Materiały źródłowe

• #1 Lyme Disease Diagnosis | Johns Hopkins Lyme Disease Research Center

  https://www.hopkinslyme.org/lyme-disease/diagnosis-of-lyme-disease/

  Many cases of Lyme disease are initially misdiagnosed. Lyme disease can be difficult to diagnose because early symptoms of fever, severe fatigue, and achiness are also common in many other illnesses. In addition, diagnostic blood tests are not always dependable, particularly in early disease. However, the round expanding red lesion rash is a unique sign that is more specific for Lyme disease, and many times a diagnosis can be made based on the tell-tale erythema migrans rash itself. Yet, it is important to understand that the erythema migrans rash is not always present or recognizable, and symptoms can fluctuate. […] Recognizing the Lyme disease erythema migrans rash can be crucial to early diagnosis and treatment. […] Diagnosis can be confirmed by serology blood tests which measure the antibodies that are formed by the immune system in response to the Lyme disease bacterial infection.

• #2 Lyme Disease Diagnostics Research | NIAID: National Institute of Allergy and Infectious Diseases

  https://www.niaid.nih.gov/diseases-conditions/lyme-disease-diagnostics-research

  There is a great need to develop rapid, point-of-care tests to determine whether people are infected with Borrelia burgdorferi, the bacterium that causes Lyme disease. […] NIAID is committed to improving Lyme disease diagnostics by supporting innovative research projects. […] Priorities include finding potential targets substances that new diagnostic tools might measure in patient samples and improving the sensitivity and specificity of currently available diagnostic tests, thereby leading to more accurate results. […] Lyme disease can be difficult to diagnose for a number of reasons. […] Current diagnostic tests have some limitations that make a clear, quick diagnosis difficult. […] Lyme antibody tests the most common diagnostic tool available today look for antibodies in the blood that show a person has been exposed to B. burgdorferi.

• #3 Diagnosis | Lyme Disease

  https://www.columbia-lyme.org/diagnosis

  Diagnosis of Lyme disease is made through a clinical decision making process that includes a medical history, physical exam, review of past diagnostic tests and consultations, and results from newly ordered tests. In early Lyme disease, one can make the diagnosis of Lyme disease with near 100% certainty when the expanding red rash is present. […] With the later disseminated manifestations of Lyme disease, blood tests have a more important role, because by then antibodies will have had time to form. […] The most common testing for Lyme disease is conducted on the blood. However, when central nervous system Lyme disease is suspected, the spinal fluid should be tested as well. […] Other tests that help with diagnosis include brain imaging tests, neurocognitive tests, tests of the peripheral nerves (nerve conduction studies, small nerve fiber biopsy studies), and tests of autonomic function.

• #4 Diagnosis and Management of Lyme Disease | AAFP

  https://www.aafp.org/pubs/afp/issues/2012/0601/p1086.html

  Erythema migrans rash following a tick bite is the only clinical manifestation sufficient to make the diagnosis of Lyme disease in the absence of laboratory confirmation. […] For diagnosis of Lyme disease, the Centers for Disease Control and Prevention recommends a two-tier serologic testing protocol using an enzyme-linked immunosorbent assay initially, followed by the more specific Western blot to confirm the diagnosis when the assay samples are positive or equivocal. […] The clinical diagnosis of Lyme disease can be straightforward in patients with a history of tick exposure and the characteristic finding of an erythema migrans rash. […] According to the Infectious Diseases Society of America (IDSA) guidelines, erythema migrans rash is the only clinical manifestation sufficient to make the diagnosis of Lyme disease in the absence of laboratory confirmation.

• #5 Lyme Disease Diagnosis | Johns Hopkins Lyme Disease Research Center

  https://www.hopkinslyme.org/lyme-disease/diagnosis-of-lyme-disease/

  Serology antibody tests are generally more helpful for second and third stages of Lyme disease than first stage Lyme disease. Antibodies take weeks to develop, and if the initial presentation of Lyme disease is in the early stage those antibody tests may be falsely negative because the immune system has not yet had enough time to produce antibodies. […] A negative antibody test does not necessarily rule out Lyme disease and should always be considered in the context of a full health history and clinical assessment. […] Diagnostic tests cannot yet accurately identify the earliest stage of Lyme disease when making the diagnosis is crucial. […] The rash is not always present or easily recognized. […] Misdiagnosis and delayed diagnosis can make Lyme disease more difficult to treat and lead to prolonged and debilitating illness.

• #6 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Laboratory diagnosis of Lyme disease relies on serologic testing for antibodies to Borrelia burgdorferi. […] CDC recommends a two-step serologic testing process using FDA-cleared assays. […] Serologic assays may be falsely negative during the first 4-6 weeks after infection. […] CDC currently recommends a two-step testing process for Lyme disease serologic testing. Both steps are required and can be done using the same blood sample. If this first step is negative, no further testing is recommended. If the first step is positive or indeterminate (sometimes called equivocal), the second step should be performed. The overall result is positive only when the first test is positive (or equivocal) and the second test is positive (or for some tests equivocal). Standard two-tier testing (STTT) uses enzyme immunoassay (EIA) as the first step and western blotting (WB) for the second step.

