GE Healthcare
Life Sciences
Data file 29-0327-18 AB
Human identification
DNAscan™ Rapid DNA Analysis™ System
The DNAscan Rapid DNA Analysis System from GE Healthcare
Life Sciences and NetBio is a fully automated rapid STR
system1 with integrated data analysis and Expert System
software. The system provides a called STR profile from
single source DNA swabs in less than 90 min.
Key features of DNAscan System include:
• Rapid DNA Analysis: The system generates STR profiles
from up to five buccal or blood2 swab samples
simultaneously in less than 90 min. An allelic ladder is
provided with every run and internal lane standard (ILS)
with every sample.
• Fully integrated lab-on-a-chip: From sample in to result
out, the instrument performs fully automated purification,
PCR amplification, electrophoresis, and Expert System data
analysis to generate an STR profile.
• Ease of use: All reagents and materials are factory
preloaded in the disposable “all-in-one” DNAscan
BioChipSet™ Cassette. The cassettes can be stored at
room temperature for up to six months (at 20°C to 30°C),
eliminating the need for freezers and refrigerators. The
system’s small footprint can be installed on a
benchtop—no pre- and post-PCR laboratory is needed.
• Closed system: All aspects of sample processing, including
waste containment, are performed on the single-use
DNAscan BioChipSet Cassette; no direct contact between
the instrument and the sample and reagents means no
flushing or cleaning of instrument lines.
• Contamination control: The DNA swab seals and locks into
the DNAscan BioChipSet Cassette to minimize the potential
for cross-contamination and sample mix-up.
• Data Security and Privacy: On-board security supports the
need to maintain data privacy and tracks chain of custody.
1
2
Forensic and research use only. Not for use in diagnostic procedures.
Protocol in development.
Fig 1. DNAscan Rapid DNA Analysis System processes five DNA samples
simultaneously in less than 90 min.
Dramatically reduces DNA analysis time
DNA analysis has become the gold standard in forensic
science, aiding law enforcement in solving crimes, convicting
criminals, and excluding the innocent (1). As convicted
offender and all-arrestee laws continue to expand worldwide,
forensic laboratories are experiencing increased logistical
burdens for implementing the laws, including training of
collection personnel, processing increased numbers of
samples, and ensuring that the collection agencies submit
the materials correctly (2).
In addition to the increased logistical burden on the crime
labs, the expansion of the offender and database laws have
compounded backlogs (3). These backlogs can slow criminal
investigations and delay the identification of suspects.
Furthermore, backlogs ultimately lead to increased financial
burden on taxpayers caused by the response, investigation,
prosecution, and adjudication of crimes committed by repeat
offenders (4, 5). DNAscan Rapid DNA Analysis System (Fig 1) is
designed to help minimize these backlogs, reduce recidivism,
and help lower the cost of law enforcement.
DNAscan Rapid DNA Analysis System components include:
• DNAscan Rapid DNA Analysis System instrument with
integrated touchscreen computer interface
• Integrated software for instrument control, data
collection, quality control and Expert System STR analysis
of sample files
• DNAscan BioChipSet Cassette—“all in one” disposable
cassette, factory preloaded with all reagents needed for
STR analysis
The system has been ruggedized to meet US Military 810F
standards and has undergone drop, shock, vibration, and
environmental change testing. Additional fortification of the
internal systems provides shielding from environmental dust
and debris. The robustness of the design supports portability
to relocate the system as required without the need for
recalibration. Side handles are ergonomically designed to
assist with instrument relocation. The instrument weighs
50 kg and meets two person lift requirements (Fig 2).
• DNAscan Collection Kits for collection of buccal samples
The DNAscan Rapid DNA Analysis System processes
and analyzes single source samples, from sample in
through called profile out and provides high quality results
comparable to the traditional DNA analysis process. The
system generates .cmf, .bmp, and .fsa files at the conclusion
of each run. Once Federal Quality Assurance Standards (QAS)
are modified to accept data from rapid DNA instruments
(in process), this short turnaround time will enable labs to
quickly reconfirm CODIS hits and process high priority and
reference samples faster. Over time, as DNAscan Rapid DNA
Analysis Systems are field installed in police booking stations
for the processing of suspect and arrestee DNA samples,
rapid DNA analysis will allow forensic labs to spend more
time focusing on crime scene samples, further improving
turnaround time and helping to reduce backlogs.
