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FlowMetric offers clinical (IVD) TBNK analysis from our CLIA certified and CAP accredited labs, providing accurate and reproducible enumeration of T- B- and NK lymphocytes for immuno-profiling.

FlowMetric Life Sciences, Inc., a high-complexity-CLIA certified and CAP accredited flow cytometry lab, is now offering a clinical TBNK panel for the enumeration of T-cells, B-cells, and Natural Killer lymphocytes. This service provides comprehensive immunological assessment and monitoring of patients with primary immunodeficiencies, viral and bacterial infections, as well as patients undergoing biological- or corticosteroid-based therapeutic interventions.

Human lymphocytes can be divided into three major subset populations based on their immunologic function and cellular phenotyping expression:

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T lymphocytes (CD3+, CD4+, CD8+)

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B lymphocytes (CD19+)

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Natural Killer (NK) lymphocytes (CD16+, CD56+)

These cells are all involved in cell-mediated immunity. IVD Flow Cytometry TBNK panels can effectively to enumerate the T- B- and NK cells and provide clinically valuable insights into the patient’s immune system.

In some clinical trials, flow cytometric enumeration of the relative percentage and absolute counts of major lymphocyte subsets represent important clinical endpoints. The inclusion of absolute counts in addition to percent positive is advantageous in monitoring changes within a given lymphocyte subset. For example, a decrease in percent positive T cells may be due to either a decrease in the number of T cells or an increase in the number of non-T cells. The inclusion of absolute count information resolves these two possibilities. Percentages and absolute counts of T and B cells along with the ratio of CD4+ (inducer):CD8+(cytotoxic) provides valuable information on patient immune status. (Fig. 1).

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Figure 1: Example of a CLIA/CAP TBNK sample report

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Historically, CD4+ T cell counts have been used for the monitoring of disease progression and effectiveness of therapy in HIV patients. HIV-infected individuals typically exhibit a steady decrease of CD3+, CD4+ counts as the infection progresses. Similar approaches where CD3+, CD4+, CD8+ percentages, along with absolute counts and totals of T- and B-cells that fall outside a normal reference range can be used to monitor certain autoimmune diseases. In addition, NK cells that are identified as CD3-, CD16+, CD56+ have been shown to mediate cytotoxicity against certain tumor and virus infected cells.

Available Lymphocyte Subset panels include:

Complete Lymphocyte Subset Panel, also known as TBNK Analysis. This panel may be useful for general immune status workups, primary immune deficiency workups, or transplant immune status monitoring. The panel includes % and absolute count values for the following analytes:

  • CD3
  • CD3, CD4
  • CD3, CD8
  • CD19
  • CD16/CD56
  • CD4:CD8 ratio

CD19 B Cell Analysis. CD19 B Cell Analysis This test is recommended to monitor patients receiving Rituximab treatment. The panel includes % and absolute count values for the following analyte:

  • CD19

CD4 T Cell Analysis. This is a preferred test for monitoring immune status in HIV infected patients or oncology patients where a CD8 value is not required. The panel includes % and absolute counts for the following analytes:

  • CD3
  • CD3, CD4

T Cell Subset Panel. This panel is useful for situations where a T helper : cytotoxic cell ratio may be desired, such as monitoring HIV patients. The panel includes % and absolute count values for the following analytes:

  • CD3
  • CD3, CD4
  • CD3, CD8
  • CD4:CD8 ratio

The FlowMetric Advantage

Our extensive knowledge in immune system analysis and reporting for drug development provides the necessary platform for our CLIA certified and CAP accredited clinical endpoints, including TBNK analysis.

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