Lab Test Info

Standard Lyme Tests Are Missing

74.9%


*

IGeneX Lab 
Tests for 
Borrelia miyamotoi

Other Labs That Test For Borrelia miyamotoi

Igenex Lab- YES

Imugen Lab- YES

Quest- YES 

PCR- CPT Code- 87798

Labcorp- NO


***

PATIENTS
To order a test kit from IGeneX Lab

PHYSICIANS
To order Physician Specimen Collection Kits
 
***

Approximately $500 MILLION is spent on the 

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!


***
 
According to a 2005 study from Johns HopkinsLyme 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%. 

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

***
Attention Doctors!
Treat the Patient
NOT The Tests!

***

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

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

23-25 outer surface protein C (OspC), specific for Bb.  Can be an early band. 

28 OspD.  Specific for Bb (Lyme).

[23-28] Potential for Central Nervous System (CNS) involvement. 

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

31 OspA, specific for Bb (Lyme). 

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.  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.  Many bacteria have flagella.  This is the most common borreliosis antibody.  

45 cross-reactive for all Borellia (sometimes people with Lyme who have 
this band positive 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

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. Possibly the same protein as in band 83, just migrates differently in some patients.

NOTES:

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

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

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

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.

Article- Testing for Borreliosis- by Dr. Charles Crist



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 
(75% of people with Lyme are missed with standard testing methods)  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1248466/pdf/0742-05.pdf

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

***

IGeneX Lab

Over the years informed health care professionals have discontinued using the standard "insurance approved" tests and will send blood samples to labs that specialize in tick borne disease testing.   If you would like to use a specialty lab to aid in the diagnostic process, you (or your doctor) can have a test kit sent upon request.  For more information please contact:    

IGeneX, Inc.
795 San Antonio Rd
Palo Alto, CA 94303
Phone: 1-800-832-3200 Toll free
Fax: 1-650-424-1196 


Difficulty Affording Lyme Testing?

The Lyme Test Access Program (Lyme-TAP) is a nationwide 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.


Lab Contact Information

(Human Testing)


IGeneX, Inc.
Tick Borne Disease Testing

795 San Antonio Rd

Palo Alto, CA 94303

Phone: 1-800-832-3200 Toll free
Fax: 1-650-424-1196 

BioHealth Diagnostics

Adrenal Testing

Phone 619-223-7074

Genova Diagnostics

Detox Profile, Hair Testing  

Phone 800-522-4762

Meridian Valley 

Allergy, Hormone Testing         

Phone 425-271-8689

Metametrix

Ion, Urine Testing                       

Phone 800-221-4640

Fry Laboratories, L.L.C.  

Tick Borne Diseases

Phone 866-927-8075

Advanced Laboratory Services

Lyme Culture Tests

855-238-4949

Genelex Lab

Liver Enzymes, MTHFR, etc.

3101 Western Ave., Ste. 100, Seattle, WA 98121

800-TEST-DNA (800-837-8362) or 800-523-3080

Medical Diagnostic Lab, LLC

Tick Borne Diseases

2439 Kuser Road 

Hamilton, NJ 0869 

877-269-0090

Galaxy Diagnostics

Bartonella & Other TBD's

7020 Kit Creek Road

Suite 130

Morrisville, NC  27560

919-313-9672


Laboratories Testing Ticks 


FREE Tick Testing


Additional Options

IGeneX, Inc.
795 San Antonio Rd
Palo Alto, CA 94303
(800) 832-3200

Up to 20 ticks per batch
Multiple Tests- Each Test You Order Is $68.00

Lyme Disease (B. burgdorferi) 
Babesiosis (B microti and/or B duncani) 
Ehrlichiosis (Ehrlichia)
Bartonella henselae
Rickettsia
Relapsing Fever 

More Information & Form
http://www.igenex.com


***

Connecticut Veterinary Medical Diagnostic Laboratory

61 North Eagleville Road

Unit 3203 Storrs, CT 06269-3203 

Phone: 860-486-3738 

Fax: 860-486-2737


Deer Tick: 1-Panel PCR- Borrelia burgdorferi - $50.00

4-Panel PCR (Human Host) - Borrelia burgdorferi, Anaplasma phagocytophilum, Babesia microti, Borrelia miyamotoi - $120.00

3-Panel PCR (Non-Human Host) - Borrelia burgdorferi, Anaplasma phagocytophilum, Borrelia miyamotoi - $100.00

Dog Tick: 3-Panel PCR (Any Host) - Francisella tularensis, Rickettsia rickettsii, Ehrlichia species - $100.00

Lonestar Tick: 3-Panel PCR (Any Host) - Francisella tularensis, Ehrlichia species, Borrelia lonestari - $100.00

Brown Dog Tick: (Non-Canine Host) - Rickettsia rickettsii - $50.00

2-Panel PCR (Canine Host) - Rickettsia rickettsii, Ehrlichia species - $80.00


More Information & Forms

http://cvmdl.uconn.edu/forms/ACCDOC007%20Tick%20Submission%20Form%20fillable%2012716.pdf


***


Analytical Services, Inc.

Tick Testing 

130 Allen Brook Lane

Williston, VT 05495

(800) 723-4432

Lyme Disease (Borrelia burgdorferiONLY-  $65 per tick

More Information & Forms  http://www.analyticalservices.com/tick-testing.html 


***


Connecticut Pathology Laboratories

1320 Main St., Ste 24

Willimantic, CT 06226

(860) 450-1823            

Individual Test (Borrelia, Anaplasma, or Babesia): $50.00 

2-Test Panel (Borrelia and Anaplasma, Anaplasma and Babesia, Borrelia and Babesia): $80.00 

3-Test Panel (Borrelia, Anaplasma, and Babesia): $100.00

Call number above for forms and instructions

 

***

Imugen

315 Norwood Park South

Norwood, MA 02062

(800) 246-8436

DEER TICKS ONLY

$75.00 for B. burgdorferi (Lyme Disease spirochete)

$75.00 for B. microti (Babesia parasite)

$98.00 for both B. burgdorferi and B. microti

More Information & Forms

http://www.imugen.com/tick_testing.html

 

***

Clongen Laboratories 

211 Perry Pkwy #6

Gaithersburg, MD 20877

(301) 916-0173

Multiple Organisms

Individual test (see list at website) – $75 two or more tests – $65 each except viruses.  ColtiVirus: $195, Heartland Virus: $195, Powassan Virus: $195.  All three viruses: $500

More Information & Forms

https://www.clongen.com/clinical-diagnostics-services/tick-testing-information/


***

Tick Chek- Tick Testing Services

1-866-713-Tick

East Stroudsburg, PA

Multiple Organisms- Check List Here



(Please see links to subpages below for more information.)
tumblr tracker
shopify visitor statistics

web counter