For crime labs that outsource database samples, DNAscan
Rapid DNA Analysis System provides an option to bring
processing of database samples in-house. In-house
processing can reduce the time lag and data reverification
effort associated with sample outsourcing. The fully integrated
design and compact footprint allows multiple instruments
to be installed on a standard lab bench without the need to
build traditional pre- and post-PCR database labs.
Instrument design
The DNAscan Rapid DNA Analysis System consists of the
instrument, DNAscan BioChipSet Cassette, and NetBio
Collection Swab. The system performs sample purification,
multiplex PCR, electrophoretic separation, laser-based
fluorescence detection, data analysis, and STR profile
generation in a single, compact benchtop unit. Dual
RFID readers and key-locked chassis enhance system
security, chain of custody and data integrity. An integrated
touchscreen serves as the user interface.
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Fig 2. DNAscan Rapid DNA Analysis System features a robust design that
supports portability to relocate the system as required without the need
for recalibration.
DNAscan BioChipSet cassette design
The single use, disposable DNAscan BioChipSet Cassette (Fig
3) includes all reagents, materials and waste containment
required to perform STR analysis, including DNA purification
chemistries, optimized STR reagents, buffers and separation
polymer. All reagents have been optimized for the
microfluidic environment to ensure consistent, balanced, and
precise results.
Electrophoretic separation channels are injection molded
into the single use DNAscan BioChipSet Cassette, eliminating
the potential for clogged capillaries. Pneumatic movement
of reagents allows the minimization of moving parts in the
system, increasing ruggedization, reliability, and data quality.
The cassette is a fully closed system. There is no direct
contact between the instrument and the sample or the
reagents, eliminating the need for flushing and cleaning of
lines. This closed system design, coupled with swabs that
lock and seal into the cassettes, minimizes any chance of
contamination.
The all-in-one DNAscan BioChipSet Cassettes are designed
for room temperature storage. To reduce storage space,
cartridges can be stored on a shelf or closet without need for
freezers, refrigerators, or a back-up power supply.
Data analysis and Expert System software
(A)
To complement the instrument and cassette design, the
DNAscan Rapid DNA Analysis System includes several
integrated software packages for instrument control, data
collection, quality control, and Expert System STR analysis
of sample files. The instrument’s integrated touchscreen
features a graphical user interface with workflow driven
instructions. The user friendly software helps streamline the
training required.
(B)
Top view
Swab chambers
Gel SC
Integrated
biochip
Cathode
PCR chambers
Bottom view
Pneumatic
interface
Smart
cartridge
Anode
After the DNAscan BioChipSet Cassette with swab samples
has been inserted into the instrument and the door closed,
the DNA analysis process starts. The system does not require
further operator intervention. The process control software
controls the pneumatic, thermal, and electrical subsystems
and controls the movement of sample and reagents during
processing. System self-checks have been built into the
instrument start-up routine and the operation steps to
assure proper functioning of the instrument.
The instrument’s Expert System software analyzes the data
after run completion and provides real-time feedback on
the usability of the STR profiles for database searching. Data
output indicates if the result of each lane is successful. In all
cases the output files are available for review by a forensic
scientist.
Output files provided include:
• .bmp for visualization of allele calls (electropherogram)
• .fsa for comparison using other HID software
• .cmf for compatibility with a CODIS database
Data privacy and chain of custody
Separation and
detection biochip
Separation
channels
Detection window
Fig 3. (A) The single use, disposable DNAscan BioChipSet Cassette includes all
reagents, materials and waste containment required to perform STR analysis.
(B) The DNAscan BioChipSet Cassette consists of three major components.
The smart cartridge (SC) accepts DNA swabs and stores the liquid reagents.
The integrated biochip accepts purified DNA from the SC, contains dried
reagents, performs PCR, and prepares the sample for electrophoresis.
The separation and detection biochip accepts sample from the integrated
biochip, performs electrophoresis, and via the detection window, allows the
detection of laser-based fluorescence.
STR reagents
The DNAscan BioChipSet Cassette includes lyophilized
Promega PowerPlex™ 16 STR reagents (CODIS core 13 loci
plus Amelogenin, Penta D and Penta E). Additional STR assays
are in development. Reagents have been stabilized for room
temperature storage and optimized for performance on the
DNAscan Rapid DNA Analysis instrument, however primer
sequences have been fully maintained to enable 100%
genotype concordance with PowerPlex 16.
