Lab Test Info

Standard Lyme Tests Are Missing

74.9%


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Testing Labs For Ticks
DIY Test Kits and Labs For Ticks (Less Expensive) 
Lyme & Tick Borne Disease Labs For Humans & Ticks 

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Labs That Test For One Of The
"Other" Lyme Disease Strains
Borrelia miyamotoi

Igenex Lab- YES

Imugen Lab- YES

Quest- YES 

PCR- CPT Code- 87798

Labcorp- NO

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Difficulty Affording Lyme Testing?

patient assistance program offered by Ferndale Foundation 
in coordination with the Lyme Patients Assistance Group 
to provide assistance for initial Lyme-related lab tests to 
patients who demonstrate true financial need.

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PATIENTS
To order a test kit from IGeneX Lab

PHYSICIANS
To order Physician Specimen Collection Kits
 
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Approximately $500 MILLION is spent on  

3.4 MILLION standard Lyme tests performed in the USA each year.

Approximately 3/4 of these tests totally miss people with Lyme disease.

What a huge waste of money!

What a dangerous health care practice!


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Lyme tests miss approximately 75% of the patients who have Lyme disease.  
Other sources have determined the percentage of people missed could be as high as 90%.
Shamefully, over a decade later the same insurance friendly tests are still being used and 
Promoted by the Infectious Diseases Society of America (IDSA) 
And the Centers For Diseases Control (CDC).  
(Think patents and follow the money.)
 

Remember, a negative test does not exclude 
The diagnosis of Lyme disease!

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Attention Doctors!
Treat the Patient
NOT The Tests!

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The CDC states.... It is possible for someone who was infected with Lyme disease to test negative because: Some people who receive antibiotics (e.g., doxycycline) early in disease (within the first few weeks after tick bite) may not develop antibodies or may only develop them at levels too low to be detected by the test.  Source


Western Blot Tests Explained

IMPORTANT-  The CDC Western Blot criteria are intended ONLY for surveillance purposes, NOT for determining a diagnosis.

List of Western Blot Bands and 
Explanations from Various Sources 


9-  cross-reactive for Borrellia

12- specific for Bb (Lyme)

18-  flagellin fragment (Lyme)

20- may be cross-reactive for Borrellia

21-  unknown

22-  specific for Bb, probably really the 23/25 band

23 thru 25- outer surface protein C (OspC), specific for Bb. Can be an early band associated with European strains and EM rashes. 

28- OspD. Specific for Bb (Lyme).

23 thru 28- potential for central nervous system (CNS) involvement. 

30- OspA- substrate binding protein- common in European and 
one California strain- specific. Check for mycoplasma.

31- OspA, specific for Bb (Lyme). Thought to be a late appearing strain 

34- outer surface protein B (OspB); specific for Bb (Lyme).

35- specific for Bb

37- FlaA gene product- specific for Bb (Lyme).

38- cross-reactive for Bb

39- BmpA- a major protein of Bb flagellin; specific for Bb- Sometimes found in those with joint involvement. It is the most specific antibody for borreliosis of all bands.

41-  flagellin protein of all spirochetes. This is usually the first to appear after a Bb infection and is specific for all Borrellia.  41 can be positive due to relapsing fever, oral spirochetes and syphilis. Flagella or tail protein.  Flagella is used to move Borrelia burgdorferi from point to point and many bacteria have flagella. This is the most common borreliosis antibody. Band 41 is one of the earliest to show up on Lyme Western Blots. It is also the most common band in control subjects. This may be due to the fact that many people are exposed to spirochetes at some time in their lives and so their blood might cross react with this (41) protein. If band 41 is showing c
heck for Ehrlichiosis. 

45- cross-reactive for all Borellia (sometimes people with Lyme who have this band also have the co-infection Ehrlichiosis). Heat shock protein. This helps the bacteria survive fever. The only bacteria that does not have heat shock proteins is Treponema pallidum, the cause of syphilis.

50- cross-reactive for all Borrellia

55- cross-reactive for all Borrellia

57- cross-reactive for all Borrellia

58- unknown but may be a heat-shock Bb protein- Check for viral infections. Can cross react with Babesia, HGE & HME (Ehrlichiosis), Bartonella and be positive in those with Epstein Barr infections. B. garinii causes intense neurological symptoms. Borrelia garinii shows on Western Blots p58 in Asia (China) and Australia.  

60- cross reactive for all Borrellia

66- Oms66- cross-reactive for all Borrelia, common in all bacteria. Check for E-coli.

83- high molecular mass protein. Specific antigen for the Lyme bacterium. This is the DNA or genetic material of Borrelia burgdorferi. It is the same as 93, based on medical literature. Laboratories vary in assigning significance to the 83 versus the 93 band.

93- an immunodominant protoplasmic cylinder antigen, associated with the flagellum. Specific for Bb. Possibly the same protein as in band 83, just migrates differently in some patients.

ADDITIONAL NOTES:

Bands 18, 23, 31, 34, 37, 39, 83 and 93 are specific for Bb (Lyme)

Healthcare professionals must ask the lab when ordering Lyme Western Blots to report all bands, except IGeneX Lab since it automatically reports all WB bands.

