Wednesday, October 5, 2022

Elisa Blood Test For Lyme Disease

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Testing Guidelines And Interpretation For This Patient

ELISA test for Lyme disease

Erythema migrans , the characteristic skin lesion of early Lyme disease, is an expanding circular patch that usually reaches at least 5 cm in diameter . Classically EM has a target-like appearance, but it can be confluent. This patients rash was not consistent with EM since it was present for more than 6 weeks and never exceeded 5 cm. Moreover, EM initially appears at the tick bite site. It is unlikely a parent or child would have missed an engorged tick on the anterior neck for more than 1 day. Residence in a low-incidence state with a rash inconsistent with EM suggests low pretest probability.5 Testing in this setting is not useful and risks a false-positive result.6

Individually positive bands in the immunoblot are not clinically significant .7 Misinterpretation can cause diagnostic errors and unnecessary antibiotic exposure.8

What Are Alternative Diagnostic Testing Approaches

Patients with EM who live in or have traveled to areas endemic for Lyme disease can be diagnosed clinically without testing. For all other patientsthose with atypical early disease or signs of disseminated infectionlaboratory testing is necessary. Testing patients with low epidemiologic risk is generally not useful, but if pursued, clinicians must recognize the high likelihood of false positives.

Using EIA or immunoblot alone is insufficient for diagnosing Lyme disease because of reduced specificity and potential for false positives.3

Polymerase chain reaction assay of blood has low sensitivity because of the short duration of spirochetemia. PCR of synovial fluid or skin biopsy samples may be useful in certain clinical situations if specimens are available.3

Laboratory-developed tests for Lyme disease are offered by some commercial laboratories claiming to specialize in Lyme disease testing. These nonstandardized tests lack adequate clinical validation and FDA clearance and are not recommended.10

Igenex Lyme Disease Test

People who wish to buy a test kit from IGeneX have to pay a $20 deposit fee. They need to complete the paperwork with their doctor to determine which tests they should use.

Afterward, an individual can collect their sample at home and mail it to IGeneX. The company then sends the results to the doctor.

The tests cost $295546.

People who use IGeneX may benefit from some of its advantages:

  • The testing centers are CLIA-certified.
  • Doctors help the clients choose a test kit.
  • There are several collection methods available.

However, there are some disadvantages to this service. Firstly, it is not a true home test, as people have to work with a doctor to complete the paperwork and receive their results. Additionally, the paperwork and billing system can be complex.

CDC , people should perform two tests for Lyme disease, and they can use the same blood sample.

If they receive a negative result, they do not need to perform another test. However, if their first test is positive or indeterminate, it is best to test again.

The CDC states the overall result is only positive for Lyme disease when the first and second tests produce a positive result.

Tests detect IgM and IgG antibodies that the body produces in response to an infection. The IgM antibodies appear early in response to the exposure, while the IgG antibodies appear 46 weeks after the infection and can persist for years.

False positives can occur if a person has other conditions, including

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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.

References Choosing A Test

Lyme disease antibody. Causes, symptoms, treatment Lyme disease antibody
  • Wormser GP, Liveris D, Hanincova K et al. Effect of Borrelia burgdorferi genotype on the sensitivity of C6 and 2-tier testing in North American patients with culture-confirmed Lyme disease. Clin Infect Dis, 47, 910-914 .
  • Wormser GP, Schriefer M, Aguero-Rosenfeld ME et al. Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease. Diagn Microbiol Infect Dis, .
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    The Role Of Lyme Disease Tests

    The purpose of the most common type of Lyme disease testing is to determine whether you have developed antibodies as a result of past exposure to the Borrelia bacteria that cause Lyme disease. Antibodies are proteins created by the immune system that target specific threats like bacteria and viruses.

    Blood testing alone cannot determine whether you have Lyme disease. Instead, testing can provide helpful information that your doctor can consider along with other factors, such as any symptoms youve had and whether youve been exposed to ticks that can carry Borrelia, to determine if a diagnosis of Lyme disease is appropriate.

    Beyond blood testing, it is possible to analyze fluid from the central nervous system for signs of the Borrelia bacteria.

    What To Know About Seeing A Doctor And Getting Tested

    Whatever kind of doctor you see, they will consider your medical history, your symptoms, and your Lyme disease test results when making a diagnosis. They should perform what is known as a differential diagnosis in order to rule out common misdiagnoses, such as Rheumatoid Arthritis, Chronic Fatigue Syndrome, ALS, MS, etc.

    Many doctors rely on the two-tier system recommended by the Centers for Disease Control and Prevention, which consists of the following two blood tests:

    • EIA
    • Western blot test

    However, research shows that these tests are severely limited in accuracy and sensitivity. A LLMD may be able to help you get tested with newer and more accurate testing technology.

