ThermoFisher Scientific Applied Biosystems RapidHIT ID System v1.3.1 User manual

For Forensic, Human Identification, or Paternity/Kinship Use Only. Not
for use in diagnostic or therapeutic applications.
RapidHIT™ID System v1.3.1
USER GUIDE
for use with:
RapidLINK™Software v1.1.5
Publication Number MAN0018938
Revision A.0

Life Technologies Corporation | 6055 Sunol Blvd | Pleasanton, CA 94566 USA
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE
LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR
ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Revision history: Pub. No. MAN0018938
Revision Date Description
A.0 05 January 2021 New document for RapidHIT™ID System v1.3.1.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these
products, you accept the terms and conditions of all applicable Limited Use Label Licenses.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2021 Thermo Fisher Scientific Inc. All rights reserved.

Contents
■CHAPTER 1 Product information .................................................. 7
Product description ............................................................. 7
Sample cartridge types .......................................................... 8
Parts of the instrument ........................................................... 9
Required materials not supplied ................................................. 10
Network and password security requirements ..................................... 11
Network configuration and security .......................................... 11
Password security ......................................................... 11
Workflow ..................................................................... 12
■CHAPTER 2 Collect and prepare the sample ................................... 14
Sample collection: GlobalFiler™Express and NGM SElect™Express sample cartridges . 14
Sample collection: RapidINTEL™sample cartridges ................................ 14
■CHAPTER 3 Run the instrument to generate a DNA profile ................... 15
Power on the internal computer .................................................. 16
Sign in to the instrument ........................................................ 17
Parts of the sample identification screen .......................................... 19
Enter the sample identification number ........................................... 19
Scan a barcode with the camera ............................................. 19
Enter a sample ID or barcode ............................................... 20
Insert the sample cartridge into the instrument (automatically starts the run) ........... 21
Run times for dierent sample cartridges ......................................... 22
Remove the sample cartridge from the instrument ................................. 23
Check the run result ............................................................ 24
View and export the run results .................................................. 25
Sign out ...................................................................... 26
RapidHIT™ID System v1.3.1 User Guide 3

■CHAPTER 4 Manage the instrument and software ............................. 28
View and export the run results for all runs (administrator or supervisor only) .......... 28
Configure instrument settings (administrator or supervisor only) ...................... 29
Manage users (administrator only) ................................................ 31
User roles and permissions ................................................. 31
Add a user ................................................................ 31
Remove authorization for an instrument ...................................... 34
■CHAPTER 5 Maintain the instrument ........................................... 35
Routine maintenance ........................................................... 35
View primary cartridge information ............................................... 36
Replace the primary cartridge (administrator or supervisor only) ...................... 37
Parts of the primary cartridge ............................................... 37
Prepare a new primary cartridge ............................................. 38
Insert the prepared primary cartridge (administrator or supervisor only) ........... 42
Run a control cartridge ......................................................... 44
Back up and restore data (administrator only) ..................................... 45
Recover the instrument (administrator or supervisor only) ........................... 45
Prepare the instrument for shipping .............................................. 45
■APPENDIX A Troubleshooting ................................................... 46
Check the RapidLINK™Software connection ...................................... 46
Troubleshooting: Symptoms, causes, and actions .................................. 46
■APPENDIX B Instrument specifications ......................................... 49
Dimensions, clearance, and weight ............................................... 49
Instrument layout and connections ............................................... 50
Environmental requirements ..................................................... 52
Electrical requirements ......................................................... 53
■APPENDIX C Analysis settings ................................................... 54
Threshold settings ............................................................. 54
Display analysis settings in the GeneMarker™HID STR Human Identity Software ....... 56
Analysis settings: GlobalFiler™Express sample cartridges .......................... 57
Analysis settings: RapidINTEL™sample cartridges ................................. 58
Analysis settings: NGM SElect™Express sample cartridges ......................... 60
Contents
4RapidHIT™ID System v1.3.1 User Guide

