Early Lyme disease has long been difficult to diagnose. Standard two‑tier testing often misses infections in the first weeks, when symptoms are vague and antibodies are still developing. A new study suggests that may be changing.

IGeneX reports that its FDA‑cleared single‑step immunoblot tests detect early Lyme disease far more effectively than the conventional system used across the U.S.

The study, published in Microbiology Spectrum, found the IGeneX tests identified 58.3% of early Lyme cases, compared to 30.0% with standard two‑tier testing.

Why the new test performs better

The improved accuracy comes from using a wider range of antigens. An antigen is a molecule — often a protein — on the surface of a bacterium or virus that the immune system recognizes as foreign. Tests look for antibodies your body makes against these antigens.

Traditional Lyme tests rely on antigens from a single Borrelia burgdorferi strain. The IGeneX immunoblots include recombinant antigens from multiple Borrelia species and strains, including those found in both the U.S. and Europe. This broader coverage helps the test detect more true infections, especially early on.

The test is also single‑step, eliminating the need for two separate tests and reducing turnaround time.

Dr. Jyotsna Shah, lead author of the study and President of IGeneX, called the findings “a meaningful advancement.” She notes that earlier and more accurate diagnosis can lead to more timely treatment and better patient outcomes.

For details, click here to read IGeneX’s press release about the new test.