    Lyme disease recovery starts with finding a doctor who has sufficient experience with Lyme as well as access to the right diagnostic testing. To learn more about what tests are available for Lyme disease today, including IGeneXs ImmunoBlot test, check out the blog The Best Test for Lyme Disease.

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    The Igenex Lyme Immunoblot Solves These Problems

    IGeneX has developed a serological test that increases specificity without sacrificing sensitivity that has changed how to test for Lyme disease. It uses specifically created recombinant proteins from multiple species and strains of Lyme borreliae and reduces inconsistencies in reading and interpreting the test bands.

    More species detected The Lyme ImmunoBlot tests for more species of Lyme borreliae than the traditional ELISA and Western blot tests, reducing the risks of false negatives due to the inability to detect antibodies to a certain strain or species of Lb. The test includes all Borrelia-specific antigens relevant in North America and Europe, not just B. burgdorferi B31 or 297.

    The result is a single test that replaces at least 8 Western blots.

    More accurate testing The ImmunoBlot uses specific recombinant proteins that are sprayed in precise amounts onto specific locations on the membrane strip, allowing for greater control of the quantity and location of the antigens. This makes reading the bands much more accurate and consistent.

    Earlier detection The ImmunoBlot can detect infections at multiple stages of illness, letting you catch infections earlier.

    The IgM and IgG ImmunoBlots superior specificity and sensitivity make them the best Lyme disease test available.

    Lyme Tests: When And What

    Understanding Lyme Testing Results

    So this is a lot of information to digest and to figure out how to use. Here is a way to proceed with testing based on the above information.

    1. Never do an IFA or an ELISA.

    2. The first test to do is the IGenex Immunoblot IGG and IGM test. This is the best test with sensitivity of 90.9% There are a couple of drawbacks though. One is cost. At $450 US it is expensive and at this writing, it is doubtful insurance will pay. By comparison the IGenex IGM and IGG Western blot is $250 and insurance often pays. In addition, because it is not a western blot, I am not sure if insurers will recognize it when determining to cover IV antibiotics. On the IGenex order form get tests: 325 and 335.

    3. As an alternative to the IGenex Immunoblot, do the Western Blot. Be sure to have it performed by a lab that tests and reports for all of the Lyme specific bands including 18, 23-25, 31, 34, 39, and 83-93. These labs include IGenex and the Lyme Disease Laboratory at Stony Brook. Note that the western blot in Canada does not test for all of these. In addition all commercial labs like LabCorp, Quest Diagnostics, PAC LAB, and PAML here in the United States use the FDA approved kit using the CDC/IDSA criteria and do not test for all of these bands either. On the IGenex order form get tests: 188 and 189.

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    Lyme Disease Laboratory Tests Available At Ripl

    The primary service provided by RIPL is serological testing using well-characterised and validated screening and confirmatory tests in accordance with the NICE Lyme disease guideline.

    RIPL participates in regular external quality assurance exercises as an independent measure of its performance.

    Details of prices and turnaround times for Lyme testing are provided in Appendix 1 of the RIPL user manual.

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    Why It Is Done

    A Lyme disease test is done to diagnose Lyme disease in people who have symptoms of Lyme disease. Symptoms may include:

    • An expanding red rash with a pale centre. This is sometimes called a “bull’s eye” rash.
    • Extreme tiredness.
    • Headache and stiff neck.
    • Muscle and joint pain.

    Symptoms of chronic Lyme disease infection include joint pain, stiffness, and problems with the heart, brain, or nerves.

    Testing is most accurate when you have risk factors for Lyme disease or symptoms of the disease.

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    Severity Of Lyme Disease

    Misconception: B. burgdorferi infection is potentially lethal.

    Science: Although Lyme disease can cause heart or brain abnormalities, there have been remarkably fewif anydeaths attributable to this infection.

    LymeScience note: After this paper was published, the CDC three case studies of deaths associated with Lyme carditis, though two patients had preexisting heart conditions. While its not entirely clear if the infection caused the deaths, the CDC still reiterates, Prompt recognition and early, appropriate therapy for Lyme disease is essential.

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    Who Should Get Testing

    ELISA or Western Blot: Which Test is Best for Lyme?

    Testing is usually indicated if a person has symptoms of Lyme disease and a known or possible exposure to ticks that can carry the Borrelia bacteria. However, because it takes time for antibodies to develop, the timing of testing is important to consider.

