ImmunoIVD SPOT-it TREC, KREC & SMN1 Screening Kit

SPOT-it™ TREC, KREC & SMN1 Screening Kit is an in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID), agammaglobulinemia (XLA) and Spinal Muscular Atrophy (SMA) in newborns.

 

Screening for SCID and XLA is performed by semi-quantification of T-cell receptor excision circle (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 T and 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.

 

Quick Assay Information

• Complete solution for SCID, XLA and SMA screening – including DNA extraction

• From Dried Blood Spot (DBS) to screening result within 3 hours

• Ready-to-use plates pre-filled with reaction mix and samples to generate a standard curve

• Just two pipetting steps for quick and easy handling

• Uses conventional 3.2 mm ⌀ DBS as input

• Designed for the needs of screening laboratories CE marked – For In Vitro Diagnostic (IVD) use in EU

 

How it works

 

1 Sample distribution Dried Blood Spot (DBS) samples are punched into SPOT-it™ filter plate.	2 Rinse DBS Samples are rinsed and rehydrated to remove hemoglobin and other impurities.
3 DNA Elution DNA is eluted by heating to 95 °C for 30 minutes.	4 qPCR TREC, KREC and ACTB copies are quantified and SMN1 detected using qPCR.

 

 

Product Details

Product name: SPOT-it™ TREC, KREC & SMN1 Screening Kit

Description: Newborn screening for SCID, XLA & SMA

 

Product Code	Format	Samples per kit
4-2020-TKS	4 x 96-well plate	324
12-2020-TKS	12 x 96-well plates	972