Aggregates consisting of IgA complexed with fibronectin are found in sera of most patients with IgA nephropathy and patients with Henoch-Schonlein purpura. Detection of these aggregates is based on their specific attachment to a fragment of type 1 collagen.

This test is not approved for New York patient testing.

See individual assay for description.

Panel Includes:

• Bordetella pertussis IgG Vaccine Response, ELISA
• Diphtheria Antitoxoid, ELISA
• Tetanus Antitoxoid, ELISA

 Vaccine Response Testing

Specimens collected just before or within 15 minutes of the next dose represent the TROUGH levels. Specimens obtained within 15-30 minutes after the end of I.V. infusion or 45-60 minutes after an IM injection or 90 minutes after oral intake represent the PEAK level.

Therapeutic levels:

Peak serum

40-55 mcg/mL

This test is available for New York patient testing.

See individual assay for description.

Panel Includes:

• IgA Fibronectin Aggregates, ELISA
• IgA, NEPH

See individual assay for description.

Panel Includes:

• Measles (Rubeola) IgG Antibody, IFA
• Mumps IgG Antibody, IFA
• Rubella IgG Antibody, ELISA

This unit code has been inactivated.

Please see the following unit codes
60524, 60545, 61015, 64605, and 60485

Decreased serum immunoglobulin levels occur in primary and secondary immunodeficiency states. Increased serum immunoglobulin levels may reflect monoclonal gammopathies or polyclonal immune activation associated with autoimmunity or infection.

This test is approved for New York patient testing.

• Immunofixation Electrophoresis

Secretory IgA is composed of approximately equal concentrations of IgA1 and IgA2. Secretory IgA will inhibit microorganisms from binding to epithelial cell surfaces. The presence of secretory IgA also affects the development of allergic (IgE) reactions to various ingested antigens by binding the antigens and preventing IgE responses. The quantitation of salivary IgA is useful in investigating recurrent upper respiratory infections in children.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is available for New York patient testing.

Immunofixation electrophoresis identifies the heavy and light chain class of monoclonal proteins produced in plasma cell dyscrasias. This procedure is qualitative and cannot be used to quantitate immunoglobulins.

This test is approved for New York patient testing.

Deficiencies in serum IgA are normally associated with deficiencies in secretory IgA and may be clinically correlated with autoimmune diseases or recurrent infection. Two IgA subclasses have been described: IgA1, which comprises 80-90% of serum IgA, and IgA2, which comprises 10-20% of serum IgA. Deficiencies in either subclass type have been associated with anaphylactic transfusion reactions; depressed IgA1 and IgA2 have been reported in patients with H. influenzae and sinopulmonary infections, respectively.

This test is approved for New York patient testing.

• IgE, NEPH

Quantitation of IgG, IgA, IgM, and identification by immunofixation electrophoresis.

IgE levels are significantly elevated in most patients with allergic rhinitis, extrinsic urticaria, and atopic eczema. Elevated IgE levels are also found in parasitic diseases and some types of immunodeficiency diseases (Wiskott-Aldrich Syndrome, DiGeorge Syndrome, and hyper-IgE syndrome).

This test is approved for New York patient testing.

Includes IgG, IgA, and IgM quantitation.

Please see the following technical sheet for more information:
 Hyper IgM Syndrome

• Alpha-1 Acid Glycoprotein, NEPH

Decreased serum immunoglobulin levels occur in primary and secondary immunodeficiency states. Increased serum immunoglobulin levels may reflect monoclonal gammopathies or polyclonal immune activation associated with autoimmunity or infection.

This test is approved for New York patient testing.

Decreased or absent IgG2 subclass levels have been associated with recurrent pyogenic infections and repeated respiratory tract infections. IgG2 deficiency is associated with IgA deficiency, and with decreased immune responses to carbohydrate antigens (for example, pneumococcal and Haemophilus influenzae polysaccharides). A decreased level of a specific IgG subclass may not be reflected in the total IgG quantitation.

This test is approved for New York patient testing.

The IgG synthesis rate/index is useful in diagnosing and monitoring patients with multiple sclerosis and other inflammatory diseases involving the brain and meninges.

Test performed at Quest Diagnostics Nichols Institute.

This unit code has been inactivated.

Please see unit code 22295.

