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+CD45RA+)
  • B lymphocytes (CD19+)
  • Natural Killer lymphocytes (CD16+CD56dim)
  • Helper T lymphocytes (CD3+CD4+)
  • Cytotoxic T lymphocytes (CD3+CD8+)
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The i.Mune NEO [CE] test consists of the following kits:

Test Procedure

Reference Ranges

Literature

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.


Identification of Severe Combined Immunodeficiency (SCID) and X-linked Agammaglobulinemia (XLA) in dried blood spot (DBS) samples from newborns (Baron et al., 2018)2)

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)


Potential Applications**:

  • Second-tier testing after conspicuous TREC or KREC newborn screening findings
  • Early-detection of lymphocyte dysregulation in newborns

**These applications are currently being investigated in several studies

References

  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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