References Choosing A Test
Molecular Testing For Detection Of Borrelia Species Bacterial Dna
PCR is available for Borrelia species DNA detection but is of limited value in routine testing for Lyme disease because the organism is only present in blood during the early stages of the disease and is predominantly restricted to the affected tissues.
Diagnostic molecular testing for Borrelia species DNA is available on request for relevant specimen types. Please call RIPL to discuss individual cases.
Can Infection Be Spread Directly From One Dog To Another Dog Or From My Dog To My Family
Direct spread of Lyme disease from one dog to another dog has not been reported, even when infected and uninfected dogs have lived together for long periods.
Spread of Lyme disease from dogs to people has not been reported either, but people are equally at risk for Lyme disease if they are bitten by an infected tick.
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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.
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.
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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
Lyme Disease Blood Test Western Blot
The Lyme disease blood test, western blot is used to detect antibodies specific for B burgdorferi.
Also Known As: Borrelia burgdorferi Antibodies Lyme Disease Antibodies , Immunoblot
Methodology: Western blot
Preparation: No special preparation required.
Test Results: 7-10 days. May take longer based on weather, holiday or lab delays.
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Which B Burgdorferi Antigens Are Used And How Is The Test Interpreted
The Equine 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, horses develop antibodies to these Osp proteins and testing for antibodies to specific Osp antigens can assist in the diagnosis of infection and Lyme disease.
Traditional Lyme Disease Tests Are Not Specific Enough
Lyme disease is caused by the spiral-shaped bacteria Borrelia. There are multiple species and strains of Lyme borreliae . Therefore, tests must be targeted to these multiple species and strains in order to be able to detect them. If a patient is infected with a species or strain of Lyme borreliae that their test cant detect, they will get a false-negative test result and thus risk missing their diagnosis. This can be costly and dangerous.
Many ELISA and Western blot Lyme disease tests are only equipped to detect one strain of one species of Borrelia: Borrelia burgdorferi B31 . This means that those tests are missing infections caused by other strains and/or species of Lyme borreliae.
In one internal study designed to test the validity of the IGeneX ImmunoBlot against traditional Western blot tests, a total of 132 patients were tested by both Lyme Western blots and Lyme IB. 43 patients were seropositive on the ImmunoBlot, and 14 were positive on standard Western blots prepared from a mixture of two species for Bb ss B31 and 297. Thus 29 of the 43 patients tested negative on Western blots i.e., the Western blot totally missed their infections with strains other than Bb ss B31 and 297.
With such limited tests, patients infected with non-B31 species and strains e.g., B. mayonii, B. californiensis, or European species are at risk of receiving false negatives and missing the chance to treat their diseases.
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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
- instructions
- 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.
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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Sample Types For Lyme Disease Testing
For routine Lyme disease serological testing, you must send a serum sample .
For testing for neurological Lyme disease, you must send paired CSF and serum samples taken on the same day. If possible, please provide CSF cell count and total albumin, IgG and IgM values. If albumin, IgG and IgM measurements are not available, RIPL will make arrangements for these measurements at additional cost.
PCR testing is available. We recommend that specialists call RIPL to discuss appropriate sample types for PCR. These may include joint fluid, biopsy tissue, CSF and EDTA plasma. Please submit biopsies as fresh tissue in a sterile container, ideally with a drop of sterile saline to prevent the tissue drying out.
Avoid Unnecessary And Unscientific Testing
As part of the admirable Choosing Wisely campaign to reduce unnecessary tests and treatments, the American College of Rheumatology warns:
Dont test for Lyme disease as a cause of musculoskeletal symptoms without an exposure history and appropriate exam findings.
The CDC , French Society of Internal Medicine, and other experts around the world have expressed similar sentiments to the ACR.
Experts also warn against unvalidated testing . Quackwatch and Science-Based Medicine both provide accessible explanations about the differences between validated and unvalidated tests.
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Lyme Disease Tests: Science Vs Misconceptions
Lyme diagnosis and testing can be very confusing. This confusion has contributed to false positive diagnoses and unnecessary treatment.