■APPENDIX D Validation of the Systematic Allelic Ladder Library (ACE
NGM sample cartridges only) .................................................... 62
Background ................................................................... 62
About the Systematic Allelic Ladder Library ....................................... 63
Study overview ................................................................ 65
Concordance .................................................................. 65
Accuracy ...................................................................... 67
Absolute size dierence ......................................................... 68
Conclusion .................................................................... 68
■APPENDIX E Software verification RapidHIT™ID System v1.3.1 ............. 69
Objective of the software verification ............................................. 69
Studies, standards, and samples ................................................. 70
Functionality testing results ...................................................... 71
Regression testing results ....................................................... 75
Accuracy testing results ......................................................... 75
Reliability testing results ........................................................ 77
Conclusion .................................................................... 78
■APPENDIX F Safety ............................................................... 79
Symbols on this instrument ..................................................... 79
Standard safety symbols ................................................... 79
Location of safety labels .................................................... 80
Control and connection symbols ............................................. 80
Conformity symbols ........................................................ 81
Safety information for instruments not manufactured by Thermo Fisher Scientific ...... 82
Instrument safety .............................................................. 82
General ................................................................... 82
Physical injury ............................................................. 82
Electrical safety ........................................................... 82
Cleaning and decontamination .............................................. 83
Instrument component and accessory disposal ................................ 83
Laser safety ............................................................... 83
Safety and electromagnetic compatibility (EMC) standards .......................... 84
Safety standards .......................................................... 84
EMC standards ............................................................ 84
Environmental design standards ............................................. 85
Radio compliance standards ................................................ 85
Chemical safety ................................................................ 87
Biological hazard safety ......................................................... 88
Contents
RapidHIT™ID System v1.3.1 User Guide 5

■Documentation and support ....................................................... 89
Related documentation ......................................................... 89
Customer and technical support ................................................. 89
Limited product warranty ........................................................ 90
References
Index ...................................................................................... 92
Contents
6RapidHIT™ID System v1.3.1 User Guide

Product information
■Product description .................................................................... 7
■Sample cartridge types ................................................................. 8
■Parts of the instrument ................................................................. 9
■Required materials not supplied ........................................................ 10
■Network and password security requirements ............................................ 11
■Workflow ............................................................................ 12
IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix
in this document.
Product description
The Applied Biosystems™RapidHIT™ID System v1.3.1
system uses the following components.
•RapidHIT™ID sample cartridges—Self-contained
sample cartridges contain reagents and size standard
for Applied Biosystems™STR (short tandem repeat)
chemistry.
You add a sample to the cartridge, then insert the
sample cartridge into the instrument.
•RapidHIT™ID System v1.3.1—The instrument provides an intuitive user interface that guides you
through routine use.
The instrument generates a DNA profile in 90–110 minutes.
•RapidLINK™Software v1.1.5—When an instrument run is complete, the DNA profile is sent to
the RapidLINK™Software. You can review DNA profiles, view electropherograms, and update DNA
profiles. With the activation of RapidLINK™applications (apps), you can perform sample matching,
kinship analysis, and familial searching. You can also compare profiles that are generated to the
optional Sta Elimination Database.
Additionally, you can monitor all instruments that contribute DNA profiles to the RapidLINK™
Software.
For information on the RapidLINK™Software v1.1.5, see the RapidLINK™Software v1.1.5 User
Guide (Pub. No. MAN0018939).
1
RapidHIT™ID System v1.3.1 User Guide 7

