GSP newborn screening system brochure
Contents
1. can be customized to meet your laboratories graphically review results for the controls and monitor the level specific requirements of a quality control sample You can also specify quality control run definitions and materials as well as QC multirules DESIGNED FOR DBS MEASUREMENT GSP is designed to measure reliably dried blood spot samples by using several control steps The used control steps are specified in the assay protocol In case a control step is not passed a notification message is reported 1 Elution control 2 New measurement technology Detects missing sample or poorly eluted disks in the wells In case a missing disk is suspected a notification message is reported New measurement step avoids outliers caused by unspecific fluorescence and reduces variation in results With GSP G6PD assay results are received even with floating disks FUNCTIONAL VERSATILITY FROM TOP TO BOTTOM Cooled reagents storage e Temperature controlled storage for assay reagents e Room for 13 reagent cassettes e Enables continuous loading Plate Manipulator e Elevator for transferring plates between different modules of the GSP e Forms the body of the instrument Disk remover washer and bulk dispenser Stacker modules e Modules used to load plates to GSP and unload them after completion of the assays e Each stacker can hold up to 26 plates Incubator and Shakers e Heated incubator operates a2. paper version and other available language 4091 0010 versions on a CD Instrument manual English 2021 3010 GSP Workstation includes Computer with GSP Workstation software GSP Workstation Quality Control manual English paper version and other available language versions on a CD GSP Workstation Result Viewer Kitlot Editor and Plate Generator manual English paper version and other available language versions on a CD Products in this brochure may not be available in all countries Confirm availability with your local PerkinElmer representative PerkinElmer Inc PerkinElmer Inc ISO 13485 940 Winter Street Wallac Oy ISO 9001 Waltham MA 02451 USA PO Box 10 CMDCAS P 800 762 4000 or 20101 Turku Finland ISO 14001 1 203 925 4602 Phone 358 2 2678 111 OHSAS 18001 www perkinelmer com Fax 358 2 2678 357 Consumables DELFIA Inducer GSP Wash concentrate Clear microplates for GSP Neonatal GALT kit or GSP Neonatal G6PD kit 50 plates Clear U bottomed microplates for GSP Neonatal Phenylalanine kit or GSP Neonatal Total Galactose kit 100 plates I a sl z D For a complete listing of our global offices visit www perkinelmer com ContactUs Copyright 2015 PerkinElmer Inc All rights reserved PerkinElmer is a registered trademark of PerkinElmer Inc All other trademarks are the property of their respective owners 1599 9791 1 April 2015 PKI
3. screen ing newborns for classical galactosemia caused by GALT deficiency using the GSP instrument THE GSP NEONATAL GALT ASSAY In the GSP Neonatal GALT assay GALT in the blood sample catalyzes a reaction between galactose 1 phosphate and uridine diphosphoglucose contained in the assay substrate reagent In the course of further reactions Galactose 1 phosphate GALT in sample Uridine diphospo glucose For Galactosemia This kit is intended for the quantitative determination of total galactose galactose and galactose 1 phosphate concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP instrument THE GSP NEONATAL TOTAL GALACTOSE TGAL ASSAY The GSP Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method The assay measures total galactose i e both galactose and Galactose 1 phosphate Galactose in sample Alkaline phosphatase Galactose in 0 sample 2 Glucose Glucose 6 phospho Ribulose Nem gt Moms gt a gt Bomonesoiriia Uridine diphospo NADP galactose e Faster assay incubation time now only 2 h e Provides results in today s preferred unit U dL blood e Floating disks control NADP is reduced to NADPH a fluorescent substance that can be measured with excitation at 355 nm and emission detection at 460 nm GSP TOTAL GALACTOSE KIT e The first fully automated Total Galactose assay
