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.
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 center. 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.
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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Cutter Lyme Disease Tick Test
The Cutter Lyme Disease Tick Test is a DNA tick test that checks whether the tick carries a Lyme disease pathogen.
The test requires a person to take one to several ticks from the same host and place them in the specimen bag. They then mail them to the lab using the pre-addressed mailing label.
Individuals can expect to receive their results through email, phone, or mail within 3 business days. The available screenings feature basic, advanced, and comprehensive test panels that check multiple pathogens.
At the time of publication, this test costs $25.
Pros and cons
This test features several advantages. Reviews state:
- It is easy to use.
- It is affordable.
- People can use it on their pets.
However, it does not test for other infections that ticks carry.
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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Everlywell Lyme Disease Test
Everlywells Lyme Disease Test checks for a persons exposure to any of the three strains of Borrelia bacteria. The test is suitable for those experiencing fatigue, headaches, or joint pain. The test offers a fingerprick sample collection.
Once people receive their kits, they can register them online, collect their sample, and return it to the labs using the prepaid shipping labels. They can access their results through their online dashboards.
The kit costs $109.
There are some advantages that Everlywell services offer:
- It works with CLIA-certified labs.
- Independent board-certified physicians review and approve peoples tests.
- It offers free shipping.
QuestDirects Lyme Disease Test is available in person. People purchase their test and book an appointment with a nearby Quest Patient Service Center, where a medical professional collects the sample.
They then receive their results through their MyQuest accounts.
The cost for the test is $89, with an additional $6 fee that covers the physicians visit.
Pros and cons
QuestDirect has some advantages. Firstly, the MyQuest portal allows individuals to view their results online. Additionally, the companys health team can contact the customer if their results require prompt attention.
However, disadvantages include the fact that there is an additional physician fee. The service is also unable to provide a receipt for health plan reimbursement.
You Should Take The Test If:
- You are presenting with symptoms of Lyme disease
- You live in a place that is rich in vegetation or a woodland area
- You live in Northern America or Northern Europe
- You go camping or hiking on a regular basis, particularly during the Summer or Autumn
- You come into contact with larger woodland animals on a regular basis
The sample must be collected before 10am on a Monday, Tuesday, Wednesday or Thursday and returned on the same day.
Fasting means that you take the test in the morning before you have breakfast. You can still drink water when fasting. Always follow the advice of your physician with regards to fasting, particularly if you have any medical conditions.
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Serological Testing Of Serum For The Diagnosis Of Lyme Disease
The most commonly used tests look for antibodies to the Borrelia species that cause Lyme disease in the UK and Europe, but they also detect infections from strains of Borrelia from the US.
The antibody response takes several weeks to reach a detectable level, so antibody tests in the first few weeks of infection may be negative. If the first sample was taken within 4 weeks from the start of symptoms and is negative and there is a clinical suspicion of Lyme disease, then retesting in 4 to 6 weeks may be useful.
It is very rare for patients to have negative antibody tests in longstanding infections. Borrelia antibodies persist indefinitely in some patients and this does not indicate continuing disease or a need for re-treatment.
Serological testing for Lyme disease in the UK and much of the world follows a two-step approach using commonly available antibody screening tests as a first stage, followed by immuno-blotting of samples that give positive or indeterminate results in the screening tests.
Sensitive screening tests are used at the first stage of testing but have the disadvantage of occasionally detecting other diseases and producing false positive results. RIPL uses the C6 Lyme ELISA for screening
Samples giving positive or indeterminate preliminary screening test results are then tested in a more specific system to confirm the presence of Borrelia-specific antibodies. RIPL uses the Borrelia ViraChip® IgG, IgM test for this purpose
Letsgetchecked Lyme Infection Test
LetsGetCheckeds kit tests for Borellia IgG and IgM antibodies through a fingerprick collection. The website states people should receive the test 57 days after ordering.
The company requires individuals to activate the kit, so they can collect the sample and send it back using the prepaid shipping label. They can then access their results on their online account within 25 days.
In addition, LetsGetCheckeds laboratories have a certification, meaning they are compliant with federal certifications.
This Lyme disease test costs $119 and comes with free shipping.
Pros and cons
The LetsGetChecked Lyme Infection Test features the following advantages:
- There is a nursing team available to discuss results.
- The company offers free shipping.
- People can pay through a health savings account or a flexible spending account .
However, the company also has some disadvantages. Firstly, its single-test kits can be expensive. Additionally, shipping is not available to all countries.
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Other Canine Diseases Carried By Ticks
Anaplasmosis can involve symptoms similar to those for Lyme disease. Babesiosis can present with a wide range of symptoms, from sudden and severe shock, high fever, and dark urine to a slowly progressing infection with more subtle clinical signs. Diagnosis of both diseases includes blood tests similar to those used to check for Lyme disease.
