NEW IMPROVED SCREENING PLATFORM MATERNAL FETAL HEALTH

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1 Introducing the new AutoDELFIA immunoassay system for prenatal screening Brochure not for distribution in the USA NEW IMPROVED MATERNAL FETAL HEALTH SCREENING PLATFORM

2 ALREADY 60 MILLION PREGNANCIES SCREENED WITH PERKINELMER PRODUCTS

3 THE WORLD S LEADING SCREENING PLATFORM PerkinElmer s AutoDELFIA immunoassay system is the most widely used platform for Down syndrome screening, now available also for pre-eclampsia screening. Fully automatic and easy to use, AutoDELFIA has become the screening solution of choice for laboratories around the world and giving reliable, high quality results both for aneuploidy and pre-eclampsia risk assessment during pregnancy. Now PerkinElmer is proud to introduce the new AutoDELFIA system. By making AutoDELFIA even more effective and easier to use, we give you a clear reason to change your screening for the better. We offer FMF approved assays with high performance and long term precision. WHY CHOOSE THE NEW AUTODELFIA Ability to run a complete range of prenatal assays User friendly instrument software Better design for improved instrument ergonomics FMF approved assays

4 THE TRUSTED SYSTEM FROM INSIDE TO OUTSIDE AutoDELFIA is a fully automatic system for sensitive and reproducible quantitation of analytes commonly used in prenatal screening programs. The instrument is supported by the widest available range of prenatal analytes available on any platform. All kits employ the sensitive and robust DELFIA chemistry, based on time-resolved fluorescence. Every assay stage from sample dispensing to measurement is performed automatically. Analytical results are easy to manage and transfer to risk calculation software such as LifeCycle. Also available Stand-alone Plate Processor for dried blood spot (DBS) assays

5 MARKEDLY IMPROVED EFFICIENCY Designed to bring a new level of convenience and efficiency to aneuploidy and pre-eclampsia screening. User-friendly design Improved ergonomics ensure better working conditions for laboratory personnel. Reliable analysis New enclosed Sample Processor minimizes the risk of contamination. Laboratory friendly The front lid moves up instead of out for more convenient instrument access. LED lights inside improve visibility. Secure and reliable audit trail Instrument is protected via safe user identification. All change actions are logged to the audit trail. Clean and fast Color-coded bulk liquid bottles with new super-quick connectors are easy to change and fill up. Comprehensive range of maternal fetal health assays Familiar AutoDELFIA assays now also including Inhibin A and PlGF. Hands-on convenience The new instrument table and optional trolley for bulk liquid bottles make for easier handling. Reliably cost-effective Robust build and excellent reliability enhance cost-effectiveness throughout the screening process. PerkinElmer instrumentation and reagents are manufactured to the highest quality and performance standards. For a more detailed description, please check out the AutoDELFIA video at AutoDELFIA-MFH-video

6 SMARTER SOFTWARE AutoDELFIA features a completely new Manager user interface program and Workstation program for managing and reporting results. AUTODELFIA MANAGER 3.0 Performs essential device operations. New graphical user interface and operational modes for improved workflow management Easier to learn and use reducing the need for training One-glance overview of screening process with new HOME PAGE feature Tracking of mandatory maintenance routines by new SYSTEM MAINTENANCE feature Software protection with user specific access rights and audit trail Improved reagent pipette error handling and recovery features AUTODELFIA WORKSTATION 3.0 Manages and reports analytical results. Replaces the current counts-to-concentration software Includes the Kitlot Editor, the Plate Generator, the Result Viewer, and the Quality Control Program Automatic import of kit lot data using new 2D-barcoded AutoDELFIA kit QC certificates Improved safety and reliability no manual work steps and minimal risk of user error Data transfer to LifeCycle and Predictor for risk calculation

7 SOFTWARE SOLUTIONS FOR YOUR SCREENING PROGRAM LIFECYCLE TM FOR PRENATAL SCREENING LifeCycle is a complete Prenatal Screening Information Management System allowing users to track samples through the laboratory, calculate risks, and provide patient reports. LifeCycle features a robust and flexible risk calculation engine and is easily interfaced with the AutoDELFIA. PRE-ECLAMPSIA PREDICTOR TM Pre-eclampsia Predictor is a software application dedicated to calculating the risk of early and late on-set pre-eclampsia in the first trimester. With Predictor biochemical marker concentrations can easily be imported from the AutoDELFIA. PERKINELMER STATISTICAL SERVICES Statistical Services offers a comprehensive statistical analysis of laboratory performance. A simple export of data from LifeCycle or Predictor is analysed by the Statistical Services team. WIDE RANGE OF MATERNAL FETAL HEALTH ASSAYS Kits available with the AutoDELFIA System are: B DELFIA/AutoDELFIA PAPP-A/Free hcgß Dual DBS kit B DELFIA/AutoDELFIA PlGF kit B DELFIA/AutoDELFIA PlGF1-2-3 kit B DELFIA/AutoDELFIA Inhibin A kit B AutoDELFIA hafp / Free hcgß Dual kit B AutoDELFIA hcg kit B AutoDELFIA ue3 kit B AutoDELFIA hafp kit B AutoDELFIA Free hcgß kit B AutoDELFIA PAPP-A kit Maternal Health Control - Early PlGF Controls