Decreased serum immunoglobulin levels occur in primary and secondary immunodeficiency states. Increased serum immunoglobulin levels may reflect monoclonal gammopathies or polyclonal immune activation associated with autoimmunity or infection.

This test is approved for New York patient testing.

• Interleukin-2 (IL-2), ELISA

• Interleukin-2 Receptor (IL-2R), ELISA

This assay aids in the detection and differentiation of influenza A virus infection and infection by the 2009 H1N1 influenza virus. The test uses real-time PCR technology to target the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate it from human influenza A virus.

This test is approved for New York patient testing.

See individual assay for description.

Panel Includes:

• C3, NEPH
• C4, NEPH
• C3d Circulating Immune Complexes
• Immune Complex, C1q Binding Assay, ELISA
• Immune Complex, Polyethylene Glycol (PEG), IgG, RID

This assay detects and differentiates between the H1 and H3 subtypes of seasonal influenza A viruses using real-time PCR. Based on current drug susceptibility and resistance patterns for seasonal influenza strains, information from this test can be used to guide treatment decisions. This assay is not intended to detect or subtype the 2009 H1N1 pandemic influenza virus. This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

This test is not approved for New York patient testing.

See individual assay for description.

Panel Includes:

• C3d Circulating Immune Complexes
• Immune Complex, C1q Binding Assay
• Immune Complex, Polyethylene Glycol (PEG), IgG

The C1q solid phase binding (C1q SP) detects immune complexes larger than 19S that are capable of activating the classical complement pathway. The immune complexes detected by C1q SP are typically formed in antibody excess.

Test performed at Quest Diagnostics Nichols Institute.

The PEG method is both antigen and antibody non-specific and is based on the property of immune complexes to precipitate at low concentrations of PEG (2.5-3.5%). The PEG method will precipitate immune complexes of various size and composition as well as other macromolecules present in serum. Elevated serum IgG may cause a false positive increase in the PEG precipitate.

This test is available for New York patient testing.

See individual assay for description.

Panel Includes:

• Adenovirus Antibody, CF
• Influenza Virus Types A and B Antibody, CF

See individual assay for description.

Panel Includes:

• Adenovirus Antibody CF
• Influenza Virus Types A and B Antibody, CF

The use of centrifugation-enhanced shell vial culture methods combined with sensitive monoclonal antibody staining techniques reduces to less than 36 hours the influenza virus types A and B isolation time that can ordinarily take as much as 10-14 days by conventional tube culture methods. Although highly sensitive and much more rapid, this test may be somewhat less sensitive than conventional culture when specimens contain a very low number of viral particles.

This test is approved for New York patient testing.

Smears are stained with fluorescent monoclonal antibodies that will detect the presence of Influenza A and Influenza B viruses in specimens.

This test is approved for New York patient testing.

Influenza types A or B viruses cause severe illness in millions of individuals each year worldwide. This assay is designed to detect all influenza virus A subtypes, including those associated with avian and swine influenza, and type B virus. If present, influenza virus is reported as type A or B. The detection of influenza virus RNA is based upon reverse transcription of specific conserved influenza type A and B genomic RNA sequences followed by real-time PCR amplification and detection.

This test is not approved for New York patient testing.

This assay aids in the detection and differentiation of seasonal influenza virus infection and infection by the 2009 H1N1 influenza virus. If Influenza A is detected, the test will reflex to Influenza A H1N1 (2009) Real-Time RT-PCR (Focus Unit Code 46585) for an additional charge.

Influenza A, including avian strains, causes severe illness in millions of individuals each year worldwide, and has the capacity to cause pandemics. Serology can be useful for diagnostic testing and epidemiological studies. A four-fold or greater increase in titer between acute and convalescent specimens indicates recent infection.
This test is not appropriate for assessing responses to Influenza vaccination.

This test is approved for New York patient testing.

Influenza B typically causes a milder form of illness than type A, but can be severe, particularly in older persons. Serology can be useful for diagnostic testing and epidemiological studies. A four-fold or greater increase in titer between acute and convalescent specimens indicates recent infection.
This test is not appropriate for assessing responses to Influenza vaccination.

This test is approved for New York patient testing.

Single titers >=1:64 are indicative of recent infection. Titers of 1:8 to 1:32 may be indicative of either past or recent infection, since CF antibody levels persist for only a few months. A four-fold or greater increase in titer between acute and convalescent specimens confirms the diagnosis.
This test is not appropriate for assessing responses to Influenza vaccination.

