Question 7 What Are Some Prominent Limitations Of Serologic Testing For Lyme Disease
As noted above, serologic tests may yield negative results early during infection, before antibodies have reached detectable levels. In addition, serologic assays may give false-positive results in individuals with other conditions, including 3,5,6
- Pathogenic spirochetal diseases, such as syphilis, yaws, pinta leptospirosis, relapsing fever, and periodontal disease
- Other bacterial and viral infections, such as Rocky Mountain spotted fever, Epstein-Barr virus, and cytomegalovirus
- Connective tissue autoimmune diseases associated with positivity for anti-nuclear antibody, including rheumatoid arthritis and systemic lupus erythematosus
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.
Lyme Tests: Old Vs New
The path to developing an accurate diagnostic method for Lyme disease has been rocky, but existing tests are considered more precise than in the past. Existing Lyme diagnostics consist of a complex, two-step system that uses separate tests the ELISA and the Western blot assayto detect antibodies to the Lyme bacteria.
Called the standard two-tiered approach, or STT, this process can take several hours or days to perform by specially-trained lab technicians, meaning vital, time-sensitive treatments may be delayed.This new test is different: It can detect Lyme antibodies in blood serum within minutes. Even more importantly, results show that this new diagnostic method may be more accurate and sensitive, particularly in diagnosing Lyme disease in the early stages another critical advantage.
Researchers are confident that, while more refinement is required, this new test will soon become a standard for the rapid diagnosis and early treatment of Lyme disease within doctors offices and clinics. This could be a game changer in this critical area of health, where more effective diagnostic and treatment solutions are urgently needed.
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Question 2 How Is The Diagnosis Of Lyme Disease Made
Diagnosis of Lyme disease is made through clinical assessment or clinical assessment supported by laboratory testing. The presence of an erythema migrans rash is diagnostic of Lyme disease without laboratory investigation.1,2
Patients who do not develop a rash but have symptoms suggesting Lyme disease, and have been to areas with a high risk of tick exposure, may undergo laboratory testing to help identify the cause of symptoms.1,2 For more information, see the Quest Diagnostics Clinical Focus Tick-borne Diseases: Laboratory Support of Diagnosis and Management available here.
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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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.
What Do Testing Kits Typically Include
Depending on the method of collection, testing kits may include:
- a device to collect the blood, urine, or saliva sample
- a container to ship the sample back to the lab
- a shipping label
Some kits come with a bandage, wipes, and a biohazard bag. Kits may contain extras such as Styrofoam holders, labels, or tubes with varying solutions inside.
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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.
Which B Burgdorferi Antigens Are Used And How Is The Test Interpreted
The Canine Lyme Multiplex Assay is based on three antigens, called outer surface proteins , of B. burgdorferi. Various research studies have shown that Osp antigen expression changes on the bacterial surface in response to tick feeding and again after infection of a warm-blooded host, such as dogs, horses, or humans . In response to infection, dogs develop antibodies to these Osp proteins and testing for antibodies to specific Osp antigens can assist in the diagnosis of infection and Lyme disease.
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Do I Need To See An Infectious Disease Specialist To Get Tested For Lyme Disease
No, you do not need to see an infectious disease specialist.
As noted above, any type of physician should be able to order the correct diagnostic tests, interpret your test results, and provide antibiotics to treat Lyme disease. This is especially true the earlier the disease is caught.
In fact, American Lyme Disease Foundation points out that waiting for an appointment with an infectious disease or other type of specialist can actually delay your diagnosis and treatment. If you were bitten by a tick, notice symptoms of Lyme disease, or believe youre at risk for Lyme or another tick-borne disease, its important that you make an appointment with a doctor immediately even if its your primary care physician.
That said, there are plenty of reasons why you may want to consult with, or get a second opinion from, someone with specific experience with Lyme disease. In other words, you may want to make an appointment with a Lyme-literate doctor . Read on to learn more.
Investigation Of Suspected Neurological Lyme Disease
The diagnosis of neurological Lyme disease can only be confirmed by examination of the CSF and a paired serum. A definite diagnosis is based on the presence of a pleocytosis in the CSF, demonstration of intrathecal synthesis of specific antibodies to Borrelia species in CSF by comparison to serum and the presence of neurological symptoms. It is not possible to confirm intrathecal synthesis and hence definite neurological Lyme disease without a paired serum .
In 2018 RIPL is introducing a service for the detection of intrathecal synthesis of Borrelia-specific antibodies which is summarised in this flow diagram.