    Lyme disease symptoms depend on the extent of the bacterial infection. Three phases are used to describe the infection:

  • Early localized: In this initial phase, symptoms are normally found only near the tick bite. This early stage is called erythema migrans and involves a noticeable rash that typically develops within a few weeks after being bitten.
  • Early disseminated: In this phase, the bacteria move through the blood to affect other parts of the body and can cause general symptoms like fever, headaches, and pain. In some cases, the bacteria can affect the heart or nervous system.
  • Late disease: This phase occurs long after the initial tick bite and most often includes symptoms affecting the joints or nervous system.
  • It is important to understand these phases because testing is not equally valuable in each stage. With early localized disease and erythema migrans, blood testing is generally not helpful because antibodies have not had enough time to develop.

    Because of similar concerns about potential false positive results, random screening for Lyme disease in people without symptoms is not recommended even in areas that are known to have ticks that can carry the Borrelia bacteria.

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    Molecular Testing For Detection Of Borrelia Species Bacterial Dna

    PCR is available for Borrelia species DNA detection but is of limited value in routine testing for Lyme disease because the organism is only present in blood during the early stages of the disease and is predominantly restricted to the affected tissues.

    Diagnostic molecular testing for Borrelia species DNA is available on request for relevant specimen types. Please call RIPL to discuss individual cases.

    Lyme Disease Antibody Test Procedure

    The Lyme disease antibody test requires no advance preparation. A lab technician will swab the inside of your elbow with an antiseptic before drawing your blood. Your blood will be drawn from a vein in your arm using a small needle.

    The blood draw should not be painful, though you might feel a slight prick when the needle is inserted into your vein.

    The blood sample will be collected in a vial. The puncture site will be bandaged, if needed, after the needle is removed. After the blood draw, you are free to go home.

    There are very few risks associated with the Lyme disease antibody test. Excessive bleeding is possible, but there may be an increased risk if you take blood thinning medications or certain anti-inflammatory drugs like:

    • heparin

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    How Is Lyme Disease Diagnosed

    Though several types of tests do exist for the diagnosis of Lyme disease, the best tests for a Lyme disease diagnosis are blood tests, also known as serological tests. These tests are indirect, meaning they dont detect the infecting bacteria or its antigens but rather the antibodies an infected persons body produces in response to these antigens.

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    Lyme Disease Serologic Testing

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    How to Prepare for the Test

    You do not need special steps to prepare for this test.

    How the Test will Feel

    When the needle is inserted to draw blood, some people feel moderate pain. Others feel only a prick or stinging. Afterward, there may be some throbbing or a slight bruise. This soon goes away.

    Why the Test is Performed

    The test is done to help confirm the diagnosis of Lyme disease.

    Normal Results

    A negative test result is normal. This means none or few to Lyme disease were seen in your blood sample. If the ELISA test is negative, usually no other testing is needed.

    Normal value ranges may vary slightly among different laboratories. Some labs use different measurements or test different samples. Talk to your health care provider about the meaning of your specific test results.

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    Lyme Disease Signs And Symptoms

    Most symptoms of Lyme disease in humans usually appear between three and 30 days after a bite from an infected blacklegged tick.

    You should contact your local public health unit or speak to a health care professional right away if you have been somewhere that ticks might live and experience any of the following symptoms:

    • rash
    • a bulls-eye rash (a red patch on the skin that is usually round or oval and more than 5 cm that spreads outwards and is getting bigger
    • a bruise-like rash
    • another type of unusual rash
    • muscle aches and joint pains
    • fatigue
    • spasms, numbness or tingling
    • facial paralysis

    If not treated, Lyme disease can make you feel tired and weak and, if it gets really bad, it can even harm your heart, nerves, liver and joints. Symptoms from untreated Lyme disease can last years and include recurring arthritis and neurological problems, numbness, paralysis and, in very rare cases, death.

    Negative C6 Elisa On Serum

    Early clinical Lyme disease in the form of erythema migrans with associated history of a tick bite should be treated empirically. There is no need for testing unless there are further symptoms.

    A negative ELISA result in the early stages of Lyme disease does not exclude infection. If acute Lyme disease is suspected but serology results are negative, we recommend that the test is repeated in 4-6 weeks with a fresh sample to look for seroconversion.

    In patients with long term symptoms a negative ELISA test usually excludes Lyme disease as a cause of these symptoms. Information on differential diagnosis for patients with persistent symptoms and negative Lyme disease serology results is available.

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    Lyme Disease Test Western Blot

    Labs performing a Western blot use electricity to separate proteins called antigens into bands. The read-out 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 bands for a positive test result. However, because some bands on the Western blot are more significant than others 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 from one lab and a negative test result from another.

    For a comprehensive explanation of the western blot test, download Understanding Western Blot Lyme disease test.

    The chart below will help you understand how to interpret the western blot test.

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