To Diagnose And Treat Lyme Disease Reliably And Securely The High Sensitivity And Specificity Of Our Testing Method Including 18 Parameters Yields A Hit Rate Of Over 90 %
Chronic diseases are a great challenge in terms of diagnosis and treatment. However, if the infection is diagnosed at an early stage, it can be treated very well and successfully.
- Assessment of the symptoms takes place via filling out a questionnaire.
- Your answers are evaluated and, if necessary, result in a Lyme borreliosis test.
- If test results are positive, we will assist you in terms of therapy and treatment.
What Do My Test Results Mean
If both tests come back positive, that means you have had Lyme disease at some point in time.
If either or both of your tests come back negative, your doctor may still diagnose Lyme disease, particularly if you recently developed Lyme-like symptoms, regardless of your test results. But, if your doctor does not diagnose you with Lyme disease, you can ask to be re-tested in a few weeks. If you do have Lyme disease, your body may build up sufficient antibodies by that point to be detected by a blood test.
Two-step blood testing for later stages of Lyme disease is more accurate than for early infection because your body should have had sufficient time to produce the antibodies detected by diagnostic tests.
Interpreting the Western blot test
The Western blot test looks at whether you have an immune response the production of IgM or IgG antibodies to specific proteins on the Lyme disease bacteria. IgM antibodies are usually made by your body when the infection is new and recent, while IgG antibodies are usually made some weeks later. When the IgM or IgG antibodies combine with specific proteins from the Lyme disease bacteria, this produces dark spots, or bands on the Western blot test strip.
The CDC considers a Western blot test to be positive for Lyme disease if at least two of three IgM bands are positive within 30 days of symptom onset, or five of 10 IgG bands are positive at any time.
If your Western blot test comes back negative, ask your doctor:
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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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.
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.
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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, IgG 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 albumin and total IgG levels compared between the 2 sample types to produce a meaningful result.
For necessary sample types and volumes see Sample types for Lyme disease testing.
Notice To Readersrecommendations For Test Performance And Interpretation From Thesecond National Conference On Serologic Diagnosis Of Lyme Disease
The Association of State and Territorial Public HealthLaboratory Directors, CDC, the Food and Drug Administration, theNational Institutes of Health, the Council of State and TerritorialEpidemiologists, and the National Committee for Clinical LaboratoryStandards cosponsored the Second National Conference on SerologicDiagnosis of Lyme Disease held October 27-29, 1994. Conferencerecommendations were grouped into four categories: 1) serologictest performance and interpretation, 2) quality-assurancepractices, 3) new test evaluation and clearance, and 4)communication of developments in Lyme disease testing. Thisreport presents recommendations for serologic test performance andinterpretation, which included substantial changes in therecommended tests and their interpretation for the serodiagnosis ofLD.
It was recommended that an IgM immunoblot be consideredpositive if two of the following three bands are present: 24 kDa * , 39 kDa , and 41 kDa . It was furtherrecommended that an that IgG immunoblot be considered positive iffive of the following 10 bands are present: 18 kDa, 21 kDa *,28 kDa, 30 kDa, 39 kDa , 41 kDa , 45 kDa, 58 kDa , 66 kDa, and 93 kDa .
The details of both plenary sessions and the work groupdeliberations are included in the publication of the proceedings,which is available from the Association of State and TerritorialPublic Health Laboratory Directors telephone 822-5227.
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Lyme Disease Laboratory Tests Available At Ripl
The primary service provided by RIPL is serological testing using well-characterised and validated screening and confirmatory tests in accordance with the NICE Lyme disease guideline.
RIPL participates in regular external quality assurance exercises as an independent measure of its performance.
Details of prices and turnaround times for Lyme testing are provided in Appendix 1 of the RIPL user manual.
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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Negative Elisa On Serum
Early clinical Lyme disease in the form of erythema migrans with an 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 to 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.
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.
