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.
Borrelia Species Pcr Results
Borrelia species DNA may occasionally be detected in the blood by PCR, but a negative PCR test is of no value in excluding localised Lyme disease.
The overall sensitivity of PCR on a skin biopsy of an EM or ACA rash is around 50% and is limited by the chance of a single biopsy hitting a site with a significant number of organisms.
In neurological Lyme disease involving the CNS, up to 10% of cases may be PCR positive on a CSF sample a negative PCR result does not exclude the diagnosis.
Synovial fluid may be positive by PCR in up to 50% of cases. A negative result does not exclude the diagnosis.
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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Where Is Lyme Disease Found
In the United States, Lyme disease has been reported in every state, but over 95% of cases are from the Northeastern, Mid-Atlantic, and upper Midwestern states, with a small number of cases reported along the West Coast, especially Northern California. In Canada, Lyme-positive dogs are found mostly in southern Ontario and southern Manitoba, with a small number of cases in southern Quebec and the Maritime provinces.
Management Of Individuals Without Symptoms Following A Tick Bite
Diagnostic testing is not recommended for individuals who do not develop any symptoms suggestive of Lyme disease after a tick bite.
Some commercial companies offer services to test removed ticks for the presence of the bacteria that cause Lyme disease. PHE does not provide such tick-testing services. The results of such tests should not be used to inform diagnosis or treatment. A positive result does not mean that the infected tick will have passed on the bacteria there are many factors that determine whether Lyme disease results from the bite of an infected tick. A negative result may not be technically valid and could give false assurance, as it does not exclude the possibility that another tick elsewhere on the body has been missed by the patient.
PHE runs a tick surveillance scheme and is happy to receive ticks for species identification and to monitor tick distribution.
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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.
Submission And Collection Notes
If European Lyme disease testing is required: enter ‘European Lyme disease’ under Test Description of the and provide travel history including location of travel and dates.
European Lyme is referred to the National Microbiology Laboratory in Winnipeg.
Indicate the following on the :
- date of onset
- exposure
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Alternative Diagnostic Tests Not Available At Ripl
Tests used in the NHS and PHE to identify Lyme disease are well characterised, standardised, and are highly reproducible between laboratories. They are the methods of choice recommended in the 2018 NICE Lyme disease guideline, following an extensive review of the evidence and literature. International external quality assurance schemes are in place to ensure consistency between different centres offering these tests.
Several private laboratories in Europe and the USA offer an alternative type of test called an ELISpot to diagnose Lyme disease. This looks for different markers in blood samples compared to conventional validated Lyme disease serology tests. The laboratories using these tests in the diagnosis of Lyme disease do not publish their methods, and have not produced any peer reviewed publications on their clinical value.
This makes it very difficult to verify their results, especially as there are no national or international EQA schemes for Lyme disease ELISpot tests and therefore no independent verification of performance between laboratories. Without independent evidence it is impossible to determine the validity of results produced using these alternative tests.
RIPL cannot interpret the results of alternative diagnostic tests.
Lyme Disease Diagnostics Research
There is a great need to develop rapid, point-of-care tests to determine whether people are infected with Borrelia burgdorferi, the bacterium that causes Lyme disease. NIAID is committed to improving Lyme disease diagnostics by supporting innovative research projects.
Priorities include finding potential targetssubstances that new diagnostic tools might measure in patient samplesand improving the sensitivity and specificity of currently available diagnostic tests, thereby leading to more accurate results.
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You Do Not Usually Need Tests To Show That You Have Lyme Disease
In most cases, theres a clear sign of Lyme diseasea painless, spreading rash that often grows to look like a bulls eye. If you have this rash, and you recently had a tick bite or were in an area known for Lyme disease, you dont need a test. Instead, your doctor can just start treating you with antibiotics, as appropriate.
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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Lyme Disease Test Two
Two-tiered Lyme disease testing uses two tests. The first is a screening test that should detect anyone who might have the disease. Tests that do this well have are regarded as having high sensitivity. This test is followed by a second test that is intended to make sure that only people with the disease are diagnosed. Tests that do this well have high specificity.
