Tuesday, April 16, 2024

How Reliable Are Lyme Disease Tests

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The Clinical Diagnosis Of Lyme Disease

Reliability of Lab Testing for Lyme Disease

Misconception: Lyme disease is a clinical diagnosis that should be made based on a list of symptoms.

Science: No clinical features, except erythema migrans or possibly bilateral facial nerve palsyin the appropriate contextprovide sufficient specificity or positive predictive value. Laboratory confirmation is essential except with erythema migrans.

Elisa And Ifa: Grade F

These are screening tests to see if a person has antibodies that attach to the covering of Lyme germs. Unfortunately not only do Lyme antibodies attach but other types of antibodies made against viral infections or other germs can also attach. Because of this these are “could” tests. When these tests are positive they indicate that a person could have antibodies against a Lyme germ.

As a screening test for Lyme the ELISA and IFA are very poor. In fact numerous studies indicate an ELISA test only has a sensitivity of 50%.

Believe it or not, even with such poor reliability, the CDC and the Infectious Disease Society of America recommend this as the first test to perform on a person suspected of having Lyme disease. They recommend a two step method that includes an ELISA or IFA as step one. If one of these are positive then the second step is to perform a western blot which I describe below.

Grade: F. These tests have such a low sensitivity that they should not be used. They are an absolute waste of money even when performed by a high quality Lyme testing lab such as IGenex.

What Abnormal Results Mean

A positive ELISA result is abnormal. This means antibodies were seen in your blood sample. But, this does not confirm a diagnosis of Lyme disease. A positive ELISA result must be followed up with a Western blot test. Only a positive Western blot test can confirm the diagnosis of Lyme disease.

For many people, the ELISA test remains positive, even after they have been treated for Lyme disease and no longer have symptoms.

A positive ELISA test may also occur with certain diseases not related to Lyme disease, such as rheumatoid arthritis.

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Common Types Of Testing For Microbes

Testing is getting better, and there are a variety of different ways to test, but none of them are anywhere near 100% accurate. Testing is mostly useful for diagnosing acute illness. This is especially true when symptoms of illness suggest infection with a higher virulence microbe that might respond to acute treatment with antibiotics. New innovations may gradually improve testing for chronic illness associated with stealth microbes.

First Its Important To Understand How A Doctor Should Test For Lyme Disease

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Standard Lyme disease lab testing uses a two-tier system to analyze your blood for antibodies, which is recommended by the CDC. First, you take an enzyme-linked immunosorbent assay testalso known as enzyme immunoassays which aims to detect Immunoglobulin G and Immunoglobulin M in your blood, or antibodies that your immune system produces in response to the bacteria that cause Lyme, the Borrelia species.2

If you test positive for IgG and IgM antibodies, then the CDC also recommends taking a Western blot test. This test looks for bands, which are barcode-like lines of proteins in the blood that signify IgG and IgM antibodies.3 Alternatively, you may take another ELISA test to confirm the results of the first test.

Some at-home Lyme disease test manufacturers claim to use a similar process to laboratory tests. Others may test urine samples or tissue from your cheeks, which are not recommended testing methods for the identification of Lyme disease antibodies, according to the National Institute of Allergy and Infectious Diseases.

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Experts Agree Around The World

A strong scientific consensus is evident about Lyme disease diagnosis and testing.

A 2018 French review of 16 Lyme diagnostic guidelines from 7 countries revealed a global consensus regarding diagnosis at each stage of the infection. The only outlier was the pseudoscience group German Borreliosis Society , a German counterpart to the pseudoscience group ILADS.

Lyme Blood Culture: C

A United States lab called Advanced Laboratory Services had a Lyme disease blood culture that may have good predictive value in finding Lyme infection. Note: ALS no longer offers this tests. Traditionally the problem with Lyme blood culture has been finding a substance to grow the Lyme germ. ALS has perfected a method that involves three separate steps. In the first step the blood is incubated on a special modified BSK medium. Then after 2 weeks it is transfered to a medium that has a protein matrix. As a third step a PCR techinique is use to determine if the growth on the medium is really borrelia. PCR is a techinique that finds the dna of an infection, in this case borrelia.

There is one study of this technique performed by Eva Sapi PhD and her research group. Of note the research was supported by ALS and Dr. Sapi is a member of the Research Division at ALS. This means there is an inherent bias built into the results of the research to find a positive result supporting the effectiveness of the test.

The test included 72 people who were known to have Lyme based on the very strict standards of the CDC and IDSA. There were also 50 people put in a control group who did not have Lyme. The study results found 94% sensitivity and 100% specificity.

In fact in my limited use of this test I found it missed many that I diagnosed with Lyme disease based on other tests and clinical grounds.

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Traditional Lyme Disease Tests Are Not Specific Enough

Lyme disease is caused by the spiral-shaped bacteria Borrelia. There are multiple species and strains of Lyme borreliae . Therefore, tests must be targeted to these multiple species and strains in order to be able to detect them. If a patient is infected with a species or strain of Lyme borreliae that their test cant detect, they will get a false-negative test result and thus risk missing their diagnosis. This can be costly and dangerous.