4. 23 The devices shown here are available as standalone products When interfaced the devices together offer optimum screening performance and efficiency PERKINELMER HAS AN ANSWER TO EVERY STAGE IN THE SCREENING PROCESS SAMPLE COLLECTION AND PREPARATION PerkinElmer 226 Sample Collection Device is a 100 pure cotton linter filter paper optimized for DBS sampling When combined with Panthera Puncher 9 or DBS Puncher you will get automatic worklist generation and transfer to GSP ANALYSIS AND MEASUREMENT The GSP instrument is the device of choice for medium to large laboratories It uses several measurement techniques for screening of NBS disorders and it supports the widest range of analytes and assay techniques The GSP workstation software is designed to follow laboratory workflows to obtain reliable quality controlled results with maximum efficiency RESULT MANAGEMENT AND REPORTING SpecimenGate is PerkinElmer s dedicated informatics solution for newborn screening laboratories e Connects punchers and analysis instruments seamlessly and gathers results into one database e Enables punchers to identify soecimen specific requests and responds accordingly Smart Positive ID e Historical result based cutoff values Cutoff analyzer e Demographic based cutoffs latter requires Screening Center COMPLETE RANGE BETTER SCREENING GSP Neonatal kits are the industry standard for ana
5. 7 Measurement unit Humidity Plate storage area lt 60 Temperature Temperature inside the instrument US ae AC Reagent storage temperature ee 2G Heated incubator module 371 C ORDERING INFORMATION 2021 0010 Genetic Screening Processor 3301 0010 The Genetic Screening Processor includes GSP instrument and GSP Workstation 3302 0010 3303 0010 The GSP instrument includes 3305 0010 High volume reagent tips 960 3306 0010 Low volume reagent tips 960 3307 0010 a 3308 0010 Cassette pack 3x for tips and reagents each containing e Reagent cassette 6x 3308 001B e Low volume tip cassette 1x 3309 0010 e High volume tip cassette 1x e Waste tip cassette 1x 3310 0010 Anti evaporation caps 3 x 10 Kits GSP Neonatal hTSH kit GSP Neonatal Thyroxine T kit GSP Neonatal GALT kit GSP Neonatal 17a OH progesterone kit GSP Neonatal IRT kit GSP Neonatal Biotinidase kit GSP Neonatal Phenylalanine kit GSP Neonatal Total Galactose kit GSP Neonatal G6PD kit All the kits include reagents for 12 plates 1152 assays except Magazine for 25 plates input output 2x the 3308 001B GSP Neonatal Phenylalanine kit which includes reagents for 60 plates 5760 assays External barcode reader External keyboard with touchpad Installation kit containing necessary cables and tubing 3304 0010 eee 4080 0010 Service kit containing parts for routine maintenance of the GSP instrument 4076 0010 User manual English
6. EE ELLE EEHEHE 5 VIEW RESULTS When the assay is complete results are delivered to you at the GSP Workstation computer You can check the calibration curve quality control levels possible notifications about the run accept the assay and export and print results 3 LOAD PLATES Load a magazine with plates into the input stacker and an empty magazine into the output stacker The instrument will start the assay runs automatically For a more detailed description please check out the step by step GSP training video at https perkinelmeremea box com GSP training video BEST IN CLASS INFORMATICS THE GSP WORKSTATION COMPRISES FOUR MODULES EACH DESIGNED TO IMPROVE WORKFLOW EFFICIENCY AND QUALITY MANAGEMENT Pom aor ceee 2 PLATE GENERATOR Kitlot Editor is an easy way to enter kitlot information It Plate Generator can be used to generate worklists if also allows to edit cut off limits and build reference curves they are not generated directly through connected from existing calibration curves You can also edit default punchers plate maps by changing sample or control definition 1 KITLOT EDITOR jo je le a F 3 RESULT VIEWER 4 QUALITY CONTROL PROGRAM Result Viewer allows you to browse assay runs and Quality Control Program supports effective long term related data in plate or worksheet formats The screen management and follow up of quality control data Store and layout
