GSP newborn screening system brochure (for
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1. 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 GSP NEONATAL BIOTINIDASE KIT e The first fully automated assay for biotinidase deficiency e All reagents ready to use N AE V D Eu Eu V V amp Solid Biotinidase Eu labeled phase IgG in sample biotin Eu gt e LS j u Vetu B z gt Streptavidin a g SA gt Eu ar A a ISa E DELFIA 47 Fluorescence measurement v inducer o INSTRUMENT SPECIFICATIONS Physical dimensions Power requirements Environmental conditions Noise Height 1960 mm 772 Width Biom Gre Depth 750mm G0 0 Weight 610kg 1345 p Power consumption 1500 VA Mains voltage 100 240 V 50 60 Hz Operating Temperature 13 30 Temperature range 183 27 C Relative humidity 10 80 Temperature range 28 30 C Relative humidity 10 65 lt 60 dB The water used for preparing wash solution and for rinsing has to be deionized Samples Loading Bulk Reagents Washing and rinsing Liquid waste Sample type Blood disks from dried blood spots punched into 96 well plates Sample identification Barcode reader or keyboard input Continuous sample loading Continuous reagent loading Continuous bulk reagent loading2. 3305 001U GSP Neonatal 17a OH progesterone kit High volume reagent tips 960 3306 001U GSP Neonatal IRT kit Low volume reagent tips 960 3307 001U GSP Neonatal Biotinidase kit 3309 001U GSP Neonatal Total Galactose kit The GSP instrument includes Cassette pack 3x for tips and reagents each containing e Reagent cassette 6x e Low volume tip cassette 1x e High volume tip cassette 1x e Waste tip cassette 1x All the kits include reagents for 12 plates 1152 assays Anti evaporation caps 3 x 10 Consumables 3304 0010 DELFIA Inducer 4080 0010 GSP Wash concentrate External barcode reader 4076 0010 Clear microplates for GSP Neonatal GALT kit Magazine for 25 plates input output 2x External keyboard with touchpad Installation kit containing necessary cables and tubing Service kit containing parts for routine maintenance of the GSP instrument User manual English paper version and other available language 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 Per
3. The GSP instrument is the device of choice for SpecimenGate is PerkinElmer s dedicated informatics Galactosemia pure cotton linter filter paper optimized for DBS medium to large laboratories It uses several solution for newborn screening laboratories Congenital Adrenal Hyperplasia sampling measurement techniques for screening of NBS E disorders and it supports the widest range of e Connects punchers and analysis instruments seamlessly Biotinidase deficiency When combined with Panthera Puncher 9 or DBS analytes and assay techniques and gathers results into one database Puncher you will get automatic worklist generation l l e Enables punchers to identify specimen specific requests and transfer to GSP The GSP workstation software is designed to follow l and responds accordingly Smart Positive ID laboratory workflows to obtain reliable quality controlled results with maximum efficiency e Historical result based cutoff values Cutoff analyzer e Demographic based cutoffs latter requires Screening Center Learn more at https perkinelmeremea box com NBS today For Congenital Hypothyroidism COMPLETE th 3 GSP NEONATAL ISH TS R A N F cu igs F The PerkinElmer GSP Neonatal hTSH assay is used e Sensitive robust DELFIA chemistry for confidence in results with dried blood spot specimens as an aid in screening e Incubation time only 3 5h R F T T F R 5 f newborns for congenital hypothyroidism S C R E E N N G
4. 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 Waste capacity Automatic disposal if connected to a waste line OR manual disposal 16 L 15 plates Performance specifications Capacity Low volume reagent pipette High volume reagent pipette Measurement unit Humidity Temperature Sample capacity Reagent capacity 26 plates 2496 wells 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 Automatic water filling and waste emptying 11 plates before user intervention required No restrictions Volume range 5 50 ul Precision CV 21 5 Accuracy within 8 Volume range 25 200 ul Precision CV lt 5 Accuracy within 4 Measurement modes TRF Fl Abs Signal with 1 nM Eu 1 000 000 cps 17 Plate storage area lt 60 Temperature inside the instrument UE ge NE Reagent storage temperature 10 E ZRC Heated incubator module 37 ee IC ORDERING INFORMATION 2021 0010 Genetic Screening Processor Kits l l 3301 001U GSP Neonatal hTSH kit The Genetic Screening Processor includes GSP instrument and GSP Workstation 3302 001U GSP Neonatal Thyroxine T kit 3303 001U GSP Neonatal GALT kit