• #7 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Laboratory diagnosis of Lyme disease relies on serologic testing for antibodies to Borrelia burgdorferi. […] CDC recommends a two-step serologic testing process using FDA-cleared assays. […] Serologic assays may be falsely negative during the first 4-6 weeks after infection. […] CDC currently recommends a two-step testing process for Lyme disease serologic testing. Both steps are required and can be done using the same blood sample. If this first step is negative, no further testing is recommended. If the first step is positive or indeterminate (sometimes called equivocal), the second step should be performed. The overall result is positive only when the first test is positive (or equivocal) and the second test is positive (or for some tests equivocal). Standard two-tier testing (STTT) uses enzyme immunoassay (EIA) as the first step and western blotting (WB) for the second step.

• #8 Lyme Disease – StatPearls – NCBI Bookshelf

  https://www.ncbi.nlm.nih.gov/books/NBK431066/

  Lyme disease, also known as Lyme borreliosis, is an infectious condition transmitted through the bite of infected ticks, primarily caused by the spirochete bacterium Borrelia burgdorferi in the United States and various Borrelia species in Europe and Asia. […] The course emphasizes the importance of a 2-step serologic testing process for accurate diagnosis and highlights the benefits of early antibiotic intervention to prevent disease progression. […] The first step is to perform a quantitative screening test for serum antibodies to Borrelia burgdorferi using a sensitive enzyme immunoassay (EIA) or immunofluorescent antibody assay. […] Standard 2-tier testing uses EIA as the first step and Western blot as the 2nd step. […] Serologic testing is unreliable during the first few weeks of infection, given the time needed for seroconversion.

• #9 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Most Lyme disease tests are serologic assays designed to detect antibodies that can take several weeks to develop following infection; patients may test negative if recently infected. […] Once elevated, antibody titers will remain so for months to years and cannot be used to determine cure. […] False positive cross-reactions may occur in patients with other conditions, including relapsing fever, syphilis, rheumatoid arthritis, and Epstein-Barr virus infection. […] 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. […] Patients who receive antibiotic treatment early in disease may be less likely to seroconvert. […] 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 (FDA).

• #10 Lyme Disease | American Lyme Disease Foundation

  https://aldf.com/lyme-disease/

  The current guidelines for antibody testing include the use of a 2-step testing. The first step uses an antibody assay such as an Enzyme Immunoassay (EIA) that has high sensitivity to detect IgG and IgM antibodies to B. burgdorferi (Bb); if this first step test is positive, it is followed by a second step EIA that will confirm the first step. […] The two-step testing has limited sensitivity during early disease with EM (25 – 50% in acute sample to about 70% in convalescent phase sample) but increases to over 70 % to 100% in samples from patients with disseminated or extracutaneous manifestations of Lyme disease. […] The limitations are predominantly due to the complexity of B. burgdorferi (Bb) and those of serology. […] The ideal laboratory method to support the diagnosis of an infectious disease is the direct detection of the organism causing disease, that in Lyme disease is difficult since Bb is not usually detected in clinical samples.

• #11 FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses | FDA

  https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnoses

  Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. […] These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients, said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDAs Center for Devices and Radiological Health. […] Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patients blood. […] The tests cleared today involve a modified approach that uses only EIA technology-based tests. […] The FDA reviewed data from clinical studies of the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System that showed this alternative approach, referred to as a modified two-tier test, is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi, the causative agent of Lyme disease, over current methods. […] CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.

• #12 Lyme Disease: Practice Essentials, Background, Etiology

  https://emedicine.medscape.com/article/330178-overview

  In July 2019, the US Food Drug Administration (FDA) approved the use of concurrent or sequential EIA testing for diagnosis of Lyme disease. […] The FDA approved the new indication on the basis of data from clinical studies showing that this alternative approach, referred to as a modified two-tier test, is as accurate as testing with EIA or IFA plus Western blot. […] If the patient has been in Europe, where different strains of Borrelia are more common, a C6 peptide ELISA is a more accurate confirmatory test than the Western blots, which have been developed to B burgdorferi, which is the most common strain found in the United States. […] The C6 peptide is less expensive than the Western blots and is as sensitive and specific for B burgdorferi; it is a reasonable alternative for the Western blots, but has not replaced it as the usual confirmatory test in the United States.

• #13 Diagnosis | Lyme Disease

  https://www.columbia-lyme.org/diagnosis

  A negative test early in infection is meaningless as the antibody response takes time to develop (one to three weeks). […] These antibody tests have poor sensitivity in early Lyme disease (35-50%) and inadequate sensitivity in some of the later stages of Lyme disease (e.g, 75-89% in neurologic Lyme disease). […] In the 1990s, in an effort to improve specificity, the Centers For Disease Control (CDC) adopted the two-tiered strategy for testing. […] If the infection is recent and a positive IgM or IgG result is detected, then this is good evidence to confirm recent infection with B. burgdorferi. […] Because the IgM tests are less specific then the IgG based tests, the CDC recommends not using the IgM for diagnosis if the infection is over four weeks old. […] A major breakthrough in antibody-based tests came with the incorporation of synthetic or recombinant antigens into the assays.

