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Testing

IGeneX has become a well-known name within the Lyme community as the only lab currently offering Lyme specific testing. Because of this, there are many nay-sayers who regard the lab's work as 'mickey-mouse' and 'not viable'.


Please visit IGeneX's site and read their statements, what US States they are licenced in, and what testing services they offer.





Diagnostic Criteria (US) 

Serologic Diagnostic Criteria recommended by Second National Conference on Serologic Diagnosis of Lyme Disease (1994) [11]

A 2-tier approach is recommended: 

 

  • All specimens positive or equivocal by a sensitive ELISA or immunofluorescence assay (IFA) should be tested by a standardized Western blot assay. Specimens negative by a sensitive ELISA or IFA need not be tested further. 
  • For early Lyme disease (first 4 weeks), Western blot should be done for both IgM and IgG antibodies. 
  • In a patient with suspected early Lyme disease who has a negative ELISA, a repeat serologic test should be done during the convalescent phase(paired sera samples) >2 weeks later. 

People with disseminated or late Lyme disease show a strong IgG response to B burgdorferi antigens. 

 

 

 

First Tests to Order:


                                                                                                                                                                                                                 

Test                                        Result 

 

ELISA or IFA*                           positive

 

* This test is also done in Canada and is NOT a reliable test as it historically misses thousands of Lyme diagnosis annually. The development of a more sensitive screen for Lyme is desperately needed.

Although this test is grossly inadequate, this test is still being used regularly by most physicians across the nation who believe that this test is reliable. Statistics show otherwise. 

An average of 6 per province in Canada vs. thousands per year in the US states across our borders is questionable.

 

What is an ELISA test? Find out here!

 

All specimens positive or equivocal by a sensitive ELISA or immunofluorescence assay (IFA) should be tested by a standardized Western blot assay for confirmation. [11] 

 

Specimens negative by a sensitive ELISA or IFA need not be tested further. However, in a patient with suspected early Lyme disease who has a negative ELISA, a repeat serologic test should be done during the convalescent phase (paired sera samples) >2 weeks later. Background seropositivity in highly endemic areas can exceed 4%. [11]

 

IgM blots should only be used in the first month of infection. [11] 

 

Both IgG and IgM may remain positive for a long period (months to years) after previous treatment.

 

 

Other Tests to Consider:


        

Test                                           Result 

 

Lyme-specific IgM and IgG         positive

Immunoblot (Western blot) assays should be ordered for Lyme-specific IgM and IgG for patients with equivocal or positive ELISA results. [11]

 

For early Lyme disease (first 4 weeks), Western blot should be done for both IgM and IgG antibodies. [11] 

 

Sensitivity is low in early disease, but specificity is high. [11]

 

People with disseminated or late Lyme disease show a strong IgG response to B burgdorferi antigens. [11] 

 

Both IgG and IgM may remain positive for a long period (months to years) after previous treatment.

 

 

skin biopsy culture                      positive

Rarely performed. 

Culture is performed in Barbour-Stoenner-Kelly medium. 

 

Positive culture is likely from biopsy specimens from erythema migrans lesions, but is less likely in serum and cerebrospinal fluid samples. [9]

 

There are only anecdotal reports about joint fluid.

 

PCR                                             positive

PCR shows positive results in later stages of infection. Best yield is with synovial fluid. [9] 

 

 

ECG                                             AV Block

An ECG is indicated only in patients with signs and symptoms of cardiac disease. [1]

 

Includes acute onset of varying degrees of intermittent AV block. 

 

Myopericarditis occurs rarely.

 

 

New Tests That Are Also Being Considered:

 
A couple new tests that have been very promising have emerged since the inception of this site information.
These are as follows:
 
For Lyme infection later than 3 wks or Chronic Lyme patient testing:
 
  • CD 57 (Dr. Striker): This test measures the lymphocyte count, which will drop below 60 in a spirochaetal infection.
  • C6 ELISA: This test can only be performed after 3 weeks of infection. This test indicates VISE lipoprotein particles of the spirochaetes.

 

 

Reference11 :Centers for Disease Control and Prevention. Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep. 1995;44:590-591.[Abstract] http://www.cdc.gov/mmwr/preview/mmwrhtml/00038469.htm