This test is approved for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is approved for New York patient testing.

Interferon-alpha is one of three species of interferon that possesses various biological properties including immunomodulating activity, anti-tumor activity and anti-viral activity. Elevated interferon-alpha levels are reportedly seen in viral disease, chronic fatigue-immune dysfunction syndrome and some inflammatory diseases.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

This assay is designed to semi-quantitatively detect neutralizing antibodies to IFNB-1b (Betaseron) in multiple sclerosis patients on IFNB-1b therapy. Only patients on IFNB-1b (Betaseron) therapy should be tested by this assay. For patients on IFNB-1a (Avonex or Rebif), please refer to Unit Code 20555. The appropriate neutralization assay will be performed as a reflex if the IgG screening method (Focus Unit Code 20358, Interferon-Beta IgG, MAID) is requested and positive. A positive Interferon-Beta IgG binding antibody screen assay is recommended prior to testing for neutralizing antibodies.

Highly elevated levels of neutralizing antibodies (NAbs >1:100) to interferon-beta used as therapy in patients with Multiple Sclerosis have been reported to correlate with predictable loss of interferon-beta bioactivity. In patients with elevated NAb levels from >1:20 to <1:100, interferon-beta bioactivity may still be present, but does not necessarily correlate to the exact NAb titer, and continued patient monitoring may be warranted. There is no apparent loss of interferon-beta bioactivity in patients who test positive in the binding antibody assay, but negative for NAbs; however, continued patient monitoring may also be warranted in this instance as well.

This test is approved for New York patient testing.

This assay is designed to semi-quantitatively detect neutralizing antibodies to IFNB-1a (Avonex and Rebif) in multiple sclerosis patients on IFNB-1a therapy. Only patients on IFNB-1a (Avonex and Rebif) therapy should be tested by this assay. For patients on IFNB-1b (Betaseron), please refer to Unit Code 20777. The appropriate neutralization assay will be performed as a reflex if the IgG screening method (Focus Unit Code 20358, Interferon-Beta IgG, MAID) is requested and positive. A positive Interferon-Beta IgG binding antibody screen assay is recommended prior to testing for neutralizing antibodies.

Highly elevated levels of neutralizing antibodies (NAbs >1:100) to interferon-beta used as therapy in patients with Multiple Sclerosis have been reported to correlate with predictable loss of interferon-beta bioactivity. In patients with elevated NAb levels from >1:20 to <1:100, interferon-beta bioactivity may still be present, but does not necessarily correlate to the exact NAb titer, and continued patient monitoring may be warranted. There is no apparent loss of interferon-beta bioactivity in patients who test positive in the binding antibody assay, but negative for NAbs; however, continued patient monitoring may also be warranted in this instance as well.

This test is approved for New York patient testing.

This unit code has been inactivated.

Please see the following unit codes
20555 or 20777

Some multiple sclerosis patients receiving recombinant interferon-beta (IFNb) develop IFNb-specific antibodies that may block the therapeutic effect of the treatment. This assay screens for IgG antibodies capable of binding to IFNb. If the Interferon-Beta IgG is >4.0, Interferon Beta (IFNB) Antibody Neutralization Assay will be performed at an additional charge.
NOTE: Collect sample at least 8 hours after interferon injection. The specific drug being used to treat the patient must be provided with the patient requisition.

This test is approved for New York patient testing.

Elevated levels of circulating IL-2 are present in patients with AIDS, multiple sclerosis, rheumatoid arthritis, SLE and type 1 diabetes mellitus. Elevated levels are also present during transplant rejection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

Clinical conditions in which elevated soluble IL-2R levels are detected include AIDS, autoimmune disease, sarcoidosis, and a variety of leukemias and lymphomas. In HIV positive individuals, IL-2R is elevated during the asymptomatic phase as well as during persistent generalized lymphadenopathy and symptomatic phases. IL-2R detection may be useful in measuring T cell activation and monitoring HIV pathogenesis. Elevated IL-2R levels have clinical and prognostic significance in patients with malignant lymphoma, non-Hodgkin's lymphoma, B cell and undifferentiated lymphomas.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

• Cryptosporidium Antigen, EIA

• Antifungal Serum Level, Itraconazole, HPLC