Lyme disease is a clinical diagnosis—based on your medical history, symptoms and exposure to ticks. Because the typical Lyme disease diagnostic tests are so insensitive, a negative test result does not mean you don’t have Lyme. There are many reasons why someone who actually has Lyme may have a negative test result. There may not have been time for antibodies to develop; the immune system may be suppressed; or the person may be infected with a strain the test doesn’t measure.
Lyme disease is known to inhibit the immune system and 20-30% of patients have falsely negative antibody tests.
Lyme Disease Diagnosis and Testing Highlights
- LLMDS consider the specificity of the particular bands that test positive for a patient.
- Although the CDC requires 5 of 10 bands for IgG surveillance purposes, 2 of 5 bands have specificity of 93-96% and a sensitivity of 100%. (Engstrom 1995).
- 56% of patients with Lyme disease test negative using the two-tiered testing system recommended by the CDC. (Stricker 2007)
- The CDC case surveillance definition allows single-tier IgG immunoblot seropositivity using established criteria. (CDC 2011; www.cdc.gov/nndss/conditions/lyme-disease/case-definition/2011/)
- The CDC states: “This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis.” (www.cdc.gov/nndss/conditions/lyme-disease/case-definition/2011/)
- The College of American Pathologists (CAP) found that ELISA tests do not have adequate sensitivity to be used for screening purposes. (Bakken 1997)
- 52% of patients with chronic disease are negative by ELISA but positive by Western blot. (Donta 2002)
Learn More About Lyme Disease Diagnosis Testing
Tests can not only help to diagnose a disease, but also to manage an illness. A good test can help a doctor assess the severity of disease, estimate the patient’s prognosis, monitor the course of disease progression, stability or resolution, detect relapse, and select drugs or adjust therapy. Unfortunately, a test with this capability does not exist for Lyme disease. To learn more about specific tests, visit: Lyme Disease Tests.
LymeDisease.org has developed a Lyme disease symptom checklist to help you document your exposure to Lyme disease and common symptoms for your healthcare provider. You will receive a report that you can print out and take with you to your next doctor’s appointment that may be helpful in your Lyme disease diagnosis.