Results That Matter

Interpreting Test Results

IGeneX provides physicians with information on how to interpret the results of each diagnostic test we offer. These test results, however, are not a diagnosis. Physicians should consider the test results from IGeneX in conjunction with a patient’s symptoms and medical history to determine the most accurate diagnosis.

  • Babesiosis Test Interpretation

    Babesia microti IgG and IgM IFA

    The Babesia microti Indirect Immunofluorescent Antibody (IFA) test detects IgM and IgG antibodies to B. microti in human serum.

    Interpretation (titers)

    IgM  < 20
    Negative. 20 may or may not indicate active infection.
    IgM  ≥ 40
    Indicates active infection.
    IgG < 40
    Negative
    IgG ≥ 40 to < 160
    May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
    IgG ≥ 160
    Indicates active infection.

    Presence of both IgM and IgG together also indicates active infection.

    There is a low level of cross-reaction between B. microti and B. duncani IFA tests. In geographic regions where both species are present, we recommend that patient sera be tested by both B. microti and B. duncani IFA tests.

    A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Babesia duncani IFA

    The Babesia duncani Indirect Immunofluorescent Antibody (IFA) test detects IgM and IgG antibodies to B. duncani in human serum.

    Interpretation (titers)

    IgM  < 20
    Negative. 20 May or may not indicate active infection.
    IgM  ≥ 40
    Indicates active infection.
    IgG < 40
    Negative
    IgG ≥ 40 to < 160
    May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
    IgG ≥ 160
    Indicates active infection.

    Presence of both IgM and IgG together also indicates active infection.

    There is a low level of cross-reaction between B. duncani and B. microti IFA tests. In geographic regions where both species are present, we recommend that patient sera be tested by both B. duncani and B. microti IFA tests.

    A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six-to-eight weeks apart is recommended for accurate diagnosis.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Babesia FISH

    The Babesia Fluorescent In-Situ Hybridization (FISH) assay is a qualitative test that detects ribosomal RNA of Babesia directly in a blood smear. The Babesia FISH test provides a significant increase in sensitivity and specificity over standard Geimsa-stained smears for the presence of intraerythrocytic parasites (piroplasts) in RBCs. The parasites exist as ring and/or merozoite forms.

    Interpretation:

    A positive sample:
    must show fluorescing rings inside at least two RBCs.
    A negative sample:
    must show no fluorescence within RBCs.
    A single negative FISH test result does not exclude the possibility of Babesia infection.
    Results should be interpreted in conjunction with other laboratory and clinical findings.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Babesia microti/duncani PCR

    The Babesia microti/duncani Polymerase Chain Reaction (PCR) screen test detects Babesia-specific (B. microti and/or B. duncani) DNA in human specimen. Babesia ribosomal DNA (rDNA) fragments are hybrid-selected by probes, followed by PCR amplification of selected Babesia rDNA. PCR products are detected Babesia-specific probes in a dot-blot assay. The primers and probes used for the selection of Babesia rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI: GI 1453221 for B. microti and GI 6272590 for B. duncani).

    Interpretation:

    Positive Babesia specific DNA detected.
    Negative Babesia specific DNA not detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

     

  • Bartonella Test Interpretation

    B. henselae IFA

    The Bartonella henselae indirect immunofluorescent antibody test is used to detect IgM and IgG antibodies to B. henselae in human serum.

    Interpretation (titers):

    IgM < 20
    Negative. 20 May or may not indicate active infection.
    IgM ≥ 40
    Indicates active infection.
    IgG < 40
    Negative
    IgG ≥ 40 to < 160
    May or may not suggest active infection.  In patients with previously high titers, such titers may indicate resolving infection.
    IgG ≥ 160
    Indicates active infection.

    Presence of IgM and IgG together also indicates active infection.

    A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

     

    B. henselae PCR

    Sample Type: whole blood and cerebral spinal fluid (CSF)

    The Bartonella henselae PCR test is an assay that detects B. henselae specific DNA in human specimen. B henselae rDNA fragments are hybrid- selected by probes, followed by PCR amplification of selected B. henselae rDNA. PCR products are detected with B. henselae specific probes in a dot blot assay. The primers and probes used for the selection of B. henselae rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI GI:2828304).

    Interpretation:

    Positive: B. henselae rDNA detected.
    Negative: B. henselae rDNA not detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Bartonella FISH

    The Bartonella Fluorescent In Situ Hybridization (FISH) test detects bacteria of the Genus Bartonella including B. vinsonii, B. berkhoffii, B. henselae, and B. quintana in whole blood smears. Bartonella are rod shaped gram negative bacteria. The FISH test provides a significant increase in specificity over standard gram stain for the presence of Bartonella in whole blood smears.

