Currently available tests are enzyme-linked immunoassays, indirect immunofluorescent assays, and Western blots.

  • Enzyme-linked immunoassay (ELISA) for Lyme Disease

Lyme IgG/IgM Antibody Serology

The IgG/IgM Antibody Serology test is an ELISA (enzyme linked immunoassay), which indicates the presence of both IgG and IgM antibodies to B. burgdorferi. The IgG antibody often persists long after symptoms have disappeared. The presence of antibody indicates exposure, not active disease. A positive or equivocal test must be confirmed by both IgG and IgM Western Blots.


Lyme IgM Antibody Serology

The Lyme IgM antibody assay is another serologic test in ELISA format, and it detects the presence of IgM antibodies to B. burgdorferi after exposure to an infected tick. Because IgM antibodies appear early in response to infection, this test may be positive two to six weeks after exposure. The level of IgM rapidly declines over time. A positive or equivocal IgM antibody test must be confirmed by an IgM Western Blot. The sensitivity concerns mentioned for the IgG/IgM assay also affect this assay.

Result Interpretation


C6 PEPTIDE

The Immunetics® C6 B. burgdorferi (Lyme) ELISA Kit is intended for use in the presumptive detection of IgG and IgM antibodies to B. burgdorferi in human serum. The assay should be used only on samples from patients with clinical history, signs or symptoms consistent with B. burgdorferi infection, including individuals who have received the licensed recombinant OspA Lyme disease vaccine (Lymerix). Positive or equivocal results should be supplemented by testing with a standardized Western Blot (second step) method. Negative results should not be used to exclude Lyme disease.

Result Interpretation


LYME IFA (INDIRECT IMMUNOFLUORESCENT)

The Lyme mmunofluorescent assay (IFA) is designed to detect Borrelia burgdorferi specific antibodies, IgA, IgM and IgG in human serum. For diagnostic purposes, IFA test results should be used in conjunction with other data available to the physician.

Principal

The Lyme IFA assay is a “two-stage” sandwich assay, based upon an antigen-antibody complex formation in the following steps:

  1. Binding of anti-Borrelia specific antibodies in human serum to fixed B. burgdorferi on a slide.
  2. Binding of fluorescent-labeled anti-human IgG/IgM antibodies to the human anti– B. burgdorferiantibodies bound to fixed B. burgdorferi on the slide.

Result Interpretation


Lyme IgG/IgM Antibody Serology

Reference Range

Borrelia burgdoferi Antibody Serology IgG/IgM Negative <1.0

Equivocal ≥1.0 to <1. Positive ≥1.2


Lyme IgM Antibody Serology

Reference Range

Borrelia burgdorferi Antibody Serology IgM Negative <0.8

Equivocal ≥0.8 to <1.2

Positive ≥1.2


C6 PEPTIDE

Reference Range

0.91-1.09 Equivocal result

≥1.10 Positive result


LYME IFA (INDIRECT IMMUNOFLUORESCENT)

Reference Range

Borrelia burgdorferi Antibodies IgG/ IgM/IgA Negative <1:40

Equivocal 1:40

Positive ≥1:80

Lyme IgG/IgM Antibody Serology

Clinical Significance

The IgG/IgM antibody serology indicates the presence of IgG and/or IgM antibodies to B. burgdorferi. The IgG antibody often persists long after the symptoms have disappeared while the IgM antibody commonly appears with initial infection. The presence of antibody indicates exposure, not active disease. This test is recommended at least four weeks after exposure. Patients with the diagnosis of Lyme disease based on clinical history have positive IgG/IgM serology results within one year of the tick bite, approximately 70% of the time. The percentage of patients with a positive serology is reduced in subsequent years. All samples with positive or equivocal results should be tested with B. burgdorferi Western Blots.


Lyme IgM Antibody Serology

Clinical Significance

The Lyme IgM antibody ELISA is a serological test for detection of IgM antibodies to B. burgdorferi after possible exposure to an infected tick. IgM antibodies appear early in response to infection, therefore this test may be positive between 2 to 6 weeks after exposure. The IgM response may persist in patients with prolonged illness and a new IgM response may appear later in persistent or recurrent disease, or from re-infection. This test is recommended approximately 2 weeks after suspected exposure. All samples with positive or equivocal results should be tested with B. burgdorferi Western Blots.