5. 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 EEE ELLE EEHEHE 5 VIEW RESULTS When the assay is complete resu
6. i pe 2 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 Sas analyte concentration in the sample GSP Neonatal kits are the industry standard for Automation and environmental controls ensure analytical performance and reliability Each kit includes that screening accuracy is clearly improved when ae rae reagents QC material and specific QC certificates compared with manual assays This also reduces ape aie i vores ence Barcoding reduces the risk of errors and all calibrators the need for additional sample runs and allows K Yeu Fa A ie A and controls come in dried blood spot format for more effective use of laboratory resources rar ar aes mera Pw 7 Solid ase o specific IgG specific IgG GSP NEONATAL KITS SPECIFICATIONS GSP TSH GSP T4 GSP 17 OHP GSP IRT GSP BTD GSP TGAL GSP GALT Combination Technology DELFIA of DELFIA and Enzymatic Enzymatic Assay duration 4 h9 min 2 h 56 min 3 h 56 min 2 h 43 min 4h 13 min 1 h 33 min 2 h 50 min On board stability 14 days 14 days 14 days 14 days 14 days 7 days 48 hours For Congenital Hyp othyroidism Measuring range 1 31 pU mL blood 0 81 g dL blood 1 61 1 2 nmol L blood 9 ng mL blood 14 8 325 U dL 64 2775 pmol L 2 5 25 U dL blood G S D N FO N ATAL THYROXI N E T4 KITS 2 91 U mL serum ug dL ser
7. HUMAN HEALTH ENVIRONMENTAL HEALTH a GSP Newborn screening system the most advanced gt system for screening NBS disorders PerkinElmer Brochure 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 so you no longer need to add water and drain the waste The cooled reagent
8. al Adrenal Hyperplasia This kit is intended for the quantitative determination of e Sensitive robust DELFIA chemistry for confidence in results human 17a OH progesterone in blood specimens dried on e Incubation time 3h 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 170 OH progesterone assay is based on the competitive binding of europium labeled 17OHP and 17OHP in the sample to 17OHP specific antibodies The fluorescence signal is inversely proportional to the analyte concentration in the sample Za A gt a A A y gt d Eu Y gt gt LP 7 V o fu V 0 Fluorescence pa te A ap Ge DELFIA gt F S Q u cy ee amp S2 e lt C measuremen Solid Analyte in Eu labeled Specific IgG E v phase IgG sample analyte and washing molecule 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 of streptavidin and the formed streptavidin
9. equired for the specific assay For Galactosemia GSP NEONATAL GALT KIT This kit is intended for the semi quantitative determination e Faster assay incubation time now only 2 h of galactose 1 phosphate uridyl transferase GALT activity e Provides results in today s preferred unit U dL blood in blood specimens dried on filter paper as an aid in screen e Floating disks control 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 NADP is reduced to NADPH a fluorescent substance that can be measured reaction between galactose 1 phosphate and uridine diphosphoglucose with excitation at 355 nm and emission detection at 460 nm contained in the assay substrate reagent In the course of further reactions Glucose Glucose 6 phospho Ribulose ON gt Momence gt a gt omolresoirlia Uridine diphospo NADP galactose Galactose 1 phosphate GALT in sample Uridine diphospo glucose For Galactosemia GSP TOTAL GALACTOSE KIT This kit is intended for the quantitative determination of e The first fully automated Total Galactose assay for total galactose galactose and galactose 1 phosphate galactosemia screening concentrations in blood specimens dried on filter paper as e The reconstituted reagent stability is improved from one an aid in screening newborns for galactosemia usi
