What to Know

ELISA (Enzyme-Linked Immunosorbent Assay) and the Western blot.

Both of these tests are indirect ones, meaning that they measure the patient’s antibody response to the infection, not the infection itself.

The CDC (Centers for Disease Control) recommends two-tiered Lyme disease testing using these two tests. The first, ELISA, is a screening test that should detect anyone who might have the disease. This test is followed by a second test that is intended to make sure that “only people with the disease are diagnosed.” (CDC

The problem with the recommended two-tier protocol has to do with a number of factors:

1. The inaccuracy of the ELISA, is the first test in this protocol. This screening test is highly insensitive, and fails to identify patients who have Lyme disease. The two- tiered system misses roughly 54% of patients (Stricker, Minerva 2010). A positive ELISA test is a reasonably accurate in detecting Lyme, but a negative is meaningless. The result is that practitioners miss an important opportunity o diagnose and treat patients.

3. The unreliable design of two-tiered protocol. During the first four to six weeks of Lyme infection, these Lyme disease tests are unreliable because most people have not yet developed the antibody response that the test measures. Even later in the illness, the two-tiered testing is highly insensitive missing roughly half of those who have Lyme disease.

Lyme (Borrelia Burgdorferi), is a clever pathogen that hides in body tissues; and therefore, many times undetected with these two tests.

4. This two-tiered protocol, in the opinion of Lyme-literatepractitioners,is flawed because it is backward. While both tests have drawbacks, but the Western blot is far more reliable test superior to the ELISA. Much like the screening for breast cancer, the ‘better’, more sensitive test SHOULD be used FIRST, so that more cases of Lyme are detected. (Remember, less than half of patients test will be positive.)

More about the Western blot test . . .

A Western blot use electricity to separate proteins called antigens into bands. The readout from the Western blot looks like a bar code. The lab compares the pattern produced by running the test with your blood to a template pattern representing known cases of Lyme disease. If your blot has bands in the right places, and the right number of bands, it is positive.

*The CDC requires 5 out of 10 specific, and particular bands for a positive test result! Many sick patients have only a couple bands, or react to other ‘Lyme bands’ that the CDC removed from its requirement.

However, because some bands on the Western blot are more significant than others, and you are very symptomatic, your doctor may decide you have Lyme disease even if your Western blot does not have the number of bands or specific bands recommended by the CDC. Different laboratories use different methods and criteria for interpreting the test, so you can have a positive test result ‘reactive’ to only one or two bands!

Information to help you advocate

Information to help you advocate for the right tests conducted by the specialized labs that focus tick-borne disease testing and are more reliable and sensitive to detect Lyme and its coinfections.

· Please know that there are many co-infections/pathogens associated with the Lyme infection that contribute to a patient being very ill, which is why many in the Lyme borne panels, offered by common labs covered by insurance i.e., Quest, Lab Corp., etc. BE SURE your provider is testing you for the co-infections associated with your region!

(Please see our additional informational sheet about these co-infections)

· We recommend that you confirm with your practitioner who is ordering these tests, that if the CDC 2-tier testing for Lyme, (Borrelia burgdorferi,) is ordered, that tier 2 is completed even if tier 1(ELISA) is NEGATIVE! **Additional names for the more accurate 2-tiered testing, depending on the lab and where it is being ordered from could be called the 'reflex' to the Western Blot or Immunoblot (IgG, IgM). We know how confusing this information can be, so please contact us to help!

*Helpful hints…if your phlebotomy results arrive in a few days, chances are, they did not do not perform the tier 2, "more reliable test Western blot”. Also, if your results are given with a simple “Negative” or “Positive,” again, the best protocol out there, was not ordered correctly, by the provider, “asking,” to proceed to Western blot with all bands listed- OR the results were not uploaded to your portal. Results should read “Reactive, Non-Reactive, Equivocal, Positive, Negative, or Present,” - which is reporting your body’s response to each protein/ antigen tested. You have a medical and legal right to these results and the full report! In many cases, unless using a lab that is recommend, you will need to advocate for these results. One example is given below.

Other Available Tests to Discuss with your Practitioner

•Other Available Tests to Discuss with your Practitioner

Lyme Immuno Blots Test-The IgM and IgG ImmunoBlot (IB) are qualitative immunoassays in which antibodies are visualized. They are used to determine whether pathogen-specific antibodies are present in patient serum or plasma. These tests are generally more sensitive and specific than the Western Blot, ELISA and IFA tests.

-Three other tests that may be used to diagnose Lyme disease are polymerase chain reaction (PCR), antigen detection and culture testing. They are called “direct” tests because they detect the bacteria, not just your immune response to it.

-PCR multiplies a key portion of DNA from the Lyme bacteria so that it can be detected. While PCR is highly accurate when the Lyme DNA is detected, it produces many false negatives. This is because the Lyme bacteria are sparse and may not be in the sample tested.

-Antigen detection tests look for a unique Lyme protein in fluid (e.g., blood, urine, joint fluid). Sometimes people whose indirect tests are negative are positive on this test. -Culture is the “gold standard” test for identifying bacteria. The lab takes a sample of blood or other fluid from the patient and attempts to grow Lyme spirochetes in a special medium.

-Although culture tests are generally accepted as proof of infection, the CDC has advised caution on the only commercially available culture test developed by Advanced Laboratory Services. Lyme + Practitioners recognize that the test is new and requires further validation in other studies. However, we believe that informed patients should be able to choose the test if they prefer. Choice is particularly important given the low quality of Lyme disease tests, generally

Other labs used by Lyme-literate practitioners:

Although the CDC recommends that patients use “FDA-approved” tests, we, along with Lymedisease.org, do not support this restriction, because there are no FDA-approved test for Lyme disease!

THIS is something to be mentioned to your practitioner and/or insurance provider when they try to use that reasoning for not wanting to use a more specific, advanced, reliable lab! Instead, the FDA has “cleared” certain lab tests, but these tests are not required to demonstrate that they are effective or safe, they are only required to be “equivalent” to test previously cleared. The current FDA cleared tests have poor sensitivity and miss more than 50% of patients with Lyme disease. The US Centers for Medicare & Medicaid Services (CMS) requires tests without FDA approval to undergo a rigorous certification process.

CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). CLIA certification is designed to ensure quality laboratory testing. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments. CLIA covers approximately 244,000 laboratory entities.

Two highly specific bands (OspA and OspB) are not included in the CDC bands because they were used for vaccine development. Your doctor may want to know if you have antibodies directed towards those proteins. A few labs test for them. Most all Lyme Foundations/Groups/Lyme docs, recommend that you use a CLIA-approved lab that specializes in testing for tick-borne diseases and reports ALL bands on the Western blot.

YOUR healthcare professional/practitioner ordering the test *must ask/require the lab to report all bands except in the case of IGeneX, which automatically reports all bands. Blots may still vary in sensitivity

Please contact our foundation with questions or additional recommendations: Neladresourcefoundation@gmail.com

·IGeneX: https://igenex.com/ phone:1-800-832-3200 (Covered by most Medicare)

·Galaxy Diagnostics- https://www.galaxydx.com phone: 919-313-9672

Sources and for additional information visit….

https://www.lymedisease.org/lyme-disease-test/and/or https://www.bayarealyme.org/get-help/lyme-testing/

Sources: IGeneX labs. Lymedisease.org, and Bay Area Lyme Foundation