A newborn screening test for Severe Combined Immunodeficiency Disorder (SCID) is an in vitro diagnostic (IVD) device that analyses a dried blood spot sample from a newborn baby to measure the quantity of T-cell receptor excision circles (TRECs) present in the blood, which indicates the level of developing T cells, thereby identifying potential cases of SCID where the immune system is severely compromised due to a lack of functional T cells; a low TREC count signifies a potential SCID diagnosis and requires further medical evaluation.

Intended Use of Newborn Screening Test for Severe Combined Immunodeficiency Disorder (SCID)

A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).

Intended Use:

SCID-kit is intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) as an aid in screening newborns for Severe Combined Immunodeficiency (SCID) and for the semiquantitative determination of KREC (Kappa-deleting recombination excision circle) as an aid in screening newborns for X-linked agammaglobulinemia (XLA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the Real-Time PCR instrument. This test is not intended for screening of SCID-like Syndromes, such as DiGeorge Syndrome, or Omenn Syndrome. It is also not intended to screen for less acute SCID syndromes such as leaky-SCID or variant SCID. The test is not indicated for screening B-cell deficiency disorders other than XLA, such as atypical XLA, or for screening of XLA carriers.

Device Description:

SCID-kit is a multiplex real-time PCR-based assay that amplifies and detects three targets: TREC, KREC, and RPP30, using target sequence-specific primers and probes. This is done in a single PCR reaction with DNA extracted from newborn dried blood spots (DBS) using a DNA extraction kit. Each SCID-kit is available in two sizes: one contains reagents for up to 384 reactions (model 3241-001U), while the other accommodates 1152 reactions (model 3242-001U), both including necessary kit controls.

• Precision/Reproducibility
• Detection studies
• Linearity
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross Reactivity)
• Interfering Substances

CLINICAL TESTING:

No Guidance available for 510k submission