How Lyme Disease Is Diagnosed
Your doctor or other healthcare provider may have difficulty diagnosing Lyme disease because many of its symptoms are similar to those of other disorders and illnesses. The only distinctive sign unique to Lyme disease is absent in at least a quarter of the people who become infected. Although a tick bite is an important clue for diagnosis, many people can’t recall having been recently bitten by a tick. This isn’t surprising because the deer tick is tiny, and a tick bite is usually painless.
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.
Polymerase Chain Reaction May Help In Some Situations
Molecular assays are not part of the standard evaluation and should be used only in conjunction with serologic testing. These tests have high specificity but lack consistent sensitivity.
That said, PCR testing may be useful:
In early infection, before antibody responses develop
In reinfection, when serologic tests are not reliable because the antibodies persist for many years after an infection in many patients
In endemic areas where serologic testing has high false-positive rates due to high baseline population seropositivity for anti-Borrelia antibodies caused by subclinical infection.
PCR assays that target plasmid-borne genes encoding outer surface proteins A and C and VisE are more sensitive than those that detect chromosomal 16s ribosomal ribonucleic acid genes, as plasmid-rich blebs are shed in larger concentrations than chromosomal DNA during active infection. However, these plasmid-contained genes persist in body tissues and fluids even after the infection is cleared, and their detection may not necessarily correlate with ongoing disease. Detection of chromosomal 16s rRNA genes is a better predictor of true organism viability.
The disadvantage of PCR is that a positive result does not always mean active infection, as the DNA of the dead microbe persists for several months even after successful treatment.
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The Role Of Lyme Disease Tests
The purpose of the most common type of Lyme disease testing is to determine whether you have developed antibodies as a result of past exposure to the Borrelia bacteria that cause Lyme disease. Antibodies are proteins created by the immune system that target specific threats like bacteria and viruses.
Blood testing alone cannot determine whether you have Lyme disease. Instead, testing can provide helpful information that your doctor can consider along with other factors, such as any symptoms youve had and whether youve been exposed to ticks that can carry Borrelia, to determine if a diagnosis of Lyme disease is appropriate.
Beyond blood testing, it is possible to analyze fluid from the central nervous system for signs of the Borrelia bacteria.
The Igenex Lyme Immunoblot Solves These Problems
IGeneX has developed a serological test that increases specificity without sacrificing sensitivity that has changed how to test for Lyme disease. It uses specifically created recombinant proteins from multiple species and strains of Lyme borreliae and reduces inconsistencies in reading and interpreting the test bands.
More species detected The Lyme ImmunoBlot tests for more species of Lyme borreliae than the traditional ELISA and Western blot tests, reducing the risks of false negatives due to the inability to detect antibodies to a certain strain or species of Lb. The test includes all Borrelia-specific antigens relevant in North America and Europe, not just B. burgdorferi B31 or 297.
The result is a single test that replaces at least 8 Western blots.
More accurate testing The ImmunoBlot uses specific recombinant proteins that are sprayed in precise amounts onto specific locations on the membrane strip, allowing for greater control of the quantity and location of the antigens. This makes reading the bands much more accurate and consistent.
Earlier detection The ImmunoBlot can detect infections at multiple stages of illness, letting you catch infections earlier.
The IgM and IgG ImmunoBlots superior specificity and sensitivity make them the best Lyme disease test available.
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Investigation Of Suspected Lyme Disease
Erythema migrans is a clinical diagnosis and does not require confirmation by laboratory testing. Lyme disease is not a notifiable disease so there is no statutory requirement to notify clinically suspected cases to the local Health Protection Team.
The 2018 NICE Lyme disease guideline provides detailed advice about when a diagnosis of Lyme disease should be suspected and about which tests to use and when.
The NICE Lyme disease guideline also contains a useful summary diagram of the routine serological testing recommendations for Lyme disease.
Management Of Individuals Without Symptoms Following A Tick Bite
Diagnostic testing is not recommended for individuals who do not develop any symptoms suggestive of Lyme disease after a tick bite.
Some commercial companies offer services to test removed ticks for the presence of the bacteria that cause Lyme disease. UKHSA does not provide such tick-testing services. The results of such tests should not be used to inform diagnosis or treatment. A positive result does not mean that the infected tick will have passed on the bacteria there are many factors that determine whether Lyme disease results from the bite of an infected tick. A negative result may not be technically valid and could give false assurance, as it does not exclude the possibility that another tick elsewhere on the body has been missed by the patient.
UKHSA runs a tick surveillance scheme and is happy to receive ticks for species identification and to monitor tick distribution.
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Unvalidated Tests And Interpretation Criteria
Several alternative testing centers use laboratory-developed tests that are not currently subject to FDA regulations and might not be clinically validated . Alternative laboratories might also use standard Western immunoblot techniques but apply nonstandard interpretation criteria or fail to perform the recommended first-tier EIA. These laboratories often claim to specialize in testing for tickborne diseases and assert that their tests have better sensitivity than standardized 2-tiered serologic analysis.
False-positive results for alternative tests or unvalidated interpretation criteria can lead to patient confusion and misdiagnosis . A recent evaluation of laboratories by Fallon et al. reported an alarming false-positive rate of 58% for samples from healthy control patients submitted to an alternative testing center that used unvalidated criteria to interpret IgM and IgG immunoblots . Moreover, evaluation of published results from a laboratory claiming to have a new Borrelia culture method demonstrated that results were highly suspicious for laboratory contamination . Additional alternative tests, such as urine antigen tests and CD57 tests, have also been shown to be inaccurate .
It is recommended that clinicians only use Lyme disease tests that have been clinically validated and cleared by the FDA . If there is ever any question regarding testing protocols or interpretation, clinicians should consult an infectious disease specialist.
