Reference Range
Negative: No B. burgdorferi antigens detected
Borreliosis is a world-wide infectious disease caused by spiral-shaped bacteria of the Genus Borrelia, which is carried by ticks and louse. The two groups of Borrelia known to cause disease in humans are:
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.
Reference Range
Borrelia burgdoferi Antibody Serology IgG/IgM Negative <1.0
Equivocal ≥1.0 to <1. Positive ≥1.2
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.
Limitations
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.
Reference Range
Borrelia burgdorferi Antibody Serology IgM Negative <0.8
Equivocal ≥0.8 to <1.2
Positive ≥1.2
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.
Limitations
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.
Reference Range
0.91-1.09 Equivocal result
≥1.10 Positive result
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.
Limitations
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:
Reference Range
Borrelia burgdorferi Antibodies IgG/ IgM/IgA Negative <1:40
Equivocal 1:40
Positive ≥1:80
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.
Limitations
Special Instructions
This test is not yet available for NY residents
The Lyme ImmunoBlot is a qualitative immunoassay in which antibodies specific to the B. burgdorferi antigens on a membrane strip are visualized. It is a qualitative test and is more sensitive and specific than the ELISA, IFA and traditional Western Blot tests. In early or late stage of the disease when antibody levels are very low, ImmunoBlot can be positive whereas ELISA and IFA tests can be negative. This test must be used if the Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA is positive or equivocal.
Principle
The Lyme ImmunoBlot assay is based upon an antigen-antibody complex formation in the following steps:
The Lyme ImmunoBlot IgM is a very sensitive indicator of exposure to B. burgdorferi. It may be positive as early as 1 week after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure and in some patients will remain positive for a very long time. Re-exposure will also cause this test to be positive for a brief period of time. For the testing to be complete, it is preferable that the IgM ImmunoBlot be run along with the IgG ImmunoBlot.
Reference Range
Negative <2 stared bands present on the blot
Clinical Significance
The Lyme ImmunoBlot IgM is a sensitive indicator of exposure to B. burgdorferi. It may be positive as early as one week after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure. Re-exposure will also cause this test to be positive for a brief period of time. In some patients this test can be positive for a very long time. Lyme ImmunoBlot IgM must be performed on any sample with positive or equivocal result for Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA. For the testing to be complete, it is preferable that the IgM ImmunoBlot be run along with the IgG ImmunoBlot.
Limitations
Presence of any of the following bands: 23-25, 31, 34, 39 and 83-93 kDa as indeterminate or if only one of these bands is present in a negative report, it may have clinical significance. Therefore, we recommend testing with another method and/or retesting in 4-6 weeks.
The IgG ImmunoBlot is an immunoassay and qualitative test in which antibodies are visualized. The IgG antibody is typically present a few months following initial infection.
Reference Range
Negative <2 stared bands present on the blot
Clinical Significance
The Lyme ImmunoBlot IgG is a sensitive indicator of an exposure to B. burgdorferi. IgG antibody is typically present a few months following the initial infection. Lyme Western Blot IgG must be performed on any sample with positive or equivocal result for Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA.
Limitations
Presence of an indeterminate number of double starred bands in a negative report may indicate clinical significance. Therefore, we recommend testing with another method and/or retesting in 4-6 weeks.
The Lyme Western Blot is a qualitative immunoassay in which antibodies specific to the B. burgdorferi antigens on a membrane strip are visualized. It is a qualitative test and is generally more sensitive and specific than the ELISA and IFA tests. In early or late stage of the disease when antibody levels are very low, western Blot can be positive whereas ELISA and IFA tests can be negative. This test must be used if the Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA is positive or equivocal.
Principle
The Lyme Western Blot assay is based upon an antigen-antibody complex formation in the following steps:
The Lyme Western Blot IgM is a very sensitive indicator of exposure to B. burgdorferi. It may be positive as early as 1 week after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure and in some patients will remain positive for a very long time. Re-exposure will also cause this test to be positive for a brief period of time. For the testing to be complete, it is preferable that the IgM western blot be run along with the IgG western blot.
Reference Range
Negative <2 double started bands present on the blot
Clinical Significance
The Lyme Western Blot IgM is a sensitive indicator of exposure to B. burgdorferi. It may be positive as early as one week after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure. Re-exposure will also cause this test to be positive for a brief period of time. In some patients this test can be positive for a very long time. Lyme Western Blot IgM must be performed on any sample with positive or equivocal result for Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA. For the testing to be complete, it is preferable that the IgM Western Blot be run along with the IgG Western Blot.
