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.
Reason : The Lab Performing Your Lyme Disease Test
|IGeneX is considered the go-to laboratory by Lyme doctors and physicians for testing a patient for Lyme disease with the western blot test. While the western blot test isnt 100% accurate, and even IGeneX insinuates this, their methods and techniques used for identifying Lyme antibodies are more modern and advanced than other labs. For one example, they use a higher concentrated polyacrylamide gel to get better separation of the important 31 kDa to 34 kDa antigens. Having better separation of antigens allows a better discernment for identifying purposes. The 31 kDa antigen is a major outer surface protein of Borrelia burgdorferi. The 34 kDa antigen is another outer surface protein of Borrelia. Antibodies generated from these Borrelia antigens indicate not just a Lyme infection, but a late stage Lyme infection.|
What Is An At
An at-home Lyme disease test will typically be a blood finger prick test.
If you have been exposed to the bacteria Borrelia that leads to the infection of Lyme disease, your body will have created two antibodies to fight it off. The test will look for the presence of both types of antibodies, known as immunoglobulin M and immunoglobulin G .
You will receive your test kit along with account information so that you can get your test results as soon as they are ready. Follow the manufacturers instructions exactly as they are described.
Each test has different instructions, so its very important that you read the kits detailed information before getting started.
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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.
Terms And Definitions For Lyme Tests
To help understand when to use a test or the meaning of a result physicians consider the test sensitivity, specificity, prevalence, and predictive value.
Sensitivity is the ability of a test to find an illness in all people with the illness.
Specificity is the ability of a test to correctly identify people without an illness from all people who do not have the illness.
Sensitivity and specificity are related. In general if a test is very sensitive and can find a very high percentage of people with an infection it is usually less specific. Sensitivity is the ability to find an infection when present while specificity indicates the accuracy of the positive test. A highly sensitive test often has many false positives and a lower specificity.
Let me use a fishing analogy. To catch 100% of salmon in a one mile square section of the ocean using a net a fishing boat will also capture many mackerel, halibut and other fish. That is to say it is very sensitive for finding all of the salmon. However fishing for all of those salmon using a net is not that specific because many other types of fish are also pulled in.
Prevalence is the amount of an illness as percentage or proportion of certain population.
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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.
Is Lyme Disease Curable
While there is no vaccine to prevent us from getting Lyme disease, it can be treated with antibiotics, and most people recover within a few weeks. However, some people can get what is known as Post-Treatment Lyme Disease Syndrome, in which symptoms such as pain, fatigue, or difficulty thinking can last for months.
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So When Do You Need Blood Tests For Lyme Disease
In some cases, you can have Lyme disease without the rash. Or you may not see the rash before it goes away on its own.
In these cases, your doctor should ask you about your medical history and do a thorough physical exam. Your doctor should look for these signs that you might have Lyme disease:
- You were in an area with ticks and Lyme disease.
- You also have fever or redness, warmth, and swelling in one or a few joints at a time usually the knees, shoulders, or wrists.
Other symptoms can occur later on. Talk to your doctor about testing and treatment choices.
This report is for you to use when talking with your healthcare provider. It is not a substitute for medical advice and treatment. Use of this report is at your own risk.
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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Should You Get Tested For Lyme Disease
The current laboratory diagnostic tests for Lyme disease are blood tests to detect the antibodies created by your body to fight and kill the bacteria that causes Lyme. This bacteria is called Borrelia burgdorferi, or Bb.
However, with early-stage Lyme your antibodies may not have had time to develop in your body. Therefore a blood test at this time will often appear negative. It can take your body up to two months to develop enough antibodies to be detected by these tests. In other words you could have Lyme but the test results will still come up negative.
What does this mean for you? By all means, if your doctor recommends a test, get the test. But dont rely on it completely. Trust your body and trust your homework. Monitor your symptoms. Ask questions.
The Elisa And Western Blot Are Not Sensitive Enough
Another major limiting factor of the traditional ELISA and Western blot is the quality. These tests tend to use lysed BB cultures, and therefore, depending on the culture conditions, some antigens are over-expressed, and some are under-expressed. This, in turn, can affect the ability to detect antibodies from patients blood.
Whats more, if a patient tests too early after a tick bite, his or her body may not have produced enough antibodies to show up on a test with suboptimal sensitivity.
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Best For Laboratory Testing Near You
- Collection method: blood or urine
- Results: sent to your doctor
IGeneX makes a comprehensive test for tick-borne illnesses. You can choose to do a blood or urine sample. Blood samples must be provided at an IGeneX-approved lab. The results will be sent to your doctor for review.
After you order a kit, youll need to fill out the appropriate paperwork. This information tells the company where to send the results.
The test will look for several markers of Lyme disease to ensure accuracy. You can also choose from five different panels of testing. Some of these panels, for example, look at T cells, antibodies, DNA, and antigens.
You can order each Lyme assay through a physician.
