i.Mune™ TBNK [RUO]


i.Mune TBNK™ [RUO] is a quantitative in vitro test to determine the percentages and absolute counts of human lymphocyte subsets in liquid venous whole blood or to determine the percentages in capillary whole blood specimens dried on filter paper.

Allows molecular quantification of:

  • T lymphocytes (CD3+)
  • B lymphocytes (CD19+)
  • Natural killer (NK) lymphocytes (CD56dimCD16+)
  • Helper T lymphocytes (CD3+CD4+)
  • Cytotoxic T lymphocytes (CD3+CD8+).

Results are comparable to flow cytometry in blood1)

Comparison of immune cell quantification by flow cytometry and epigenetic qPCR in whole blood samples of healthy donors (n=25). Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl) (Baron et al., Sci Transl Med. 2018)
Comparison of immune cell quantification by flow cytometry and epigenetic qPCR in whole blood samples of healthy donors (n=25). Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl) (Baron et al., Sci Transl Med. 2018)

Comparison of immune cell quantification by epigenetic qPCR with flow cytometry in whole blood samples of healthy donors (n=25)

Top: Relative quantification (% cells); bottom: Absolute quantification (cells/μl)1)


Enables immune cell quantification using dried blood spots (DBS)1)

Method comparison (flow cytometry from whole blood vs. epigenetic qPCR from DBS) of T cell subsets in an HIV+ cohort (n=97). Relative quantification (% cells), only, for DBS samples. (Baron et al., Sci Transl Med. 2018)
Method comparison (flow cytometry from whole blood vs. epigenetic qPCR from DBS) of T cell subsets in an HIV+ cohort (n=97). Relative quantification (% cells), only, for DBS samples. (Baron et al., Sci Transl Med. 2018)

Method comparison of flow cytometry from whole blood with epigenetic qPCR from DBS in a HIV+ cohort (n=97). Relative quantification (% cells), only, for DBS samples1)


Produces comparable reference ranges to fresh venous whole blood from healthy subjects

108 capillary whole blood samples were prospectively collected from self-declared healthy subjects (age 18 to 71; female and male). Capillary blood was dried on filter paper and analyzed using i.Mune™ TBNK (RUO). Reference ranges were defined using the lower and upper limit for each parameter applying a 2.5 to 97.5 percentile.

Data show comparison of reference ranges from Dried Blood Spots with those obtained from liquid venous whole blood. 


Quantification of T-/B- and NK lymphocytes can be useful for**:

  • Follow-up and diagnostic evaluation of primary immunodeficiency2)
  • Monitoring of HIV-positive patients3)
  • Immune monitoring following immunosuppressive therapy for transplantation, autoimmunity and other immunological conditions4)
  • Assessment of immune reconstitution post hematopoietic stem cell transplantation5)
  • Early screening of gross quantitative anomalies in lymphocyte subsets in infections and malignancies
  • Absolute quantification of circulating B cells for diagnosis of chronic lymphocytic leukemia (CLL) patients6)

*i.Mune TBNK (RUO) is for research use, only and has not been registered as an IVD product and has not been approved or cleared by a regulatory authority.

 

**The above clinical applications have been established using technologies currently being employed in clinical laboratory routine (e.g. flow cytometry). Epimune has demonstrated equivalence of its epigenetic immune cell quantification method to flow cytometry (in whole blood) and the concordance of epigenetic immune cell quantification between whole blood and dried blood spots1)

Literature

  1. Baron U. et al. Epigenetic immune cell counting in human blood samples for immunodiagnostics. Sci Transl Med. 2018 Aug 1; 10 (452)
  2. Aluri J, et al. Clinical, Immunological, and Molecular Findings in 57 Patients With Severe Combined Immunodeficiency (SCID) From India. Front Immunol. 2019 Feb 4;10:23
  3. Ford N, et al. The evolving role of CD4 cell counts in HIV care. Curr Opin HIV AIDS. 2017 Mar;12(2):123-128
  4. Omana-Zapata I, et al. Accurate and reproducible enumeration of T-, B-, and NK lymphocytes using the BD FACSLyric 10-color system: A multisite clinical evaluation. PLoS One. 2019 Jan 28;14(1):e0211207
  5. Riley RS. Laboratory evaluation of the cellular immune system. In: McPherson RA, Pincus MR, eds. Henry's Clinical Diagnosis and Management by Laboratory Methods. 23rd ed. St Louis, MO: Elsevier; 2017:chap 45
  6. Hallek M, et al. International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56
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