infected persons produce primarily low-avidity or low binding strength antibodies to the HIV-1 virus, and persons with longer term infections produce more high-avidity antibodies. HIV incidence, which is the rate of new HIV infections in a population over time, is estimated from data measuring recent infections. Conventional diagnostic screening tests only indicate that the person is infected, not whether the disease is a new one or one that may have happened years earlier. HIV incidence estimates are a critical public health tool in the effort against the HIV pandemic, and are used to monitor infection rates in the population, identify “hot spots” of infections, assess effectiveness of public health intervention programs, and identify suitable populations to evaluate vaccine effectiveness.
The Sedia™ HIV-1 LAg-Avidity EIA uses technology developed by and licensed from the U.S. Centers for Disease Control and Prevention (“CDC”) and commercialized by Sedia. Sedia’s assay was first made available to the CDC and other select HIV incidence researchers last year for validation trials including those conducted under the direction of the CDC’s Global AIDS Program. These studies have been and continue to be conducted around the world in many countries including the U.S., Swaziland, Kenya, South Africa, Ukraine, Thailand and Vietnam. According to Dr. Ronald Mink, President and Chief Science Officer of Sedia, “We are very excited about the performance of the Sedia™ HIV-1 LAg-Avidity EIA in the field studies conducted to date, which have shown significantly improved accuracy, reported as a low rate of falsely reported recent infections of less than 1-2% in populations, compared to previously used laboratory methods.” Dr. Mink further stated, “Because of these exciting results, Sedia is launching the product globally beyond these initial validations so that other researchers will be able to use the assay in their own studies.” The assay uses liquid serum or plasma specimens. It is intended for research use only and not for use in diagnostic procedures.
The CDC and Sedia have collaborated in the development of the assay, and each lot manufactured by Sedia is tested and approved by the CDC prior to release. Sedia is the only manufacturer that sells CDC approved assay kits. Steve Piacentini, Sedia’s Director of Assay Development, commented on the product design: “The Sedia™ HIV-1 LAg-Avidity EIA is a uniquely designed 2 hour assay that uses a more efficient single well assay system, instead of conventional ‘two-well avidity assays’. It incorporates a multi-clade protein marker (antigen) representing the major HIV-1 subtypes to ensure good cross-reactivity among HIV-1 subtypes, and uses assay plates subdividable down to individual wells to maximize efficient use of the assay.” Sedia, the market leader in HIV incidence assays, also manufactures and supplies the HIV-1 BED Incidence Assay which measures HIV-1 incidence based on alternative antibody ratio principles licensed from the CDC and was first commercialized by the same scientists who have developed the Sedia™ HIV-1 LAg-Avidity EIA at Sedia. Additional information about both assays is available at http://www.hivincidence.com.
Sedia is also developing the assay to enable testing of dried blood spot specimens, often the specimen of choice in resource-constrained developing countries, and is further developing the assay for individual diagnostic use to enable targeted intervention and case management of individual recent infections, which will require FDA approval.
Research reported in this press release was supported by a Small Business Innovation Research grant from the National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R43AI097001. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.