IGeneX Lyme ImmunoBlot test kit receives FDA clearance

The Lyme ImmunoBlot test first introduced by IGeneX in 2017 has been augmented. Now converted to a test kit, it has received FDA clearance.

The name of the test is iDart™ Lyme IgG ImmunoBlot Kit.

It’s a stand-alone test for the detection of IgG antibodies against Borrelia-causing Lyme disease.

The iDart ImmunoBlot Kit features 31 Lyme antigen bands, which are more antigen bands than any other Lyme immunoblot test on the market.

Moreover, it is the only immunoblot that includes Osp A (P31) and Osp B (P34). (Note: those are the two bands removed from other Lyme tests in the 1990s because of their use in the development of Lyme vaccines.)

The inclusion of 31 antigens improves the sensitivity of the detection of Lyme-specific IgG antibodies. This in turn will improve the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.

“We are delighted to have received FDA clearance for our Lyme ImmunoBlot Kit,” said Dr. Jyotsna Shah, Ph.D., President and Director of IGeneX Labs.

These kits are not available for sale to consumers, but only to labs who perform Lyme diagnostic testing.

Key features of the iDart Lyme IgG ImmunoBlot kit

• Results interpretation is based upon new criteria and not CDC criteria.
• The bands are grouped according to their antigen groups. The test is considered positive if the Lyme Screen Antigen (LSA) band and one or more bands from at least two other groups are present on the ImmunoBlot.
• Bands 31 and 34 are included, making this the only FDA-cleared Lyme serological test that includes these bands.

SOURCE: IGeneX, Inc.