10. he 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 The devices shown here are available as Standalone products When interfaced C O M P LET E the devices together offer optimum S O U 7 O N Sere screening performance and efficiency Sag lt Sac we A D VA N TAG z S Ahlstr m 228 LOT 8040201 0901123 Name Date of Collection 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 and colection 10 analysis and results management PERKINELMER HAS AN ANSWER TO EVERY STAGE IN THE SCREENING PROCESS NBS DISORDERS SCREENED SAMPLE COLLECTION ANALYSIS AND RESULT MANAGEMENT BY THE GSP SYSTEM IN THE US AND PREPARATION MEASUREMENT AND REPORTING Congenital Hypothyroidism PerkinElmer 226 Sample Collection Device is a 100
11. kinElmer 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 7 i www perkinelmer com Fax 358 2 2678 357 Perki Nn Elmer 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 9793 1 April 2015 PKI
12. lts 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 can be customized to meet your laboratories graphically review results f
13. ng the hour in the manual kit to several days GSP instrument e Resorufin step added for improved performance THE GSP NEONATAL TOTAL GALACTOSE TGAL ASSAY The GSP Neonatal Total Galactose kit makes use of a fluorescent galactose galactose 1 phosphate The fluorescence is measured using an excitation wave oxidase method The assay measures total galactose i e both galactose and length of 505 nm and an emission wavelength of 580 nm Galactose Galad D galacto 1 A hexadialdose Alkaline Galactose phosphatase oxidase Galactose in 0 sample 2 Horseradish peroxidase Acetyl dihydroxy phenoxide For Cystic Fibrosis GSP NEONATAL IRT KIT This kit is intended for the quantitative determination Sensitive robust DELFIA chemistry for confidence in results of human immunoreactive trypsin ogen IRT in blood Linear curve fitting improved precision specimens dried on filter paper as an aid in screening Incubation time 2h 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 Analyte in cubation antibodies bind to different epitopes on the target molecule The fluores sample s P cence signal is proportional to the analyte concentration in the sample m V u gt n Eu Solid phase Eu labeled specific IgG specific IgG Fluorescence measurement A i a j Y DELFIA F yr Eu inducer u For Congenit
14. or 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 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 at 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 t
15. um 0 9 ng mL serum 20 ng mL serum blood 1 15 50 250 pU mL blood 15 g dL blood 300 nmol L blood 500 ng mL blood mg dL 555 U mL serum 30 pg dL serum 220 ng mL serum 1110 ng mL serum l l o l l l The PerkinElmer GSP Neonatal Thyroxine T4 assay is used e Sensitive robust DELFIA chemistry for confidence in results Fully automated V V V V V V V with dried blood spot specimens as an aid in screening e Incubation time only 2h EE newborns for congenital hypothyroidism Controls in DBS format v v v v v v v Elution control V V V V V V V New measurement 7 2 V technology THE GSP NEONATAL THYROXINE T4 ASSAY Floating disk control j i j i JY In the GSP Neonatal Thyroxine T4 assay the analyte competes with euro pium labeled T4 for the binding sites on T4 specific monoclonal antibodies Disk detection control V V V V V x and the fluorescence signal is inversely proportional to the analyte concen tration in the sample Reagents plates and QC materials barcoded V Vv Vv Vv Vv V V 24 hrs valid a 4 calibration curve V V V V Vv V g d H TY Eu Eu Fu gt o tu Fluorescence Reagents V V V V V 2 reconstitution 1 reconstitution lt 4 _ Ev 4 lt lt a 1 a measurement ready to use steps step V y ea analy in eens Specific IgG W FDA recistered phase IgG sample analyte and washing v v v v v molecule Prod No Prod No Pate ne Mure Vv Vv Vv Vv Vv 4091 0010 4076 0010 The measurement control step is not r
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