C6 PEPTIDE

Clinical Significance

The Immunetics® C6 B.burgdorferi (Lyme) ELISA™ kit is intended for use on patients with clinical history, signs or symptoms consistent with B. burgorferi infection, including individuals who have received the licensed recombinant OspA Lyme Disease vaccine (Lymerix). This test detects IgG and IgM antibodies to B.burgdorferi in human serum. A synthetic peptide (C6 peptide) in the serum samples is bound by an immobilized antigen and detected by a HRP goat anti-human IgG/IgM conjugate. A blue-green product is produced where the antibodies have been bound to the antigens. The optical absorbance of each sample is measured at 450nm. A Lyme index value of ≥ 1.10 is a positive result. All samples with positive or equivocal results should be tested with B. burgdorferi Western Blots.


LYME IFA (INDIRECT IMMUNOFLUORESCENT)

Clinical Significance

The Lyme Immunofluorescense Antibody (IFA) assay detects IgA, IgG and IgM antibodies against B. burgdorferi. Seroconversion usually occurs 2-3 weeks after infection and may remain elevated in the case of persistent disease.

Lyme IgG/IgM Antibody Serology

Limitations

  1. This test should only be performed in conjunction with Western Blots.
  2. Cross Reacting Antibodies:
    1. Sera from patients with other pathogenic spirochetal diseases such as syphilis, yaws, pinta, leptospirosis, and relapsing fever may give false positive results.
    2. Sera from patients with mononucleosis or lupus erythomatosis (LE) may also give false positive results.
    3. In cases where false positive results occur, clinical epidemiological and laboratory workups should be carried out. Active syphilis and Lyme disease can be differentiated by the use of VDRL or RPR tests. In active syphilis, the VDRL and RPR are positive, whereas in Lyme disease they are not.
  3. Antibiotic therapy given early in the disease may prevent the development of an antibody response. Negative results early in the disease have a low predictive value. Retesting may be warranted if symptoms consistent with Lyme disease persist.
  4. The evaluation must include review of all test results, the clinical history presented by the patient, the patient’s exposure to endemic regions for Lyme disease, epidemiological data, and potential exposure to other spirochetal diseases.
  5. The use of this assay has not been evaluated for individuals who have received a Lyme disease vaccine.

Lyme IgM Antibody Serology

Limitations

  1. This test should only be performed in conjunction with Western Blots.
  2. Cross Reacting Antibodies:
    1. Sera from patients with other pathogenic spirochetal diseases such as syphilis, yaws, pinta, leptospirosis, and relapsing fever may give false positive results.
    2. Sera from patients with mononucleosis or lupus erythomatosis (LE) may also give false positive results.
    3. In cases where false positive results occur, clinical epidemiological and laboratory workups should be carried out. Active syphilis and Lyme disease can be differentiated by the use of VDRL or RPR tests. In active syphilis, the VDRL and RPR are positive, and in Lyme disease they are not.
  3. Antibiotic therapy given early in the disease may prevent the development of an antibody response. Negative results early in the disease have a low predictive value. Retesting may be warranted if symptoms consistent with Lyme disease persist.
  4. The evaluation must include all test results, the clinical history presented by the patient, the patient’s exposure to endemic regions for Lyme disease, epidemiological data, and any potential exposure to other spirochetal diseases.
  5. Positive or equivocal first-tier test results should not be reported until second-tier testing of the specimen is performed using a method that is more specific, such as Western Blot.
  6. The use of this assay has not been evaluated for individuals who have received a Lyme disease vaccine.

