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Gold Standard Test For Lyme Disease

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Severity Of Lyme Disease

New two step test for Lyme claims improvement over the standard test

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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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.

What Is Lyme Disease

Lyme disease is a bacterial infection transmitted to humans through the bite of infected blacklegged ticks. The causative agent of Lyme disease, bacteria of the genus Borrelia, are known as spirochetes for their unique corkscrew shape.3 Several Borrelia species have been identified and are associated with different regions including North America , Europe and Asia . In the United States, B. burgdorferi is spread by deer ticks in the northeastern, mid-Atlantic and north-central regions, while the western blacklegged tick spread disease on the Pacific Coast.4 Recently, an additional species, B. mayonii, has been discovered in blacklegged ticks collected in northwestern Wisconsin and Minnesota and has been found to also cause Lyme disease.5

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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.

Lyme Disease Diagnosis And Testing Highlights

Choosing A Lyme Disease Test
  • LLMDS consider the specificity of the particular bands that test positive for a patient.
  • Although the CDC requires 5 of 10 bands for IgG surveillance purposes, 2 of 5 bands have specificity of 93-96% and a sensitivity of 100%. .
  • 56% of patients with Lyme disease test negative using the two-tiered testing system recommended by the CDC.
  • The CDC case surveillance definition allows single-tier IgG immunoblot seropositivity using established criteria.
  • The CDC states: This surveillance case definition was developed for national reporting of Lyme disease it is not intended to be used in clinical diagnosis.
  • The College of American Pathologists found that ELISA tests do not have adequate sensitivity to be used for screening purposes.
  • 52% of patients with chronic disease are negative by ELISA but positive by Western blot.

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How It Is Done

The health professional taking a sample of your blood will:

  • Wrap an elastic band around your upper arm to stop the flow of blood. This makes the veins below the band larger so it is easier to put a needle into the vein.
  • Clean the needle site with alcohol.
  • Put the needle into the vein. More than one needle stick may be needed.
  • Attach a tube to the needle to fill it with blood.
  • Remove the band from your arm when enough blood is collected.
  • Put a gauze pad or cotton ball over the needle site as the needle is removed.
  • Put pressure on the site and then put on a bandage.

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What The Experts Say

According to the CDC:

  • Patients who have had Lyme disease for longer than 4-6 weeks, especially those with later stages of illness involving the brain or the joints, will almost always test positive.
  • A patient who has been ill for months or years and has a negative test almost certainly does not have Lyme disease as the cause of their symptoms.
  • Serologic testing is generally not useful or recommended for patients with single EM rashes. For this manifestation, a clinical diagnosis is recommended.

Experts around the world agree with the CDC. 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.

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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.

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A Practical Approach To The Diagnosis Of Lyme Borreliosis: From Clinical Heterogeneity To Laboratory Methods

Lyme Disease Serologic Testing
  • 1DSM-Department of Medical Sciences, University of Trieste, Trieste, Italy
  • 2ASU GI-Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy

Clinical evaluation of Lyme Borreliosis is the starting point for its diagnosis. The patient’s medical history and clinical symptoms are fundamental for disease recognition. The heterogeneity in clinical manifestations of LB can be related to different causes, including the different strains of Borrelia, possible co-infection with other tick transmitted pathogens, and its interactions with the human host. This review aims at describing the heterogeneous symptoms of Lyme Borreliosis, as well as offering a practical approach for recognition of the disease, both in terms of clinical features and diagnostic/research tools.

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British Columbia Specific Information

Ticks are tiny bugs which feed on blood. For information on ticks, removing ticks, and how to avoid being bitten, see HealthLinkBC File #01 Tick Bites and Disease. You may also be interested in the HealthLinkBC File #96 Insect Repellent and DEET.

While most tick bites do not result in diseases, some can. Some of the diseases passed on by ticks include relapsing fever, tularemia, Rocky Mountain Spotted Fever , Q Fever and anaplasmosis. The most well-known is Lyme disease. For more information on Lyme Disease, visit BC Centre for Disease Control â Lyme Disease .

Bottom Line: Experts Say At

I would be a bit hesitant and a bit skeptical about using them, Dr. Dattwyler says. Home tests may not be covered by your insurance company if you have insurance, but it is typically an accepted health care expense if you have a flexible spending account or a health savings account . These tests can run anywhere between about $90 to $120, according to various at-home test company websites. So initially, this may cost less than getting tested through a medical provider if you dont have insurance or if your insurance doesnt cover Lyme disease testing.