Clinicians may ask for guidance on laboratory testing of CSF from RIPL if required.
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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.
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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Advantages Of The Canine Lyme Multiplex Assay
The Canine Lyme Multiplex Assay is available only at the Animal Health Diagnostic Center at Cornell University. It combines the results obtained by previous ELISA and Western blot testing and exceeds the information obtained by tests that are based on a single antigen of B. burgdorferi such as C6. The Lyme Multiplex Assay provides information whether the dog got infected with B. burgdorferi and when the infection occurred. The test results are fully quantitative and appropriate to follow-up on treatment success or response to vaccination. The advantages of the Lyme Multiplex Assay compared to other Lyme tests are:
The Lyme Multiplex Assay result provides advanced information beyond any of the currently available Lyme disease testing methods. Lyme Multiplex Assay testing allows a better definition of the dogs current infection status and assists in determining treatment options and prognosis. The infection status can also be determined in most vaccinated dogs. Interpretation varies slightly depending on the vaccine used.
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.
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How Do False Negatives Occur
When it comes to Lyme disease test accuracy, some people wonder why false negatives occasionally occur.
One key reason why is that both the EIA and Western blot tests are indirect tests. They measure the antibody response to the infection rather than directly checking for the genetic material of the bacteria. It can take several weeks for your body to produce enough antibodies for the tests to recognize them, which can sometimes yield false negative results if the tests are taken too soon after getting bitten by an infected tick.
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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How Can The Lyme Multiplex Assay Be Compared To Other Serological Lyme Assays
Researchers at the Animal Health Diagnostic Center at Cornell University have compared the former ELISA/Western blot procedure and the commonly used C6-based assays with the Canine Lyme Multiplex Assay9. Lyme Multiplex Assay OspF and C6 results highly correlate for the identification of infected or non-infected dogs. Antibodies to OspF and C6 provide robust markers of infection in dogs. However, the multiplex assay provides additional information on the dogs infection stage and vaccination status.
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.
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Lyme Disease Pcr Testing
A polymerase chain reaction test, also known as a PCR test, checks blood for evidence of a pathogens DNA. In some cases, a PCR test will be performed using a sample of synovial fluid, which is found in the joints. This test has become very common in the past two years because of the COVID-19 pandemic. Millions of people have had to undergo PCR testing for coronavirus.
A Lyme disease PCR test is designed to look for the borrelia bacterias DNA to identify whether or not it has made its way into the body through a bite from an infected tick. When DNA material is found, it can be determined that a Lyme infection is present.
Image by on The PCR test looks for DNA that confirms a case of Lyme disease is present.
What Is Lyme Disease
Lyme disease is a bacterial infection caused by the bacteria Borrelia burgdorferi. It is spread to humans through the bite of a carrier black-legged tick or deer tick. The disease causes flu-like symptoms and rashes.
While most people with Lyme disease can recover completely, provided they get early diagnosis and treatment, the symptoms can reoccur in some people later in the future. For this reason, it is important to test for Lyme disease years later, especially if you have developed syndromes after the disease was treated.
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Should You Get A Test For Lyme Disease
If Lyme disease is treated soon after a tick bite, the outlook is great. Most cases of Lyme disease respond to a 2- to 4-week round of antibiotics.
If Lyme disease goes untreated, it can be more difficult to eliminate. For some, it can lead to inflammation of the joints, heart, and nervous system. Progression of the disease, and its severity, can vary from person to person.
Lyme disease is staged in categories: acute, early disseminated, and late disseminated. Later stages of Lyme disease may involve multiple systems in the body.
The most common sign of Lyme disease is an erythema migrans, or bulls-eye rash. The rash often appears after a delay of 3 to 30 days after the tick bite, according to the
Research from 2014 suggests that the bulls-eye rash may last for 3 to 4 weeks. About 80 percent of people with Lyme disease have a single erythema migrans rash. But the bacteria can spread and lead to multiple rashes, indicating disseminated Lyme disease.
While a rash is the most common symptom of Lyme disease, it isnt the only one.
With disseminated Lyme disease, symptoms can also include neurologic conditions, such as cranial nerve palsy and meningitis that mimics aseptic meningitis. Heart inflammation can also be a sign of Lyme disease.
If youre experiencing any of these signs or symptoms, an at-home test may help you identify Lyme disease. With the click of a button, a test can be shipped to your front door.
To select the best tests, we look at studies and user reviews.