The DNAscan Rapid DNA Analysis System has been designed
to ensure that samples and sample data are safe and
secure, helping the agency maintain chain of custody and
data integrity. Password protection of the software prevents
unauthorized use of the instrument and tracks usage. To
increase privacy and data security, the sample ID files
include a unique identifier/serial number, RFID information,
timestamp, and optional GPS location tag (if activated).
The system includes two RFID readers to avoid sample mixup. An RFID reader on the front panel of the instrument links
the DNA swab to the identification field corresponding to the
swab donor as entered on the touchscreen. Once the sample
is inserted into any of the available chambers in the DNAscan
BioChipSet Cassette, the swab permanently locks, sealing
the chamber to minimize the risk of cross-contamination.
Following insertion of the DNAscan BioChipSet Cassette
into the instrument, an internal RFID reader verifies that the
correct samples are inserted and notes which of the five
chamber positions the swab occupies. After the instrument
processes the sample and analyzes the data, the data
is encrypted and can be transferred to a separate DNA
database for further review and handling2.
2
Local DNA database software and hardware not included, available separately.
29-0327-18 AB 3
Data quality comparable to traditional
DNA analysis
After PCR, the amplified DNA fragments move to the
separation and detection biochip component (Fig 3B), located
on the underside of the cassette for electrophoresis. Emitted
fluorescence is detected by a set of photomultipliers, and
the emission data is sent to the on-board computer. Expert
System software analyzes the data and a DNA profile is
generated (Fig 6). The Expert System identifies STR fragments
and size standards, processes the allelic ladder, and
designates the alleles. As buccal swabs are intended to be
sole source samples, the Expert System identifies any mixed
samples and excludes them.
The DNAscan Rapid DNA Analysis System provides data
quality and concordance comparable to traditional STR
analysis methods. Reagents have been optimized and tested
along with the DNAscan instrument and software to provide
robust and reliable amplification. The system has undergone
extensive performance testing (Figs 4 to 8).
Additional testing is in progress. Each lab should perform its
own internal validation studies to ensure compliance and
performance per their laboratory’s validation standards.
The DNAscan Rapid DNA Analysis System provides high
quality CODIS compatible data output with single base pair
resolution (Fig 7) and precision tests showing a standard
deviation of < ± 0.25 base pairs (Fig 8).
Performance specifications
DNA is purified using a guanidinium based bind/wash/elute
process. Because DNA content varies from swab to swab, the
quantity of purified DNA is normalized during the process,
providing 0.5 to 2 ng of purified DNA taken forward to PCR.
Lyophilized STR reagents (PCR mix, internal lane standard,
and allelic ladder) are room temperature stabilized,
eliminating the need to refrigerate or freeze the cassette
during storage. All reagents are stable for greater than six
months at 20°C to 30°C (Fig 4). Each DNAscan BioChipSet
Cassette contains a preloaded allelic ladder which is run
concurrently with the five samples (Fig 5). An internal lane
standard is also included with each sample and ladder.
rfu
18 000
16 000
0 mo
14 000
1 mo
12 000
2 mo
3 mo
10 000
4 mo
8000
6 mo
6000
9 mo
12 mo
4000
18 mo
2000
0
D5S
Amel
vWA
D3S
TH01
D13
D7S
D8S
TPOX
D21
D18
D16
FGA
CSF
Penta E
Penta D
Loci
Fig 4. Performance testing of lyophilized PCR/STR reagents used in the DNAscan BioChipSet Cassette. Loci are listed according to length of amplicon product.
Vertical axis shows intensity of peaks for five time points. The signal strength of each locus is presented as a function of storage time of the lyophilized
reagent. Data shows reagent stability at 30ºC for greater than 12 mo (studies ongoing).
4 29-0327-18 AB
Fig 5. Allelic ladder and internal lane standard for PowerPlex 16 run on the DNAscan Rapid DNA Analysis System. Allelic ladder shows the collection of all alleles
commonly found in the population.