    Interpretation:

    Positive: Fluorescing rod-shaped bodies detected in the smear.
    Negative: Fluorescing rod-shaped bodies not detected in the smear.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

  • CD57 Test Interpretation

    CD57 Test

    CD57 is expressed on both natural killer (NK) cells and T lymphocytes. This test measures only the NK cells that express CD57 as surface markers. In some patients with late or chronic diseases, including Lyme disease, the CD57 positive NK cells can be low, and the number may improve with successful treatment. (Stricker, et al., AAEM: 9, 111-113, 2002)

    Special Instructions:

    Medicare patients, download ABN forms here. This test is not available for New York residents.

    Interpretation:

    CD57 NK Cells Absolute Count (count/µl):
    <40
    Low
    to 98
    Borderline
    > 98
    Normal
    CD57 NK Cells (% lymphocyte):
    <2.26
    Low
    to 4.65
    Borderline
    > 4.65
    Normal

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

  • C. pneumoniae Test Interpretation

    C. pneumoniae IgG and IgA ELISA

    The Chlamydophila pneumoniae IgG and IgA ELISA test is intended for use in the detection of IgG and IgA antibodies against C. pneumoniae in human serum. The test is a semi-quantitative ELISA test using serum samples from patients with clinical history, signs or symptoms consistent with C. pneumoniae infection. Presence of IgG and/or IgA indicates past or current C. pneumoniae infection.

    Interpretation

    IgG (Ratio) (Interpretation)
    ≥ 1.1
    Positive
    ≥ 0.8 to < 1.1
    Equivocal
    < 0.8
    Negative
    IgA (Ratio) (Interpretation)
    ≥ 1.1
    Positive
    ≥ 0.8 to < 1.1
    Equivocal
    < 0.8
    Negative

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

  • Ehrlichia & Anaplasma Test Interpretation

    E. chaffeensis (HME) IFA

    HME (Human Monocytic Ehrlichiosis) immunofluorescent antibody test detects IgM and IgG antibodies to Ehrlichia chaffeensis, the causative agent of HME in human serum.

    Interpretation (titers)

    IgM  < 20
    Negative. 20 May or may not indicate active infection.
    IgM  ≥ 40
    Indicates active infection.
    IgG < 40
    Negative
    IgG ≥ 40 to < 160
    May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
    IgG ≥ 160
    Indicates active infection.

    Presence of both IgM and IgG together also indicates active infection.

    Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.

     

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    A. phagocytophilum (HGA) IFA

    The HGA (Human Granulocytic Anaplasmosis) immunofluorescent antibody test is used to detect IgM and IgG antibodies to Anaplasma phagocytophilum, the causative agent of HGA in human serum.

    Interpretation (titers):

    IgM  < 20
    Negative. 20 May or may not indicate active infection.
    IgM  ≥ 40
    Indicates active infection.
    IgG < 40
    Negative
    IgG ≥ 40 to < 160
    May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
    IgG ≥ 160
    Indicates active infection.

    Presence of both IgM and IgG together also indicates active infection. Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Ehrlichia chaffeensis (HME) PCR

    The HME (Human Monocytic Ehrlichiosis) PCR test detects Erhlichia chaffeensis rDNA fragments in the patient samples. The E. chaffeensis rDNA fragments are hybrid selected by probes, followed by PCR amplification of the selected fragments using Ehrlichia specific primers. E. chaffeensis specific PCR products are then detected with probes in a dot-blot assay.

    Interpretation:

    Positive: E. chaffeensis rDNA detected.
    Negative: E. chaffeensis rDNA not detected.

     

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Anaplasma phagocytophilum (HGA) PCR

    Sample Type: whole blood

    The HGA (Human Granulocytic Anaplasmosis) PCR test detects Anaplasma phagocytophilum rDNA fragments in the patient specimens. The A. phagocytophilum rDNA fragments are hybrid-selected by probes, followed by PCR amplification of the selected fragments using Anaplasma specific primers. A. phagocytophilum specific PCR products are then detected with probes in a dot-blot assay.

    Interpretation:

    Positive: A. phagocytophilum rDNA detected
    Negative: A. phyagocytophilum rDNA not detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

  • Lyme Disease Test Interpretation

    Lyme IgG ImmunoBlot

    The Lyme ImmunoBlot Test is a qualitative assay that detects B. burgdorferi sensu lato specific IgG antibodies in human serum to the following Borrelia burgdorferi species: B. burgdorferi B31, B. burgdorferi 297, B. californiensis, B. mayonii, B. spielmanii, B. afzelii, B. garinii and B. valaisiana. Recombinant B. burgdorferi sensu lato species antigens are sprayed at specific positions onto a nitrocellulose membrane and cut into strips. These strips are used to detect B. burgdorferi sensu lato specific antibodies in patient serum.

