Published on June 28, 2012 at 12:38 AM
Standard Diagnostics (GSD) today announced FDA clearance of its
disease Line Immunoassay which offers excellent specificity and
sensitivity at any disease stage. The testing procedure is highly
intuitive and has sharper results than the traditional "Western blot".
and IgG LIA's satisfy CDC recommendations for confirmation testing
and offer many improvements including: simple procedure, intuitive
results, easy handling, durability and a well-defined antigen
strips contain specific Lyme disease antigen proteins that serve as
markers for general infection and for specific stages. Lyme disease
phases include: 1) early, 2) disseminated (also known as
neuroborreliosis), and 3) late stage. The IgM strip contains markers for
early and disseminated Lyme disease (IgM antibodies are generally not
present beyond the disseminated stage). The IgG LIA contains a multitude
of proteins to diagnose the disease at a specific stage, and also a
number of general markers that are present throughout the disease cycle.
GSD also offers the sensitive, polyvalent
EIA screen that the CDC recommends as the first step in diagnosis of
Lyme disease. The EIA is certified as "ThunderBolt-Ready" ensuring quick
and easy automation on the ThunderBolt™
EIA Platform. Along with Lyme disease, over 200 other assays from 20
different manufacturers are also certified as "ThunderBolt-Ready".
Source: Gold Standard Diagnostics