Fig 6. Bitmap (.bmp file) of an STR profile and ILS automatically generated from the 9947A immortalized cell line processed on the DNAscan Rapid DNA Analysis
System. Results show good balance within each color. All alleles are designated according to international standards, e.g., 9.3 allele in TH01. Since no primer
sequences have been changed, allele calls are identical to PowerPlex 16 results obtained in the forensic DNA laboratory.
29-0327-18 AB 5
Standard deviation (bases)
Fig 7. Enlarged view of TH01 locus. Data shows single base resolution achieved on the DNAscan Rapid DNA Analysis System and separation of alleles 9.3 and 10.
0.3
0.15
0
100
150
200
250
300
350
400
450
500
350
400
450
500
350
400
450
500
Standard deviation (bases)
Fragment size (bases)
0.3
0.15
0
100
150
200
250
300
Standard deviation (bases)
Fragment size (bases)
0.3
0.15
0
100
150
200
250
300
Fragment size (bases)
Fig 8. Precision testing of the DNAscan Rapid DNA Analysis System shows standard deviation of < ± 0.25 base pairs over a fragment size range of 100 to
500 bases, N = 7.
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Standardized DNA Collection
GE Healthcare Training
Standardized DNA collection Kits (Fig 9) are also available
to complement the ease of use of the DNAscan Rapid DNA
Analysis System. These standardized kits enable consistent
sample collection and contribute to increased productivity.
Each DNA Collection Kit contains a NetBio BioChipSet Swab,
an EasiCollect™ DNA collection device for collection of a
backup DNA sample, peelable barcodes, return mailing
envelope, peel and stick secondary envelope and a pair of
nitrile gloves.
GE understands the importance of having the knowledge
and skills to operate analytical equipment in everyday
business. Training on the DNAscan Rapid DNA Analysis
system provides technical knowledge to members of your
lab on a range of topics, including:
• Operation of the DNAscan Rapid DNA Analysis System
• Proper collection of biological samples using the NetBio
buccal collection swab and WhatmanTM EasiCollect device
• Maintenance and troubleshooting
• Review of frequently asked questions
• Advanced administrator training
Validation Support
Fig 9. DNAscan Collection Kits standardize the DNA collection process.
Global technical support and training
GE Healthcare offers global technical support and training
programs to ensure maximum success with the DNAscan
Rapid DNA Analysis System. Our global technical support
and training staff can provide instrument service, technical
application support, training and educational information,
ordering assistance, and professional services.
GE Healthcare Services has over 50 years of experience
as a provider of service solutions for the pharmaceutical
and biotechnology industries—experience that can help
the forensic, biometric, and law enforcement communities
stay productive. We understand that maintaining complex
instruments in prime condition is a science in itself. As
your dedicated service provider, we help you to improve
productivity and efficiency by optimizing the maintenance
of your equipment, thereby minimizing downtime and repair
costs. With our service teams and technology you can count
on high quality support: a solid foundation to build on.
The testing and validation of new equipment is essential to
performing quality work in any department. Confidence in
forensic DNA results is gained through validation studies,
which provide objective evidence that the DNA testing
method is robust, reliable, and reproducible. With the
assistance of GE Healthcare personnel, we can support an
appropriate validation of your instrument by providing the
knowledge and skills of our experts to do the work with you.
Allowing GE Healthcare to provide the resources to help with
validation reduces the time and resources needed from the
laboratory—saving time to work on criminal cases.
For more information on training or validation support,
please contact your local GE Healthcare representative.
References
1.
U.S. Department of Justice, Office of the Inspector General, Audit Division. U.S.
Department Of Justice Audit of the Convicted Offender DNA Backlog Reduction
Program. Audit Report 09-23, March 2009.
2.
Samuels, J. et al. Collecting DNA From Arrestees: Implementation Lessons.
NIJ J. 270, 18–25 (2012).
3.
Nelson, M. Making Sense of DNA Backlogs, 2010 — Myths vs. Reality. U.S.
Department of Justice, Office of Justice Programs. February 2011.
4.
City of Chicago. Chicago’s Study on Preventable Crimes. (2005) [Online] http://
www.dnasaves.org/files/ChicagoPreventableCrimes.pdf. Accessed 14 June 2012.
5.
Siegel, J. Why Arrestee DNA Legislation Can Save Indiana Taxpayers Over
$60 Million Per Year (2009) [Online] http://www.dnaresource.com/documents/
IndianaArresteeLegislation-Jan142009.pdf. Accessed 14 June 2012.
