i.Mune® NEO [CE]


i.Mune NEO [CE] 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.

i.Mune NEO [CE]  is suitable for epigenetic quantification of:

  • T lymphocytes (CD3+)
  • T helper lymphocytes (CD3+CD4+)
  • Cytotoxic T lymphocytes (CD3+CD8+)
  • Memory T helper lymphocytes (CD3+CD4+CD45RA+)
  • B lymphocytes (CD19+)
  • Natural killer cells (CD16+CD56dim) (NK)

in dried blood spot (DBS) samples from newborns


Proof of concept: Epigenetic immune cell quantification allows early detection of inborn errors of immunity in newborns.

Identifizierung von Neugeborenen mit Severe Combined Immunodeficiency (SCID) und X-Linked Agammaglobulinämie (XLA) durch epigenetische Quantifizierung von T-, B- und NK-Zellen in Trockenblutproben (Baron et al., Sci Transl Med. 2018)
Identifizierung von Neugeborenen mit Severe Combined Immunodeficiency (SCID) und X-Linked Agammaglobulinämie (XLA) durch epigenetische Quantifizierung von T-, B- und NK-Zellen in Trockenblutproben (Baron et al., Sci Transl Med. 2018)
Vergleich der epigenetischen Quantifizierung mit dem kombinierten TREC/KREC Screening Test zur Identifizierung von Neugeborenen mit SCID bzw. XLA (Baron et al., Sci Tranl Med, 2018)
Vergleich der epigenetischen Quantifizierung mit dem kombinierten TREC/KREC Screening Test zur Identifizierung von Neugeborenen mit SCID bzw. XLA (Baron et al., Sci Tranl Med, 2018)

A cohort of 250 apparently healthy newborns and 24 confirmed SCID and XLA cases was analyzed using epigenetic immune cell quantification of T-, B- and NK cells in dried blood spot samples2)

 

23 out of 24 confirmed SCID or XLA cases were correctly identified using the epigenetic immune cell quantification method.

 

Using combined TREC/KREC Analysis, 22 out of 24 cases were correctly identified2)

 

Epigenetic immune cell quantification identifies false-positive SCID screening cases (Blom et al., 2021)1) 


Applications:

  • Early detection of immune cell dysregulation in newborns
  • Confirmation of a conspicuous SCID screening result in newborns

**The above applications are currently tested in several studies

Literature

  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)
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