Focus Diagnostics, Inc has received 510(k) clearance from the U.S. Food and Drug Administration to market its two new Plexus™ EBV Multi-Analyte Diagnostics serology test kits for detecting the presence or absence of IgG and IgM antibodies in blood serum. The two tests are indicated as aids in the diagnosis of Epstein-Barr virus (EBV) infection and EBV-associated infectious mononucleosis.
The tests provide information that physicians can use to help diagnose infectious mononucleosis, and determine whether the infection is acute or stems from recent or past exposure to EBV. The Plexus IgM panel identifies the presence of EBV IgM viral capsid antigen (VCA) and heterophile antibodies, which are associated with acute or recent EBV infection. The IgG panel identifies the presence of IgG VCA, early antigen-diffuse (EA-D) and nuclear antigen (EBNA-1), which are associated with recent or past EBV infection.
EBV infections are common throughout the world, causing a wide range of diseases of varying severity. The most common and best known of these EBV-associated diseases in developed countries is infectious mononucleosis.
Detecting the IgM and IgG antibodies and identifying whether they are from recent or past exposure to the virus can help correctly diagnose acute mononucleosis. Accurate diagnosis of EBV-associated infectious mononucleosis can be difficult without serological testing to detect specific antigens and antibodies.
Focus Diagnostics’ Plexus Multi-Analyte Diagnostics line of multiplex infectious-disease assays use Luminex® xMAP® technology, which enables simultaneous detection of multiple target analytes in clinical specimens, tested in diagnostic panels. The Plexus multiplex immunoassay panels have been specifically designed to correspond with laboratory tests that physicians might order to help them diagnose specific infections. Specially designed Plexus software runs on Luminex-based analyzers and allows the laboratory to report results for the entire panel or only specific assays.
Focus Diagnostics plans to add additional multiplex antibody and antigen detection panels to the Plexus Multi-Analyte Diagnostics line of immunoassay products. The Plexus EBV serology panels are the latest multiplex immunoassay products sold under the Plexus brand name to be launched by the company, following the Plexus HerpeSelect® 1 and 2 IgG test kit, which received FDA 510(k) clearance in 2007.
The Plexus Parasite kit was CE marked in 2008 and is now available in Europe; the kit is not available in the U.S., but Focus Diagnostics intends to apply for FDA clearance in the near future.