Newborn Screening

NADP+ is reduced by glucose-6-phosphate dehydrogenase enzyme (G-6-PD) in the presence of glucose-6-phosphate, and the rate of formation of NADPH is proportional to the G-6-PD activity, and is determined fluorometrically.

 

It is an enzymatic method for the quantitative determination of glucose-6-phosphate dehydrogenase activity from dried blood spots, with fluorometric detection.

 

Other Details:

• Neonatal G6PD, 5 solid plates (96) 480 wells  6199 861 
• Neonatal G6PD, 10 solid plates (96) 960 wells  6199 860

 

Benefits:

• Excellent reproducibility
• Superior agreement with external quality samples 
• Good stability

Labsystems Diagnostics' Neonatal Toxoplasma gondii IgM FEIA is a fluorometric enzyme immunoassay intended for the determination of IgM-class antibodies to Toxoplasma gondii in blood samples dried on filter paper. The test is intended as a primary method for screening newborns for congenital toxoplasmosis (CT).

In a 5 year study in Brazil over 285 000 neonates were screened with Labsystems Diagnostics' Neonatal Toxoplasma gondii IgM FEIA and the prevalence was found to be 1/1867.

 

Fluorometric enzyme immunoassay for the determination of IgM antibodies to Toxoplasma gondii from dried blood spots. This is the first Neonatal Toxoplasma screening test in the world.

 

Benefits:

• First Neonatal Toxoplasma screening test in the world
• Quantitative results
• Clinically proven performance
• High sensitive ??-capture test

NeoMass AAAC is used with Tandem Mass Spectrometry to detect concentrations of amino acid, free carnitine, acylcarnitines, succinylacetone and argininosuccinic acid.

As a first in the world achievement, Labsystems Diagnostics has established a methodology to measure OTC, CPS1 and NAGS deficiencies on dried blood spot along with the traditional detection of ASS, ASL and ARG1 enzyme deficiencies. NeoMass AAAC for tandem MS will therefore enable detection of all urea cycle abnormalities.

 

Patented innovation by Labsystems Diagnostics: NeoMass AAAC innovation enables detection of all urea cycle deficiencies, including proximal abnormalities along with classical distal deficiencies measurements.

 

The urea cycle is a metabolic pathway occurring in the liver and kidney. Ammonia, a product of protein metabolism, is removed from circulating blood through urea cycle by conversion into urea and its elimination in urine. Urea Cycle Disorders (UCD) occurs in some inborn errors of metabolism, resulting in accumulation of nitrogenous waste which leads to vomiting, increasing lethargy, seizures, hypotonia, respiratory distress, coma, and to death if untreated. Protein restriction is the mainstay of therapy for the management of urea cycle defects.

 

Unique Properties of NeoMass AAAC kit – detection of OTC, CPS1 and NAGS deficiencies: Deficiencies of enzymes in the proximal part of the urea cycle have been challenging to detect in the past but the patented innovation in the new NeoMass AAAC kit changes this. As a first in the world achievement, Labsystems Diagnostics has established a methodology to measure OTC, CPS1 and NAGS deficiencies on dried blood spots along with the traditional detection of ASS, ASL and ARG1 enzyme deficiencies. NeoMass AAAC for tandem MS will therefore enable detection of all urea cycle abnormalities.

 

Features:

• The broadest available panel of analytes
• Easy sample preparation without derivatization
• More Analytes with less expenses
• Possibility of Automatic Sample Preparation
• 3 levels of blood spots controls - Low, Mid, High
• Unique endogenous level control
• Unraveling of Proximal & Distal Urea Cycle Disorder
• Includes Succinylacetone (SUAC) and Argininosuccinic Acid (ASA) standards
• Assay for screening more than 50 inherited metabolic disorders

Technical Specification:

• Ready-to-use kit for 960 tests
• 4 of steps: Punch, Extraction, Transfer, Injection into MS/MS
• Sample extraction without derivatization
• 4 sets of Isotope labelled internal Standards: 15 Amino Acids + 13 (Acyl) Carnitines + SUAC (Tyrosemia type-1) + ASA (Argininosuccinic Acidemia)
• 3 Dried Blood Spot Controls framing the decisional cut-off area for each of the matching internal standards
• Turnaround time for 96 samples approximately 3 hours
• High specificity and sensitivity by MS/MS detection
• Validation for multiple instrument applications
• Final concentrations calculated based on accurate peak area ratios compared to only peak intensities ratios

NS496 plus DBS puncher with air humidification system and clean punch mechanism designed to automate laboratory automate system and is used to punch dried blood spot samples into a 96 wellmicrotitre plates for subsequent analysis


The NS496 Plus is designed to automate laboratory sample preparation and is used to punch dried blood spots samples into a 96 wells microtitre plates for subsequent analysis. It offers a four-plate capacity with the disc size of 3.2 mm. The NS496 Plus can also be programmed to punch multiple discs into one or more wells or plates.


The NS496 Plus is a next generation instruments with new features and improvements for ease of use.      


Features:

• Integrated Barcode reader
  Enables positive identification and traceability of plates, samples, controls, and standards.
  Allows for traceability at all levels of the punching process, delivering unique identification information.

• Quick release Punch and Die Set (mark 4)
  Allows for quick and easy removal of the punch by laboratory operator, either to change punch size or for cleaning purposes.
  Minimizes downtime for laboratories.

• Disk Detector System
  Recognizes if a disk has not passed into the receiving well and automatically responds.
  Beam design for high detection reliability.

• Air Humidi???cation System
  Ensures the punched disk is delivered to the correct receiving well for downstream processing and reduces the chances of well ‘jumping’.

• Dedicated Cleaning receptacle
  A dedicated cleaning receptacle is provided to minimize cross-contamination issues.

Benefits:

Main Menu:

• The main menu allows entry to software modules.
• Access to each module is controlled using Supervisor and User level passwords.

Test Editor Module:

• Used to define and program individual tests.
• Set punch sizes, number of disks and filling order for individual plates.
• Allows individual definition of each well for sample, test or standard.
• Set cleaning strikes.
• Up to 10 disks per well can be specified.

Distribution Module:

• Used to run punching tests defined in the test editor.
• Displays the current punching pattern and progress.
• Shows instrument status messages for routine operation.

Configuration Module:

• Used to view and change the instrument configuration, preferences and options.
• Change settings and calibrate the instrument during installation.
• Supervisor access level is required.

CDC an WHO recommended 903 grade filter paper for Newborn Screening sample collection

Features:

• Comprises of wrap around card to protect samples from unwanted exposure
• Specific place for serial number and barcode sticker Specific columns to record the demographic and clinical information of the babies

Benefits: Protection of sample spots from unwanted exposure Minimal blood requirement Acceptable and compatible for NBS tests globally.