Legacy Tests
IGeneX continues to be the global leader in the research and development of tests that accurately detect Lyme disease, Rickettsiosis, Bartonellosis, and other tick-borne diseases. The tests listed on this page are no longer offered by IGeneX, and have been replaced with superior tests.
C6 Peptide - Test #170
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
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.
CD57
Discontinued effective 4/5/2021
The CD57 marker is present on natural killer cells (NK) and T lymphocytes. In cases of chronic diseases, including Lyme disease, the number of CD57 NK cells has been shown to be below normal. Following treatment, the count can return to normal (Stricker and Winger, 2001. Immunol Letter. 76:43-48). However, the utility of this test is controversial. Marques et. al. (2009 Clin. Vaccine Immunol. 16:1249-50) reported that there was no difference between the CD57 NK cell counts among patients with Lyme disease and normal controls. This test measures only the CD57 NK cells and may be useful for patients with known Lyme disease who present with chronic symptoms. If the count is low, the cause of the symptoms may be from Borrelia burgdorferi. If the count is normal, the cause may still be from Lyme disease, but it could also be due to some other agent.
Reference Range
CD57 NK Cells (Absolute Count/l)
<40 LOW
40 to 98 BORDERLINE
98 NORMAL
CD57 NK Cells (% Lymphocytes)
<2.26 LOW
2.26 to 4.65 BORDERLINE
>4.65 NORMAL
Clinical Significance
The CD57 is expressed on both natural killer (NK) cells and T lymphocytes. The CD57 test measures CD57 positive NK cells only. The test is performed on EDTA whole blood. In patients with low CD 57 counts, Lyme disease and Chlamydophila pneumoniae infections should be included in differential diagnosis.
Limitations
If laboratory tests are positive for Lyme disease in a chronically ill patient, this test can be useful prior to antimicrobial therapy, to suggest that the cause of the symptoms is due to Lyme disease. If the count is low, repeat testing after therapy can also be useful.
For Healthcare Professionals
Physicians may want to consider having blood tested for other possible causes of their patient’s symptoms, including other tick-borne infections, such as Lyme disease.
Tick-Borne Relapsing Fever (TBRF) Western Blots
IgM Reference Range
Negative: Relapsing Fever Borrelia specific IgM antibodies not detected
IgG Reference Range
Negative: Relapsing Fever Borrelia specific IgM antibodies not detected
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
Patients with negative results should be re-tested using a fresh specimen after six weeks if clinical symptoms persist.
The results of this test must be interpreted based on patient’s clinical history and other laboratory results.
Lyme IFA
The Lyme Immunofluorescent 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.
Principle
The Lyme IFA assay is a two-stage sandwich assay, based upon an antigen-antibody complex formation in the following steps:
- Binding of anti-Borrelia specific antibodies in human serum to fixed B. burgdorferi on a slide.
- Binding of fluorescent-labeled anti-human IgG/IgM antibodies to the human anti B. burgdorferi antibodies bound to fixed B. burgdorferi on the slide.
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
- This test should only be performed in conjunction with Western Blots/ ImmunoBlots.
- Cross-reactions occurs with other Borrelia species and spirochetes.
Special Instructions
This test is not yet available for NY residents.
Stage of Disease
Screen test
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