Many ELISA and Western blot Lyme disease tests are only equipped to detect one strain of one species of Borrelia: Borrelia burgdorferi B31 . This means that those tests are missing infections caused by other strains and/or species of Lyme borreliae.

In one internal study designed to test the validity of the IGeneX ImmunoBlot against traditional Western blot tests, a total of 132 patients were tested by both Lyme Western blots and Lyme IB. 43 patients were seropositive on the ImmunoBlot, and 14 were positive on standard Western blots prepared from a mixture of two species for Bb ss B31 and 297. Thus 29 of the 43 patients tested negative on Western blots i.e., the Western blot totally missed their infections with strains other than Bb ss B31 and 297.

With such limited tests, patients infected with non-B31 species and strains e.g., B. mayonii, B. californiensis, or European species are at risk of receiving false negatives and missing the chance to treat their diseases.

Lyme Disease Pcr Testing

Lyme Disease Serologic Testing

A polymerase chain reaction test, also known as a PCR test, checks blood for evidence of a pathogens DNA. In some cases, a PCR test will be performed using a sample of synovial fluid, which is found in the joints. This test has become very common in the past two years because of the COVID-19 pandemic. Millions of people have had to undergo PCR testing for coronavirus.

A Lyme disease PCR test is designed to look for the borrelia bacterias DNA to identify whether or not it has made its way into the body through a bite from an infected tick. When DNA material is found, it can be determined that a Lyme infection is present.

Image by on The PCR test looks for DNA that confirms a case of Lyme disease is present.

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If My Dog Tests Positive Does He Need To Be Treated

The decision to treat Lyme disease is somewhat controversial since many infected dogs show no signs of illness. Factors that would support treatment include:

a moderate to high value of QC6 signs of illness compatible with Lyme disease at the time of testing a history of illness compatible with Lyme disease within the past year the presence of abnormal levels of protein in the urine.

Important: Dont Misinterpret A Negative Test As Positive

Many people without Lyme disease will test positive for some bands. Therefore, CDC cautions:

It is not correct to interpret a test result that has only some bands that are positive as being mildly or somewhat positive for Lyme disease.

For example, in one study, 43% of healthy people and 75% of syphilis patients tested positive for IgG band 41. In a study of US veterans in New York, 76% of those without Lyme disease tested positive for IgG band 41. In a 1996 study, in healthy people, 55% and 21% tested positive for IgG band 41 and IgM band 41, respectively.

Even without a Borrelia burgdorferi infection, many of us produce antibodies that will react on a Lyme test. Notably, harmless bacteria found naturally in our mouths can cause us to test positive for band 41.

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Is There A Blood Test For Lyme Disease

If your doctor suspects that you have Lyme disease, they may order two blood tests. These will look for signs that your body is trying to fight it off. The results are most precise a few weeks after youâve been infected.

These tests are:

ELISA test. This test canât check for the bacteria that causes Lyme disease. It can only look for your immune systemâs response to it.

Once Borrelia burgdorferi gets into your blood, your body begins to make special proteins called antibodies to fight it off. The ELISA test checks for those antibodies.

Although itâs the most common way to check for Lyme disease, the ELISA test isnât perfect. It can sometimes give false âpositiveâ results. On the other hand, if you have it done too soon after youâve been infected, your body may not have developed enough antibodies for the test to detect them. This will give you a ânegativeâ result even though you do have Lyme disease.

Western blot test. Whether your ELISA test comes back positive or negative, your doctor will need to do this blood test, too.

A Western blot uses electricity to split certain proteins in your blood into patterns. This is then compared to the pattern of people known to have Lyme disease.

At least five band matches means that you have Lyme disease. Still, not all labs have the same standards. Thereâs a chance that you could get a âpositiveâ result from one and a ânegativeâ result from another.

Pcr Antigen Detection And Culture Testing

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Other types of tests for Lyme disease include PCR , antigen detection, and culture testing. These tests look for the bacteria as opposed to the antigens created by your body in response to the bacteria.

A PCR test uses a portion of DNA from the borrelia bacteria to help with detection. Antigen testing looks for a specific protein of the Lyme bacteria to help diagnose Lyme disease and can identify infection in people who have had negative results using the ELISA and Western blot tests.

The final option is culture testing, which is highly regarded as the gold standard for diagnosis. Blood is taken from a person suspected of having Lyme disease, and the lab attempts to grow Lyme bacteria using the blood culture. This test is new, however, and the CDC has exercised caution against using it since there is only one commercially available culture test for Lyme disease.

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First Comes Igm Then Igg

The pathogenesis and the different stages of infection should inform laboratory testing in Lyme disease.