• #14 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Most Lyme disease tests are serologic assays designed to detect antibodies that can take several weeks to develop following infection; patients may test negative if recently infected. […] Once elevated, antibody titers will remain so for months to years and cannot be used to determine cure. […] False positive cross-reactions may occur in patients with other conditions, including relapsing fever, syphilis, rheumatoid arthritis, and Epstein-Barr virus infection. […] 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. […] Patients who receive antibiotic treatment early in disease may be less likely to seroconvert. […] 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 (FDA).

• #15 Lyme Disease – StatPearls – NCBI Bookshelf

  https://www.ncbi.nlm.nih.gov/books/NBK431066/

  In later stages of the disease, the 2-step approach is recommended for the serologic diagnosis of Lyme disease. […] Testing is recommended for patients presenting with meningitis, painful radiculoneuritis, mononeuropathy multiplex including confluent mononeuropathy multiplex, acute cranial neuropathies, or in patients with evidence of spinal cord or brain inflammation, and with epidemiologically plausible exposure to ticks infected with Borrelia burgdorferi. […] Joint aspiration is only recommended if a clinician suspects inflammatory arthritis. When assessing possible Lyme arthritis, serum antibody testing is recommended over polymerase chain reaction or culture of blood, synovial fluid, or tissue.

• #16 Lyme Disease Workup: Approach Considerations, Serologic Testing, Polymerase Chain Reaction Testing

  https://emedicine.medscape.com/article/330178-workup

  In patients with Lyme disease meningitis, cerebrospinal fluid (CSF) analysis often reveals a mild pleocytosis ( 1000 cells/L) with lymphocyte predominance. CSF antibody is considered positive when the titer is higher than in serum. […] Polymerase chain reaction (PCR) testing is growing in uses and availability, but is not readily available to most clinicians in routine practice. PCR remains a research technique in part because laboratories performing PCR tests must be meticulous in technique to minimize the likelihood of false-positive results. […] PCR can be used to detect B burgdorferi DNA in the blood, CSF, urine, or synovial fluid within weeks of infection. The result is positive in approximately 30% of patients with active Lyme disease. […] A notable disadvantage of PCR testing is the likelihood of false-negative results because of a sparsity of spirochetes in infected tissues.

• #17 A Review of Diagnostic Testing and Automation for Lyme Disease | myadlm.org

  https://myadlm.org/cln/articles/2023/septoct/a-review-of-diagnostic-testing-and-automation-for-lyma-disease

  According to a recent metaanalysis, molecular testing of blood and cerebrospinal fluid for Lyme disease was associated with a median sensitivity of 18% and 22% across studies, with the highest sensitivity observed in synovial fluid (median, 77%) and erythema migrans (EM) tissue biopsies (median, 68%). […] Notably, EM rashes are considered pathognomonic for Lyme disease, and patients who present with such lesions (alongside appropriate geographic tick exposure) can be diagnosed clinically. […] Serologic testing is not indicated for these individuals, because the humoral immune response is still developing and would likely be undetectable by current assays. […] Due to the limitations associated with molecular assays, diagnostic testing for Lyme disease remains based on detecting an anti-B. burgdorferi humoral immune response using an algorithmic, two-tiered testing approach.

• #18 Lyme Disease | American Lyme Disease Foundation

  https://aldf.com/lyme-disease/

  The current guidelines for antibody testing include the use of a 2-step testing. The first step uses an antibody assay such as an Enzyme Immunoassay (EIA) that has high sensitivity to detect IgG and IgM antibodies to B. burgdorferi (Bb); if this first step test is positive, it is followed by a second step EIA that will confirm the first step. […] The two-step testing has limited sensitivity during early disease with EM (25 – 50% in acute sample to about 70% in convalescent phase sample) but increases to over 70 % to 100% in samples from patients with disseminated or extracutaneous manifestations of Lyme disease. […] The limitations are predominantly due to the complexity of B. burgdorferi (Bb) and those of serology. […] The ideal laboratory method to support the diagnosis of an infectious disease is the direct detection of the organism causing disease, that in Lyme disease is difficult since Bb is not usually detected in clinical samples.

• #19 Diagnosis | Lyme Disease

  https://www.columbia-lyme.org/diagnosis

  Patients with neurologic symptoms suggestive of central nervous system involvement should have a lumbar puncture with determination of opening pressure. […] When the cerbrospinal fluid (CSF) is examined, the fluid should be sent for routine studies such as cell count, and protein and glucose levels. […] When the index is positive, that indicates that there is a preferential production of antibodies against Bb in the CSF a finding strongly suggestive of central nervous system invasion by the agent of Lyme disease. […] The brain MRI of a young patient reveals MS-like lesions in this individual with a fully positive IgG Lyme Western blot, indicating immune reactivity against the agent of Lyme disease. […] Electromyography (EMG) and nerve conduction studies assess the integrity and function of muscle and nerve, respectively.