Limitations
Presence of any of the following bands: 23-25, 31, 34, 39 and 83-93 kDa as indeterminate or if only one of these bands is present in a negative report, it may have clinical significance. Therefore, we recommend testing with another method and/or retesting in 4-6 weeks.
The IgG Western Blot is an immunoassay and qualitative test in which antibodies are visualized. The IgG antibody is typically present a few months following initial infection.
Clinical Significance
The Lyme Western Blot IgG is a sensitive indicator of an exposure to B. burgdorferi. IgG antibody is typically present a few months following the initial infection. Lyme Western Blot IgG must be performed on any sample with positive or equivocal result for Lyme IgG/IgM antibody serology or Lyme IgG/IgA/IgM IFA.
Limitations
Presence of an indeterminate number of double starred bands in a negative report may indicate clinical significance. Therefore, we recommend testing with another method and/or retesting in 4-6 weeks.
The Lyme IgG or IgM 31kDa Epitope** test is a qualitative immunoblot assay that determines whether the 31kDa band present on a Lyme Western Blot IgG or IgM is due to B. burgdorferi specific antibody or not.
Reference Range
Negative – No visible bands present
Clinical Significance
It is known that Western blots, especially IgM, can give false positive results with some viral and bacterial infections. This test determines whether the band present at position 31 kDa on the IGeneX Lyme Western Blot IgM is specific for B. burgdorferi. Serum from the patient is tested against a Western Blot strip with fixed B. burgdorferi specific recombinant antigen fragments.
Limitations
Special Instructions
This test is not yet available for NY residents.
The Lyme Multiplex PCR-based diagnostic test for Borrelia burgdorferi, performed directly on a clinical specimen. The combination of the following three steps imparts very high specificity and sensitivity:
Reference Range
Negative- Genomic: B. burgdorferi DNA not detected
Negative- Plasmid: B. burgdorferi DNA not detected
Clinical Significance
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects B. burgdorferi specific DNA sequences. The gene fragments are first selected with specific probes. Then, DNA is amplified in two independent PCR assays using different primers from the Osp A gene and flagellin gene. Lastly, the amplified products are detected by hybridizations to specific probes in a Southern Dot-Blot Assay. This test detects DNA from:B. burgdorferi, B. afzelii, B. andersonii, B. garinii and B. mayoni (based on sequence information). The sample is considered positive if either the genomic or plasmid result is positive.
Limitations
Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of Borrelia burgdorferi specific antigens in urine using anti-B. burgdorferi antibodies.
Reference Range
Negative: No B. burgdorferi antigens detected
Limitations
Special Instructions
This test is not yet available for NY residents. Test 805 is included in panel 875.
The Lyme IGXSpot is an Enzyme-Linked ImmunoSpot assay that detects human T cells reactive to B. burgdorferi specific antigens in vitro. It is well documented that both humoral and cellular immune responses develop in Borrelia infection. The cellular immune response develops much earlier than humoral response in most patients infected with B. burgdorferi. In some patients sero-conversion from cellular to humoral response does not occur or occurs much later in disease; and in some patients with chronic form of the disease, the humoral response is poor. Thus the Lyme IGXSpot test is recommended for detection of very early and/or late B. burgdorferi infection; and in seronegative patient’s whole blood samples.
Principle
The B. burgdorferi IGXSpot is an Enzyme-Linked ImmunoSpot (ELISPOT) assay that detects human T-cells reactive to B. burgdorferispecific antigens in vitro. ELISPOT is a widely used method for detecting and monitoring cellular immune responses to specific antigens. The IGXSpot assay allows visualization of the secretory product(s) of individual activated or responding cells to B. burgdorferi specific antigens. Each spot that develops in the assay represents a single reactive cell.
Advantage
Detects specific T-cell responses soon after infection, when antibodies to the organisms are not detectable or late in the disease when the levels of antibodies are very low. When combined with Lyme ImmunoBlot tests, provides information on the full spectrum of patient’s immune response to infection and stage of disease. Especially useful for seronegative patients.
Reference Range
Reference Range: >2 colonies positive.
Clinical Significance
It is well documented that both humoral and cellular immune responses develop to Borrelia infection. Assessment of both the function and the frequency of Borrelia-specific T cells is crucial for evaluating the cellular immune response to, and diagnosis of Borrelia infection. Due to the clonal expansion (proliferation) of antigen-specific T cells in vivo during an immune response, the presence of increased frequencies of Borrelia antigen-specific effector/memory T cells in peripheral blood suggests prior infection/exposure to Borrelia. Because of the apparent prevalence of either humoral or cellular immunity in infected individuals, combination of the B. burgdorferi IgXSpot with Lyme serology assay would further increase the sensitivity of Lyme disease diagnosis.
