COST-EFFICIENT SYSTEM FOR NEWBORN SCREENING The semi-automated system for optimized newborn screening Brochure for distribution in the US THE TRUSTED SYSTEM FOR AFFORDABLE AND EXPANDABLE NEWBORN SCREENING PerkinElmer is the global market leader in neonatal screening, currently serving customers in more than 90 countries. Almost 500 million babies have been screened with our products. Every day 65 babies around the world get a healthier start to life thanks to the early detection of a serious disorder. Since 1999, the semi-automated system has been used in over 200 NBS laboratories all over the world. The large number of users is a testament to the quality and reliability of the platform: nearly 10 million newborns are screened with Victor™ 2D each year. The semi-automated system is a robust, cost-efficient solution for screening of six NBS disorders in the US: congenital hypothyroidism, phenylketonuria, congenital adrenal hyperplasia, galactosemia, cystic fibrosis and biotinidase deficiency . EFFECTIVE DETECTION FOR A HEALTHIER FUTURE WHY CHOOSE THE SEMI-AUTOMATED NBS SYSTEM? Ideal solution for small to mid-size and start-up laboratories Total solution guarantees excellent support and service throughout the whole workflow Fully expandable when needs in the laboratory change – adding new parameters or increasing sample volume is easy and cost-efficient All instruments and assays are CE marked Over 200 satisfied NBS customers globally OPTIMIZED PRODUCTS FOR BEST RESULTS PERKINELMER 226 SAMPLE COLLECTION DEVICE DBS PUNCHER® INSTRUMENT DELFIA® PLATE DISPENSE • Dried blood spot collection card comprised of 100% pure cotton linter filter paper •Validated for even and uniform sample distribution •PerkinElmer can custom-print and manufacture a device format that meets specialized newborn screening requirements • Semi-automatic device for punching dried-blood spot samples into microtitration plates • The 2-plate capacity puncher is easy-to-use • Robust option for lower capacity screening • Alternatively Panthera-Puncher™ 9 • Automatic and precise addition of Enhancement solution • Optimized for DELFIA reagents • As an option DELFIA Dispense Unit can be ADDED allowing automatic dispensing e.g. buffer or tracer solution All products and instruments are especially optimized for use with PerkinElmer kits. They may be supplied alone or as part of a complete semi-automatic system for performing DELFIA and other assays. VICTOR™ 2D FLUOROMETER DELFIA® WASHER-DISKREMOVE TRINEST™ INCUBATOR SHAKER DELFIA® PLATESHAKE • • • Automatically removes the eluated filter paper disks from the wells • Performs all needed wash stages as specified in the assay protocol • Overfilling of wells is avoided • Up to 100 protocols can be stored • Optimized for use with DELFIA neonatal assays • Two preset shaking speeds optimized for DELFIA assays •Fully adjustable shaking speed between 100-1350 rpm for general use •With non-slip surface easy to load and easy to use •Electronic feedback circuit ensures that shaking speeds remain constant • Easy to use and reliable measurement device Preset protocols for neonatal assays based on - Time-resolved fluorescence (TSH, T4, 17-OHP, IRT) - Prompt fluorescence (PKU, GALT, TGAL, BTD) MultiCalc software included for result calculation, QC control and communication with LIMS THE SEMI-AUTOMATED SYSTEM FOR YOUR SCREENING PROGRAM • A high quality, easy to use device for processing standard-height microplates • Accurate and uniform temperature assures highly repeatable results • Capacity for 3 plates • Up to 20 incubating and shaking programs can be stored MULTICALC SOFTWARE For data evaluation and quality control Included with Victor™ 2D Can be connected