When reporting bands, the reporting laboratory many marks bands with the following indicators of intensity:

-Not present
+Low
++Medium
+++High
+/-Equivocal = indeterminate (present, but not as intense as the "Low" reading)

The CDC recommends using FDA-approved Lyme tests; however, there aren't any FDA-approved tests for Lyme disease. 

Laboratories use different methods and criteria for interpreting their own tests, sometimes resulting in a positive test from one lab and a negative result from another.

The CDC/IDSA preferred two-tiered test system misses approximately 54% of patients.  (2010 Stricker Minerva)  

Due to the inaccuracy of the two-tiered testing system and high number of false negative tests we recommend physicians and patients order only the Western Blot test and not the ELISA. 

Other bacteria besides Borrelia burgdorferi may produce the 45, 58, 66, and 73 kDa bands.

CDC Western blot surveillance criteria fails to include the 31 and 34 kDa bands. Antibodies with these molecular weights correspond to the OspA and OspB proteins of B. burgdorferi, which are considered to be among the most species-specific proteins of the organism. 

Some patients might have an IgM response at the time of the EM rash.  The IgG response tends to start several weeks after infection and peak months to years later.  In some patients, the IgM response can remain elevated- in others it might decline, regardless of whether or not treatment is successful.

Many Lyme disease experts believe it is a mistake to exclude 31 and 34 kDa antibody proteins from the list of significant bands. 

Lyme disease patients may not test positive for exposure to B. burgdorferi because their antibodies to the organism are bound up in immune complexes.

An indeterminate number of patients with late or chronic Lyme disease are simply seronegative for unknown reasons.

If the IgM or IgG sections of the test had 31 kDa, 34 kDa or 83-93 kDa it is fairly good confirmation of past infection along with a current one.  

Dr. Sam Donta- 52% of patients with chronic disease are negative by ELISA, but positive by Western blot (2002). 

Testing for Borreliosis- by Dr. Charles Crist

List of Labs With Contact Information




Some of The Reasons Why Someone Could 

Have A False-Negative Lyme Test

 

Dr. Robert Bransfield


1. Recent infection- before immune response has had time to produce antibodies

2. Antibodies are bound in immune complexes

3. Spirochete encapsulated by host tissue (i.e. lymphocytic cell walls)

4. Spirochete is deep in host tissue (i.e. fibroblasts, neurons, etc.)

5. Blebs in body fluid, no whole organisms needed for PCR

6. No spirochetes in body fluid on day of test

7. Genetic heterogeneity (300 strains, 100 in U.S.)

8. Antigenic variability

9. Surface antigens change with temperature

10. Utilization of host protease instead of microbial protease

11. Spirochete in dormancy phase (L-form) with no cell walls

12. Recent antibiotic treatment for any condition

13. Recent anti-inflammatory treatment

14. Concomitant infection with Babesia may cause immunosuppression

15. Other causes of immunosuppression

16. Lab with poor technical capability for Lyme disease

17. Lab tests not standardized for late stage disease

18. Lab tests labeled "for investigational use only"

19. CDC criteria is epidemiological and is not a diagnostic criteria

20. Lack of standardized control

21. Most controls use only a few strains as a reference point

22. Few organisms are present

23. Encapsulated by glycoprotein "S-layer" which impairs immune recognition

24. "S"- layer binds to IgM

25. Immune deficiency

26. Possible down regulation of immune system by cytokines

27. Revised Western Blot criteria fails to include most significant bands

Source

 



A false-negative Lyme disease test is a disadvantage in several ways.
 
1.  Your health care professional may not realize you have Lyme disease and not treat you as a result.  

2.  False negative tests may cause a delay in obtaining a proper diagnosis.  Not receiving proper treatment in the early stages allows a complex infectious organism(s) to spread throughout your body, making your condition worse and allowing the disease to advance to later stages.  

3.  You may be improperly diagnosed with fibromyalgia, CFS, MS, Parkinson's, ALS, ADD, depression and other disorders when in fact Lyme disease is the underlying culprit.  Treatment for those conditions will not reach the source of the problem.  
 
4.  A negative test provides the insurer another reason to deny your medications and any further testing or treatment for Lyme and tick borne diseases.



Johns Hopkins 2005 Lyme Test Study 
(Approximately 75% of people with Lyme are missed with standard testing methods)

Study Here

Problems with Hopkins study were addressed by an independent researcher (Joel Spinheim).  J. Stephen Dumler, coauthor of the highly contested 2006 Lyme Disease Guidelines who was investigated for potential conflicts of interest by the Attorney General, responded to these concerns.  

Dumler dismissed the independent researchers concerns of over estimating the ability of the tests to detect Lyme disease, kicked a lab (IGeneX) used as as alternative due to better performing tests and that wasn't suspect in the AG's investigation, referred to the 2006 IDSA (also part of the investigation) and curtly stated... 

QUOTE-  "...it would be a disservice to evidence-based medicine to misclassify patients by broadening gold standards to those derived from questionably objective clinical manifestations, subjective “accumulated experience,” or well-intentioned but unsupported opinions."



Lyme Disease Diagnosis


Lab Contact Information

Human Testing & Tick Testing Lists and Labs 

List Located Here



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