Major Changes Expected in Lyme disease test

1. Major Changes Expected in Lyme Disease Test

2. The most successful way to approach Lyme disease includes multiple methods of treatment and an open mind. • The symptoms of Lyme are nonspecific and overlap with many other disease conditions. Not all people present with the classic bulls-eye rash after a tick bite. People with a chronic Lyme infection may have had it for months or years and will likely present with very low antibody concentrations. The numbers may be low enough to not register on standard laboratory testing and would officially, falsely, test negative for Lyme disease.

3. Sometimes treatment for Lyme is necessary to stimulate the immune system to mount a response and then subsequent laboratory tests will report positive for the infection. According to statistics released by a pet insurance provider (Veterinary Pet Insurance), Lyme disease is the most common canine infectious disease for the third year in a row. Forty-sever percent of all the claims Veterinary Pet Insurance received were for tick born infectious diseases. Lyme disease, ehrlichiosis (caused by the Brown Dog tick and the lone star tick, infection enters the white blood cells and causes anemia and other complications) and anaplasmosis (caused by deer ticks, the disease is similar to Lyme disease) are among the three leading infectious tick diseases.

4. The following schematic is from the CDC regarding the protocol for medical laboratory testing for suspected Lyme disease. One blood sample gets tested via EIA or IFA first and if positive, gets further tested by Western Blot. The tests look for evidence of antibodies against the BorreliaBurgdorferi, the Lyme disease bacteria. Like many chronic problems officially undiagnosed by the medical community, laboratory tests for Lyme do not necessarily lead to recovery. If they are negative, they do not help inform treatment. There exist medical doctors who specialize in and understand Lyme disease and treatment, but they are rare. However, if you have Lyme disease, I believe it is worth your time to find a medical doctor who can help manage medications you might need during your recovery, if you choose to take prescription medicine.

5. Last November the FDA stated it was going to start regulating what it calls "Laboratory Developed Tests". These are tests that are developed by and for single laboratories (often genomic firms) but have not been subjected to regulatory approval. At the time the FDA's regulation was created these tests were rare but with the development of genomic testing thousands have been developed. Many labs do subject their tests to stringent internal and/or independent testing but not all do. That announcement was met by fierce opposition by industry and some academics. They stated the new regulations - which will likely make tests more expensive to develop - would stifle innovation and hurt patients.

6. Lyme disease tests were featured front and centre in a recent FDA report highlighting 20 offending lab tests. The FDA and Lyme disease labs and some Lyme physicians have been butting heads for years. In 2005 the CDC posited an alert about the same types of tests included in this most recent report. The CDC has gone so far as to produce video's featuring patients misdiagnosed with Lyme disease who were later found to have something else. (See below).

7. In a report titled IGENEX - Lyme Disease Tests, the Centre for Investigative Reporting found, however, that thousands of people were being assessed for Lyme disease every year using invalidated and inaccurate tests. It noted that New York State - the only state that attempts to independently verify the accuracy of the tests - is not allowing seven labs to run Lyme disease tests there.

8. IGeneX, a large Lyme disease testing lab, took several tries to get accredited in New York but finally did. According the Centre report IGeneX offers a Western Blot and urine tests and allows fewer bands is present for a Lyme Diagnosis than the CDC. IGeneX argues that their test is fully validated and that the CDC's stricter criteria allow some cases of Lyme disease to be missed. The FDA asserts that a diagnosis of Lyme disease should be made based on a history of tick exposure, symptoms and two positive tests: a positive initial enzyme-linked immunodeficient assay test followed by a confirmatory Western Blot test. One FDA official stated it was very important that both tests be done. The Western blot tests are not affected by the new oversight; the FDA has OK-ed over 80 Western Blot tests by different laboratories for Lyme.

9. Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year. The FDA apparently has little good to say about the rest of the Lyme disease tests. It asserts that many urine, blood and culture tests for Lyme disease are not accurate and are causing harm. The Western Blot test identifies IgM and IgG antibodies against several different B. burgdorferi antigens. Because the test can pick up antibodies other than the Lyme bacteria everyone will probably test positive to at last one band. The FDA requires that at least 5 of 10 bands on the IgG assay and 2 of 3 bands on the IgM assay be positive for a Lyme diagnosis.

10. About IGeneX Lyme test - IGeneX is an American specialist Lyme testing lab. IGeneX has been accredited by the Centres for Medicare and Medicaid Services (CMS) and in addition, it holds California, New York, licensure since these States require a separate license to perform testing for patients.

11. They have a number of options including testing for other infections that you can receive from a tick bite alongside Lyme. Many of these extra tests can become quite expensive. To get an IGeneX test you will need a doctor to take your blood, sign the request form for the tests and receive the results, IGeneX will not post results to a patient alone. If you have an open minded GP they may do this, some private doctors will or there are 2 private clinics in England who will see you for Lyme and carry out a test with IGeneX at your request, but be aware you will pay for the consult with these as well as the test.

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