• #20 Lyme Disease Workup: Approach Considerations, Serologic Testing, Polymerase Chain Reaction Testing

  https://emedicine.medscape.com/article/330178-workup

  Although most PCR results become negative within 2 weeks of antimicrobial therapy, results can remain positive for years after apparent cure. […] In patients with Lyme disease, the white blood cell count (WBC) can be normal or elevated. The erythrocyte sedimentation rate (ESR) is usually elevated. […] In patients with Lyme arthritis, synovial fluid is usually inflammatory, with cell counts ranging from 500-98,000/L reported. […] A lumbar puncture should be performed if Lyme meningitis is in the differential diagnosis. […] Unlike most bacterial infections in the spinal fluid, Lyme disease produces a pleocytosis characterized by mononuclear cells. […] A positive Lyme disease serology in CSF does not mean that the patient has neuroborreliosis. It could represent evidence of a previous infection or simply reflect potential leakage of serum antibodies across the blood-brain barrier. […] Intrathecal anti-Borrelia antibody production is typically seen within 3-6 weeks of infection.

• #21 Lyme Disease Diagnosis | Johns Hopkins Lyme Disease Research Center

  https://www.hopkinslyme.org/lyme-disease/diagnosis-of-lyme-disease/

  Serology antibody tests are generally more helpful for second and third stages of Lyme disease than first stage Lyme disease. Antibodies take weeks to develop, and if the initial presentation of Lyme disease is in the early stage those antibody tests may be falsely negative because the immune system has not yet had enough time to produce antibodies. […] A negative antibody test does not necessarily rule out Lyme disease and should always be considered in the context of a full health history and clinical assessment. […] Diagnostic tests cannot yet accurately identify the earliest stage of Lyme disease when making the diagnosis is crucial. […] The rash is not always present or easily recognized. […] Misdiagnosis and delayed diagnosis can make Lyme disease more difficult to treat and lead to prolonged and debilitating illness.

• #22 Lyme Disease Diagnosing, Testing & Treatment | NAPNAP Knows Lyme

  https://napnapknowslyme.org/for-providers/diagnosis-testing-treatment-2/

  Diagnostic testing is recommended when the pretest probability of Lyme disease in a patient is moderate to high. This is the case when a patient has symptoms or signs that are characteristic of Lyme disease and when they have had possible exposure to infected blacklegged ticks in an area where Lyme disease occurs. […] For patients who present with classic erythema migrans rash who live in or have visited an area where Lyme disease is common, Lyme disease may be a clinical diagnosis. In the early stages of disease when erythema migrans is present, antibodies often have not yet developed, and serologic testing can be negative. […] CDC currently recommends a two-step serum antibody (serology) testing protocol for Lyme Disease. Both testing steps are required and can be done using the same blood sample. If this first step is negative, no further testing is recommended. If the first step is positive or indeterminate (sometimes called “equivocal”), the second step should be performed. The overall result is positive only when the first test is positive (or equivocal) and the second test is positive (or for some tests equivocal).

• #23 Lyme Disease: Laboratory Support of Diagnosis and Management | Clinical Focus | Quest Diagnostics Lyme Disease: Laboratory Support of Diagnosis and Management Lyme Disease: Laboratory Support of Diagnosis and Management

  https://testdirectory.questdiagnostics.com/test/test-guides/CF_Lyme_Disease/lyme-disease-laboratory-support-of-diagnosis-and-management

  Importantly, serologic testing during the acute phase of Lyme disease is less sensitive than at later stages of disease. […] Two-tiered testing is recommended when clinical findings are suggestive of early disseminated Lyme disease (Table 1). […] A diagnosis of Lyme neuroborreliosis involving either the peripheral nervous system or central nervous system (CNS) can be supported if Borrelia antibody or DNA are detected in serum or cerebrospinal fluid (CSF); however, serum antibody testing is recommended over PCR due to low clinical sensitivity (38%). […] In patients with suspected Lyme disease that has been left untreated for months to years after a tick bite, symptoms that are characteristic of late-stage disease such as Lyme arthritis or LNB can help guide diagnostic test selection. Detection of Borrelia DNA in synovial fluid, commonly from the knees, supports the diagnosis of Lyme arthritis (sensitivity, 78%; specificity, 100%).

• #24 Lyme Disease – StatPearls – NCBI Bookshelf

  https://www.ncbi.nlm.nih.gov/books/NBK431066/

  In later stages of the disease, the 2-step approach is recommended for the serologic diagnosis of Lyme disease. […] Testing is recommended for patients presenting with meningitis, painful radiculoneuritis, mononeuropathy multiplex including confluent mononeuropathy multiplex, acute cranial neuropathies, or in patients with evidence of spinal cord or brain inflammation, and with epidemiologically plausible exposure to ticks infected with Borrelia burgdorferi. […] Joint aspiration is only recommended if a clinician suspects inflammatory arthritis. When assessing possible Lyme arthritis, serum antibody testing is recommended over polymerase chain reaction or culture of blood, synovial fluid, or tissue.