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What Is The Difference Between This Indirect Blood Diagnostic Test And A Direct Test
Direct diagnostic tests measure the presence of the bacteria directly and are much more reliable than tests looking for indirect measurement of antibodies that measure a persons immune response to an infection. Lyme disease diagnoses and disease management would benefit from validated diagnostic tests that directly measure the infection such as a culture, PCR test, or antigen detection tests. Direct tests are vital to the management of other infectious diseases such as HIV, hepatitis C, strep, and COVID-19, but have not yet become widely available for 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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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.
Enzyme Immune Assay Testing:
This test detects antibodies to the different kinds of bacteria that are known to cause symptoms of Lyme disease. Different strains of Borrelia are found in the USA and Europe but the tests are designed to detect all of the Borrelia that cause symptoms.
The EIA is the first test performed as it is designed to be very sensitive . If the EIA test is negative for Lyme disease, this can be relied upon to exclude Lyme disease in the patient, especially if the sample is taken when symptoms have been present for several weeks.
The disadvantage of the EIA is because it is very sensitive it can give false positive results. This means that the EIA test is reacting with something else present in the blood sample which is not related to Lyme disease. False positive EIA results can happen when there are infections with other bacteria or viruses, or in certain inflammatory /automimmune conditions. This is why a positive EIA test should be confirmed by a second test the Western Blot.
In Ireland, 2.5% of over 4,800 people who were tested by the National Virus Reference Laboratory in a single year had a positive Lyme test result. In Europe, between 3- 5% of the general population show evidence of infection with Borrelia bacteria at some point in their lifetime while a study in Ireland previously found that the background rate of infection in the Irish population was 3.4%.
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What Is A Lyme Disease Blood Test
A Lyme disease blood test is used to determine if you have contracted Borrelia burgdorferi , the bacterium that causes Lyme disease. Lyme disease tests are conducted with a routine blood draw.
While there are other species of Borrelia that cause Lyme disease, B. burgdorferi is the most common cause in the United States. Most antibody tests in the United States only test for B. burgdorferi, but other species-specific tests are available depending on a persons travel history.
Lyme disease is transmitted to humans through ticks that are infected with Borrelia.
- shortness of breath
Lyme disease can be difficult to diagnose. Ticks are very small, and the bites are not always noticeable. Symptoms of the disease can vary from person to person. Not everyone experiences the classic bulls-eye rash pattern around a tick bite.
It should be noted that testing is not always required to make a diagnosis. For people with a classic bulls-eye rash living in a high risk area, testing is not recommended for diagnosis.
Your doctor will use the results of a Lyme disease antibody test, along with the report of your symptoms, to confirm a diagnosis.
Antibodies are proteins your body makes in response to foreign or harmful substances called antigens. Common antigens include:
Your body produces antibodies if you have contracted B. burgdorferi. These Lyme disease-specific antibodies will be present in your blood, and your test will be positive if you have the bacterial infection.
Alternative Diagnostic Tests Not Available At Ripl
Tests used by the NHS and UKHSA 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 guidelines, 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 US 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 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.
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Who Should Get Testing
Testing is usually indicated if a person has symptoms of Lyme disease and a known or possible exposure to ticks that can carry the Borrelia bacteria. However, because it takes time for antibodies to develop, the timing of testing is important to consider.
Lyme disease symptoms depend on the extent of the bacterial infection. Three phases are used to describe the infection:
It is important to understand these phases because testing is not equally valuable in each stage. With early localized disease and erythema migrans, blood testing is generally not helpful because antibodies have not had enough time to develop.
Because of similar concerns about potential false positive results, random screening for Lyme disease in people without symptoms is not recommended even in areas that are known to have ticks that can carry the Borrelia bacteria.
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.
|Contributors: Ryan Llera, BSc, DVM Kristiina Ruotsalo, DVM, DVSc, Dip ACVP Margo S. Tant, BSc, DVM, DVSc|
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