It is estimated that only 5% of infected ticks that bite people actually transmit their spirochetes to the human host. However, once infected, the patients innate immune system mounts a response that results in the classic erythema migrans rash at the bite site. A rash develops in only about 85% of patients who are infected and can appear at any time between 3 and 30 days, but most commonly after 7 days. Hence, a rash occurring within the first few hours of tick contact is not erythema migrans and does not indicate infection, but rather an early reaction to tick salivary antigens.

Antibody levels remain below the detection limits of currently available serologic tests in the first 7 days after exposure. Immunoglobulin M antibody titers peak between 8 and 14 days after tick contact, but IgM antibodies may never develop if the patient is started on early appropriate antimicrobial therapy.

If the infection is not treated, the spirochete may disseminate through the blood from the bite site to different tissues. Both cell-mediated and antibody-mediated immunity swing into action to kill the spirochetes at this stage. The IgM antibody response occurs in 1 to 2 weeks, followed by a robust IgG response in 2 to 4 weeks.

Because IgM can also cross-react with antigens other than those associated with B burgdorferi, the IgM test is less specific than the IgG test for Lyme disease.

What Do Testing Kits Typically Include

Depending on the method of collection, testing kits may include:

  • a device to collect the blood, urine, or saliva sample
  • a container to ship the sample back to the lab
  • a shipping label

Some kits come with a bandage, wipes, and a biohazard bag. Kits may contain extras such as Styrofoam holders, labels, or tubes with varying solutions inside.

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Hallmark Signs And Symptoms Of Infection

Chronic infection with any stealth microbe is associated with nonspecific symptoms . Even the symptoms that are considered classic for a particular microbe do not always occur. There are numerous species and strains of all of the different microbes, each of which have slightly different characteristics. If a classic symptom is present, however, it may help with diagnosis and treatment.

Why Do I Need A Lyme Disease Test

What’s the Best Test for Lyme Disease?

You may need a test if you have symptoms of infection and were exposed or possibly exposed to ticks that carry the bacteria that causes Lyme disease. The first symptoms of Lyme disease usually show up between 3 and 30 days after the tick bite.

Early signs and symptoms may include:

  • A reddish round skin rash that slowly gets bigger over several days. It usually doesn’t itch or hurt, but it may be warm. As it gets better, it may look like a bull’s-eye , but not always.
  • Muscle and joint aches
  • Swollen lymph nodes

Later signs and symptoms of Lyme disease usually affect your joints and nervous system. They include:

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Are Lyme Disease Tests Accurate

Yes and no.

The key to an accurate Lyme disease test and any other serological test is timing. To get accurate results, the body must have time to develop antibodies.

It might seem as if this would be easy. A tick bites someone, shortly after they develop symptoms, doctors administer a test, and they know if they have Lyme disease. But it isnt that simple.

Sometimes the body hasnt produced antibodies even if symptoms are present. Sometimes patients dont even develop typical Lyme disease symptoms, so its difficult to know when or if to administer the test. If a patient does not develop migraines, testing wont be able to confirm an infection for at least four weeks after becoming ill. The delay of diagnosis means there will likely be an increased chance of persistent symptoms.

Another issue that arises with Lyme disease testing is its inability to confirm a cure. Even after someone heals, antibodies persist and youll get a positive test result. This is a possibility for months or years after treatment. This can result in two issues:

  • If someone suspects reinfection months or years later, the serological test might not do any good. The antibodies are present but might be linked to the first infection.
  • If someone is exhibiting Lymes symptoms and had Lyme months or years ago but that is not the problem now, the test could prevent or extend an accurate diagnosis of the current problem.
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    Cdc Supports The Development Of New Tests

    New tests may be developed as alternatives to one or both steps of the two-step process. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration . For more details, see: Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease.

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    Choosing A Lyme Disease Test

    Often the diagnosis of Lyme disease depends upon the physicians readiness to listen and ask questions and on the mutual exchange of information, beginning with the initial doctor-patient interview.

    Often the diagnosis of Lyme disease depends upon the physicians readiness to listen.

    Lyme disease should be diagnosed clinically, without reliance on testing. However, all too often, physicians will ignore clinical presentations if laboratory tests are negative. Yet there are numerous scientific articles documenting false negatives and low sensitivity of such tests.

    There can be several reasons for the inaccurate results. The sensitivity of the tests varies greatly depending upon how long an individual has been infected and on the type of clinical manifestations. If a patient has received antibiotics in the early stage of the disease, antibody levels may be too low to be detected or nonexistent. Antibodies to Borrelia burgdorferi do not appear in the blood until several weeks after the tick bite. The Lyme bacteria are not always present in the blood. The person could have been infected with a strain of Bb that is not covered in testing.

    That said, laboratory tests can be used to support the diagnosis. Because of the varied presentations and necessity of relying on a patients symptoms, several tests may be helpful.

    The ELISA and Western blot are the most common tests used to diagnose Lyme disease. Both tests measure antibodies to Bb, the bacterium that causes Lyme disease.

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