• #25 Lyme Disease Workup: Approach Considerations, Serologic Testing, Polymerase Chain Reaction Testing

  https://emedicine.medscape.com/article/330178-workup

  On urinalysis, microscopic hematuria and mild proteinuria have been described. Urine antigen testing has not been studied sufficiently. Because it has not been proven reliable or accurate, it should not be used as a diagnostic tool. […] Joint aspiration for diagnostic reasons is unnecessary if only Lyme arthritis is suspected. However, arthrocentesis may be appropriate to exclude other causes of effusions, such as septic arthritis or, in adults, gout and pseudogout. […] A joint guideline from the Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) recommends testing for Lyme disease in patients with plausible exposure to high-risk ticks who present with meningitis, painful radiculoneuritis, mononeuropathy multiplex, acute cranial neuropathies, or evidence of spinal cord (or rarely brain) inflammation.

• #26 AAN/ACR/IDSA 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease

  https://www.idsociety.org/practice-guideline/lyme-disease/

  (XXI) What is the preferred diagnostic testing strategy for Lyme arthritis? […] When assessing possible Lyme arthritis, we recommend serum antibody testing over PCR or culture of blood or synovial fluid/tissue (strong recommendation, moderate quality of evidence). […] (XXII) What are the preferred antibiotic regimens for the initial treatment of Lyme arthritis? […] For patients with Lyme arthritis, we recommend using oral antibiotic therapy for 28 days (strong recommendation, moderate-quality evidence). […] (XXV) Should patients with persistent symptoms following standard treatment of Lyme disease receive additional antibiotics? […] For patients who have persistent or recurring nonspecific symptoms such as fatigue, pain, or cognitive impairment following recommended treatment for Lyme disease, but who lack objective evidence of reinfection or treatment failure, we recommend against additional antibiotic therapy (strong recommendation, moderate-quality evidence).

• #27 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Most Lyme disease tests are serologic assays designed to detect antibodies that can take several weeks to develop following infection; patients may test negative if recently infected. […] Once elevated, antibody titers will remain so for months to years and cannot be used to determine cure. […] False positive cross-reactions may occur in patients with other conditions, including relapsing fever, syphilis, rheumatoid arthritis, and Epstein-Barr virus infection. […] 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. […] Patients who receive antibiotic treatment early in disease may be less likely to seroconvert. […] 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 (FDA).

• #28 Testing and Diagnosis for Lyme disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/diagnosis-testing/index.html

  Laboratory diagnosis of Lyme disease relies on a blood test that detects antibodies to the Lyme bacteria. It can take several weeks after infection for the immune system to make enough antibodies to be detected by the test. […] CDC recommends using antibody tests that have been cleared by the U.S. Food and Drug Administration (FDA) and follow a two-step process. […] CDC recommends the use of FDA-cleared antibody tests for laboratory diagnosis of Lyme disease. As with antibody tests for other infectious diseases, the accuracy of these tests depends upon how long you’ve been infected. Antibody tests may appear falsely negative during the first few weeks of infection, typically when a patient has an erythema migrans rash, but FDA-cleared assays have good sensitivity after 4-6 weeks have passed. […] Because the immune system continues to make the antibodies for months or years after an infection is gone, your blood test will remain positive after the bacteria are no longer present.

• #29 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Most Lyme disease tests are serologic assays designed to detect antibodies that can take several weeks to develop following infection; patients may test negative if recently infected. […] Once elevated, antibody titers will remain so for months to years and cannot be used to determine cure. […] False positive cross-reactions may occur in patients with other conditions, including relapsing fever, syphilis, rheumatoid arthritis, and Epstein-Barr virus infection. […] 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. […] Patients who receive antibiotic treatment early in disease may be less likely to seroconvert. […] 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 (FDA).

• #30 Clinical Testing and Diagnosis for Lyme Disease | Lyme Disease | CDC

  https://www.cdc.gov/lyme/hcp/diagnosis-testing/index.html

  Most Lyme disease tests are serologic assays designed to detect antibodies that can take several weeks to develop following infection; patients may test negative if recently infected. […] Once elevated, antibody titers will remain so for months to years and cannot be used to determine cure. […] False positive cross-reactions may occur in patients with other conditions, including relapsing fever, syphilis, rheumatoid arthritis, and Epstein-Barr virus infection. […] 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. […] Patients who receive antibiotic treatment early in disease may be less likely to seroconvert. […] 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 (FDA).

