Newborn Screening

Product Details:

Expanded newborn screening panel for quantitative determination of 15 Amino acids, free Carnitines, 12 Acylcarnitines, Argininosuccinic acid (ASA) and Succinylacetone (SUAC) under the same extraction method and single injection/single run step without using any toxic compounds, on Tandem MS.

Quantitative Analysis of:

• 15 Amino Acids
• 13 Acyl Carnitines
• Argininosuccinic Acid (ASA)
• Succinylacetone (SUAC)

Features:

• Kit for 960 tests
•  Multiple Diagnosis (> 50 Disorders) with single injection/single run protocol
•  Three levels of dried blood spot controls covering the clinically valid range
• Sample extraction without derivatisation, using non toxic reagents
• Patented technology for detection of complete Urea cycle disorders (UCDs)
• High throughput analysis, measuring each sample in 1.5 min with shortest extraction time

 

Note: Single protocol and single injection for all analytes including SUAC

Product Details:

Labsystems Diagnostics' Neonatal Biotinidase kit is for enzymatic determination of biotinidase enzyme activity from blood samples dried on filter paper, with fluorometric detection, intended for newborn screening for biotinidase deficiency.

The fluorescent reaction product formed as a result of the biotinidase activity is measured. This is based on direct enzyme assay in which the dietary protein or biotin intake does not influence.

Other Details:

• Neonatal Biotinidase, 5 solid plates (96), 480 wells   6199 820
• Neonatal Biotinidase, 10 solid plates (96), 960 wells  6199 821

Benefits:

• Easy to perform
• No centrifuging or filtration step needed
• Fluorescence detection provides high  sensitivity
• Assay is compatible with Labsystems Diagnostics NS2400 automation system

Product Details:

Labsystems Diagnostics' Neonatal Phenylalanine is a chemical method, with fluorometric detection, for quantitative determination of phenylalanine from blood specimens dried on filter paper, intended for newborn screening for phenylketonuria (PKU).

Phenylalanine eluted from the dried blood spots forms a fluorescent compound with ninhydrin. The fluorescent signal is enhanced and stabilized by additional reagents before measuring the fluorescence. It is a chemical method intended for the quantitative determination of phenylalanine from dried blood spots.


Benefits:

• Simple and easy to perform
• Excellent analytical sensitivity
• Extensive experiences from worldwide customers
• Calibrated against the latest international references

      
Specification:

• Neonatal Phenylalanine, 10 solid plates (96), 960 wells 6199896

Product Details:

IRT is eluted from dried blood disks simultaneously forming a sandwich between the solid phase, coated with an antibody that recognizes Trypsinogen-1 (IRT-1) and a second antibody, which is labeled with horseradish peroxidase (HRP).

Other Details:

• Neonatal IRT FEIA, 10 solid plates (96), 960 wells   6199831
• Neonatal IRT FEIA, 10 strip plates (12x8), 960 wells 6199832

 

Benefits:

• Fluorescence detection provides high  sensitivity
• Easy to perform, similar procedure than in TSH and 17-OHP kits
• Stable reagents
• Assay is compatible with Labsystems Diagnostics NS2400 automation system

Product Details:

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

Product Details:

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

Product Details:

Labsystems Diagnostics' Neonatal hTSH FEIA Plus is a  fluorometric enzyme immunoassay for the quantitative determination of human thyroid stimulating hormone (hTSH, human thyrotropin) in blood samples dried on filter paper as a primary test for screening of babies for congenital hypothyroidism (CH).

hTSH is eluted from dried blood disks. It simultaneously forms a sandwich between the solid phase, coated with an antibody that recognizes a subunit of hTSH and a second antibody derived against another subunit of hTSH, which is labeled with horseradish peroxidase (HRP).

Other Details:

• 61 99 882, Grade 903,   5 strip plates (12x8), 480 wells
• 61 99 883, Grade 903, 10 strip plates (12x8), 960 wells
• 61 99 880, Grade 903, 10 solid plates, 960 wells

 

Bebefits:

• Minimal background
• Good stability
• Good agreement with CDC samples
• Calibrated against the latest international references (WHO and ISNS)

Product Details:

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

Product Details:

Product Details:

Reliable Newborn Screening devices provided by Labsystems Diagnostics.     

Stand-alone NS96 Disc Remover effectively removes the sample discs after incubation and reduces the chances of cross-contamination.

Product Details:

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.

Product Details:

Revolutionary NS2400 Neonatal Screening Automate With 25 plate capacity, 10 Assays on board, NS2400 automates the highest throughput sites or can handle the highest workload with extremely flexible, could be customized to your needs.     

Revolutionary Automation in Neonatal Screening: The Labsystems Diagnostics'/ Tecan's Neonatal platform is a high throughput system intended for quantitative NS2400 AUTOMATE analysis of neonatal screening samples on 96-well microplates.

• Fully robotic platform with integrated incubator, shaker, washer, disc remover and reader
• Performs all assays - hTSH, T4, PKU, Galactose, GALT, Biotinidase, 17OHP, IRT,Toxo-IgM and G6PD
• Excellent performance and a large linear range
• High capacity - Fully loaded 25 microplates / run
• Integrated disc remover connected to the washer
• Low running costs (no disposable tips / reagent basins)
• Fully automated with hands off operations
• High sensitivity fluorometric detection
• Unique liquid handling system allows all assays to be performed on the same platform
• Top level flexibility - upgradable according to changed needs, can even be used for automatic sample preparation for other applications, such as tandem MS based screening

Features:

• 25 plates per run (NS2400)
• Reduced running costs (no disposable tips)
• Integrated disc remover
• High sensitive fluorometric detection
• Patient management software
• Highly specific
• Expandable Panels

Benefits:

• High throughput, less consumables, more results
• Highly sensitive fluorometric detection
• Run upto 5 Assays simultaneously
• More tools ensuring sample integrity
• No disposable tips required

Specification:

• Fully integrated robotic platform with integrated incubator, shaker, washer, disc remover and reader
• Performs all assays (TSH, T4, PKU, 17OHP, G6PD, Galactose, GALT, IRT, Biotinidase & Toxo IgM)

Product Details:

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.