As in other infections like HIV, testing for Lyme disease involves looking for antibodies produced by the bodys immune system in response to infection. This is called serologic testing because the antibodies are found in blood serum.
Testing positive for antibodies is called seropositive and testing negative for antibodies is called seronegative.
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 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.
How Do They Test For Lyme Disease
Lyme disease is best tested using two different blood testing methods. These are:
- The Enzyme-linked Immunosorbent Assay test: In a nutshell, this test will look for signs that your body is trying to fight off Lyme disease by producing antibodies. However, the ELISA test may come back negative even when a person is infected by the Borrelia burgdorferi bacteria. False-negatives can occur during the early stages of the disease, where the infected persons body has not produced enough antibodies to fight off the B. burgdorferi bacteria. For this reason, reliable diagnosis is not usually based only on the ELISA test results.
- Western Blot test: Heres a simple way to explain the western blot test without getting into all the nitty-gritty details of what it does and how it does it. Put simply, it separates the blood proteins and detects antibodies to the bacteria causing the Lyme disease. Usually, when an ELISA test comes back positive, a western blot test is performed to confirm the diagnosis.
Ideally, the CDC recommends standard two-tier testing to confirm the veracity of the Lyme disease test accuracy. Together, the ELISA and western blot tests are 99.9% accurate.
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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.
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.
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What To Think About
- It may be hard to tell if you have Lyme disease. False-positive and false-negative Lyme disease test results are common. Many people do not make antibodies to Lyme disease bacteria for up to 8 weeks after being infected.
- Doctors often do not rely on test results alone when recommending treatment for a person who may have Lyme disease. Treatment is often based on a person’s symptoms, the time of year, having a tick bite, and other risk factors for Lyme disease.
Lyme Testing: Accurate When Used Appropriately
A 2016 systematic review that included 8 studies of CDC-recommended two tier test performance in Late Lyme showed Lyme antibody testing to be 99.4% sensitive and 99.3% specific** in North America.
In other words, out of 100 people with Late Lyme disease, 99-100 of them will test positive. Out of 100 people who may believe they have Late Lyme disease but do not, 99-100 of them will test negative.
Misinformation can convince patients to ignore or misinterpret negative tests to justify a false Chronic Lyme diagnosis.
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Completion Of Lyme Disease Test Request Form
Diagnostic samples must be submitted with a completed RIPLLyme disease test request form . Please use a single request form for each patient even when sending several samples.
Please provide details of the sample type, patients symptoms and onset date, tick bite or exposure history and, if relevant, travel and treatment history. Symptom onset date is particularly important for interpretation of laboratory results.
When sending CSF, please provide the cell count and total albumin, IgG and IgM levels for the CSF and serum pair, if available.
Ideally the clinician who sees the patient should print out and complete the appropriate request form . Send the request to the local laboratory with the clinical sample along with a local laboratory request form, whether this is paper or electronic.
The local laboratory should complete the senders information on the request form and then forward the completed form and sample to RIPL. Before sending samples, clinicians are advised to liaise with their local laboratory because local arrangements may vary.
If only immunoblot confirmation is required because the local laboratory has already obtained a positive Lyme screening test result on the serum sample being submitted, tick the Line blot confirmation only box and write the positive screening test result below.
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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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 If Lyme Disease Goes Untreated
If Lyme disease goes untreated, it can affect other systems in the body. According to the , common symptoms of later stage Lyme disease include:
- severe headaches and neck stiffness
- additional erythema migrans rashes on other areas of the body
- facial palsy, which is a loss of muscle tone or droop on one or both sides of the face
- arthritis with severe joint pain and swelling, particularly in the knees and other large joints
- intermittent pain in tendons, muscles, joints, and bones
- heart palpitations or an irregular heartbeat
- episodes of dizziness or shortness of breath
- inflammation of the brain and spinal cord
- nerve pain
- shooting pains, numbness, or tingling in the hands or feet
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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.
Is Treatment 100% Effective
Scientists are divided on this topic. Some studies suggest that that even long-term antibiotics may not completely clear infection dogs may get sick again at some point after antibiotic treatment is stopped. Other studies suggest that complete clearance of infection is possible with antibiotic treatment. Further research is required to answer this question.
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