Sometimes, dogs and people can become sick with co-infection of multiple tick-borne diseases, where more than one type of disease-causing bacteria is transmitted through a tick bite. This situation can make diagnosis and treatment even more challenging and difficult.
Key Points To Remember
- Most Lyme disease tests are designed to detect antibodies made by the body in response to infection.
- Antibodies can take several weeks to develop, so patients may test negative if infected only recently.
- Antibodies normally persist in the blood for months or even years after the infection is gone therefore, the test cannot be used to determine cure.
- Infection with other diseases, including some tickborne diseases, or some viral, bacterial, or autoimmune diseases, can result in false positive test results.
- Some tests give results for two types of antibody, IgM and IgG. Positive IgM results should be disregarded if the patient has been ill for more than 30 days.
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Other Lyme Disease Tests
Three other tests that may be used to diagnose Lyme disease are polymerase chain reaction , antigen detection and culture testing. They are called direct tests because they detect the bacteria, not just your immune response to it.
PCR multiplies a key portion of DNA from the Lyme bacteria so that it can be detected. While PCR is highly accurate when the Lyme DNA is detected, it produces many false negatives. This is because the Lyme bacteria are sparse and may not be in the sample tested.
Antigen detection tests look for a unique Lyme protein in fluid . Sometimes people whose indirect tests are negative are positive on this test.
Culture is the gold standard test for identifying bacteria. The lab takes a sample of blood or other fluid from the patient and attempts to grow Lyme spirochetes in a special medium.
Although culture tests are generally accepted as proof of infection, the CDC has advised caution on the only commercially available culture test developed by Advanced Laboratory Services. LDo recognizes that the test is new and requires further validation in other studies. However, we believe that informed patients should be able to choose the test if they prefer. Choice is particularly important given the low quality of Lyme disease tests generally.
How Much Do At
Generally, at-home Lyme disease tests cost around $100, while others may cost closer to $500. The difference comes down to how many pathogens you are hoping to test for. On average, the test will look for two or three, but more expensive tests may screen for 10 to 15.
Depending on your insurance and which test you select, it may be covered. Another option is to pay for the Lyme disease test with your HSA/FSA, since some companies will accept that as a payment form.
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How Can I Prevent My Dog From Getting Lyme Disease Or Other Tick
Recommendations on preventing ticks include these from AKCs Chief Veterinary Officer Dr. Jerry Klein:
- Inspect your dogs and yourself daily for ticks after walks through the woods or grassy settings. On dogs, look especially on the feet , on lips, around eyes, ears , near the anus, and under the tail.
- Remove ticks stat. The quicker you find them the less likely your dog will contract a secondary illness related to tick bites. Learn the proper method of tick removal. Invest in a pair of fine tweezers used for this purpose. If you are unable to do so, consult with a veterinarian.
- Ask your veterinarian to conduct a tick check at each exam. Theyll be able to find any you may have missed.
- Prevent ticks from jumping on your dog with one of the many veterinary-approved flea and tick preparations available on the market. Speak to your veterinarian to find the best and most appropriate product for your dog.
- Keep grass mowed as short as possible. Refrain from walking into grassy patches in endemic tick areas if you can.
- Get your dog vaccinated. Vaccination could prevent your dog from getting Lyme disease. They may not be appropriate for some dogs, so discuss with your vet.
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 PHE Porton where ISO15189 accredited confirmatory testing is also provided. RIPL is also introducing 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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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 Cost Will Be Between $5300 And $18900
Lyme Disease Test Cost minimal is in Jason Health , Immunoblot) with price $53.00. Lyme Disease Test Cost max is in True Health Labs Lyme Disease Test | IgM + IgG) with price $189.00. This laboratory test is available in 12 online lab test stores.
Lyme Disease Antibodies , Immunoblot Lab Test procedure CPT Code: 86617
Screening for the next conditions: Lyme Disease, Meningitis and Encephalitis
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Lyme Disease Test Overview
A Lyme disease test will detect antibodies to the Lyme disease bacteria Borrelia burgdorferi in the blood, according to WebMD.com.
An antibody test can either be drawn from the fluid within the spine or joints, or it can be via a simple blood test however, if your blood is drawn, it can take up to two months after becoming infected before the antibodies are detected. Once these antibodies form, they can stay in your system for years, even after a treatment plan is developed.
An antibody test often starts with the ELISA test, as mentioned in the table above and recommended by the CDC, followed by the Western blot test to confirm the positive results of an ELISA test. Both of these tests work in the same way as that of a blood test. At your local doctors office or lab, a blood sample is drawn from your upper arm and sent off for analysis.
Test results are readily available within one to two weeks.
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.
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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.