    IGeneX Criteria:

    Based on internal validation studies, IGeneX established the following criteria:

    Positive: If two or more of the following bands are present: 23, 31, 34, 39, 41 and 93 kDa.

    Negative: Any profile that does not meet positive criteria

    CDC/NYS Criteria:

    Positive: If ≥5 of the following 10 bands are present: 18, 23, 28, 30, 39, and 41, 45, 58, 66 and 93kDa.
    Negative: Any profile that does not meet the positive criteria.

    Limitation: Positive ImmunoBlot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons. A positive result suggests exposure to B. burgdorferi. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If only one of the following bands: 23, 31, 34, 39 and 93kDa is present or if one or more of these bands are indeterminate on the ImmunoBlot, testing with another method or retesting after 6-8 weeks is recommended.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme IgM ImmunoBlot

    The Lyme ImmunoBlot IgM Test is a qualitative assay that detects B. burgdorferi sensu lato specific IgM antibodies in human serum to the following Borrelia burgdorferi species: B. burgdorferi B31, B. burgdorferi 297, B. californiensis, B. mayonii, B. spielmanii, B. afzelii, B. garinii and B. valaisiana. Recombinant B. burgdorferi sensu lato species antigens are sprayed at specific positions onto a nitrocellulose membrane and cut into strips. These strips are used to detect B. burgdorferi sensu lato specific antibodies in patient serum.

    IGeneX Criteria:

    Based on internal validation studies, IGeneX established the following criteria:

    Positive: If two or more of the following 4 bands are present: 23, 31, 39 and 41kDa.

    Negative: Any profile that does not meet positive criteria

    CDC/NYS Criteria:

    Positive: If ≥2 of the following 3 bands are present: 23, 39, and 41kDa.
    Negative: Any profile that does not meet the positive criteria.

    Limitation: Positive ImmunoBlot result with 31kDa may be present after Lyme vaccination in uninfected persons. A positive result suggests exposure to B. burgdorferi. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If only one of the following bands: 23, 31, 39kDa is present or if one or more of these bands are indeterminate on the ImmunoBlot, testing with another method or retesting after 6-8 weeks is recommended.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme IGXSpot

    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.

    Interpretation:

    Positive: >2 CFU
    Negative: <2 CFU

     

    Limitation: For diagnostic purposes, the IGXSpot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is negative, testing with another method is recommended. Depending on the stage of the disease patients can have either humoral or cellular immune response to infection. Thus, it is advisable to perform Lyme ImmunoBlot IgM and IgG tests with IGXSpot test.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

     

    LYME IgM Serology

    This test detects presence of specific IgM antibodies to B. burgdorferi. Positive results with clinical history may indicate early stage Lyme disease. IgM may also be present in Stage II or Stage III Lyme disease

    Lyme Index Value (LIV) Interpretation

    ≥ 1.2  
    Positive. Confirmatory assays recommended.
    ≥ 0.8 and < 1.2  
    Equivocal. Retesting in two to four weeks recommended.
    <0.8   
    Negative. Indicates IgM antibodies to B. burgdorferi not detected.

    If Lyme disease is suspected in a patient exhibiting a negative result, an IgG and IgM Western Blot should be performed.

    C6 ELISA

    The Immunetics C6 B. burgdorferi (Lyme) ELISA is intended for use on 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). This test detects IgG & IgM antibodies to B burgdorferi in human serum.

    Result Interpretation

    > or = 1.10
    Positive: antibodies to B. burgdorferi detected.
    0.91-1.09
    Equivocal
    < or = 0.90  
    Negative: antibodies to B. burgdorferi detected.

    This test was developed and its performance characteristics determined by Immunetics, Inc. It has been cleared by the FDA for use on patient serum samples.

    Lyme IFA, IgG/IgM/IgA

    The Lyme Immunofluorescence Assay (IFA) detects antibodies (IgG, IgM, IgA) against B. burgdorferi. Seroconversion usually occurs 2-3 weeks after infection and may remain elevated in case of persistent disease. Cross-reactions with other Borrelia and other spirochetes occur. A positive or equivocal result is preliminary and should be confirmed with IgG and IgM Western blot.