But its not that simple. Again: Testing for Lyme disease is far from perfect even when its done in a qualified lab and analyzed by an expert. Add on the margin for user erroryoud need to collect a perfect blood sample during the ideal post-infection window and it would need to make it to its destination intactand youve got a recipe for misleading results.

Plus, even if you do test positive for Lyme disease using an at-home kit, you still need to see a doctor. Chances are, your physician wont accept an at-home test in place of a standard laboratory test, so they would likely recommend going through the official process anyway. They will also need to do a thorough assessment of your overall health because diagnosing Lyme relies on more information than a lab test alone, Dr. Dattwyler says.

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The Most Common Lyme Disease Blood Tests

The two most common diagnostic tests for Lyme disease are the enzyme-linked immunosorbent assay and the Western blot. These Lyme disease tests allow physicians to visualize the reaction between antibodies in an infected persons blood to specific antigens or parts of the bacteria that cause Lyme disease.

In the case of the Western blot, for example, antigens are separated by size and then transferred onto a membrane strip. When an antibody reacts with an antigen on the strip, that band will turn dark purple. For test results to be positive, a specific combination of bands on the membrane strip must be present.

Get Started Withigenex Today

Testing and treating lyme. Not as easy as you may think.

The first step in getting tested with IGeneX is to order a test collection kit. Choose between a Blood, Urine, or Miscellaneous kit, depending on the test you will be doing. The Blood Kit is the most common, and works with 95% of tests. Doctors can order unlimited quantities of kits at no charge. Patients are required to deposit $20, which is applied to the testing fees.

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Limitations Of Serologic Tests For Lyme Disease

Currently available serologic tests have inherent limitations:

  • Antibodies against B burgdorferi take at least 1 week to develop

  • The background rate of seropositivity in endemic areas can be up to 4%, affecting the utility of a positive test result

  • Serologic tests cannot be used as tests of cure because antibodies can persist for months to years even after appropriate antimicrobial therapy and cure of disease thus, a positive serologic result could represent active infection or remote exposure

  • Antibodies can cross-react with related bacteria, including other borrelial or treponemal spirochetes

  • False-positive serologic test results can also occur in association with other medical conditions such as polyclonal gammopathies and systemic lupus erythematosus.

Future Perspectives On Lyme Disease Diagnosis

MTTT’s high performance has been demonstrated in various studies in the United States, Canada and Europe following FDA approval.22,23 In the United States, clinical testing labs have implemented the MTTT, and more manufacturers are offering solutions that are aligned with the MTTT. Some labs, on the other hand, continue to utilize STTT or both because some clinicians want to know what bands are positive in the immunoblots to gain more information about the disease, such as those antigens that are relevant to the detection of Lyme arthritis.12 Therefore, both CDC testing algorithms are projected to be used in the coming years.

If laboratories intend to perform alternative testing in addition to, or instead of, the testing established by the CDC, they must validate the new test with the relevant assay as a lab-developed test according to state and local guidelines. An example of alternate testing would be the use of immunoblots, as a second-tier test, containing extra and/or different antigens than those required by the CDC. A good example is the VlsE antigen, which stands for variable major protein-like sequence expressed. According to studies, adding the VlsE antigen, in an immunoblot to detect IgG, improves the sensitivity of Lyme disease testing in the early and late stages while retaining a high level of specificity.16,24-26

Table 1: Clinical symptoms and testing in early and convalescent phases of Lyme disease.

References

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Interpret Laboratory Results Based On Pretest Probability

The usefulness of a laboratory test depends on the individual patients pretest probability of infection, which in turn depends on the patients epidemiologic risk of exposure and clinical features of Lyme disease. Patients with a high pretest probabilityeg, a history of a tick bite followed by the classic erythema migrans rashdo not need testing and can start antimicrobial therapy right away.

How Is It Diagnosed

Think the Lyme Disease Rash is Always a Bull’s-eye? Think Again! | Johns Hopkins Rheumatology

If youâve been outside in an area where ticks are known to live, you should tell your doctor. Theyâll also want to know about the symptoms youâre having. These details are crucial to making a diagnosis of Lyme disease.

Early symptoms that usually occur within the first month after a tick bite can include:

  • Rash at the site of the tick bite that may look like a âbullâs-eyeâ
  • Racing heart
  • Problems with your short-term memory

Symptoms that come and go are common with Lyme disease. They will also depend on the stage of the disease.

