FDA approval of a new paradigm for existing Lyme disease tests could help simplify diagnosis

, the U.S. Food and Drug Administration has approved four previously proven trials to help diagnose Lyme disease. Today's approved tests are the first to show that new test examples have been followed, with two tests called enzyme immunoassays (EIA) performed simultaneously or sequentially, rather than the current two-step process, where separate protein testing, known as WesternBlot, must be performed after the initial EIA test.
“ Lyme disease can have a devastating effect on patients. With today's action, clinicians have a new option to test Lyme disease, thanks to simplified testing methods that make it easier for clinical laboratories to interpret. These tests can increase patient confidence in conditions that require early treatment to ensure optimal outcomes," said Dr. Tim Stenzel, director of the Office of In-body Diagnostics and Radiological Health at the FDA's Center for Equipment and Radiological Health.
Lyme disease is caused by the bacteria Borreliaburgdorferi and is transmitted to humans through infected ticks. Typical symptoms include fever, headache, fatigue, and rash, called migrating erythema. If left untreated, the infection can spread to the joints, heart and nervous system. In 2017, the last year the Centers for Disease Control and Prevention (CDC) released data, a total of 42,743 confirmed and likely cases of Lyme disease were reported to the Centers for Disease Control and Prevention, an increase of 17 percent over 2016.
Laboratory diagnostics for Lyme disease traditionally use a double-layered process to detect the presence of antibodies in the patient's blood against bursos. Antibodies are proteins present in the blood when the body responds to a particular infection. In the previous two-tier approach, different types of tests (EIA and Western imprinting) were used to confirm clinical diagnosis. The tests approved today involve a modification method that uses only tests based on EIA technology.
The FDA reviewed clinical studies of ZEUS ELISA Borrelia VlsE1 / pepC10 IgG / IgM test system, ZEUSELISA Borrelia Burgdorferi IgG / IgM test system, ZEUS ELISA Borreliaburgdorferi IgM test system and ZEUS EL Borrelia Burgdorferi test system. This alternative, called an improved double-layered test, is as accurate as the current method used to detect and evaluate exposed antibodies to Borreliaburgdorferi, the pathogenic factor for Lyme disease.
follow the Recommendations of the Centers for Disease Control and Prevention to diagnose Lyme disease and determine when a laboratory test is appropriate.
the enzyme immunometric test through a pre-market notification (510(k)). The A510(k) is a pre-market submission to the FDA to demonstrate that the device to be listed is at least as safe and effective as the device legally sold.FDA approves ZEUS Scientific's ZEUS ELISA enzyme immunoassay trial. （cyy123.com）