    Result Interpretation

    < 40
    Negative
    40
    Equivocal
    ≥ 80
    Positive

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme IgM Western Blot

    IGeneX Criteria:
    Based on internal validation studies, IGeneX established the following criteria:
    Positive If two or more of the following bands are present:
    23-25, 31, 34, 39, 41 and 83-93 kDa.
    Exception:
    Negative: If only bands 41 kDa and 83-93 kDa are present.
    Indeterminate If:
    only bands 31 and 41kDa OR only bands 31 and 83-93kDa are present.

    Note: An indeterminate result could be due to presence of antibodies to viruses or other spirochetes. Therefore, the following confirmation test of an Indeterminate Western Blot IgM result is recommended: Test # 488 – 31 kDa Epitope Test IgM.

    Negative If:
    only bands 41 and 83-93kDa from the positive criteria are present OR if test result does not meet either positive or indeterminate criteria.
    Limitation:
    Positive Western Blot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons.

    CDC/NYS Criteria:
    The Lyme IgM Western Blot is considered positive if:
    2 of the following 3 bands are present: 23-25, 39, and 41kDa.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme IgG Western Blot

    IGeneX Criteria:
    Based on internal validation studies, IGeneX established the following criteria:

    Positive If:
    two or more of the following bands are present: 23-25, 31, 34, 39, 41 and 83-93 kDa.
    Exception – Indeterminate:
    If only bands 31 and 41kDa are present.

    Note: An indeterminate result could be due to presence of antibodies to viruses or other spirochetes. Therefore, the following confirmation test of an Indeterminate Western Blot IgG result is recommended: Test # 489 – 31 kDa Epitope Test IgG.

    Negative If:
    test result does not meet either positive or indeterminate criteria.
    Limitation:
    Positive Western Blot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons.

    CDC/NYS Criteria:

    The Lyme IgG Western Blot is considered positive if 5 of the following 10 bands are present: 18, 23-25, 28, 30, 39, and 41, 45, 58, 66 and 83-93kDa.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

     

    IgM 31 kDa Epitope

    This test determines whether the band present at position 31 kDa on the IGeneX Lyme IgM Western Blot is specific for B. burgdorferi. Serum from the patient is tested against a Western Blot strip with fixed B burgdorferi specific recombinant antigen fragments.

    Interpretation

    IGeneX interpretation is based on internal validation studies performed on well-defined Lyme patients:
    67
    Positive
    161
    Negative
    The assay sensitivity is 95% and specificity is 98%.
    Limitations: Positive results for band 31kDa may be present after vaccination in uninfected persons. The Lyme 31kDa Epitope test specificity was >97% in a viral positive panel.
    Positive: Antibodies specific for B. burgdorferi detected.
    Negative: Antibodies specific for B. burgdorferi not detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme Multiplex PCR

    Sample type: Serum, whole blood, urine, pooled urines, CSF and miscellaneous clinical samples.

    The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay.

    The test also detects DNA to other Borrelia: B. afzeli, B. andersonii and B. garinii.

    Interpretation:

    Genomic Positive: 
    B. burgdorferi DNA detected.
    Negative: 
    B. burgdorferi DNA not detected.
    Plasmid Positive: 
    B. burgdorferi DNA detected.
    Negative: 
    B. burgdorferi DNA not detected.
    Sample is considered positive if either genomic or plasmid is positive.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Lyme Dot-blot Assay

    Sample types: urine, CSF.

    The Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of B. burgdorferi specific antigens in urine that react specifically to the following B. burgdorferi antibodies: 23-25kDa (OspC), 31kDa, 39kDa and 93kDa.

    Interpretation:

     Positive 
    B. burgdorferi antigens detected
    Negative 
    B. burgdorferi antigens not detected

    Cross-reactions can occur with other microorganisms present in urine samples. Therefore, clinicians should use caution in the interpretation of a positive result when no other Lyme diagnostic test result is positive.

     

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

     

  • Relapsing Fever Test Interpretation

    TBRF PCR

    Sample type: Serum, Whole blood, CSF, Urine, Pooled Urines and miscellaneous clinical samples

    The Relapsing Fever (RF) Borrelia real-time PCR detetcts RF Borrelia specific ribosomal DNA (rDNA) and B. miyamotoi rDNA specifically. The purified DNA is amplified with Borrelia specific rDNA primers and the amplified product is detected by hybridization to RF Borrelia specific probes. The primers and probes used for the selection of BorreliarDNA fragments are designed from published small subunit ribosomal DNA sequences of Borrelia.

