Our CE IVD Products

SPOT-itTM
TREC & SMN1
Screening Kit

SPOT-it™ TREC & SMN1 Screening Kit is an in vitro diagnostic kit intended for simultaneous screening for Severe Combined Immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) in newborns.

It aids in identifying newborns, who potentially suffer from SCID caused by a lack of mature T-lymphocytes or SMA caused by homozygous exon 7 deletion in the SMN1 gene.

Multiplex Screening

Newborn screening for SCID and SMA from a single Dried Blood Spot (DBS) sample.

The SPOT-it™ TREC & SMN1 Screening kit detects three markers, T-cell receptor excision circles (TRECs), survival motor neuron 1 (SMN1) gene, and Beta-actin (ACTB).

SCID screening is performed by semi-quantification of TRECs, and SMA screening by a qualitative detection of exon 7 of the SMN1 gene.

Newborns with SCID or other immunodeficiencies often show a significant reduction or absence of TREC copies, making TREC a key indicator for SCID.

Homozygous deletion of exon 7 in the SMN1 gene is found in approximately 95% of SMA patients, and it is used as a marker for SMA. SMN1 encodes for the survival motor neuron (SMN) protein. Insufficient levels of SMN protein can result in motor neuron loss and severe physical disability.

The ACTB gene, encoding Beta-actin protein, serves as an internal control to verify sample quality and assay performance.

Diagnosis shall be made by healthcare professionals through confirmatory testing, according to local requirements or recommendations.

Quick Assays
Information

SPOT-it™
TREC & SMN1
Screening Kits

Reliable and accessible in vitro diagnostic assays manufactured in Sweden

01

qPCR test method

Real-time quantitative polymerase chain reaction (qPCR) assay principle.

02

Quick procedure

From Dried Blood Spot (DBS) to screening result within 3 hours and without manual transfer of samples.

03

Easy handling

Liquid transfer through innovative plate-stacking method and ready-to-use pre-filled reagent plates.

04

No need for separate clean room

No need for separate clean room for MasterMix preparation.

05

Trusted kits

Used in national screening programs in multiple European countries since 2016.

06

CE-marked

Certified for in vitro diagnostic use in Europe.

Discover how the assay works

The test is intended for use by laboratory professionals to aid in identifying newborns, who potentially suffer from SCID or SMA
01

Sample distribution

Distribute a 3.2 mm diameter punch from each Dried Blood Spot (DBS) sample into the SPOT-it™ Filter Plate.

02

Rinse Dried Blood Spots

Rinse and rehydrate the samples to remove hemoglobin and other impurities.

03

Elution of the DNA

Transfer rinsed punches into the pre-filled Elution Plate using centrifugation and plate-stacking technology. DNA is then eluted by the heating process.

04

qPCR Amplification

Transfer the eluted DNA to the pre-filled qPCR Plate using centrifugation and plate-stacking technology; and launch the qPCR run.

05

Result Interpretation

Understand results rapidly by visualizing the data, and verify control parameters.

Newborn screening from a single blood spot punch identifies SCID and SMA, ensuring an efficient screening for early detection and timely intervention.
Erna Domsgen

CEO at ImmunoIVD

Product details

Product name:

SPOT-it TREC & SMN1 Screening Kit

Description:

Newborn screening for SCID and SMA

Product Code Format Samples per kit
4-2020-TS 1 x 96-well plate 328
12-2020-TS 4 x 96-well plate 384

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