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Immune deficiency can result in impaired cellular or antibody-mediated immune responses. Individuals with immune deficiency experience recurrent infections due to common and uncommon infectious agents, or cancers. The immune defect may be present at birth or may be induced by immunosuppressive drugs, which are used to prevent transplant rejection or treat autoimmune disease. Immune deficiency is also encountered at the extremes of age, and with HIV infection.

The immune deficiency panel assesses the distribution of common lymphocyte subsets in peripheral blood. T-cell-mediated immune function toward viruses that affect immune-deficient individuals and T-cell-mediated immune response to non-specific stimulants called mitogens.

Immune competence can be assessed with counts and relative frequencies of common immune cell subsets and with mitogen-stimulated T-cell function. Cell-mediated immunity can be measured with T-cell response to viruses to plan personalized treatment.

Lymphocyte subset testing reports counts and relative frequencies of T-cells, T-helper cells, T-cytotoxic cells, B-cells, and NK cells. T-cell function is assessed after stimulation with viral antigens and non-specific antigens called mitogens. The PlexCMVTM and the PlexEBVTM tests respectively measure T-cell response to CMV (cytomegalovirus) and EBV (Epstein-Barr virus). Both tests incorporate a reaction condition in which the T-cell response to mitogen is measured in parallel.

Knowledge about counts and relative frequencies of the lymphocyte subsets and their functional response to viral antigens and mitogens can be used to assess the general health and function of the cellular immune system:

 

# CATEGORY DETAILS

1

Assay Category

Lab-developed test, lymphocyte phenotyping.

2

Intended Use

To measure counts and relative frequencies of lymphocytes in peripheral blood.

3

Methodology

Stimulation and counting of peripheral blood lymphocytes with dye-labeled antibodies to cell-specific markers, flow cytometry.

4

Test Report

Available within 30 hours of receiving a blood sample.

5

Test Readout

Counts and relative frequencies of CD3, CD4, CD8, CD19, and CD16/56 lymphocytes, frequencies of T-cells that respond to stimulation with specific viral antigens, and non-specific mitogens.

6

Reference Range

See the test report for the reference range.

7

Test Interpretation

Results within the reference range are seen in healthy individuals.

Purpose

General immune competence can be assessed with counts and relative frequencies of common immune cell subsets in blood, and with mitogen-stimulated T-cell function. Cell-mediated immunity to specific pathogens can be measured with T-cell response to viruses such as cytomegalovirus (CMV) and Epstein-Barr virus (EBV) which cause infection in immune-deficient individuals. This information can be combined with available clinical data to plan additional treatment for your patient.

Test Panel

The test panel measures counts and relative frequencies of common immune cells in blood, and T-cells which express the inflammatory marker, CD154, in response to stimulation with mitogens and viral antigens.

  • Peripheral blood lymphocyte subsets.
  • Mitogen stimulated T-cell responses to Phytohemagglutinin (PHA) and PMA-Ionomycin (PMA). PMA-stimulated T-cell function is a component of the PlexCMVTM and PlexEBVTM tests. PHA-stimulated T-cell function is a component of the PlexEBVTM test. This test is performed to assess whether the patient presents immune deficiency or not.
  • Viral antigen-stimulated T-cell responses to CMV and EBV.

Sample type and advantages

A sample of whole blood, 5 mL from children, 10 mL from adults in sodium heparin green-top tubes, is shipped at ambient temperature overnight to Plexision’s reference laboratory.

Rapid results: within 6-30 hours compared with 5-7 days for tests that measure proliferation.

Highly reproducible results with non-permeabilizing detection of CD154 compared with cell-permeabilizing techniques which are used to measure intracellular cytokines.

Results

  • Results are reported within 30 hours of receiving a blood sample at the laboratory. Results for CMV-specific T-cells are reported within 6 hours.
  • Test results are reported as frequencies of mitogen-specific T- and B-cells or viral antigen-specific T-cells. These results are reported along with a reference range of frequencies from healthy subjects and organ transplant recipients. These reference ranges can help determine whether cell-mediated immunity is in the normal range or not.

Sample & Shipping

# CATEGORY DETAILS

1

Sample Type

A whole blood sample is collected in a sodium heparin (green-top) tube.

2

Volume

5 mL in children and 10 mL in adults.

3

Transport Conditions

Ship priority overnight, at room temperature. The sample must get to Plexision within 30 hours of the phlebotomy.

4

Specimen Stability

30 hours at room temperature from the time of the phlebotomy.

5

Sample Discard Criteria

  • Transport time more than 30 hours from phlebotomy.
  • Lithium heparin (green-top) tube or ACD (yellow-top) tube.
  • Clotted, hemolyzed, frozen, refrigerated, or broken vacutainer seal.

How to order

# CATEGORY DETAILS

1

Test Brochure View and download the product brochure here.

2

Ordering Tests

To order tests or clarify questions, please reach us via email info@plexision.com or call us at +1 (855) 753-9474

Lymphocytes are a type of white blood cell. The different types of lymphocyte include a) T-cells that kill foreign cells like viruses, bacteria, or transplanted cells directly. T-cells also help other lymphocytes mount defensive responses. Another lymphocyte, b) B-cells which recognize foreign antigens, make antibodies or transition to long-lived antibody-producing cells, and c) NK cells which also kill foreign cells directly, and help with antibody-mediated immune defense. Immune cell function is measured by stimulating white blood cells with viral antigens and non-specific antigens called mitogens.

Individuals who show evidence of impaired immune function such as frequent infections, cancers, and those who are receiving immune suppressive medications can benefit from measurement of lymphocyte subsets, and the response of T-lymphocytes to viral antigens and non-specific antigens called mitogens.

One to two teaspoons of blood is drawn for a sample, white blood cells are purified and stimulation is performed using viral antigens and mitogens. Cells are then counted using a flow cytometer. Results are reported on the same day that the sample is received at the laboratory.

Results are reported on the day the sample is received at the laboratory.

The test determines whether counts and percentages of one or all lymphocyte subsets and the T-cell response to viral antigens and mitogens are normal, increased, or decreased compared with corresponding values in healthy people.

The test provides counts and percentages of the different lymphocyte subsets and measurements of T-cell response to viral antigens and mitogens which are seen in healthy individuals. These results should be discussed with your physician who can further explain what they mean.

Abnormal counts and frequencies of one or all lymphocyte subsets and abnormal cellular immune function can guide the selection of subsequent diagnostic tests to confirm whether a specific immune deficiency is present or not.

The immune deficiency panel must be ordered by your healthcare provider. The test requisition form is provided on http://plexision.com/PlexCMV/ordering-information. The completed form can be faxed to 412-224-2776. If there are any questions, please contact (855) PLE.XISION (753.9474) or 412-224-2504.

Plexision will bill your healthcare facility or your insurance plan as indicated on the requisition form. Plexision’s patient assistance plans will assist with the cost of PleximarkTM if there is no insurance coverage.

Lymphocyte subsets and antigen and mitogen-stimulated immune function are lab-developed blood tests.

US Patent 9606109.

Pediatr Transplant. 2019 Oct 27: PMID: 31657119

About

Plexision develops cellular biomarkers for personalized diagnosis and drug development in solid organ transplantation and immunological disorders. We also pioneer in R&D projects centered on integrating biomarker targets in all phases of drug development, from preclinical to post-marketing. Plexision’s technology can be adapted to

  • - Assess disease risk for several immunological disorders.
  • - Predict the success of a drug for a specific patient.
  • - Develop dosing recommendations for new immunological drugs.

Our state-of-the-art laboratory is CLIA-certified and located in Pittsburgh, PA.

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