NEW IMPROVED MATERNAL FETAL HEALTH SCREENING PLATFORM

Introducing the new AutoDELFIA® immunoassay system for prenatal screeningBrochure not for distribution in the USA

ALREADY 60 MILLION PREGNANCIES SCREENED WITHPERKINELMER PRODUCTS

THE WORLD’S LEADING SCREENING PLATFORM

Ability to run a complete range of prenatal assays

User friendly instrument software

Better design for improved instrument ergonomics

FMF approved assays

WHY CHOOSE THE NEW AUTODELFIA

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.

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

For a more detailed description, please check out

the AutoDELFIA video at https://perkinelmer.box.com/

AutoDELFIA-MFH-video

Secure and reliable audit trailInstrument is protected via safe useridentification. All change actions are

logged to the audit trail.

Hands-on convenienceThe new instrument table and

optional trolley for bulk liquid bottles make for easier handling.

Comprehensive range of maternal fetal health assays

Familiar AutoDELFIA assays now also including Inhibin A and PlGF.

Clean and fastColor-coded bulk liquid bottles with new super-quick connectors are easy

to change and fill up.

Reliably cost-effectiveRobust build and excellent reliability en-hance cost-effectiveness throughout the

screening process. PerkinElmer instrumenta-tion and reagents are manufactured to the highest quality and performance standards.

User-friendly design Improved ergonomics ensure better working conditions for laboratory

personnel.

Reliable analysisNew enclosed Sample Processor

minimizes the risk of contamination.

Laboratory friendlyThe front lid moves up instead of

out for more convenient instrument access. LED lights inside improve

visibility.

MARKEDLY IMPROVED EFFICIENCYDesigned to bring a new level of convenience and efficiency to aneuploidy and pre-eclampsia screening.

SMARTER SOFTWARE

AutoDELFIA features a completely new Manager user interface program and Workstation program for managing and reporting results.

AUTODELFIA WORKSTATION 3.0Manages 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

AUTODELFIA MANAGER 3.0Performs 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

LIFECYCLETM FOR PRENATAL SCREENINGLifeCycle™ 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.

SOFTWARE SOLUTIONS FOR YOUR SCREENING PROGRAM

Kits available with the AutoDELFIA System are:

PRE-ECLAMPSIA PREDICTORTM

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.

B027-105 DELFIA/AutoDELFIA PAPP-A/Free hCGß Dual DBS kit

B055-201 DELFIA/AutoDELFIA PlGF kit

B055-301 DELFIA/AutoDELFIA PlGF1-2-3 kit

B064-102 DELFIA/AutoDELFIA Inhibin A kit

B067-101 AutoDELFIA hAFP / Free hCGß Dual kit

B082-101 AutoDELFIA hCG kit

B083-301 AutoDELFIA uE3 kit

B096-101 AutoDELFIA hAFP kit

B097-101 AutoDELFIA Free hCGß kit

B098-201 AutoDELFIA PAPP-A kit

3015-0010 Maternal Health Control - Early

3090-0010 PlGF Controls

PERKINELMER STATISTICAL SERVICESStatistical 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

1235-5220 AutoDELFIA systemThe 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:• 1235-0110 AutoDELFIA Plate Processor• 1235-4230 AutoDELFIA Plate Processor table• 1297-0110 AutoDELFIA Sample Processor• 1297-4230 AutoDELFIA Sample Processor table• 1235-8100 AutoDELFIA V3.0 PC, including the Wallac Instrument PC with LED touch screen, PCI Arcnet card, Windows 7 (or newer), and the 1235-8090 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)• 2011-0030 Wallac laser printer (230 V)• 2011-0040 Wallac laser printer (115 V)• 1235-4140 Waste pump option• 1235-4240 Bottle trolley• 1297-404 Tube racks 37–72 (36 pcs)• 1235-3010 AutoDELFIA Astraia Link

Consumables (sold separately)• 1235-411 Dilution vessels (100 pcs)• 1235-402 Reagent tips (960 pcs)• 1297-402 Diluent troughs 70 mL (6 pcs)• 1297-4210 Dilution strips (400 pcs)• B117-100 DELFIA/AutoDELFIA Wash Concentrate (8 x 250 mL)• B118-100 DELFIA/AutoDELFIA Enhancement Solution (8 x 250 mL)

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 tubesCalibrator vials in closed tray at +15 ºCTube dimensions Height 45 – 125 mm (max 75 mm for control tubes) Outer diameter 10 – 16 mm Inner diameter min 8 mmCarry-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 sizeManual filling of wash solution and rinse, no intervention needed during runAutomatic emptying of waste bottles (optional)

PrecisionCV% of one plate with 1 nM Eu solution < 1%

Physical dimensions (SP + PP incl table but excl PC)Height 1740 mm (2280 mm with SP lid open)Width 1780 mmDepth 910 mmWeight 443 kg, incl table (SP alone 127 kg, PP alone 216 kg)

Power requirementsPower consumption max 900VAMains voltage 100 – 240 V, 50 – 60 Hz

Environmental conditionsOperating temperature 15 - 30 CRelative humidity 20 - 80 %Noise < 66 dB

Water requirements for wash and rinseCLRW, CLSI or equivalent deionized water

SamplesLiquid samples in barcoded tubesBlood disks from dried blood spots punched into 96-well plates for DBS assays

LoadingSamples, plates, reagents and bulk liquids loaded in a batch

For a complete listing of our global offices, visit www.perkinelmer.com/ContactUs

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. 1599-9803, November 2015 PKI

PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 USA P: (800) 762-4000 or (+1) 203-925-4602www.perkinelmer.com

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.

ORDERING INFORMATION

INSTRUMENT SPECIFICATIONS

PERFORMANCE SPECIFICATIONS

Measurement unitMeasurement mode TRF (filters for Eu and Sm)Linearity error < ±10% up to 6 nM Eu solution (approx. 6 million counts)

Temperature controlInside temperature controlled to +25 ± 3 ºC