• #31 Lyme Disease Diagnostics Research | NIAID: National Institute of Allergy and Infectious Diseases

  https://www.niaid.nih.gov/diseases-conditions/lyme-disease-diagnostics-research

  Used appropriately, the Western blot test is designed to be specific, meaning that it will usually be positive only if a person has been truly infected by B. burgdorferi. […] Some laboratories offer Lyme disease testing using urine or other body fluids. […] The development of new, rapid, clearly validated diagnostic tests continues to be a need. […] NIAID actively supports research on Lyme disease diagnostics. […] NIAID is supporting research on a variety of approaches to improve the diagnosis of Lyme disease. […] The development and testing of a new cytokine-based immunoassay for Lyme diagnosis, if successful, could allow for earlier and more rapid diagnosis of Lyme disease. […] Several investigators are working on the development of a new, rapid point-of-care Lyme diagnostic test using lateral flow technologies.

• #32 Lyme Disease Diagnosis | Johns Hopkins Lyme Disease Research Center

  https://www.hopkinslyme.org/lyme-disease/diagnosis-of-lyme-disease/

  Antibody testing done after early treatment may be negative and never turn positive for some cases. […] 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.

• #33 Rapid single-tier serodiagnosis of Lyme disease | Nature Communications

  https://www.nature.com/articles/s41467-024-51067-5

  In the absence of EM, serological (antibody) testing of LD remains the mainstay approach for laboratory confirmation. The US Centers for Disease Control and Prevention (CDC) recommends a two-tiered approach for the diagnosis of LD, consisting of a first-tier enzyme immunoassay (EIA) which if positive or equivocal is followed by a second-tier western blot (WB) or a different EIA. The two-tier system is widely understood to have significant drawbacks, requiring longer turnaround times, underreporting of cases, and a general failure to detect and treat LD in its early stages when treatment is most efficacious at preventing disseminated disease sequelae. […] Here, we report a synthetic peptide-based multiplexed vertical flow assay (xVFA) for single-tier POC-compatible diagnosis of LD, overcoming limitations posed by current two-tier tests and traditional protein-based assays. The multiantigen panel consists of synthetic peptide-based immunogenic targets that detect combined IgM and IgG antibody responses from patient serum samples in a single assay, resulting in efficient diagnosis and improved patient outcomes.

• #34 Lyme Disease Diagnostics Research | NIAID: National Institute of Allergy and Infectious Diseases

  https://www.niaid.nih.gov/diseases-conditions/lyme-disease-diagnostics-research

  Used appropriately, the Western blot test is designed to be specific, meaning that it will usually be positive only if a person has been truly infected by B. burgdorferi. […] Some laboratories offer Lyme disease testing using urine or other body fluids. […] The development of new, rapid, clearly validated diagnostic tests continues to be a need. […] NIAID actively supports research on Lyme disease diagnostics. […] NIAID is supporting research on a variety of approaches to improve the diagnosis of Lyme disease. […] The development and testing of a new cytokine-based immunoassay for Lyme diagnosis, if successful, could allow for earlier and more rapid diagnosis of Lyme disease. […] Several investigators are working on the development of a new, rapid point-of-care Lyme diagnostic test using lateral flow technologies.

• #35 Lyme Disease Diagnostics Research | NIAID: National Institute of Allergy and Infectious Diseases

  https://www.niaid.nih.gov/diseases-conditions/lyme-disease-diagnostics-research

  Used appropriately, the Western blot test is designed to be specific, meaning that it will usually be positive only if a person has been truly infected by B. burgdorferi. […] Some laboratories offer Lyme disease testing using urine or other body fluids. […] The development of new, rapid, clearly validated diagnostic tests continues to be a need. […] NIAID actively supports research on Lyme disease diagnostics. […] NIAID is supporting research on a variety of approaches to improve the diagnosis of Lyme disease. […] The development and testing of a new cytokine-based immunoassay for Lyme diagnosis, if successful, could allow for earlier and more rapid diagnosis of Lyme disease. […] Several investigators are working on the development of a new, rapid point-of-care Lyme diagnostic test using lateral flow technologies.

• #36 A Potential New Test for Diagnosing Lyme Disease | Tufts Now

  https://now.tufts.edu/2022/03/15/potential-new-test-diagnosing-lyme-disease

  Tufts University School of Medicine researchers identify a key testing area that could help clinicians diagnose the disease sooner and determine efficacy of treatments. […] For scientists and clinicians alike, one of the Holy Grails for successfully treating and curing Lyme disease is developing tests that identify the disease sooner, show when people are cured of infection, and can diagnose reinfection. […] Now, researchers at Tufts University School of Medicine say they have identified just such a testing mechanism. It detects a type of antibody that infected individuals produce against a substance the Lyme bacteria acquires from the host in order to grow. The researchers believe tests to detect these autoantibodies that mistakenly target and react with a person’s own tissues or organs could provide clinicians with a way to diagnose the disease sooner, know whether treatment with antibiotics is working, and identify patients who have been reinfected.

