IGeneX Lyme ImmunoBlot test receives FDA clearance

Important Read

SEP 5, 2024

This is a huge win for Lyme patients and may diagnose Lyme faster and save patients the cost and pain of long-term treatment. The key point is that the tests are only available from labs that perform Lyme testing and do not meet the CDC standards which means that insurance companies will not pay for the cost. I would encourage you to seek out a lab for the test regardless of insurance pay, IGeneX has led the way in Lyme testing for years and is the gold standard. Paying for the test is worth every penny because you are testing for even possible antigens out there and you won’t receive that from your doctor. This test could make a huge difference in your treatment by pinpointing the virus versus a cross-the-board method.

The Lyme ImmunoBlot test first introduced by IGeneX in 2017 has now been converted to a test kit–and 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, which 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 that 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.

Melinda

Reference:

https://www.lymedisease.org/lyme-immunoblot-fda-clearance/