HIV/AIDS is diagnosed with tests that are both highly sensitive and highly specific. They are accurate more than 99% of the time. In Lyme disease, the second test is highly specific. So there are few false positives. Unfortunately, the screening test is highly insensitive and fails to accurately identify patients who have Lyme disease. The two-tiered test system misses roughly 54% of patients.
Because of this, LDo recommends the patients and physicians skip the ELISA and go straight to the Western blot.
What Does An At
Once ordered, an at-home Lyme disease test kit is delivered to your home, where you can collect the sample privately and comfortably. The kit will include the instructions, the sample collector, and the box to return the sample.
Once the results are ready, you will receive them in your email or through the company’s online portal, or they will be sent to your doctors office.
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What Happens If You Go Untreated For Lyme Disease
If you happen to test positive for Lyme disease but go untreated, then your symptoms may increase significantly. You may develop early-onset arthritis, facial palsy, and inflammation of the brain stem and spine. Those symptoms can affect how your brain works and your ability to function cognitively.
Where Lyme Disease Occurs
In the United States, Lyme disease typically occurs in the Northeast, Mid-Atlantic, and North Central states. It has also been reported to occur in Northern California. The most prevalent strain causing Lyme Disease in the United States is Borrelia burgdorferi.
If you live or have traveled to a state where Lyme disease is endemic, this increases your risk. Lyme disease is endemic in the following states: California, Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington DC, West Virginia, and Wisconsin. For regulatory reasons, Everlywell is not able to offer testing in New Jersey, New York, or Rhode Island.
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Most Accurate: Dna Connexions
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Test looks for Borrelia burgdorferi, in addition to 10 other common vector-borne pathogens
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Urine Sample
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Does not accept insurance
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No assistance after testing results are received
DNA ConneXions is a company known in the scientific community for its detailed analysis of lab results. This at-home Lyme disease test, for example, is superior to the others because it tests for all 10 vector-borne pathogens, while others only test the most common two or three.
DNA ConneXions earned our most accurate distinction because of its detailed Lyme disease test, as well as its impressive laboratory with a biosafety level 2 lab with a CLIA license. This means the company knows its stuff and is able to help people with accurate testing.
After DNA ConneXions receives your urine sample, it will review your sample, and email you your results within two to three weeks. It is unclear how much support the company offers after you receive your results, so it would be wise to schedule an appointment with your primary care doctor. This is to ensure that your body heals entirely if your Lyme disease test is positive.
This is the most expensive kit on this list, costing about $650 for the full Lyme panel. As of now, it will not work with insurance companies or accept HSA. The DNA ConneXions lab, however, is one of the most trusted laboratories worldwide.
Other Diagnostic Tests For Lyme Disease
Some laboratories offer Lyme disease testing using urine or other body fluids. These tests are not approved by FDA because they have not been proven to be accurate. For example, one study of urine-based polymerase chain reaction assays for Lyme disease diagnosis showed that with currently available tools, urine cannot be used to accurately diagnose Lyme disease. Another study by NIAID-supported scientists showed that the Lyme Urinary Antigen Test was unreliable and resulted in excessive numbers of false positives. In the same study, researchers confirmed that an ELISA followed by a Western blot test was nearly 100 percent reliable in diagnosing Lyme disease. With the availability of so many Lyme disease tests, including non-commercial tests developed by individual facilities, it is impossible to address the accuracy of each one. The development of new, rapid, clearly validated diagnostic tests continues to be a need.
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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.
Lyme Disease Is Remarkably Difficult To Diagnose
The problem with Lyme disease is that the bacteria can create a hard shell around themselves when inactive so that the blood tests are unable to detect them. This is especially true when the disease has reached the chronic stage. The timing of the symptoms is often used by a medical provider to establish a time line to a tick bite or exposure to a high-risk region where the disease is commonly transmitted.