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Fda Clears Gold Standard Diagnostics Lyme Disease Test

Apr 5, 2021 | Emerging & Zoonotic Diseases, Immunoassay |

Gold Standard Diagnostics , Davis, Calif, a Eurofins Technologies company, announced FDA clearance of a new B. burgdorferi IgG/IgM VlsE-OspC EIA test. This test, when used in conjunction with the other FDA cleared GSD Lyme EIA tests, can be used in the CDC recommended modified two-tiered testing algorithm.

In 2014, the CDC issued an updated recommendation for the serologic diagnosis of Lyme disease, endorsing the use of a two-tier testing algorithm that uses a second enzyme immunoassay, or EIA, in place of a western immunoblot assay.

Read Cost-Effective Tests for Lyme Disease and TBRF

Gold Standard Diagnostics now offers a solution for this Lyme testing algorithm, which complements GSDs existing market-leading Lyme test portfolio. With the addition of the B. burgdorferi IgG/IgM VlsE-OspC EIA test, customers can choose which tests and algorithms best meet their laboratory and clients needs. All six assays are designed for optimal performance and can be run on any open automation platform.

For more information, visit Gold Standard Diagnostics.

Lyme Disease Testing: Useful When Performed Appropriately

One known problem is that we can produce antibodies for years or decades after a Lyme infection has been eradicated. Therefore, a seropositive test on its own is not necessarily indicative of active infection.

In addition, it can take a few weeks for detectable antibodies to build up in the body. Pseudoscience advocates frequently mislead about Lyme antibody testing by failing to differentiate testing performance in early infection from testing performance in late infection.

Below is a CDC-produced illustrative example of antibody production in Lyme disease, which triggers a positive test once a detection threshold is reached.

Two types of antibodies are shown: IgG and IgM. Typically, a detectable IgM antibody response is produced first, followed by a detectable IgG response.

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New B Burgdorferi Serological Assay Available

Gold Standard Diagnostics has launched a new Lyme Disease serologic assay, the B. burgdorferi IgG/IgM VlsE-OspC ELISA.

This assay has been FDA cleared for use as an integral part of the Modified Two-Tiered Testing algorithm available from GSD.

“Using the B. burgdorferi IgG/IgM VlsE-OspC test in combination with a second GSD Lyme EIA, we maintain > 98% specificity while demonstrating a nearly 20% increase in early Lyme disease detection compared with the Standard Two-Tiered Testing algorithm “, said GSD in a press release.

Gold Standard Diagnostics is the only company offering kits in the U.S. to fulfill Lyme testing requirements for both the Standard and Modified two-tiered testing algorithms. Their four EIA kits and two Immunoblot kits allow flexibility for a lab to meet their clients needs.

Image: Modified Two-Tiered Testing Algorithm

If you want further details about this product, please use the ‘Request Information’ button below.

What Does The Test Measure

What I Want You To Know About Late Stage Lyme Disease

Lyme disease testing measures the levels of antibodies in the blood. In particular, it looks for forms of antibodies known as immunoglobulin M and immunoglobulin G that are specific to Borrelia bacteria. The immune system produces these antibodies as part of its response to infection.

IgM levels are usually highest a few weeks after infection. IgG levels can take longer to build up, peaking within a few months after infection. While elevated IgM can reflect a current infection, both IgM and IgG antibodies can be present for months or even years after infection, and, as a result, may be found in people who do not have a current or active Borrelia infection.

To improve accuracy, the Centers for Disease Control and Prevention advises laboratories to conduct two stages of blood testing for these antibodies. If the first test is positive, a second test is conducted, usually with a different type of laboratory method.

Some products marketed as at-home Lyme disease test kits measure substances other than antibodies and use test samples other than blood. These alternative tests have not been shown to accurately or reliably determine if a person has Lyme disease or Borrelia infection. The CDC recommends against the use of any such unvalidated tests.

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High Endemicity Constitutional Symptoms No Erythema Migrans Rash

A patient from an area of high endemicity of Lyme disease presents with fever, headache, and arthralgias that had lasted several weeks, but no erythema migrans rash. After a thorough clinical evaluation, the cause of the symptoms remains unresolved.

The physician should consider serologic testing with the complete two-step approach. For this patient, the pretest probability is moderately low, taking into account the endemicity of the disease and the presence of prolonged , unexplained nonspecific symptoms. In this scenario, if the two-step approach is positive, the probability of Lyme disease is about 90 percent. Although testing probably is beneficial in this type of patient, this has not been proven. There is no clear evidence that treatment is beneficial in patients with Lyme disease who exhibit only nonspecific symptoms.

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