• #37 Lyme Disease – NYC Health

  https://www.nyc.gov/site/doh/health/health-topics/lyme-disease.page

  Lyme disease diagnosis is based on symptoms and possible exposure to infected blacklegged ticks. If you experience symptoms of Lyme disease after spending time in tick-habitat, visit your health care provider. […] Blood tests can help diagnose Lyme disease. The Centers for Disease Control and Prevention (CDC) recommends a two-step testing process. If the first blood test is positive or indeterminate, a second test is done. Testing is not recommended if you do not have symptoms typical of Lyme disease. […] Blood tests are not necessary to diagnose patients with erythema migrans, also known as a bulls-eye rash. The bulls-eye rash is a diagnosis of Lyme disease and lab tests may be negative in the early stages of Lyme disease when the rash is present.

• #38 Frontiers | A Practical Approach to the Diagnosis of Lyme Borreliosis: From Clinical Heterogeneity to Laboratory Methods

  https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.00265/full

  Clinical evaluation of Lyme Borreliosis (LB) is the starting point for its diagnosis. The patient’s medical history and clinical symptoms are fundamental for disease recognition. […] This review aims at describing the heterogeneous symptoms of Lyme Borreliosis, as well as offering a practical approach for recognition of the disease, both in terms of clinical features and diagnostic/research tools. […] Recognition of an EM rash is very important in LB as it is a hallmark symptom of LB, even when the patient does not recall the tick bite. […] The most important diagnostic criterion is the EM centrifugal evolution. Erythema migrans is pathognomonic for LB, therefore it should be treated immediately as serology testing to confirm infection is not necessary. […] Serological testing is not recommended because of their poor sensitivity in the early stages of LB. In order to achieve the best outcome for patients, antibiotic treatment should be started without delay. […] In the presence of this clinical manifestation the following exams should be performed: serology for Borrelia burgdorferi (ELISA and Western-Blot), β2-Microglobulin, and serological tests for Ehrlichia (Anaplasma).

• #39 Appropriate laboratory testing in Lyme disease | Cleveland Clinic Journal of Medicine

  https://www.ccjm.org/content/86/11/751

  Testing for Lyme disease is challenging and if done incorrectly can lead to unnecessary treatment. To interpret serologic test results, first assess the patients pretest probability of infection based on the probability of exposure and clinical findings. Two-tiered testing remains the gold standard in diagnosing Lyme disease, although new guidelines may be published soon. […] Lyme disease preferably affects the skin, joints, and nervous system and presents with typical and atypical features. Certain clinical features are diagnostic. Its diagnosis is mainly clinical and epidemiologic and, when doubtful, is supported by serologic testing. […] Standard 2-tiered testing is the diagnostic testing method of choiceenzyme-linked immunoassay followed by Western blot. Interpretation of the bands depends on the duration of infection.

• #40 Lyme Disease Diagnosis: Key Steps in Diagnosing Lyme Disease

  https://www.globallymealliance.org/about-lyme/diagnosis/

  According to the CDC, the diagnosis should be based upon your symptoms, medical history, tick exposure, and geographical area (endemic locations). Blood tests as a diagnostic test should only be used to provide supporting evidence for the diagnosis. […] A report published in Clinical Infectious Diseases acknowledges the need for better laboratory tests. Newer approaches in direct detection show promise and could help thousands of people with Lyme to get the treatment they need. […] Without diagnosis and persistent symptoms, Lyme disease can be present in your body after the initial infection for weeks, months, or even years. It is best to catch early Lyme disease before it progresses to a later stage or chronic Lyme disease. […] Varying symptoms, combined with the fact that blood tests are highly inaccurate, contribute to the difficulty in diagnosing Lyme disease.

• #41

  https://www.health.nsw.gov.au/Infectious/factsheets/Pages/lyme-disease-testing-advice.aspx

  The diagnosis of Lyme disease is based on clinical presentation and history, supported by laboratory testing performed in an accredited laboratory. The interpretation of diagnostic test results can be difficult. […] Diagnosis of Lyme disease is based on clinical presentation and history, and laboratory testing performed in an Australian accredited pathology laboratory. […] Testing should be performed in NATA-accredited laboratories using validated methods. […] The recommended testing strategy follows European and US-CDC guidelines for two-step serological testing with a screening immunoassay and a confirmatory immunoblot for antigens from Borrelia burgdorferi sensu lato genospecies (including B. afzelii, B. garinii). […] Diagnosis should be made according to the patient’s clinical presentation, risk of exposure to infected ticks in an endemic area, and the results from laboratory tests performed in a NATA-accredited laboratory. When interpreting testing results, advice should be sought from a specialist in infectious diseases or clinical microbiology.

• #42 Lyme Disease Diagnosis and Testing

  https://www.lyme.health.harvard.edu/diagnosis-and-testing/

  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. […] 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. […] If your doctor does not consider Lyme disease, you can raise the possibility of being tested for it based on how your symptoms and risk factors compare to those of Lyme disease. You’ll start with a standard two-step blood test. […] 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.