7. HUMAN HEALTH ENVIRONMENTAL HEALTH EARLIER DETECTION FORA HEALTHIER i FUTURE I i GSP Newborn screening system the most advanced gt system for screening NBS disorders PerkinElmer Brochure not for distribution in the US For the Better GSP THE MOST ADVANCED SOLUTION FOR SCREENING NBS DISORDERS Every life is exceptional and every child is unique That s why your screening program should deliver exceptional performance when it matters most at the beginning of a child s life As the most advanced platform for screening of NBS disorders the GSP Newborn screening system offers outstanding screening accuracy and reliability coupled with high efficiency and user friendliness It brings the future of neonatal screening to your laboratory helping you provide children with a healthier start to life THEGSP INSTRUMENT AN ANALYZER LIKE NO OTHER WHAT THE GSP INSTRUMENT CAN DO FOR YOUR SCREENING PROGRAM More flexible workflow The GSP instrument is optimized for continuous sample loading The loaded plates are processed automatically or users can prioritize the order in which plates are processed Reduced risk of error Plates reagents QC materials and lot specific QC certificate information are all barcoded to support improved traceability and ease of use Safer and more convenient GSP can be connected directly to a deionized water supply and waste line s
8. escence signal is inversely proportional to the analyte concentration in the sample Q j a d Eu 7 gt Lee tu g t Tent AA E2 o ER Yc amp Solid Analyte in Eu labeled Specific IgG Incubation phase IgG sample analyte and washing molecule For Congenital Hypothyroidism GSP NEONATAL hTSH AND GSP NEONATAL THYROXINE T4 KITS e Sensitive robust DELFIA chemistry for confidence in results e Incubation time only 3 5h and 2h THE GSP NEONATAL THYROXINE T4 ASSAY In the GSP Neonatal Thyroxine T4 assay the analyte competes with euro pium labeled T4 for the binding sites on T4 specific monoclonal antibodies and the fluorescence signal is inversely proportional to the analyte concen tration in the sample gt n O pr a C g tu O SP Eu e F Tent A E ey A Solid Analyte in Eu labeled Specific IgG Incubation phase IgG sample analyte and washing molecule Q A gt gu o an DELFIA Fluorescence lt a a inducer Q gt v a measurement 0 P For Congenital Adrenal Hyperplasia GSP NEONATAL 1 7a OH PROGESTERONE KIT e Sensitive robust DELFIA chemistry for confidence in results e Incubation time 3h S Eu lt dias S DELFIA n Fluorescence g inducer 24 measurement a vw For Galactosemia GSP NEONATAL GALT KIT This kit is intended for the semi quantitative determination of galactose 1 phosphate uridyl transferase GALT activity in blood specimens dried on filter paper as an aid in
9. for galactosemia screening e The reconstituted reagent stability is improved from one hour in the manual kit to several days e Resorufin step added for improved performance galactose 1 phosphate The fluorescence is measured using an excitation wave length of 505 nm and an emission wavelength of 580 nm D galacto hexadialdose Galactose oxidase Horseradish peroxidase Acetyl dihydroxy phenoxide For Cystic Fibrosis GSP NEONATAL IRT KIT This kit is intended for the quantitative determination of human immunoreactive trypsin ogen IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP instrument THE GSP NEONATAL IRT ASSAY The assay is based on a direct sandwich technique where two monoclonal antibodies bind to different epitopes on the target molecule The fluores cence signal is proportional to the analyte concentration in the sample For Biotinidase deficiency This kit is intended for the quantitative determination of human biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency using the GSP instrument THE GSP NEONATAL BIOTINIDASE ASSAY The Neonatal Biotinidase assay combines an enzyme reaction with a solid phase time resolved immunofluorescence assay The amide bond in EU la beled biotin is cleaved by the biotinidase present in the sample The enzyme reaction is stopped by addition
10. lytical performance and reliability Each kit includes reagents QC material and specific QC certificates Barcoding reduces the risk of errors and all calibrators and controls come in dried blood spot format GSP NEONATAL KITS SPECIFICATIONS GSP TSH GSP T4 GSP 17 OHP Technology DELFIA Assay duration 4 h9 min 2 h 56 min 3 h 56 min On board stability 14 days 14 days 14 days Measuring range 1 31 pU mL blood 0 81 pg dLblood 1 2 nmol L blood 2 91 U mL serum 1 61 g dL serum 0 9 ng mL serum 250 U mL blood 15 g dL blood 300 nmol L blood Automation and environmental controls ensure that screening accuracy is clearly improved when compared with manual assays This also reduces the need for additional sample runs and allows for more effective use of laboratory resources 555 U mL serum 30 g dL serum 220 ng mL serum 1110 ng mL serum Fully automated V V V Calibrators and Controls in V V V DBS format Elution control V V M New measurement x 5 technology Floating disk a ie control Disk detection control Reagents plates and QC materials barcoded 24 hrs valid calibration curve Reagents ready to use LISIS SIS SSS Sa sn AIS Plates included GSP IRT GSP BTD GSP PKU GSP TGAL GSP GALT GSP G6PD Combination of DELFIA and Enzymatic Enzymatic 2 h 43 min 4h 13 min 2 h 28 min 1 h 33 min 2 h 50 min 1h21 min 14 days 14 days 4 days 7 days 48 hours 14 days 9 ng mL blood 14 8 325 U dL 68 1200 p