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 sample. 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 introduced a service for the detection of intrathecal synthesis of Borrelia-specific antibodies which is summarised in this flow diagram. An accessible text version of this flowchart is available below.
Clinicians may ask for guidance on laboratory testing of CSF from RIPL if required.
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Access To Lyme Disease Testing Services
This guidance on the laboratory diagnosis of Lyme disease is intended for healthcare professionals in the UK. Patients concerned about possible Lyme infection should consult an appropriate healthcare professional, for example their GP, in the first instance.
Health professionals wishing to discuss a possible case or ascertain local arrangements for testing should contact a local Infection specialist .
NHS testing for Lyme disease is available through local service providers and the Rare and Imported Pathogens Laboratory at UK Health Security Agency Porton where ISO15189 accredited confirmatory testing is also provided. RIPL also provides a testing service for neurological Lyme disease.
RIPL provides medical and laboratory specialist services to the NHS and other healthcare providers, covering advice and diagnosis of a wide range of unusual bacterial and viral infections, including Lyme disease.
RIPL continuously updates its methods and will make further information on Lyme disease diagnostic testing available as it arises.
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Microbiologist Elli Theel, who directs the Infectious Diseases Serology Laboratory at Mayo Clinic, calls the 2015 study incredibly promising. The sensitivity they showed just in early Lyme disease patients was very high, the highest Ive actually seen, she said.
In an upcoming publication, the researchers also showed that metabolomics can differentiate Lyme from a similar tick-borne disease called southern tick-associated rash illness . The disease causes similar symptoms as Lyme, including a bullseye rash, and occurs in overlapping geographic regions. Currently there is no laboratory test to diagnose STARI, and little is known about how the disease progresses and how to treat it, something Molins hopes will change with better testing.
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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.
How Much Does A Lyme Disease Test Cost
The cost of a Lyme disease test depends on what type of test is performed an ELISA test or a combination of ELISA and western blot tests.
Averagely, the cost for an ELISA test for Lyme disease is in the vicinity of $120 or more. If you include a confirmation western blot test, it can attract an additional $130 or more. More details on pricing can be referenced on our website.
Although an ELISA test might come back negative, it is best to combine it with a western blot test because not everyone shows the rash or bulls eye symptoms of Lyme disease.
After a successful diagnosis and treatment, it is equally important to do a follow-up test for Lyme disease years later to be sure that any similar flu-like symptoms are something else and not the same disease reoccurring.
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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.
What Is On The Horizon For Lyme Testing
Because Lyme bacteria are not usually present in high enough numbers to be detectable, blood tests to look for Borrelia are not helpful.
Better diagnostic tests are needed that are direct and can detect infection at all stages of Lyme disease. Researchers are studying new diagnostic methods using better antibody tests, direct detection methods, and different ways to measure immune response to Lyme disease.
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What Happens During Lyme Disease Testing
Lyme disease testing is usually done on a sample of blood. In certain cases, a cerebrospinal fluid test may be done.
For a Lyme disease blood test:A health care professional will take a blood sample from a vein in your arm, using a small needle. After the needle is inserted, a small amount of blood will be collected into a test tube or vial. You may feel a little sting when the needle goes in or out. This usually takes less than five minutes.
For a CSF test:You may need a cerebrospinal fluid test if your symptoms could mean that Lyme disease is affecting your nervous system, such as a stiff neck or numb hands or feet. Providers may order a CSF test if the results of your blood test show you likely have Lyme disease or if the results are uncertain.
To get a sample of your cerebrospinal fluid, a provider will do a procedure called a lumbar puncture, also known as a spinal tap. During the procedure:
Interpret Laboratory Results Based On Pretest Probability
The usefulness of a laboratory test depends on the individual patients pretest probability of infection, which in turn depends on the patients epidemiologic risk of exposure and clinical features of Lyme disease. Patients with a high pretest probabilityeg, a history of a tick bite followed by the classic erythema migrans rashdo not need testing and can start antimicrobial therapy right away.
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How Is It Diagnosed
If youâve been outside in an area where ticks are known to live, you should tell your doctor. Theyâll also want to know about the symptoms youâre having. These details are crucial to making a diagnosis of Lyme disease.
Early symptoms that usually occur within the first month after a tick bite can include:
- Rash at the site of the tick bite that may look like a âbullâs-eyeâ
- Problems with your short-term memory
Symptoms that come and go are common with Lyme disease. They will also depend on the stage of the disease.
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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Positive 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 borrelia-specific antibodies may persist for several years in patients who have had Lyme disease in the past, long after the bacteria have been cleared from the body. Therefore, detection of borrelia specific antibodies in someone with no evidence of current clinical symptoms or recent tick exposure argues against active Lyme disease infection. 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 UKHSA and analysed for inclusion in UKHSA Health Protection Reports as part of Lyme disease epidemiology and surveillance.
Surveillance Versus Clinical Diagnostic Testing
One misconception is that 2-tiered serologic analysis is intended only for surveillance, rather than patient diagnosis. This misconception is an apparent conflation of clinical serologic testing recommendations for Lyme disease and the surveillance case definition of the Council of State and Territorial Epidemiologists . Recommendations for 2-tiered testing are meant to aid the diagnosis of individual patients in the clinical setting. Serologic test results might be used by public health officials to determine whether a given illness meets the surveillance case definition, but the methods themselves were not developed for this purpose. Furthermore, for practical reasons, serologic results might be used slightly differently in surveillance than is recommended in the clinical setting. For example, although it is not recommended to perform Western immunoblot without a first-tier EIA for laboratory diagnosis, a positive IgG result by Western immunoblot alone is accepted as laboratory evidence of infection for surveillance purposes . This operational definition enables simplification of reporting practices because it can be difficult to track down records of the first-tier test. However, it does not represent best clinical practice.
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