CEPHIA comparative evaluation demonstrates that Sedia assay has lowest false recency rate
PORTLAND, Ore.–(BUSINESS WIRE)–October 23, 2014–
Sedia Biosciences Corporation of Portland Oregon, USA, reported today that its new product, the Sedia™ HIV-1 Limiting Antigen (LAg)-Avidity EIA has been evaluated by an independent group, the Consortium for Evaluation and Performance of HIV Incidence Assays (CEPHIA). CEPHIA evaluates and supports the development of improved assays for HIV incidence measurements. The study, published in today’s issue of the journal AIDS, evaluated five HIV incidence assays for a variety of parameters important to laboratory measurements of HIV incidence rates. Of the five assays, only two were specifically developed by their manufacturer as incidence assays. Both of these assays, which include the Sedia™ HIV-1 LAg-Avidity EIA, were developed by the Centers for Disease Control and Prevention (CDC) and commercialized by Sedia Biosciences. The second assay developed specifically for HIV-1 incidence measurement was the Sedia™ BED HIV-1 Incidence Assay, which is based on an older technology.
In the study, several performance characteristics were measured including false recency rate (the number of infections reported incorrectly as recent infections), performance across HIV subtypes, response in subjects that are on antiretroviral (ARV) therapy have low viral load and CD4+ cell counts, as well as response of elite controllers, which are individuals that are infected but do not develop into AIDS in the absence of therapy. The false recency rate of the Sedia™ HIV-1 LAg-Avidity EIA was low across all samples (1.3%) compared to the other assays (6.2-9.7%). However, all assays gave higher false recency rates in the more challenging ARV, low viral load and elite controller patients.
Development of more accurate HIV tests for recent infection, such as the Sedia™ HIV-1 LAg-Avidity EIA, for surveillance of the HIV epidemic and estimation of HIV incidence rates, has been an important goal for HIV scientists for the past several years, since the alternative is to track large cohorts of at risk persons over a long time and monitor the frequency of new infections that occurs. This latter approach is not only time-consuming, but also costly and impractical for public health organizations and governments with limited resources. The Sedia™ HIV-1 LAg-Avidity EIA is sold in 40 countries around the world.
CEPHIA is an independent consortium of worldwide laboratories that are funded by the Bill and Melinda Gates Foundation for the development of a clinical HIV specimen repository, and independent evaluation of HIV incidence assays. CEPHIA works with the CDC, World Health Organization, researchers, epidemiologists, public health groups and assay developers to promote the development and use of these assays. CEPHIA consortium members are Public Health England, the South African Centre for Epidemiological Modeling and Analysis, Blood Systems Research Institute and the University of California San Francisco.
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 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.
Sedia Biosciences Corporation
Ronald Mink, 503-459-4159