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.
Laboratory Testing For Lyme Disease: Possibilities And Practicalities
Lyme disease is a multisystem and multistage infection caused by three species of tick-borne spirochetes in the Borrelia burgdorferi sensu lato genogroup. These include B. burgdorferi sensu stricto , Borrelia afzelii , and Borrelia garinii . LD has become the most common vector-borne disease in North America and Europe . In 1999, over 16,000 cases of human LD were reported in the United States by the Centers for Disease Control and Prevention , representing an overall incidence of 6.0 per 100,000 persons . Many cases go unreported in areas of endimicity conversely, LD is probably overreported in some geographic areas where the disease is not known to be endemic.
Since the initial description of Lyme arthritis 25 years ago, there have been tremendous gains in knowledge of the pathogenesis, epidemiology, diagnosis, and treatment of LD . The CDC has developed a case definition of LD for surveillance purposes that includes either physician-diagnosed EM along with solitary lesions with diameters of at least 5 cm or at least one late joint, neurologic, or cardiac manifestation along with laboratory confirmation . This definition is not intended to be 100% sensitive or specific for clinical diagnosis but is useful as a starting point for the development of a differential diagnosis and highlights the central role of laboratory testing, especially for extracutaneous LD.
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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Is Lyme Disease Curable
While there is no vaccine to prevent us from getting Lyme disease, it can be treated with antibiotics, and most people recover within a few weeks. However, some people can get what is known as Post-Treatment Lyme Disease Syndrome, in which symptoms such as pain, fatigue, or difficulty thinking can last for months.
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
- Racing heart
- 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.
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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.
The Best Test For Lyme Disease
Lyme disease is a tick-borne illness spread by Lyme borreliaebacteria which includes, but is not limited to, Borrelia burgdorferi sensu stricto. The Centers for Disease Control and Prevention estimate that there are 400,000 cases of Lyme disease annually, making Lyme a serious public health concern that only stands to grow as the spread of ticks affects disease endemicity and seasonality.
One of the biggest challenges of fighting Lyme disease is providing patients with accurate diagnostic tests. Without access to the best tests for Lyme disease, its impossible to diagnose this treatable disease in a timely manner. When the disease isnt caught in time, it can spread throughout the body and cause chronic health problems that could otherwise be avoided with earlier detection and treatment.
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If The C6 Test Is Positive What Is The Next Step
A positive C6 test means antibodies to C6 were found. The next step is to do a QC6 test, which determines if the levels of antibody are high enough to justify treatment. If the value of the QC6 is higher than 30 IU/mL and signs of illness are present, then antibiotic treatment should be considered. If the QC6 is less than 30 IU/mL and there are no signs of illness, then treatment may not be necessary.
In addition to doing the QC6 test, your veterinarian may want to take samples of blood and urine to assess kidney function and to look for protein in the urine. A positive test for protein in the urine could signal serious underlying kidney disease.
Cdc Supports The Development Of New Tests
New tests may be developed as alternatives to one or both steps of the two-step process. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration . For more details, see: Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease.
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Important: Dont Misinterpret A Negative Test As Positive
Many people without Lyme disease will test positive for some bands. Therefore, the CDC cautions:
It is not correct to interpret a test result that has only some bands that are positive as being mildly or somewhat positive for Lyme disease.
For example, in one study, 43% of healthy people and 75% of syphilis patients tested positive for IgG band 41. In a study of US veterans in New York, 76% of those without Lyme disease tested positive for IgG band 41. In a 1996 study, in healthy people, 55% and 21% tested positive for IgG band 41 and IgM band 41, respectively.
Even without a Borrelia burgdorferi infection, many of us produce antibodies that will react on a Lyme test. Notably, harmless bacteria found naturally in our mouths can cause us to test positive for band 41.
A positive Lyme antibody test requires both tiers to be positive, as many without Lyme infections can test positive on single tests. For example, one study found up to 40% of patients with Lupus and other rheumatic diseases test positive on the first tier ELISA test. The second tier test is necessary to stop a false positive diagnosis.
The American Society for Microbiology recommends against ordering the Western blot without a positive ELISA screening:
The Lyme immunoblot test is designed only as a confirmatory test, so it is important not to test screen-negative samples.
LymeScience recommends against:
Table excerpted and reformatted*** from the longer 2013 paper :
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.
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How Is Lyme Disease Diagnosed
Though several types of tests do exist for the diagnosis of Lyme disease, the best tests for a Lyme disease diagnosis are blood tests, also known as serological tests. These tests are indirect, meaning they dont detect the infecting bacteria or its antigens but rather the antibodies an infected persons body produces in response to these antigens.
References Choosing A Test
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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.
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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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.
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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Question 8 Is There A Test To Prove Cure For Lyme Disease
There is no test to prove cure for Lyme disease. Antibodies frequently persist in the blood for months or even years after the infection is resolved, despite absence of detectable/viable B burgdorferi.7 Therefore, antibody tests cannot be used to determine a cure. There is no evidence that antibiotics cause Lyme serology blood tests to become negative following treatment.3,5,6
What Is The Most Accurate Test For Lyme Disease
Lyme disease is more common than many people think. Figures from the Center for Disease Control suggest that roughly 300,000 Lyme disease cases occur every year in the US.
The numbers are alarming, but it gets worse as finding accurate diagnostic tests can be challenging. Although the disease is treatable, it is nearly impossible to tackle it effectively if it is not diagnosed accurately and early enough.
Late detection can lead to severe health problems such as arthritis, heart blockage, and inability to concentrate, among other problems.
Given the prevalence and seeming elusiveness of the disease, some of the logical questions concerned persons would ask are: what is the most accurate test for Lyme disease? And when should I get checked for Lyme disease? This article will proffer answers to these and many other related questions. But first, a little background would be in order.
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Persistent Lyme Disease Symptoms Arent Helped By Long
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.