Our service agreements deliver:
• Confidence in your results through regular preventive
maintenance (PM) visits
• Predictable ownership costs through guaranteed rates for
the duration of the contract
• Minimal disruption with on-site priority response from our
trained service engineers
29-0327-18 AB 7
Technical Specifications
Ordering Information
Sample capacity
Sample type
Products
Quantity
DNAscan Rapid DNA Analysis
System
1 Unit
29-0228-52
DNAscan BioChipSet Cassette
and DNAscan Collection Kits*
5 cassettes and
30 collection kits
29-0228-53
DNAscan Collection Kits*
30 Kits
29-0228-54
STR chemistry
STR loci
DNAscan cassette
storage
Precision
Resolution
Run time
Data output files
Dimensions
Weight
Power
Laser
Humidity
Internal memory
External
connections
Security
System clock
1
2
5 samples
Fresh or stored buccal, blood1, or purified
DNA1 on swab
Promega Powerplex™ 16 optimized for rapid
DNA analysis2
CODIS core 13 loci, plus Penta D, Penta E and
Amelogenin
Room temperature stable
Standard deviation of < ± 0.25 BP
Single base pair
< 90 min
.bmp, .fsa and .cmf formats
68 x 42 x 59 cm (26.6 × 16.5 × 23.1 in; w × h × d)
50 kg (110 lb)
100 to 240 VAC +/-10%, (50 or 60 Hz) line
power; < 5 A peak load at 120 VAC (60 Hz) line
power, < 3 A peak load at 230 VAC (50 Hz) line
power
IEC-320-C13 / NEMA 5-15 cable / plug for 120 V,
15 A
Generator: 100 to 250 VAC (50–60 Hz) sine wave
200 mW solid state laser
20% to 80% RH, non-condensing
80 GB solid-state HDD
USB 2.0
GPS (USB 2.0, L1 frequency reception;
sensitivity > -150 dBm)
Wi-Fi 802.11
Ethernet (RJ45 10/100/1000 megabit data rates)
SVGA, DVI
Multiple encryption systems for stored data;
WPA2 encryption
Strong passwords; Secure logging of all
accesses to local database
Clock synchronizes with GPS when a GPS
signal is available
*
Code number
Each DNAscan Collection Kit contains 1 × NetBio BioChipSet Swab, with protective tube;
1 × EasiCollect DNA collection device; 6 × peelable barcodes; 1 × return mailing envelope,
Tyvek™ with security seal; 1 × instructions for use; 1 × peel and stick secondary envelope;
1 × pair large nitrile gloves.
Protocol in development.
Additional STR assays in development.
For local office contact information, visit
www.gelifesciences.com/contact
DNAscan Rapid DNA Analysis System is for forensic and research use only.
Not for use in diagnostic procedures.
GE, imagination at work, and GE monogram are trademarks of General
Electric Company.
DNAscan, EasiCollect, and Whatman are trademarks of General Electric
Company or one of its subsidiaries.
www.gelifesciences.com/dnascan
BioChipSet, NetBio, and Rapid DNA Analysis are trademarks of NetBio Inc.
PowerPlex is a trademark of Promega Corp. Tyvek is a trademark of E. I. du
Pont de Nemours and Company.
All other third party trademarks are the property of their respective owners.
GE Healthcare UK Ltd
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
UK
© 2012–2014 General Electric Company — All rights reserved.
First published Dec. 2012.
All goods and services are sold subject to the terms and conditions of
sale of the company within GE Healthcare which supplies them. A copy
of these terms and conditions is available on request. Contact your local
GE Healthcare representative for the most current information.
GE Healthcare Bio-Sciences AB
Björkgatan 30
751 84 Uppsala
Sweden
GE Healthcare Europe, GmbH
Munzinger Strasse 5
D-79111 Freiburg
Germany
GE Healthcare Bio-Sciences Corp.
800 Centennial Avenue, P.O. Box 1327
Piscataway, NJ 08855-1327
USA
imagination at work
GE Healthcare Japan Corporation
Sanken Bldg., 3-25-1, Hyakunincho
Shinjuku-ku, Tokyo 169-0073
Japan
29-0598-78 AB 06/2014