Every health insurance policy is different, but the company does work with insurance providers and sometimes Medicare. To ensure youll be reimbursed for IGeneX, contact your insurance provider for benefit-specific information before purchasing.
How Will Pregnancy Affect Treatment For Lyme Disease
Early treatment of Lyme disease during pregnancy is important. Thats because if Lyme disease is left untreated, it can affect the placenta. According to the CDC , transmission of Lyme disease from mother to fetus is possible, though rare.
For pregnant people, treatment includes a round of antibiotics. Certain treatments for Lyme disease may not be used, as they can affect the fetus. If you suspect that you have Lyme disease, talk with a healthcare professional immediately.
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Who Should Not Be Tested
The American College of Physicians recommends against testing in patients:
Presenting with nonspecific symptoms without objective signs of Lyme disease
With low pretest probability of infection based on epidemiologic exposures and clinical features
Living in Lyme-endemic areas with no history of tick exposure
Presenting less than 1 week after tick exposure
Seeking a test of cure for treated Lyme disease.
List Of Lyme Testing Labs
Here is a list of different labs that specialize in Lyme disease or other tick borne infection testing. The currently used Elisa and Western Blot tests that your traditional doctor is using may not be accurate. In fact, many states have now passed laws requiring doctors to notify their patients that a negative Lyme test does not mean you do not have Lyme disease. The labs below are well respected by those in the Lyme community and Lyme specialists and are more sensitive offering a higher change of correct diagnosis.
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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.
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.
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An Introduction To Lab Testing
Lyme disease tests can serve as valuable resources for the diagnosis and treatment of tick-borne disease. But its important not to get too hung up on the results.
The problem of chronic Lyme disease, cant be solved exclusively by looking at lab results, which is something I know from personal experience. In fact, becoming overly obsessed with lab results can hinder the recovery process.
Lab work provides a snapshot of whats going on inside your body. But multiple other factors including your symptoms, the length of time youve had them, and clinical presentation, as well as the environments in which you live, work, and travel all factor into making an accurate diagnosis.
Furthermore, the human body is an immensely complex biological machine, with millions of different biochemical functions happening simultaneously. Lab tests provide an ever-so-small glimpse at certain key functions of different systems in the body. From those indicators, determinations can be made about how well the body is functioning and whether illness is present.
Laboratory assessment, however, is far from absolute. Because the human body is so complex, the ability of lab testing to predict a specific chronic illness, such as one from a tick-borne disease, is often limited. All labs are subject to variability and different interpretations.
Laboratory Testing In Vaccinated Individuals
In 1998 the Food and Drug Administration approved a recombinant OspA vaccine for use in patients at risk of acquiring LD . Since the efficacy of the vaccine is reported to be in the range of 76% after three doses, there will be instances where vaccinated individuals acquire natural infection with B. burgdorferi sensu lato. ELISAs and IFA assays utilizing OspA-producing strains of B. burgdorferi sensu lato will not discriminate between vaccinated and naturally infected individuals. Therefore, the CDC two-step algorithm is not applicable to vaccinated patients and immunoblotting must be relied on for serologic confirmation of infection. In addition to increasing costs, the issue is complicated further by reports that some vaccinated patients produce antibodies that bind to various borrelial proteins, making interpretation of immunoblots more difficult . This will continue to be problematic until ELISAs and other first-line assays based on non-OspA-producing strains or recombinant borrelial proteins are in widespread use and physicians become aware of the specific limitations of the testing methods provided by their laboratories .
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Central Nervous System Lyme Disease
Central nervous system Lyme disease is diagnosed by 2-tiered testing using peripheral blood samples because all patients with this infectious manifestation should have mounted an adequate IgG response in the blood.
B cells migrate to and proliferate inside the central nervous system, leading to intrathecal production of anti-Borrelia antibodies. An index of cerebrospinal fluid to serum antibody greater than 1 is thus also indicative of neuroborreliosis. Thus, performing lumbar puncture to detect intrathecal production of antibodies may support the diagnosis of central nervous system Lyme disease however, it is not necessary.
Antibodies persist in the central nervous system for many years after appropriate antimicrobial treatment.
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When Should I Get A Lyme Disease Test
Lyme disease testing is only recommended under certain circumstances. In general, antibody tests are conducted when you have symptoms of Lyme disease and a confirmed or likely exposure to ticks that are known to carry Borrelia. In these cases, the timing of testing is important. Because antibodies may not form for a few weeks, testing soon after a tick bite or development of a skin rash may cause misleading results.
Antibody testing is not advised if you do not have symptoms of Lyme disease, including for people who live in areas that are confirmed to have the types of ticks that can transmit Borrelia. Testing is also not recommended if you have general symptoms, such as joint pain, but no likely exposure to Borrelia-carrying ticks.
If you have had a tick bite and/or symptoms of Lyme disease, you should talk with your doctor who can address whether Lyme disease antibody testing is appropriate in your situation.