to LIMS Automatic QC follow-up of assays SAMPLE COLLECTION SAMPLE PREPARATION SAMPLE PROCESSING MEASURING DATA PROCESSING & REPORTING Software includes all the protocols for PerkinElmer Measuring device Software Results directly ready from the software Sample collection Puncher Sample preparation device Panthera-PuncherTM 9 or DBS Puncher (or Puncher from another supplier) TriNEST™ incubator shaker VICTOR™2D fluorometer MultiCalc PerkinElmer 226 sample collection device DELFIA® Plate dispenser DELFIA® Platewash DELFIA® Plateshake Reagents neonatal assays as default INSTRUMENT SPECIFICATIONS COMPLETE RANGE. BETTER S C R E E N I N G. BENEFITS OF THE ASSAYS • • • • • • PerkinElmer offers reagents, instruments, software, training and support The widest test panel - easy and cost-efficient to expand the analyte menu - Low repeat testing rate due to high accuracy - Low lot-to-lot variation - no need to constantly reset cut-offs Long-standing provider and market leader in NBS - proof of our reliability and customer satisfaction Calibrators and controls in DBS, lot-specific format The unique fluorescent properties of lanthanide chelates of DELFIA technology are the basis for high sensitivity and low assay variation All assays can be run either separately or together DBS® PUNCHER INSTRUMENT VICTOR™ 2D INSTRUMENT TRINEST™ INCUBATOR SHAKER DELFIA® WASHER-DISKREMOVE DELFIA® PLATESHAKE DELFIA® PLATE DISPENSE INSTRUMENT SPECIFICATIONS INSTRUMENT SPECIFICATIONS INSTRUMENT SPECIFICATIONS INSTRUMENT SPECIFICATIONS INSTRUMENT SPECIFICATIONS INSTRUMENT SPECIFICATIONS Physical dimensions Height: 305 mm Width: 420 mm Depth: 480 mm Weight: 20 kg Power requirements Voltage/Frequency: 110 -120 V/ 220 - 240 V, 50/60 Hz Physical dimensions Height: 383 mm (510 mm with stackers) Width: 485 mm Depth: 590 mm Weight: 49 kg (stacker model 60 kg) Power requirements Power consumption max: 400 VA Voltage/Frequency: 110 -120 V/ 220 - 240 V, 50/60 Hz Physical dimensions Height: 223 mm Width: 388 mm (plate carrier out) Depth: 310 mm Weight: 15 kg Physical dimensions Height: 483 mm Width: 530 mm (plate carrier out) Depth: 310 mm Weight: 16.0 kg Physical dimensions Height: 128 mm Width: 245 mm Depth: 310 mm Weight: 5.5 kg Physical dimensions Height: 268 mm Width: 290 mm (plate carrier out) Depth: 300 mm Weight: 10.3 kg Power requirements Power consumption max: 160VA Voltage/Frequency: 100-120 V or 220-240V, 50/60 Hz Power requirements Power consumption max: 100 VA Voltage/Frequency: 240/100 VAC, 50/60 Hz Power cord: on CEI socket Power requirements Power input: 15 W Voltage/Frequency: 1296-003: 220/240V, 50/60 Hz 1296-004: 110/240V, 50/60 Hz Power requirements Power consumption max: 35 VA Voltage/Frequency: 220/240 V 50/60 Hz or 100/120 V 40/60 Hz Environmental conditions Temperature: 15-35 °C Relative humidity: 10-85 % Environmental conditions Operating: 15°C to +35°C, RH 10-75% Environmental conditions Temperature: 15-33 °C Relative humidity: 15-85 % Environmental conditions Temperature: 15-35 °C Relative humidity: 20-80 % Punch diameter: 1.5 mm (1/16”) 3.2 mm (1/8”) 4.7 mm (3/16”) 6 mm Plate height: 15 -41mm (suits standard and deep well plates Operational control: 4 selection button for: - operation mode selection - plate movement - barcode display - operation guidance - protocol editing DBS® Puncher DELFIA® Plateshake TSH x T4 x TriNEST™ Incubator shaker DELFIA® Washer Diskremove DELFIA® Plate Dispenser Victor™2D x x (x) x x x (x) x 17-OHP x x x (x) x IRT x x x (x) x PKU x TGAL x GALT x x x BTD x x x (x) = Alternatively manual pipeting x x x x Measurement time: 1 s / sample, 3 min / plate Noise of the device in function: max 70 dB Light sources Continuous light source for fluorometric