Newly-Cleared Technology a Game Changer for Diagnosis of Lyme Disease

Lyme disease is one of the fastest-growing infectious diseases, with approximately 476,000 cases diagnosed annually in the United States. The symptoms of Lyme disease, such as fever, headache, fatigue, chills, joint pain, and in some cases, a rash, make it challenging to diagnose quickly and accurately. Standard testing methods may not provide full diagnostic coverage, especially since IgM antibodies appear first and indicate a current or recent infection, while IgG antibodies, appearing weeks later, can suggest chronic or past infection. Using both IgM and IgG tests allows for full diagnostic coverage of a disease. Now, a more sensitive Lyme disease test that includes both IgM and IgG antibody detection improves the ability to detect the disease at various stages.

The iDart Lyme IgM and IgG ImmunoBlot Kits from ID-FISH Technology (Milpitas, CA, USA) feature 26 and 31 Lyme antigen bands, respectively, surpassing the antigen bands available in other Lyme immunoblot tests on the market. The inclusion of multiple antigens, including Osp A (P31) and Osp B (P34), improves the sensitivity of the test, providing a more accurate diagnosis of Lyme disease in suspected patients. The test works by identifying specific Lyme disease antigens in blood samples, which enhances diagnostic accuracy without compromising specificity.

The iDart Lyme IgM and IgG ImmunoBlot test kits were validated and have received FDA clearance, marking a significant advancement in Lyme disease diagnostics. The tests offer new criteria for interpreting results, which differ from the CDC criteria. The inclusion of bands 31 and 34 makes these the only FDA-cleared Lyme serological tests to feature these bands. ID-FISH Technology plans to start shipping these kits in late 2025, with laboratories as the primary target customers. The future goal is to expand the use of these tests to provide more reliable diagnostics for Lyme disease.

"We are delighted to have received FDA clearance for our Lyme kits," said Dr. Jyotsna Shah, PhD, Chief Scientific Officer of ID-FISH Technology. "The R&D team at ID-FISH has worked tirelessly on making sure that we deliver the most accurate tests possible for the detection of Lyme disease. We look forward to working with partners to get these tests to patients."

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