11. mol L 64 2775 pmol L 2 5 25 U dL 2 4 130 U dL 20 ng mL serum blood 1 12 blood 1 15 50 blood blood 500 ng mL blood 19 8 mg dL mg dL V V 2 reconstitu 2 reconstitu 1 reconstitu 1 reconstitu tion steps tion steps tion step tion step V V Prod No Prod No Prod No Prod No 4091 0010 4091 0010 4076 0010 4076 0010 The measurement control step is not required for the specific assay The PerkinElmer GSP Neonatal hTSH and GSP Neonatal Thyroxine T4 assays are used with dried blood spot specimens as an aid in screening newborns for congenital hypothyroidism THE GSP NEONATAL hTSH ASSAY The GSP Neonatal hTSH assay is based on a direct sandwich technique where two monoclonal antibodies recognize separate antigenic determi nants on the hTSH molecule The fluorescence signal is proportional to the analyte concentration in the sample Analyte in Incubation sample 2 P A2 ek Fs en Eu a wy Eu Solid phase Eu labeled specific IgG specific IgG Fluorescence measurement Foou om Fie a This kit is intended for the quantitative determination of human 17a OH progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia CAH using the GSP instrument THE GSP NEONATAL 170 OH PROGESTERONE ASSAY The GSP Neonatal 17a OH progesterone assay is based on the competitive binding of europium labeled 17OHP and 17OHP in the sample to 17OHP specific antibodies The fluor
12. ng NADH In the presence of NADH resazuring dye is reduced to fluo Phenylalanine in sample Phenylalanine dehydro genase GSP NEONATAL PHENYLALANINE KIT e Incubation time only 2x 1h e Resorufin step added for improved performance e Also bulk kit with reagents for 5760 tests 60 plates available 3308 001B rescent resorufin which is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm Phenyl pyruvate Diaphorase Resazurin For G6PD deficiency GSP NEONATAL GOPD KIT This kit is intended for the quantitative in vitro determination of glucose 6 phosphate dehydrogenase G6PD activity in blood specimens dried on filter paper as an aid in screening newborns for G6PD deficiency using the GSP instrument THE GSP NEONATAL G6PD ASSAY The assay is based on the oxidation of glucose 6 phosphate by the G6PD enzyme present in the sample At the same time NAPD is reducted to a fluo rescent NAPDH which is measured with excitation wacelength at 340 nm and emission at 460 nm e The first fully automated assay for G6PD deficiency screening e Reliable sample results even with floating disks 6 PG NADP INSTRUMENT SPECIFICATIONS Physical dimensions Height 1960 mm 77 27 Width BIOMASE Depth 750mm G0 0 Weight 610kg 1345 p Power requirements Power consumption 1500 VA Mains voltage 100 240 V 50 60 Hz Environmental conditions Operating Temperature 18 30 C Temperature ra
13. nge st 27 SE Relative humidity 10 80 Temperature range 28 30 C Relative humidity 10 65 Noise lt 60 dB The water used for preparing wash solution and for rinsing has to be deionized Blood disks from dried blood spots punched into 96 well plates Barcode reader or keyboard input Samples Sample type Sample identification Loading Continuous sample loading Continuous reagent loading Continuous bulk reagent loading Bulk Reagents Washing and rinsing Wash solution Automatic dilution of Wash concentrate from a mains water line deionized or from an external bottle outside the instrument Rinse water Automatic filling from a mains water line deionized or from an external bottle outside the instrument Liquid waste Waste capacity Automatic disposal if connected to a waste line OR manual disposal 16 L 15 plates Performance specifications Capacity Sample capacity 26 plates 2496 wells Reagent capacity up to 13 reagent cassettes Heated incubator module 12 plates Shaking module 3 x 6 plates Wash concentrate capacity 2 liters Manual water filling or waste emptying 11 plates before user intervention required Automatic water filling and waste emptying No restrictions Low volume reagent pipette Volume range 5 50 ul Precision CV 21 5 Accuracy within 8 High volume reagent pipette Volume range 25 200 ul Precision CV lt 5 Accuracy within 4 Measurement modes TRE F Abs Signal with 1 nM Eu 1 000 000 cps 1