measurements: 1. Tungsten-halogen lamp, 75W, lifetime > 300h, Spectral range 340 - 700 nm. 2. Rotatable filter wheel A, provided with 8 filter positions (Ø 15 mm). Standard high quality interference filters 340 nm, 355 nm, 390 nm, 485 nm, 544 nm. Changeable rotatable filter wheel B, provided with 4 filter positions (Ø 25.4 mm) Flash light source for TR-fluorometric measurements: 1. UV xenon flash tube, L4642 or equivalent, spectral range 280 - 400 nm. 2. Filter slide, provided with 3 filter positions (Ø 22.4mm). Filters 340 nm and 320 nm are fitted. Detection units Fluorometry and TR-fluorometry: 1. Photomultiplier tube, R 1527 2. Emission filter slide A, provided with 8 filter positions (Ø 25.4mm) with the following filters: 405, 460, 486, 535, 590, 615 and 642 nm Changeable emission filter slide B, provided with 8 filter positions (Ø25.4mm) PERFORMANCE SPECIFICATIONS General Capacity: 3 plates per unit, 3 units stackable 96-well and 384-well plates Programmable: up to 20 programs LCD graphics display The 3 plates are processed with the same program but can be loaded at different times Buzzer and LED lights indicate when incubation is complete Incubation Temperature range: from 3°C above ambient to 70°C in 1°C increments Precision: ± 0.5°C Variation across plate: < 0.6°C Warming speed: less than 15 min from +24°C to +70°C Incubation time: 0-48h in increments of 1 min Preheat function assuring incubation starts at precisely the specified temperature Shaking Shaking frequency: 400-1200 rpm (or 0 rpm) in 100 rpm increments Precision: ± 2% Orbit: ~2 mm Time: 0-48h in increments of 1 min Interval shaking: interval up to 60 min in increments of 1s or 1 min PERFORMANCE SPECIFICATIONS Hardware specifications Manifold: 12 channels, 8 channels available on request Vacuum: separate vacuum unit Volumes of bottles: Waste 8L, Wash 5L, Rinse 2L Software specifications Protocols: Up to 100 washing protocols, up to 75 freely programmable. Wash modes: Strip or Plate VACUUM UNIT Physical dimensions Height: 370 mm Width: 140 mm Depth: 400 mm Weight: 13.0 kg (approx.) Power requirements Power consumption max: 230VA Voltage/Frequency: 200-230/100-115 VAC, 50/60 Hz Environmental conditions Temperature: 15-30 °C Relative humidity: 15-85 % Environmental conditions Temperature: 0-50 °C Relative humidity max: 80 % Suitable for use in gassing and incubating cabinets PERFORMANCE SPECIFICATIONS Shaking frequency: 100 - 1350 cycles/min Total stroke/orbit: 1.5 mm The platform has a non-slip, removable moulded rubber pad for accommodating the microtitration plates. Shaking modes: Fast, Slow or Variable Environmental conditions Temperature: +15 – 35 °C Relative humidity: max 85 % PERFORMANCE SPECIFICATIONS Speed 3 min 20 sec / plate Volume dispensed 200 μl per well (preadjusted) Accuracy better than 1 % at 200 μl Precision better than 3 % at 200 μl DELFIA® DISPENSE UNIT INSTRUMENT SPECIFICATIONS Physical dimensions Height: 85 mm Width: 150 mm (+65 mm for the bottle holder) Depth: 135 mm Weight: 2 kg PERFORMANCE SPECIFICATIONS Speed 2 min 20 sec for one plate Volume dispensed 50 or 100 μl per stroke (user adjustable) Accuracy better than 1 % at 200 μl Precision better than 3 % at 200 μl HIGH QUALITY ASSAYS FOR OPTIMIZED SCREENING ORDERING INFORMATION DELFIA NEONATAL HTSH KIT • Based on DELFIA technology • The intended use is for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital hypothyroidism. • Kit reagents for 10 plates (960 assays) DELFIA NEONATAL IRT KIT • Based on DELFIA technology • The intended use is 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. • Two package sizes available: 4 plates (A005-204) and 10 plates (A005-210) NEONATAL TOTAL GALACTOSE KIT • Controls