Almost all labs are subject to variability therefore laboratory testing is far from absolute.  For example at the time of the blood draw the antibody production and microbe concentration may be very low in chronic infections therefore false negatives are common.  The two tests individuals receive at their doctor’s office to rule out whether someone has Lyme disease are the ELISA/EIA and Western Immunoblot test.  

“Lyme disease diagnostic testing strategy is known to have a sensitivity/specificity averaging around 56%, and per the Centers for Disease Control and Prevention (CDC), the ELISA/EIA and Western Immunoblot tests are not intended to be used by health care workers for making a clinical diagnosis.  Approximately half of the individuals with Lyme may go undiagnosed” (Horowitz & Freeman, 2018).

There was a study done by the Lyme Disease Biobank that had 550 participants and among the findings, the CDC’s standard two-tier testing algorithm for Lyme disease failed to accurately diagnose 71% of the blood samples (Horn et al, 2020)

Both the ELISA/EIA test and Western blot tests are indirect tests meaning that they are measuring the patient’s antibody response to the infection, not the infection itself.   The Infectious Disease Society of America, which is a board panel of 14 doctors that set standards for how all physicians are to diagnose and treat Lyme do not believe Lyme is a chronic infection, they believe that it is only an acute infection.  You can hear the two board members saying those exact words to the video camera on the documentary “Under Our Skin.”  Therefore our common diagnostic and treatment methods that are utilized when you go to your Western MD are only intended for looking at Lyme as an acute infection (early disseminated phase) and not a chronic infection (late disseminated phase).  The testing criteria are designed for epidemiological study and are not for clinical diagnostics (Horowitz & Freeman, 2018).  Below is a list of the most common reasons why the laboratory tests ELISA/EIA and Western blot can have a false negative therefore incorrectly diagnosing why someone has Lyme disease.

22 reasons why Lyme tests fail:

1. You were recently infected and tested before your body produced Lyme antibodies.
2. You took antibiotics before testing which co-opted the antibody response.
3. You were already on long term antibiotics for another illness.
4. Not enough “free” Lyme antibodies were detectable in your blood because they were all doing their job binding to the Lyme bacteria.
5. Lyme spirochetes were protected and hiding inside a biofilm colony.
6. Spirochetes were burrowed deep inside your body (i.e. cartilage, fibroblasts, neurons.etc).
7. Only small blebs were in your body, no whole bacteria which are needed for the PCR (polymerase chain reaction) based tests.
8. No free spirochetes in body fluid on the day of the test.
9. Genetic heterogeneity (there are at least 300 strains of Lyme, 100 in the U.S). You might be infected by a strain of Borrelia that the test doesn’t recognize.
10. Antigen variability: Borrelia can change its outer surface protein to suit its environment so the test will detect a “non-Lyme specific” antibody.
11. Spirochetes are in dormancy phase (L-form) with no cell walls so there is nothing for the immune system to attack with antibodies.
12. Lyme’s surface antigens can change body temperature.
13. You have an immune deficiency (the body isn’t producing antibodies).
14. You have had a recent anti-inflammatory treatment which suppresses the immune system. (i.e., steroids, arthritis meds).
15. Co-infections with Babesia (protozoa) which causes immune suppression
16. Down-regulation of your immune system by your body’s own cytokines.
17. Lab error or poor technical capability/training to detect Lyme.
18. You might have late-stage Lyme. Lab test are not standardized for detecting late-stage Lyme.
19. The lab tests might only have been approved for investigational use.
20. Lack of adequate reference points for the test (most tests only use a few genetic strains as reference).
21. The revised Western Blot criteria fail to include important antibody bands (i.e., 31,34).
22. CDC testing criteria is designed for epidemiological study, not clinical diagnostics.

‍

References

Horn et al. (2020, May 26).  The Lyme Disease Biobank: Characterization of 550 Patient and Control Samples from the East Coast and Upper Midwest of the United States. Journal of Clinical Microbiology. Volume 58, No.6. https://journals.asm.org/doi/10.1128/jcm.00032-20

Horowitz, R. & Freeman, P.   (2018, December 6).  Precision Medicine: The Role of the MSIDS Model in Defining, Diagnosing, and Treating Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome and Other Chronic Illness: Part 2.  National Library of Medicine. PMID: 30400667.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316761/#:~:text=Since%20the%20present%20Lyme%20disease,contracted%20a%20tick%2Dborne%20illness.

‍