8 INSTRUMENT SPECIFICATIONS Physical dimensions (SP + PP incl table but excl PC) Height 1740 mm (2280 mm with SP lid open) Width 1780 mm Depth 910 mm Weight 443 kg, incl table (SP alone 127 kg, PP alone 216 kg) Power requirements Power consumption max 900VA Mains voltage V, Hz Environmental conditions Operating temperature C Relative humidity % Noise < 66 db Water requirements for wash and rinse CLRW, CLSI or equivalent deionized water Samples Liquid samples in barcoded tubes Blood disks from dried blood spots punched into 96-well plates for DBS assays Loading Samples, plates, reagents and bulk liquids loaded in a batch PERFORMANCE SPECIFICATIONS Sample processing Sampling probes 4 parylene coated probes Liquid and clot detection Sample capacity Up to 432 patient tubes in 36 racks, 12 samples/rack Automatic sample dilution when specified (dilution factors 1:5 1:100) Separate rack for control tubes Calibrator vials in closed tray at +15 ºC Tube dimensions Height mm (max 75 mm for control tubes) Outer diameter mm Inner diameter min 8 mm Carry-over < 0.01% Accuracy Better than +/- 3% or +/- 1 µl (whichever is greater) at 25 µl and larger volumes Precision CV% < 3% for volumes 25 µl Plate processing Loading capacity 12 plates (1152 wells) Reagent capacity Up to 8 reagent cassettes, depending on kit size Manual filling of wash solution and rinse, no intervention needed during run Automatic emptying of waste bottles (optional) Precision CV% of one plate with 1 nm Eu solution < 1% Measurement unit Measurement mode TRF (filters for Eu and Sm) Linearity error < ±10% up to 6 nm Eu solution (approx. 6 million counts) Temperature control Inside temperature controlled to +25 ± 3 ºC ORDERING INFORMATION AutoDELFIA system The AutoDELFIA Sample and Plate Processor system includes the AutoDELFIA Sample processor, the AutoDELFIA Plate Processor, an external PC with Windows, the AutoDELFIA Manager user interface software, and the AutoDELFIA Workstation software, including the Kitlot Editor, Plate Generator, Result Viewer, and Quality Control modules, with user manuals. A table for the Sample and Plate Processors, and bottles for bulk liquids are also included. The AutoDELFIA Sample Processor consists of 4 probes, conveyor with barcode reader for sample tubes, trays for calibrators, control racks and dilution strips, and diluent troughs. The AutoDELFIA Plate Processor consists of a Barcode reader for plates and reagent cassettes, Reagent dispenser, Shaker/Incubator, Disk remover (for DBS assays), Washer, Enhancement Solution dispenser, Time-resolved fluorometer, and Plate transport system. Together they include all modules needed to fully automatically run the AutoDELFIA assays. The AutoDELFIA system includes: AutoDELFIA Plate Processor AutoDELFIA Plate Processor table AutoDELFIA Sample Processor AutoDELFIA Sample Processor table AutoDELFIA V3.0 PC, including the Wallac Instrument PC with LED touch screen, PCI Arcnet card, Windows 7 (or newer), and the AutoDELFIA V3.0 Software package. Options (sold separately) AAAJA-0002 APC Smart-UPS 2200 VA, Uninterruptible Power Supply (230 V) UPSAP200 APC Smart-UPS 2200 VA, Uninterruptible Power Supply (115 V) Wallac laser printer (230 V) Wallac laser printer (115 V) Waste pump option Bottle trolley Tube racks (36 pcs) AutoDELFIA Astraia Link Consumables (sold separately) Dilution vessels (100 pcs) Reagent tips (960 pcs) Diluent troughs 70 ml (6 pcs) Dilution strips (400 pcs) B DELFIA/AutoDELFIA Wash Concentrate (8 x 250 ml) B DELFIA/AutoDELFIA Enhancement Solution (8 x 250 ml) The AutoDELFIA system is CE marked, but may not be available outside Europe prior to registration notifications. Reagent products presented are not available in the USA and Japan. Products may not be available in China and some other Asian or Latin-American countries. Products may not be licensed in accordance with Canadian law. For information on availability of PerkinElmer products please contact your local representative. PerkinElmer, Inc. 940 Winter Street Waltham, MA USA P: (800) or (+1) For a complete listing of our global offices, visit Copyright 2014, PerkinElmer, Inc. All rights reserved. PerkinElmer is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners , November 2015 PKI