The Sedia™ HIV-1 Limiting Antigen Avidity Enzyme Immunoassay, a leading HIV incidence assay, can now be used on dried blood specimens without need for cold chain storage.
Portland, Oregon – Sedia Biosciences Corporation announced today the commercial launch of a new product, the Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA for Dried Blood Spot Specimens. The new assay supplements its highly regarded HIV incidence assay, the Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA originally designed for liquid serum and plasma specimens. The new assay enables users to test dried blood spot specimens, which are commonly used to collect and ship blood specimens to testing labs in developing countries and other areas without access to cold chain storage. The Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA is the leading commercial HIV incidence assay used by epidemiologists, researchers and public health scientists as an accurate laboratory tool to identify recent infections previously identified as positive. This enables scientists to determine HIV-1 incidence rates in populations to monitor the the spread of the pandemic, identify “hot spots” of infections, assess effectiveness of public health intervention programs and identify suitable populations to evaluate vaccine effectiveness. Sedia sells the assay in over 30 countries.
The assay application was developed in cooperation with the Centers for Disease Control and Prevention (CDC) who evaluates and approves HIV incidence assays for programs funded by the U.S. Government, such as PEPFAR (the President’s Emergency Action Plan for AIDS Relief), a multi-year program to support HIV/AIDS programs in developing countries funded for $6.6 Billion in 2015 alone. Sedia has received approval for two commercial lots of the dried blood spot (DBS) version of the assay to date. The first lot was provided to CDC and for Sedia internal studies, while the second lot, which is now available, is for commercial sale to scientists in other programs.
Steve Piacentini, Sedia’s Director of Assay Development, and Senior Project Manager for the development of both HIV-1 LAg-Avidity EIAs, said, “We were very focused on developing a quality product that can be manufactured on a consistent basis, to ensure the continued supply of the assay for the ongoing needs of the CDC’s and other public health groups’ programs. Now with the extensive evaluations completed by CDC and the approval they have issued, we look forward to supplying this product to our other customers.”
Dr. Ronald W. Mink, Sedia’s President and Chief Science Officer stated, “We are delighted to be able to offer the Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA for DBS to programs reliant on collection of dried blood spots, enabling them to use this cutting edge technology to monitor and manage their programs. Providing this kind of information on these programs is critical to their long-term success in the battle against AIDS globally.”
The Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA including its DBS version, works by quantitatively measuring the maturation of the antibody response, measurind 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, allowing differentiation between new and established 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. Sedia Biosciences is the world’s leading manufacturer of commercial assays to measure HIV-1 incidence and identify recent infections.
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 R44AI097001. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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About Sedia Biosciences Corporation:
Sedia Biosciences Corporation (www.sediabio.com) is a U.S.-based healthcare company focused on the development and commercialization of novel in vitro diagnostic and epidemiological tests including the Sedia™ BED HIV-1 Incidence EIA and HIV-1 LAg-Avidity EIA. The company is dedicated to advancing access to medical care by developing innovative diagnostic and monitoring products that enable more cost effective and expanded testing for infectious diseases and other conditions. Based in Portland, Oregon, Sedia develops, manufactures, licenses and sells in vitro diagnostic and epidemiological tests as well as specimen collection devices.