C6 PEPTIDE

Limitations

  1. Negative result does not exclude the possibility of B. burgdorferi infection.
  2. Patients who have received antibiotic treatment and those who are in the early stages of Lyme disease may not exhibit detectable antibody titers.
  3. In the event that the initial test result is negative, patients with clinical history, signs or symptoms suggestive of Lyme disease should be re-tested in 2-4 weeks.
  4. A positive result is not a definitive evidence of infection with B. burgdorferi. It is possible that other disease conditions may produce artifactual reactivity in the assay. All samples with equivocal or positive results should be tested on a standardized B. burgdorferi Western Blots.
  5. The C6 B. burgdorferi (Lyme) ELISA kit has been tested on serum samples from individuals vaccinated with a licensed OspA vaccine (Lymerix®). The performance of the test has not been determined on serum samples from recipients of other Lyme vaccines.
  6. This assay should only be used on patients with clinical symptoms of Lyme disease or suspected exposure to B. burgdorferi and should not be used to screen general populations.
  7. Lipemic, hemolyzed, bilirubinemic or turbid samples might produce artifactual results. Fresh samples should be collected for re-testing.
  8. Serum obtained from patients with diseases other than Lyme disease such as syphilis, periodontal disease, rheumatoid arthritis, systemic lupus erythematosis and other autoimmune diseases may result in false positive results.

LYME IFA (INDIRECT IMMUNOFLUORESCENT)

Limitations

  1. This test should only be performed in conjunction with Western Blots.
  2. Cross reactions occurs with other Borrelia species and spirochetes.

Special Instructions This test is not yet available for NY residents

Lyme IgG/IgM Antibody Serology

Ordering Information

  • Specimen Serum
  • Minimum volume 0.5 ml
  • Container SST (Serum Separator Tube) OR Leak-proof tube
  • Collection and Shipping Instructions See Serum and Whole Blood Samples- Collection & Shipping Instructions
  • Rejection Criteria Refer to general collection procedure

Lyme IgM Antibody Serology

Ordering Information

  • Specimen Serum
  • Minimum volume 0.5 ml
  • Container SST (Serum Separator Tube) OR Leak-proof tube
  • Collection and Shipping Instructions See Serum and Whole Blood Samples- Collection & Shipping Instructions
  • Rejection Criteria Refer to general collection procedure

C6 PEPTIDE

Ordering Information

  • Specimen Serum
  • Minimum volume 0.5 ml
  • Container SST (Serum Separator Tube) OR Leak-proof tube
  • Collection and Shipping Instructions See Serum and Whole Blood Samples- Collection & Shipping Instructions
  • Rejection Criteria Refer to general collection procedure

LYME IFA (INDIRECT IMMUNOFLUORESCENT)

Ordering Information

  • Specimen Serum
  • Minimum volume 0.5 ml
  • Container SST (Serum Separator Tube) OR Leak-proof tube
  • Collection and Shipping Instructions: See Serum and Whole Blood Samples- Collection & Shipping Instructions [THIS WILL LINK TO THAT PAGE]
  • Rejection Criteria Refer to general collection procedure

Lyme IgM Antibody Serology

Test Offered

Test# 183 Lyme IgG/IgM Serology CPT Code 86618
Test# 195 Lyme IgM Serology CPT Code 86618

C6 PEPTIDE

Test Offered

Test# 170 C6 Peptide – B. burgdorferi CPT Code 86618

LYME IFA (INDIRECT IMMUNOFLUORESCENT)

Test Offered

Test# 230 Lyme G/M/A IFA Screen** CPT Code 86618
Lyme G/M/A IFA Screen part of the following Test Panels:
Test Panel# 4090 Basic Lyme Panel**
Test Panel# 6050 Complete Lyme Panel**
Test Panel# 6060 Basic Borreliosis Panel**
Test Panel# 6070 Complete Borreliosis Panel**
Test Panel# 6090 Super Borreliosis Panel**
Test Panel# 8015 Basic Relapsing Fever Panel**
Test Panel# 8035 Complete Relapsing Fever Panel**
Test Panel# 8045 Complete Relapsing Fever Panel with Urine**
Test Panel# 8055 NN Special Borrelia Panel**
Test Panel# 5060 TBD Panel**

**Test/Panels are not yet available for New York Residents