The FDA cleared kits are currently not available from any labs. ID-FISH hopes to start selling to laboratories in late 2025. However, the IGeneX IgM and IgG ImmunoBlots, which are the foundation of the FDA cleared kits, are available now. Specifically, they are tests #325 and #335 on this form.
iDart™ Lyme IgM ImmunoBlot Kit and iDart™ Lyme IgG ImmunoBlot Kit.
The kits are available to CLIA certified labs across the United States, as well as International labs with comparable certification. We are not able to sell kits directly to doctors or patients.
IgM antibodies are produced first and suggest a current or recent infection, while IgG antibodies appear a few weeks later and point to past infection or immunity. Testing for both leads to a more accurate diagnosis.
ID-FISH Technology is the manufacture of the FDA-cleared kits. For more than 15 years, ID-FISH Technology has been the leader in the development of diagnostic assays using their patented fluorescent in situ hybridization (FISH) and ImmunoBlot technologies. These technologies provide greater sensitivity for the detection of tick-borne diseases.
