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.
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.
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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Serologic Tests Are The Gold Standard
Prompt diagnosis is important, as early Lyme disease is easily treatable without any future sequelae.
Tests for Lyme disease can be divided into direct methods, which detect the spirochete itself by culture or by polymerase chain reaction , and indirect methods, which detect antibodies . Direct tests lack sensitivity for Lyme disease hence, serologic tests remain the gold standard. Currently recommended is a standard 2-tier testing strategy using an enzyme-linked immunosorbent assay followed by Western blot for confirmation.
Diagnostic testing methods in Lyme disease
The Earlier In The Course Of Tick Borne Disease That The Treatment Is Started The Better For The Patient And The Worse For The Microbes
Early detection, however, can be difficult. Lyme IS the most prevalent tick borne disease in the states and it is increasing in incidence year to year. Yet the Center for Disease Control estimates only 10% of the cases of Lyme disease are reported annually. This is because only 50% to 68% of patients have a clear bulls-eye rash. Only 26% ever see the tick that gives them Lyme disease. Most people do not know that a flu in the late spring, summer or early fall can be a sign of Lyme disease. Most doctors do not know that Lyme exists anywhere but the northeast part of the United States. So early treatment is a challenge. I try during tick season in Northern California to have short appointments to check out a tick bite or erythema migrans rash, in order to effect early treatment.
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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 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.
Antibody Testing Of Cerebrospinal Fluid
Testing for intrathecal antibody production is integral in the diagnosis of Lyme neuroborreliosis in Europe, where multiple Borrelia species and high background seroprevalence limit the usefulness of serologic analysis . In the United States, the presence of serum antibodies in the appropriate clinical setting is highly sensitive and specific for Lyme neuroborreliosis, making 2-tiered serologic analysis the diagnostic test of choice in most instances . Adjunctive testing for intrathecal antibody production is highly specific and might be helpful in confirming the diagnosis, particularly in regions of high seroprevalence. However, a negative result is insufficient to rule out Lyme neuroborreliosis except in cases of encephalomyelitis.
When testing for intrathecal antibodies, it is essential to note that antibodies in serum are passively transferred to cerebrospinal fluid in some patients with Lyme disease . To control for this transfer, CSF and serum should be collected on the same day and diluted to match the total protein or IgG concentration. A CSF/serum IgG EIA optical density ratio > 1.0 indicates active intrathecal antibody production.
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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:
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 commercial C6- based assays with the Lyme Multiplex Assay12-14. Multiplex Assay OspF and C6 results highly correlate in infected or non-infected dogs12. In horses, comparisons of C6 results and Lyme Multiplex Assay OspF values showed that antibodies to OspF are more robust and the preferred infection markers in horses14. The Equine Lyme Multiplex Assay provides comprehensive information on the horses stage of infection and, in vaccinated horses, on the antibody status induced by vaccination.
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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.
First Comes Igm Then Igg
The pathogenesis and the different stages of infection should inform laboratory testing in Lyme disease.
It is estimated that only 5% of infected ticks that bite people actually transmit their spirochetes to the human host. However, once infected, the patients innate immune system mounts a response that results in the classic erythema migrans rash at the bite site. A rash develops in only about 85% of patients who are infected and can appear at any time between 3 and 30 days, but most commonly after 7 days. Hence, a rash occurring within the first few hours of tick contact is not erythema migrans and does not indicate infection, but rather an early reaction to tick salivary antigens.
Antibody levels remain below the detection limits of currently available serologic tests in the first 7 days after exposure. Immunoglobulin M antibody titers peak between 8 and 14 days after tick contact, but IgM antibodies may never develop if the patient is started on early appropriate antimicrobial therapy.
If the infection is not treated, the spirochete may disseminate through the blood from the bite site to different tissues. Both cell-mediated and antibody-mediated immunity swing into action to kill the spirochetes at this stage. The IgM antibody response occurs in 1 to 2 weeks, followed by a robust IgG response in 2 to 4 weeks.
Because IgM can also cross-react with antigens other than those associated with B burgdorferi, the IgM test is less specific than the IgG test for Lyme disease.
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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.
Why It Is Done
A Lyme disease test is done to diagnose Lyme disease in people who have symptoms of Lyme disease. Symptoms may include:
- An expanding red rash with a pale centre. This is sometimes called a “bull’s eye” rash.
- Extreme tiredness.
- Headache and stiff neck.
- Muscle and joint pain.
Symptoms of chronic Lyme disease infection include joint pain, stiffness, and problems with the heart, brain, or nerves.
Testing is most accurate when you have risk factors for Lyme disease or symptoms of the disease.
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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:
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In early infection, before antibody responses develop
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In reinfection, when serologic tests are not reliable because the antibodies persist for many years after an infection in many patients
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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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Lyme disease is a serious problem here in the United States and we really need to find solutions to some of the limitations that we have, particularly in diagnosing this infection, said Claudia Molins, a microbiologist at the CDC. We want a test that can be used within the first two weeks of infection and that does not rely on antibody production.
So Molins and her colleagues are focusing on metabolomics an approach that, rather than testing directly for the immune response to the infection, instead looks for a wide spectrum of collateral damage.
Specifically theyre looking for so-called metabolite biosignatures: the litany of sugars, peptides, lipids, amino acids, fatty acids, and nucleotides normally present in the blood.
Infections like Lyme, the thinking goes, change the levels of these things and they do so in a predictable, measurable way.
Molins and her team tested that hypothesis by tapping a unique CDC resource freezers filled with well-characterized blood serum samples. They used serum from 89 early Lyme patients, within the first month of infection, and 50 healthy controls to develop an algorithm to detect Lyme blood signatures.
The researchers then tested that algorithm on a larger sample of serums and found that they could diagnose 88 percent of early Lyme cases, and could differentiate Lyme from other diseases 93 percent of the time. The results were published in a 2015 study in Clinical Infectious Diseases.
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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.
Lyme Serum Repository For Validation Of Novel Diagnostic Tests
When developing new tests or assessing their performance, researchers must have access to well-characterized positive and negative controls. Moreover, it is essential to include samples from patients with diseases that have overlapping clinical features and that are known to be serologically cross-reactive because sensitivity and specificity are heavily dependent on the types of patient samples used. However, collecting and characterizing a wide variety of clinical samples for this purpose can be challenging, costly, and time-consuming.
To improve availability of serum sample sets to evaluate novel diagnostic tests, the Centers for Disease Control and Prevention and the National Institutes of Health have developed a repository of well-characterized serum samples from patients with Lyme disease . The repository includes samples from patients with various stages of Lyme disease patients with cross-reactive conditions, such as multiple sclerosis and infectious mononucleosis and healthy controls from both disease-endemic and nondisease-endemic areas. Panels of serum, along with accompanying clinical and laboratory testing results, are now available to researchers for validation of novel diagnostic testing.
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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.
Lyme Disease Blood Test Results Fully Explained
The Lyme disease blood test is used to discover if someone who has the symptoms of a Borrelia burgdorferi infection actually has the bacteria in their bloodstream. Recent infections are much easier to detect and an IgM and IgG blood test will often be ordered as complimentary information gathering tools. This blood test does not always detect the presence of the disease, so patients that have persistent symptoms after having the test may be re-tested in a few weeks.
If any of these tests come back as positive, then other samples will be used to track the stage of the disease to determine if it has reached the chronic infection stage. At this point, a medical provider will order a Western blot test to confirm the presence of Lyme disease.
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