ID-FISH Expertise, Inc., a number one supplier of diagnostic instruments for the detection of tick-borne illnesses, in the present day introduced that its Lyme ImmunoBlot check has obtained FDA clearance. The title of the check is iDart™ Lyme IgG ImmunoBlot Package.
The iDart Lyme IgG ImmunoBlot Package is a stand-alone check for the detection of IgG antibodies in opposition to Borrelia-causing Lyme disease.
The iDart ImmunoBlot Package options 31 Lyme antigen bands, that are extra antigen bands than every other Lyme immunoblot check in the marketplace. Furthermore, it’s the solely immunoblot that features Osp A (P31) and Osp B (P34).
The inclusion of 31 antigens improves the sensitivity of the detection of Lyme-specific IgG antibodies, which in flip will enhance the sensitivity of the analysis of Lyme disease in suspected sufferers with out sacrificing specificity.
“We’re delighted to have obtained FDA clearance for our Lyme ImmunoBlot Package,” mentioned Dr. Jyotsna Shah, Ph.D., Chief Scientific Officer of ID-FISH Expertise.
“The R&D group at ID-FISH has labored tirelessly on ensuring that we ship probably the most correct check potential for the detection of Lyme disease. We stay up for working with companions to get these checks to sufferers who want an accurate analysis.”
ID-FISH Expertise plans to start out delivery kits within the fourth quarter. Its major buyer base can be laboratories trying to get into Lyme disease testing or those that want to add the iDart ImmunoBlot expertise to their check menu.
IGeneX, Inc., a specialty testing lab situated in Northern California, has a licensing settlement with ID-FISH Expertise to make use of the Lyme IgG ImmunoBlot strips in its laboratory-developed Lyme ImmunoBlot IgG assay.
Key options of the iDart Lyme IgG ImmunoBlot equipment
- Outcomes interpretation relies upon new standards and never CDC standards.
- The bands are grouped in line with their antigen teams. The check is taken into account optimistic if the Lyme Display Antigen (LSA) band and a number of bands from a minimum of two different teams are current on the ImmunoBlot.
- Bands 31 and 34 are included, making this the one FDA-cleared Lyme serological check that features these bands.
Lyme disease is likely one of the fastest-growing infectious illnesses in the USA. Round 475,000 individuals are identified with Lyme disease yearly within the U.S. It’s brought on by Borrelia burgdorferi, a kind of micro organism carried by deer ticks. Lyme disease signs embrace fever, headache, fatigue, chills, joint and muscle ache, and, in some situations, the presence of a rash.
SOURCE: ID-FISH Technology, Inc
