The Semi-Automated System for Optimized Newborn Screening (Rest of World)

COST-EFFICIENT
SYSTEM FOR
NEWBORN
SCREENING
The semi-automated system for optimized newborn screening
Brochure not 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 seven NBS
disorders: congenital hypothyroidism, phenylketonuria, congenital adrenal hyperplasia,
galactosemia, cystic fibrosis, biotinidase deficiency and G6PD 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, G6PD)
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
THE MANUAL SYSTEM FOR
PRENATAL SCREENING
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 220-240 V,
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 %
VICTOR 2D can also be
used for 1st and 2nd
trimester prenatal
screening*
* The reagent products for prenatal screening using manual system are not
available in Japan, Singapore and some other Asian or Latin-America countries.
Products may not be licenced in accordance with Canadian law.
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
G6PD
x
(x) = Alternatively manual pipeting
x
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 G6PD 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
• The assay involves the oxidation of
G-6-P substrate to 6-PG by the G6PD
enzyme present in the sample
• The intended use is for the quantitative
determination of glucose-6-phosphate
concentrations in blood specimens
dried on filter paper as an aid in
screening newborns for G6PD
deficiency
• Two packages sizes available: 10
plates (NP-1000*) and 50 plates (NP4000*)
• Kit reagents for 10 plates (960 assays)
NEONATAL GALT KIT
NEONATAL BIOTINIDASE KIT
• The assay is an adaptation of the
semi-quantitative enzymatic assay of
Beutler and Baluda
• The assay is based on a semiquantitative fluorometric assay
• 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)
• 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)
• ND-1000 Neonatal G6PD kit (10 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
Products for neonatal screening may not be available in Japan, Singapore and some other Asian or Latin-America countries. Products may
not be licenced in accordance with Canadian law. Confirm availability with your PerkinElmer representative
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
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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.
1599-9806 BRO The semi-automated Victor2D system (ROW), April 2016
PerkinElmer