SPOT-it TREC, KREC & SMN1 Screening Kit

Primary DI

37350134361794

Basic UDI-DI Code

B-37350134361794

Reference

4-2020-TKS

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

ImmunoIVD AB

SPOT-it™ TREC, KREC & SMN1 Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID), agammaglobulinemia (XLA) and Spinal Muscular Atrophy (SMA) in newborns. SCID and XLA screenings are performed by semi-quantification of T-cell receptor excision circles (TREC) and kappa-deleting recombination excision circles (KREC) and SMA screening by a qualitative detection of exon 7 of the SMN1 gene. DNA is extracted from fresh, dried blood spots (DBS) sampled on filter paper. The principle of the assay is real-time quantitative polymerase chain reaction (qPCR). The test is intended for use by laboratory professionals to aid in identifying newborns who potentially suffer from SCID caused by a lack of mature T- or Tand B-lymphocytes or XLA caused by a selective lack of mature B-lymphocytes or SMA caused by homozygous exon 7 deletion in the SMN1 gene. Diagnosis shall be made by healthcare professionals through confirmatory testing, according to local requirements or recommendations.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).