Genesys

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GeneSys™ Newborn Screening platform is the first on the market to offer a fully automated approach for newborn screening while providing presumptive identification for all key infant haemoglobin variants.
Newborn screening for inborn errors of metabolism offers the potential of substantially altering the natural history of these diseases by reducing morbidity and mortality.
Neonatal identification of sickle cell disease can significantly reduce mortality and morbidity during the first 5 years of life.
High performance liquid chromatographic methods with high sensitivity and specificity have been developed for haemoglobin fractionation.
The HPLC screening method quantifies the relative concentrations of haemoglobin variants and has a good reproducibility with singleton determination.
Trinity Biotech leader in HPLC haemoglobin variant testing now brings its expertise to Newborn Screening.
GeneSys™ system is designed for high-volume throughput and ease of use. The established reliability of the instrument adds efficiency, reduces costs and sets the industry standard for haemoglobin variant testing.

Enhanced Newborn testing from paper spots

Automated haemolysate preparation:

Eliminates all pipetting steps
Able to import sample ID lists from automated punchers
Load plates, press button, walk away and pick up results later

Option of automatic reflex of abnormal samples to a high resolution:

Assay same specimen used for screening with no re-prep

Quick Scan Assay (2 minutes): Screens for abnormal haemoglobins
High Resolution Assay (8 minutes): Further resolves abnormal haemoglobins for presumptive identification

Identifies F, A, and clinically significant variants S, C, D, E, O, Bart’s

The red cells of newborns with alpha-thalassemia contain hemoglobin Bart's, a tetramer of gamma globin.

Many, but not all neonatal screening programs detect and report Hb Bart's.

Newborns with >30% hemoglobin Bart's by HPLC and/or who develop more severe anemia may have Hb H disease or Hb H Constant Spring disease.

More extensive diagnostic testing and consultation with a pediatric hematologist is generally needed for accurate diagnosis and appropriate treatment. The identification of Hb Bart's in Asian infants can have important genetic implications for couples who may be at risk for pregnancies complicated by hydrops fetalis.

Report quantitative results and phenotypes

Provide speed, accuracy and reliability

Specifications

Sample:

Haemolysates made from dried blood spots
Whole blood
Packed red blood cells from any type blood tube

Elements of Analysis

Characterisation of haemoglobin variants.
Quick Scan for the detection of abnormal haemoglobins
High Resolution for confirmatory testing of samples with suspected variants

Principle: Ion-exchange high performance liquid chromatography

Minimum readable division

Area percent = 0.1%
Retention time = 0.001 minutes

Computer

The Genesys™ software is a Windows XP™ based program especially designed for hemoglobin variant analysis of neonatal samples.
The software will be installed on the hard drive of the computer system so disks will not be needed for either running the instrument or saving data.

Product	Brand	Code	Format
FASC Reference Material	Trinity Biotech	01-04-0042	6 Vials
A2 & F Control	Trinity Biotech	01-04-0043	2 x 2 Vials
Variant Column	Trinity Biotech	01-05-0015	1 Pack