Limitations
For diagnostic purposes, the IgXSpot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician.
The Tick-Borne Relapsing Fever (TBRF) ImmunoBlot is a qualitative immunoassay in which antibodies specific to the TBRF Borrelia antigens on a membrane strip are visualized. It is a qualitative test and is more sensitive and specific than the IFA and traditional Western Blot tests. In early or late stage of the disease when antibody levels are very low, ImmunoBlot can be positive whereas IFA tests can be negative.
Principle
The TBRF ImmunoBlot assay is based upon an antigen-antibody complex formation in the following steps:
The TBRF ImmunoBlot IgM is a very sensitive indicator of exposure to TBRF Borrelia. It may be positive as early as 2 weeks after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure and in some patients will remain positive for a very long time. Re-exposure will also cause this test to be positive for a brief period of time. For the testing to be complete, it is preferable that the IgM ImmunoBlot be run along with the IgG ImmunoBlot.
Reference Range
Negative <2 bands present on the blot
Clinical Significance
The TBRF ImmunoBlot IgM is a sensitive indicator of exposure to TBRF Borrelia. It may be positive as early as 2 weeks after a tick bite. This test will usually remain positive for six to eight weeks after initial exposure. Re-exposure will also cause this test to be positive for a brief period of time. In some patients this test can be positive for a very long time. For the testing to be complete, it is preferable that the IgM ImmunoBlot be run along with the IgG ImmunoBlot.
Limitations
TBRF ImmunoBlot can be false negative early in the disease.
The IgG ImmunoBlot is an immunoassay and qualitative test in which antibodies are visualized. The IgG antibody can be present as early as 6 to 8 weeks after infection.
Reference Range
Negative <2 bands present on the blot
Clinical Significance
The TBRF ImmunoBlot IgG is a sensitive indicator of an exposure to B. burgdorferi. The IgG antibody can be present as early as 6 to 8 weeks after infection.
Limitations
TBRF ImmunoBlot can be false negative early in the disease.
IgM Reference Range
IgG Reference Range
Clinical Significance
The Lyme Dot-Blot Assay (LDA) is a qualitative immunoassay for the direct detection of Borrelia burgdorferi specific antigens in urine or cerebral spinal fluid using B. burgdorferi antibodies. The antigens present in urine or CSF are immobilized onto a membrane in a Dot-blot format and are incubated with anti-B. burgdorferi specific antibodies. After washing, the bound anti-B. burgdorferi specific antibodies are reacted with anti-rabbit IgG, which is visualized by an enzyme/substrate reaction.
If the initial Lyme panel tests on blood samples are negative, including PCR, but symptoms for Lyme disease are present, the follow-Up Lyme Panel 875, which includes LDA on urine and PCR, can be helpful in making the diagnosis.
Clinical Significance
The Relapsing Fever (TBRF) Western Blot is a sensitive indicator of an exposure to Relapsing Fever Borrelia. The TBRF Western Blot should be performed on patients with Lyme-like symptoms but negative on all Lyme tests.
Limitations
IGeneX Relapsing Fever Borrelia q-PCR detects the specific DNA of relapsing fever Borrelia group and speciates to B. miyamotoi in human specimens and ticks.
Reference Range
Clinical Significance
The Relapsing Fever (RF) Borrelia group real-time PCR Assay is designed for qualitative detection of RF Borrelia group DNA in clinical samples. The RF group includes B. miyamotoi, B. hermsii, B. coriaceae, B. lonestari and B. anserine, etc. The assay detects RF Borrelia group genomic DNA and B. miyamotoi specific DNA.
Limitations
Panels | Blood | Urine | Misc |
LPA | Lyme Panel A | ✓ | ||
*IB1 | Lyme Immunoblot Panel 1 | ✓ | ||
*IB2 | Lyme Immunoblot Panel 2 | ✓ | ||
*IB3 | Lyme Immunoblot Panel 3 | ✓ | ||
LPCR1 | Lyme PCR Panel 1 | ✓ | ||
*LU1 | Lyme Urine Panel 1 | ✓ | ||
*300 | Lyme IGXSpot | ✓ | ||
*CSF1 | CSF Panel 1 | ✓ | ||
*LTP1 | Lyme/TBRF Panel 1 | ✓ | ||
*LTP2 | Lyme/TBRF Panel 2 | ✓ | ||
*LTP3 | Lyme/TBRF Panel 3 | ✓ | ||
*TBD1 | Tick Borne Disease Panel 1 | ✓ | ||
*TBRF1 | TBRF Panel 1 | ✓ | ||
*TBRF2 | TBRF Panel 2 | ✓ | ||
(*) Not yet available for New York residents. |