14. o you no longer need to add water and drain the waste The cooled reagent compartment also eliminates the need to unload reagents after assay runs and improves screening accuracy Laboratory friendly The GSP instrument is easy for laboratory staff to learn to use and is controlled via an intuitive touch screen interface The instrument requires minimal user training and supports effective staff rotation Improved results management The GSP Workstation software tracks your laboratory workflow effectively so you obtain reliable quality controlled results with maximum efficiency USER FRIENDLY AT EVERY STAGE 1 LOAD REAGENTS Load bulk reagents and kit reagents as needed It is not necessary to work out in advance the estimated use of reagents since they can be loaded in excess or added whenever they run low 4 CHECK STATUS The touch screen allows you to prioritize the running order of your plates as you wish and see instantly the status of your assays consumables reagents and waste capacity PREPARE WORKLIST If the worklist has not been generated automatically by the punching device you can create it using GSP Workstation running on an adjacent computer im Results one ims ve oe gt z E i f l ii i i i 5 R54 itli FEEFEE TL EEL TL 2 F ceire EYE Se suns E23ggteetese EF Ey HE Tt EEETERLETEL EERE f i f HP Yew Se ET E
15. of streptavidin and the formed streptavidin biotin complexes are captured by the solid phase monoclonal antibodies DELFIA Inducer dissociates the molecules into the solution where the eu ropium fluorescence is measured The measured fluorescence is inversely proportional to the biotinidase activity of the sample e Sensitive robust DELFIA chemistry for confidence in results e Linear curve fitting improved precision e Incubation time 2h Analyte in Incubation sample gt on an 9 m te ye Z yur Eu Solid phase Eu labeled specific IgG specific IgG Fluorescence measurement a D Fav tO omma Ba yeu inducer y GSP NEONATAL BIOTINIDASE KIT e The first fully automated assay for biotinidase deficiency e All reagents ready to use O A Eu V E gt PE es SO u Solid Biotinidase Eu labeled phase IgG in sample biotin Eu mo e Le u Se Eu B gt gt Streptavidin 4 4 Eu Eu S amp SA gt Eu Eu Pi Eu r o Eu Dg ab 6 gt E Fluorescence 4 Eu DELFIA measurement inducer y Eu For Phenylketonuria This kit is intended for the quantitative determination of phenylalanine concentrations in blood specimens dried on filter paper as an aid in screening newborns for phenylketonuria by using the GSP instrument THE GSP NEONATAL PHE ASSAY In the first reaction of GSP Neonatal Phenylalanine assay phenylalanine dehydrogenase converts phenylalanine in sample to phenylpyruvate gener ati
16. t 37 C and can hold up to 12 plates e Three non heating shakers Measurement module can each hold up to 6 plates e xy conveyer to move the plate under the measurement head e Enables time resolved fluorescence prompt fluorescence and absorbance measurements Liquid module e Prepares Wash solution from the Wash concentrate e Handles the waste solutions 3 Floating disk control 4 Disk detection Detects floating disks that may influence screening results wells before measurement Detects the removal of disks in DELFIA assays from the COMPLETE SOLUTION EXCEPTIONAL ANDAVA VNITAT C sy HOW GSP CAN HELP INTEGRATE YOUR ENTIRE SCREENING PROCESS Neonatal screening is a highly complex workflow involving numerous process stages and continuous attention to quality control Each link in the screening process must be as reliable and efficient as the next one By combining the GSP Newborn screening system with other PerkinElmer products you can manage your entire screening program from sample preparation and collection to analysis and results management NBS DISORDERS SCREENED BY THE GSP SYSTEM Congenital Hypothyroidism Galactosemia Congenital Adrenal Hyperplasia Cystic Fibrosis Phenylketonuria Biotinidase deficiency Glucose 6 phosphate dehydrogenase G6PD deficiency Learn more at https perkinelmeremea box com NBS today Name Date of Collection Ahlstr m 228 8040201 09011
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