i.Mune® NEO [CE]

i.Mune NEO is a quantitative in vitro diagnostic test to determine the percentages of lymphocyte subsets in newborn capillary whole blood specimens collected and dried on filter paper.


The test uses a real-time polymerase chain reaction (PCR) for the detection of immune cell type specific demethylated genomic target regions associated with the following immune cell types::

  • T-lymphocytes (CD3+)
  • Memory Helper T lymphocytes (CD3+CD4+CD45RO+)
  • B lymphocytes (CD19+)
  • Natural Killer lymphocytes (CD16+CD56dim)
  • Helper T lymphocytes (CD3+CD4+)
  • Cytotoxic T lymphocytes (CD3+CD8+)

The i.Mune NEO [CE] test consists of the following kits:

Test Procedure

Reference Ranges


Epigenetic quantification of CD3+ T lymphocytes for second-tier testing after conspicuous SCID (Severe Combined Immunodeficiency) screening findings (Blom et al., 2021)1)


Second tier testing using epigenetic immune cell quantification can reduce the number of non-actionable secondary findings and false-positive referrals in newborn screening for SCID.

Potential Applications:

  • Second-tier testing after conspicuous TREC newborn screening findings


  1. Blom, M et al. Second Tier Testing to Reduce the Number of Non-actionable Secondary Findings and False-Positive Referrals in Newborn Screening for Severe Combined Immunodeficiency. J Clin Immunol (2021).
  2. Baron U et al., Epigenetic immune cell counting in human blood samples for immunodiagnostics. Sci Transl Med. 2018 Aug 1;10 (452)