in DBS including both Gal and Gal-1-P • The kit makes use of a fluorescent galactose oxidase method • The intended use is 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 • Kit reagents for 10 plates (960 assays) DELFIA NEONATAL THYROXINE (T4) KIT • Based on DELFIA technology • The intended use is for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital hypothyroidism. DELFIA NEONATAL 17α-OHPROGESTERONE KIT • Based on DELFIA technology • The intended use is for the quantitative determination of human 17α-OHprogesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia. • Kit reagents for 10 plates (960 assays) • Two package sizes available: 4 plates (A024-104) and 10 plates (A024-110) NEONATAL PHENYLALANINE KIT NEONATAL BIOTINIDASE KIT • The kit makes use of a fluorescent ninhydrin method. • The intended use is for the quantitative determination of phenylalanine in blood specimens dried on filter paper as an aid in screening newborns for elevated levels phenylalanine in the blood. • Two packages sizes available: 10 plates (NP-1000*) and 50 plates (NP-4000*) • The assay is based on a semiquantitative fluorometric assay. • The intended use is for the semiquantitative determination of biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency • Two packages sizes available: 10 plates (3018-0010) and 50 plates (3018001B) Instruments •1296-071 DBS® Puncher • 1296-0050 TriNEST™ Incubator Shaker •1296-003 DELFIA® Plateshake (220/240V) •1296-004 DELFIA®Plateshake (110/240V) • 1296-0010DELFIA® Washer-Diskremove •1296-041 DELFIA® Plate Dispense •1420-020 Victor™2D fluorometer, manual loading •1420-021 Victor™2D fluorometer, stacker model - Victor™2D including PC, monitor, necessary filters, instrument software and MultiCalc Kits •A032-310 DELFIA® Neonatal hTSH kit (10 plate) •A065-110 DELFIA® Neonatal Thyroxine (T4) kit (10 plate) •A024-104 DELFIA® Neonatal 17α-OH-progesterone kit (4 plate) •A024-110 DELFIA® Neonatal 17α-OH-progesterone kit (10 plate) •A005-204 DELFIA® Neonatal IRT kit (4 plate) •A005-210 DELFIA® Neonatal IRT kit (10 plate) • NP-1000 Neonatal Phenylalanine kit (10 plate) • NP-4000 Neonatal Phenylalanine kit (50 plate) • 3029-0010 Neonatal Total Galactose kit (10 plate) • NG-1100 Neonatal GALT kit (10 plate) • NG-4100 Neonatal GALT kit (50 plate) • 3018-0010 Neonatal Biotinidase kit (10 plate) • 3018-001B Neonatal Biotinidase kit (50 plate) Options (sold separately) • 1420-221D Barcode reader • 2011-0010 Laboratory laser printer (230 V) • 2011-0040 Laboratory laser printer (115 V) •1296-043 DELFIA® Dispense Unit Consumables (sold separately) • 3033-0010 Clear, V-bottomed microplates (for Neonatal Phenylalanine kit) Bulk package of 100 plates • 4090-0100 96-well plate covers • 1420-450 ID-labels for 1-99, 10 sheets NEONATAL GALT KIT • The assay is an adaptation of the semi-quantitative enzymatic assay of Beutler and Baluda • The intended use is for the (semi-quantitative) determination of galactose-1-phosphate uridyl transferase (GALT) concentrations in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency • Two packages sizes available: 10 plates (NG-1100) and 50 plates (NG-4100) PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 USA P: (800) 762-4000 or (+1) 203-925-4602 www.perkinelmer.com PerkinElmer, Inc. Wallac Oy PO Box 10 20101 Turku, Finland Phone: + 358 2 2678 111 Fax: + 358 2 2678 357 ISO 13485 ISO 9001 CMDCAS ISO 14001 OHSAS 18001 For a complete listing of our global offices, visit www.perkinelmer.com/ContactUs Copyright ©2016, PerkinElmer, Inc. All rights reserved. PerkinElmer® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners. 1599-9807 BRO The semi-automated Victor2D system (US) , April 2016 PerkinElmer