Because the ticks that can spread Lyme disease are often the size of a pinhead, the ticks might not even be notice. A bulls-eye rash at the bite location is a trademark symptom of Lyme disease, but only about half of the people who are infected with the bacteria develop the rash. Once the disease reaches the chronic stage, chronic arthritis, joint pain, and neurological symptoms begin to appear, sometimes several months after the infection.
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Limitations Of Serologic Tests For Lyme Disease
Currently available serologic tests have inherent limitations:
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Antibodies against B burgdorferi take at least 1 week to develop
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The background rate of seropositivity in endemic areas can be up to 4%, affecting the utility of a positive test result
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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
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Antibodies can cross-react with related bacteria, including other borrelial or treponemal spirochetes
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False-positive serologic test results can also occur in association with other medical conditions such as polyclonal gammopathies and systemic lupus erythematosus.
When Is The Lyme Disease Blood Test Ordered
When someone has the signs and symptoms of Lyme disease or they live in a region that has deer ticks or black-legged ticks, then this blood test will be ordered. It will also be ordered when these symptoms occur without improvement over the course of 7-14 days by most medical providers.
- A bulls-eye rash that grows from the bite site.
- Fevers, chills, and a persistent headache that does not go away.
- Unusual and persistent fatigue that does not immediately improve.
The IgM and IgG tests are generally ordered first when Lyme disease is suspected. This is because people who have never been exposed to the bacteria that causes the disease will not have any antibodies present. If these tests are positive and followed up by a positive Western Blot test, then the chances are very good that Lyme disease is present. This is especially true if antibody levels continue to rise over time.
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Serological Testing Of Csf For The Diagnosis Of Neurological Lyme Disease
Serological testing for neurological Lyme disease is based on demonstrating intrathecal synthesis of Borrelia-specific antibodies in CSF. For laboratory testing for neurological Lyme disease, separate IgG and IgM ViraChip® serology assays are performed on CSF and paired serum and the results compared.
CSF samples must be tested in parallel with a contemporaneous serum sample and protein and immunoglobulin levels compared between the two sample types to produce a meaningful result.
For necessary sample types and volumes see Sample types for Lyme disease testing
Future Possibilities For Diagnostic Tools
NIAID-supported scientists have identified genome sequences for multiple strains of B. burgdorferi. Greater advances in diagnostics are anticipated as genetic information is combined with advances in microarray technology, imaging, and proteomics. These growing fields of science are expected to lead to improved diagnostic tools as well as provide new insights on the pathogenesis of Lyme disease. Examples of tools being developed with NIAID support include use of metabolomics to characterize new biomarkers of infection, next generation T-cell based measurements, and novel antigens for improved measurement of effective treatment.
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Key Points To Remember
- Most Lyme disease tests are designed to detect antibodies made by the body in response to infection.
- Antibodies can take several weeks to develop, so patients may test negative if infected only recently.
- Antibodies normally persist in the blood for months or even years after the infection is gone therefore, the test cannot be used to determine cure.
- Infection with other diseases, including some tickborne diseases, or some viral, bacterial, or autoimmune diseases, can result in false positive test results.
- Some tests give results for two types of antibody, IgM and IgG. Positive IgM results should be disregarded if the patient has been ill for more than 30 days.
The Best Test For Lyme Disease
Lyme disease is a tick-borne illness spread by Lyme borreliaebacteria which includes, but is not limited to, Borrelia burgdorferi sensu stricto. The Centers for Disease Control and Prevention estimate that there are 400,000 cases of Lyme disease annually, making Lyme a serious public health concern that only stands to grow as the spread of ticks affects disease endemicity and seasonality.
One of the biggest challenges of fighting Lyme disease is providing patients with accurate diagnostic tests. Without access to the best tests for Lyme disease, its impossible to diagnose this treatable disease in a timely manner. When the disease isnt caught in time, it can spread throughout the body and cause chronic health problems that could otherwise be avoided with earlier detection and treatment.
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