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
Positive C6 Elisa On Serum
RIPL will automatically proceed to do IgM and IgG immunoblot tests after a positive or indeterminate ELISA test and will provide an overall interpretation of the ELISA and immunoblot in the light of the clinical details provided on the request form.
Please provide clinical details to allow the interpretation of serological results. These are needed for interpretation because antibody levels from a protective humoral immune response to Borrelia species may persist indefinitely in patients who have had Lyme disease in the past. After successful treatment of Lyme disease antibody concentrations may slowly fall over time.
Borrelia species are notifiable organisms. The numbers of positive results from laboratory confirmed cases in RIPL are reported to PHE and analysed for inclusion in PHE Health Protection Reports as part of Lyme disease epidemiology and surveillance.
Final Comment About Lyme Tests
I opened this article stating that Lyme is always a clinical diagnosis. Again a test does not diagnose a disease. Also be aware based on the concepts of predictive value and prevalence I present above. Based on these concepts there is a great chance of a false positive test in someone who does not have Lyme disease symptoms. For more information see How to Diagnose Chronic Lyme Disease.
Finally, I am often asked about test from a lab called DNA Connexions. This lab runs a urine pcr test for Lyme and coinfections. I do not order tests from this lab because they have not done any validation studies to prove their tests are accurate. Be aware they have done an effective job marketing to the naturopathic doctor community and some integrative medicine physicians. The reason I am very skeptical is the number of times I saw people in my Seattle practice with positive DNA Connexions testing for bartonella or babesia who simply did not have any symptoms of these coinfections. I suggest staying away from testing from this lab.
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Important: Dont Misinterpret A Negative Test As Positive
Many people without Lyme disease will test positive for some bands. Therefore, the 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.
A positive Lyme antibody test requires both tiers to be positive, as many without Lyme infections can test positive on single tests. For example, one study found up to 40% of patients with Lupus and other rheumatic diseases test positive on the first tier ELISA test. The second tier test is necessary to stop a false positive diagnosis.
The American Society for Microbiology recommends against ordering the Western blot without a positive ELISA screening:
The Lyme immunoblot test is designed only as a confirmatory test, so it is important not to test screen-negative samples.
LymeScience recommends against:
Table excerpted and reformatted*** from the longer 2013 paper :
Serology And Dna Testing
There are two main types of Lyme testing. The first one tests the bodys reaction to the bacteria. You can do this by detecting whether antibodies are being created against that particular microbe. Secondly, you can check for the presence particles of the DNA of the bacteria.
There are other types of testing available, but the above are the two main types, namely, serology or antibody testing and, DNA or PCR testing.
Both these types of tests are designed to detect acute Lyme disease.
In the initial stages of infection, the bacteria is still in the blood, and it is relatively easy to find it. Later on however when the bacteria have moved away from the blood and invaded the tissue, then it becomes harder to detect.
This latter scenario highlights one of the problems with testing for Lyme in that many people who are initially infected with Lyme often do not have an acute reaction.
Many people begin to exhibit symptoms much later after their immune system begins to deteriorate, and by then the bacteria is deeply embedded in tissue.
So whether you are going to find the bacteria depends on firstly if the concentration of microbes in tissue is high enough to give a reaction and secondly if the immune system is reacting to it.
In acute Lyme, research shows that current testing has a pickup rate of 95%. On the flip side, in chronic Lyme, scientists do not know the pickup rate. They do not know if it a 30% pickup rate or 80%.
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Are There Any Risks To Lyme Disease Tests
There is very little risk to having a blood test or a lumbar puncture. If you had a blood test, you may have slight pain or bruising at the spot where the needle was put in, but most symptoms go away quickly. If you had a lumbar puncture, you may have pain or tenderness in your back where the needle was inserted. You may also get a headache after the procedure.
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.
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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.
Pros and cons
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
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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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 – Lyme Disease .
What Is Lyme Disease How Does My Dog Get Infected
Lyme disease is an infectious disease caused by bacteria called Borrelia. The bacteria are most commonly carried by the deer tick . Infection occurs when a dog is bitten by an infected tick. It appears that the disease is not transmitted until the tick has fed for approximately 12 hours. The tick itself becomes infected by feeding on infected mice, birds, deer, and other animals.
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Implementation Of Federal Framework And Action Plan
- Focus on implementing the action items that are still in the early stages of implementation, or for which more needs to be done to achieve full implementation.
PHAC has made clear progress on implementing many of the action items described in the Federal Framework and Action Plan. However, there are number of areas where progress on action items has been limited or where further work is warranted . PHAC’s abilities to complete some Framework activities have been delayed due to competing pressures and priorities resulting from the response to COVID-19. In this context, PHAC should focus on fully implementing outstanding action items as soon as possible.
How Lyme Antibody Testing Works
Antibody testing for Lyme disease requires two different tests to establish a positive result. If either the first tier test or the second tier test is negative, the test result is negative overall.
