Current methods used to detect Lyme disease aren’t good enough. That’s why we’re working to find better tests that can be used to catch the disease in its various stages and ultimately enable better outcomes.
Lyme Disease is Difficult to Diagnose
Ticks and tick bites are tiny and often go unnoticed. Most people never know they were bitten. The distinctive bullseye skin rash is an atypical presentation (many patients never have any rash) and other symptoms like fatigue, joint pain, and fever, mimic many other illnesses.
The widely used diagnostic testing regime for Lyme disease is the two-tier serological ELISA/Western Blot process, which indirectly detects Lyme disease by measuring the presence of antibodies that form against the pathogen. Because it can take 2-4 weeks for the body to generate antibodies, these tests have been shown to miss up to 60% of acute Lyme cases. They also do not detect other related Borrelia species (e.g., the Lyme-like Borrelia miyamotoi), have high inter-and intra-laboratory variability, and cannot be used to assess treatment response following antibiotics.
Unfortunately, direct detection of the infection has proven challenging due to low bacterial counts that disperse quickly throughout the human body and the insufficient sensitivity of current detection methods. Newer, more accurate detection approaches are being developed, but many of these tests have not yet been through formal controlled clinical trials.
The Problems with the Current Two-Tier Test*
- Misses up to 60% of acute cases (Rosenfeld , Wang, Schwartz, Wormser, 2005)
- Can not differentiate between active infection and previous exposure
- Does not detect other Borrelia species including B. miyamotoi, which causes Lyme-like symptoms
- Requires subjective interpretation of results, leading to significant variability across and even within laboratories
*Two-tiered ELISA / Western Blot blood test.
Developing Better Methods
Lyme cannot be cured if it cannot be diagnosed accurately. Now more than ever there is both the need and opportunity for better diagnostics. New advances in genomics, proteomics, metabolomics, nanotechnology, microarrays, high-throughput sequencing, and imaging offer promising new approaches for both direct and indirect detection. Innovative scientists are applying technologies and novel approaches from other fields of medicine with encouraging results.