    Interpretation:

    RF Borrelia Screen
    Positive:
    RF Borrelia Group specific rDNA detected.
    Negative:
    RF Borrelia Group specific rDNA not detected in the sample analyzed.
    Species: B. miyamotoi
    Positive:
    B. miyamotoi specific rDNA detected.
    Negative:
    B. miyamotoi specific rDNA not detected in the sample analyzed.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA.  The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    TBRF Western Blot IgM

    Tick-borne relapsing fever (TBRF) is caused by Borrelia species: B. duttoni, B. hermsii, and B. parkerii. Recently, B. miyamotoi has been added to the list. TBRF is a complex and progressively systemic illness which tends to mimic other diseases including Lyme disease. Therefore, determination of specific antibodies is helpful in the diagnosis of TBRF. The Relapsing Fever IgM Western Blot detects RF specific antibodies in human serum. IGeneX interpretation is based on internal validation studies.

    Interpretation:

    Positive:
    Antibodies against two or more TBRF antigens are detected. This suggests exposure to Relapsing Fever Borrelia.
    Negative:
    Antibodies against less than two TBRF antigens detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA.  The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    TBRF Western Blot IgG

    Tick-borne relapsing fever (TBRF) is caused by Borrelia species: B. duttoni, B. hermsii, and B. parkerii. Recently, B. miyamotoi has been added to the list. TBRF is a complex and progressively systemic illness which tends to mimic other diseases including Lyme disease. Therefore, determination of specific antibodies is helpful in the diagnosis of TBRF. The Relapsing Fever IgG Western Blot detects RF specific antibodies in human serum. IGeneX interpretation based on internal validation studies.

    Interpretation:

    Positive:
    Antibodies against two or more TBRF antigens are detected. This suggests exposure to Relapsing Fever Borrelia.
    Negative:
    Antibodies against less than two TBRF antigens detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA.  The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    TBRF IgG ImmunoBlot

    The TBRF IgG ImmunoBlot Test is a qualitative immunoblot assay that detects IgG antibodies in human serum to the following TBRF associated Borrelia species: B. miyamotoi, B. hermsii, B. turicatae and B. coriaceae. Recombinant TBRF Borrelia antigens are sprayed at specific positions onto nitrocellulose membrane and cut into strips. These strips are used to detect TBRF Borrelia specific antibodies in patient serum.

    Interpretation:

    Positive:
    If two TBRF Borrelia specific bands are present.
    Indeterminate:
    If one TBRF Borrelia specific bands is present.
    Negative:
    Any profile that does not meet the positive or indeterminate criteria.

    Limitations: A positive result suggests exposure to TBRF Borrelia. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    TBRF IgM ImmunoBlot

    The TBRF IgM ImmunoBlot Test is a qualitative immunoblot assay that detects IgM antibodies in human serum to the following TBRF associated Borrelia species: B. miyamotoi, B. hermsii, B. turicatae and B. coriaceae. Recombinant TBRF Borrelia antigens are sprayed at specific positions onto nitrocellulose membrane and cut into strips. These strips are used to detect TBRF Borrelia specific antibodies in patient serum.

    Interpretation:

    Positive:
    If two TBRF Borrelia specific bands are present.
    Indeterminate:
    If one TBRF Borrelia specific bands is present.
    Negative:
    Any profile that does not meet the positive or indeterminate criteria.
    Limitations: A positive result suggests exposure to TBRF Borrelia. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.

     

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

  • Rickettsia Test Interpretations

    Rickettsia IFA

    The Rickettsia indirect immunofluorescent antibody test detects IgG antibodies to Rickettsia species in human serum. The species include Rickettsia rickettsii, causative agent of Rocky Mountain Spotted Fever and Ri. typhi, causative agent of Murine typhus respectively.

    Interpretation (titers):

    Spotted Fever Group or Typhus Fever Group
    IgG < 40
    Negative
    ≥ 40 to < 160
    May or may not suggest active infection.  In patients with previously high titers, such titers may indicate resolving infection.
    ≥ 160
    Suggests active infection.

     

    Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.

    Rickettsia PCR

    Sample Type: whole blood and cerebral spinal fluid (CSF)

    The Rickettsia PCR test detects Rickettsia species specific DNA in clinical samples. Rickettsia 17kDa antigen gene fragments are hybrid selected by probes, followed by PCR amplification of the selected DNA fragment. PCR products are detected with Rickettsia specific probes: Rickettsia rickettsii and Rickettsia felis/typhi in dot blot assays.  The primers and probes used for the selection of Rickettsia gene fragment encoding the 17kDa antigen DNA fragments are designed from published sequences (NCBI: GI:30844225) (Anderson et al 1988 J Bacteriol 170:4493-4500); Tzianabos et al J Clin Microbiol 1989:2866-2868).

    Interpretation:

    Positive:  
    Rickettsia specific DNA detected.
    Negative:  
    Rickettsia specific DNA not detected.

    Disclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.