But in the event of a negative result, Dr. Adriana Marques of the NIH states:
For patients with signs or symptoms consistent with Lyme disease for less than or equal to 30 days, the provider may treat the patient and follow up with testing of convalescent-phase serum.
The first tier of the two-tiered testing system is an Enzyme Immunoassay .
The second tier of the well-established Standard Two-Tiered Testing involves a Western Blot test, which can be complicated to understand. The Western Blot is also called an immunoblot or a line blot.
The Western Blot test typically reports two types of antibodies that may be indicative of a Lyme infection: IgM and IgG.
According to the CDC, Positive IgM results should be disregarded if the patient has been ill for more than 30 days.
According to a consensus of experts, including representatives of the American Academy of Pediatrics, American Academy of Neurology, American College of Rheumatology, and Infectious Diseases Society of America:
Immunoglobulin G seronegativity in an untreated patient with months to years of symptoms essentially rules out the diagnosis of Lyme disease, barring laboratory error or a rare humoral immunodeficiency state.
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Questions For Your Doctor After At
If you take an at-home test, you can review the results with your doctor and consider asking some of the following questions:
- Is my at-home test result reliable?
- Is repeat blood testing or any other kind of testing appropriate?
- Are my symptoms consistent with possible Lyme disease?
- If I donât have Lyme disease, what could be causing my symptoms? What tests can help determine this more concretely?
What Is The Most Accurate Test For Lyme Disease
Lyme disease is more common than many people think. Figures from the Center for Disease Control suggest that roughly 300,000 Lyme disease cases occur every year in the US.
The numbers are alarming, but it gets worse as finding accurate diagnostic tests can be challenging. Although the disease is treatable, it is nearly impossible to tackle it effectively if it is not diagnosed accurately and early enough.
Late detection can lead to severe health problems such as arthritis, heart blockage, and inability to concentrate, among other problems.
Given the prevalence and seeming elusiveness of the disease, some of the logical questions concerned persons would ask are: what is the most accurate test for Lyme disease? And when should I get checked for Lyme disease? This article will proffer answers to these and many other related questions. But first, a little background would be in order.
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Other Lyme Disease Tests
Three other tests that may be used to diagnose Lyme disease are polymerase chain reaction , 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 . 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. LDo recognizes 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.
Serologic Tests Are The Gold Standard
Prompt diagnosis is important, as early Lyme disease is easily treatable without any future sequelae.
Tests for Lyme disease can be divided into direct methods, which detect the spirochete itself by culture or by polymerase chain reaction , and indirect methods, which detect antibodies . Direct tests lack sensitivity for Lyme disease hence, serologic tests remain the gold standard. Currently recommended is a standard 2-tier testing strategy using an enzyme-linked immunosorbent assay followed by Western blot for confirmation.
Diagnostic testing methods in Lyme disease
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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.
The Swiss Agent: Long
Lyme disease is a serious problem here in the United States and we really need to find solutions to some of the limitations that we have, particularly in diagnosing this infection, said Claudia Molins, a microbiologist at the CDC. We want a test that can be used within the first two weeks of infection and that does not rely on antibody production.
So Molins and her colleagues are focusing on metabolomics an approach that, rather than testing directly for the immune response to the infection, instead looks for a wide spectrum of collateral damage.
Specifically theyre looking for so-called metabolite biosignatures: the litany of sugars, peptides, lipids, amino acids, fatty acids, and nucleotides normally present in the blood.
Infections like Lyme, the thinking goes, change the levels of these things and they do so in a predictable, measurable way.
Molins and her team tested that hypothesis by tapping a unique CDC resource freezers filled with well-characterized blood serum samples. They used serum from 89 early Lyme patients, within the first month of infection, and 50 healthy controls to develop an algorithm to detect Lyme blood signatures.
The researchers then tested that algorithm on a larger sample of serums and found that they could diagnose 88 percent of early Lyme cases, and could differentiate Lyme from other diseases 93 percent of the time. The results were published in a 2015 study in Clinical Infectious Diseases.
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The Western Blot Test
Currently, the standard and arguably the best test for chronic Lyme disease is called a Western Blot, which is not available in Canada.
The Western Blot tests for specific antibodies to Borrelia. In this test, you are looking at different bands which highlight how various antibodies react to different parts of the bacteria. For Western Blot testing, you must have a certain number of specific bands present to be a positive test.
The problem with the standard Western Blot is that it misses out some of the critical bands that would help to identify the bacteria.
Some companies including Igenex and Medical Diagnostics in the USA have added these missing bands back into the Western Blot, and so the test is much more sensitive. On the downside, however, this has increased the rate of false positive testing a positive test for someone who does not have the microbe.
This situation creates a considerable problem because testing is very lucrative. When have symptoms of chronic Lyme, and you go to your doctor, and the test is negative then this can be very frustrating. So, there is a massive incentive for labs to produce a positive test.