• #43 Patient education: Lyme disease symptoms and diagnosis (Beyond the Basics) – UpToDate

  https://www.uptodate.com/contents/lyme-disease-symptoms-and-diagnosis-beyond-the-basics

  LYME DISEASE DIAGNOSIS […] The diagnosis of Lyme disease is based on an individual’s history of possible exposure to ticks, the presence of characteristic signs and symptoms, and the results of blood tests. However, the results of blood tests for Lyme disease can vary from laboratory to laboratory. Results can be difficult to interpret if there are no risks for tick exposure or EM. […] Blood tests for Lyme disease are not recommended in people with nonspecific symptoms since tests may be falsely positive. Blood testing is also not recommended for a person who has classic features of early localized Lyme disease, including erythema migrans. Testing may be falsely negative during the first several weeks of infection, potentially delaying the correct diagnosis and treatment. […] There are two major categories of blood tests, enzyme-linked immunosorbent assay (ELISA) and Western blot, which are used to check for current or prior infection with Borrelia burgdorferi, the bacterium that causes Lyme disease. Both tests detect specific antibodies (proteins made by the immune system to fight the bacteria) made when the body’s immune system responds to the organism that causes Lyme disease. The antibodies decline slowly after adequate antibiotic treatment; however, the Western blot, a nonquantitative test, does not change much after treatment, and typically remains positive for years. Thus, a positive test result does not prove that the person has active infection.

• #44 Lyme Disease: Symptoms, Treatment, Prevention & Recovery

  https://my.clevelandclinic.org/health/diseases/11586-lyme-disease

  A healthcare provider will diagnose Lyme disease based on symptoms, physical findings (like a rash) and whether or not you’ve been in an area populated by infected ticks. […] Your provider will confirm the diagnosis using a blood test. If your first blood test is negative for Lyme disease, you won’t need another test. If the first test is positive or equivocal, your provider will conduct the test again. You have to have two positive (or sometimes equivocal) results to be diagnosed with Lyme disease. […] Antibiotics, usually doxycycline or amoxicillin, are effective treatments for Lyme disease. How long your treatment lasts depends on the stage of infection. In general, its true that the sooner youre treated, the quicker and more complete the recovery. […] Taking oral antibiotics typically cures Lyme disease after two to four weeks. You may need to get antibiotics through the vein (intravenously) for four more weeks. However, theres no reason to think that Lyme disease stays in you forever after treatment.

• #45 Lyme Disease Diagnosis: Key Steps in Diagnosing Lyme Disease

  https://www.globallymealliance.org/about-lyme/diagnosis/

  According to the CDC, the diagnosis should be based upon your symptoms, medical history, tick exposure, and geographical area (endemic locations). Blood tests as a diagnostic test should only be used to provide supporting evidence for the diagnosis. […] A report published in Clinical Infectious Diseases acknowledges the need for better laboratory tests. Newer approaches in direct detection show promise and could help thousands of people with Lyme to get the treatment they need. […] Without diagnosis and persistent symptoms, Lyme disease can be present in your body after the initial infection for weeks, months, or even years. It is best to catch early Lyme disease before it progresses to a later stage or chronic Lyme disease. […] Varying symptoms, combined with the fact that blood tests are highly inaccurate, contribute to the difficulty in diagnosing Lyme disease.

• #46 Lyme disease – Symptoms and causes – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/lyme-disease/symptoms-causes/syc-20374651

  Most people who get Lyme disease don’t remember having a tick bite. And many symptoms of Lyme disease relate to other conditions. See your health care provider if you have Lyme disease symptoms. An early diagnosis and proper treatment can improve outcomes. […] If you know you had a tick bite or might have been around ticks, watch for symptoms. If they show up, see your care provider as soon as possible. […] Lyme disease is caused by borrelia bacteria. In North America, the black-legged tick, also called the deer tick, mainly carry the bacteria. […] The best way to prevent Lyme disease is to avoid tick bites when you are outdoors. Most ticks attach themselves to your lower legs and feet as you walk or work in grassy, wooded areas or overgrown fields. After a tick attaches to your body, it often crawls upward to find a spot to burrow into your skin.

• #47 Up to Years to Get a Lyme Disease Diagnosis | TecScienceDocumentDocumentDocument

  https://tecscience.tec.mx/en/health/lyme-disease-diagnosis/

  Another important piece of information for proper diagnosis is a tick bite, which most people do not remember, especially if the symptoms do not appear immediately. […] In the event of Lyme being suspected due to symptoms or clinical history, the next step is to conduct diagnostic tests. […] The most commonly used diagnostic tests are indirect. […] It is estimated that 50-65% of these test results are false negatives; in other words, more than half of those who test negative for Lyme actually have the disease. […] “What is most worrying about Lyme is failing to make an accurate diagnosis, taking too long to make it, and not treating the disease properly, which can lead to serious or chronic conditions. […] According to the U.S. Lyme Disease Association, the average time taken to diagnose it in the U.S. is two years. […] Martinez believes that doctors in Mexico are not sufficiently versed in this disease.

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