Sample cartridge types
Abbreviation
on labels / in
software
Sample type STR chemistry Features For more information see
RapidHIT™ID ACE GlobalFiler™Express Sample Cartridge
ACE GFE / GFE Single-source,
buccal swab
GlobalFiler™
Express
Optimized data
analysis thresholds
(based on v 1.3)
Appendix E, “Software verification
RapidHIT™ID System v1.3.1”
RapidINTEL™Sample Cartridge
AB RI Casework,
single-source,
blood and
saliva samples
GlobalFiler™
Express
Increased sensitivity
for investigative leads
samples
RapidINTEL™Sample Cartridge
for Blood and Saliva
Samples Validation User Bulletin
(Pub. No. MAN0018979)
RapidHIT™ID ACE NGM SElect™Express Sample Cartridge
ACE NGM /
NGM
Single-source,
buccal swab
NGM SElect™
Express
Systematic allelic
ladder library
•Appendix D, “Validation of
the Systematic Allelic Ladder
Library (ACE NGM sample
cartridges only)”
•RapidHIT™ID ACE
NGM SElect™Express
Sample Cartridge for
RapidHIT™ID System v1.2
Validation User Bulletin
(Pub. No. MAN0018973)
Chapter 1 Product information
Sample cartridge types
1
8RapidHIT™ID System v1.3.1 User Guide

Parts of the instrument
2
3
4
5
6
7
8
1
1Camera
2Sample cartridge port
3Touchscreen (display screen)
4Fingerprint reader
5Primary cartridge (contains gel cartridge)
6Power button (controls the internal computer)
7USB port
8Rear panel with main power switch, USB, and
computer connections
The instrument also includes an internal environmental sensor that monitors temperature and humidity.
Do not lean on any part of the instrument. This action could cause damage or breakage, especially to
the display screen.
Chapter 1 Product information
Parts of the instrument 1
RapidHIT™ID System v1.3.1 User Guide 9

Required materials not supplied
Unless otherwise indicated, all materials are available through thermofisher.com. "MLS" indicates that
the material is available from fisherscientific.com or another major laboratory supplier.
Table 1 RapidHIT™ID Primary Cartridge GlobalFiler™Express 100 Kit (Cat. No. A41841)[1]
Contents Amount Storage
Box 1
Primary cartridge—GlobalFiler™
Express 100
1 primary cartridge for 100 runs[2] Room temperature (15–30°C)
Utility cartridge (for primary cartridge
replacement)
2 utility cartridges
Box 2
Gel cartridge (for primary cartridge
replacement)
1 gel cartridge 4–10°C
ACE GlobalFiler™Express control
cartridge (allelic ladder, for
installation)
1 control cartridge
RapidHIT™ID ACE GlobalFiler™
Express positive control cartridge (for
installation)
1 positive control cartridge
[1] The primary, utility, gel, and allelic ladder cartridges are also used for the RapidINTEL™Sample Cartridge Kit (Cat. No. A43942).
[2] Primary cartridges can be ordered separately (Cat. No. A41841, includes gel, utility, and ACE GFE Control Cartridge [allelic ladder] cartridges).
Table 2 RapidHIT™ID Primary Cartridge NGM SElect™100 Kit (Cat. No. A41847)
Contents Amount Storage
Box 1
Primary cartridge—NGM SElect™
Express 100
1 primary cartridge for 100 runs[1] Room temperature (15–30°C)
Utility cartridge (for primary cartridge
replacement)
2 utility cartridges
Box 2
Gel cartridge (for primary cartridge
replacement)
1 gel cartridge 4–10°C
NGM control cartridge (allelic ladder,
for installation)
1 control cartridge
NGM positive control cartridge (for
installation)
1 positive control cartridge
[1] Primary cartridges can be ordered separately (Cat. No. A43409, includes gel, utility, and ACE NGM Control Cartridge [allelic ladder] cartridges).
Chapter 1 Product information
Required materials not supplied
1
10 RapidHIT™ID System v1.3.1 User Guide

Table 3 Sample cartridges
Component Cat. No.
RapidHIT™ID ACE GlobalFiler™Express 50 Sample Kit
50 sample cartridges, 2 positive control cartridges, 2 negative control cartridges
A41831
RapidHIT™ID ACE NGM SElect™Express 50 Sample Kit
50 sample cartridges, 2 positive control cartridges, 2 negative control cartridges
A41838
RapidINTEL™Sample Cartridge Kit
50 sample cartridges, 2 positive control cartridges, 2 negative control cartridges
A43942
Table 4 Accessories
Component Cat. No.
(Optional) Barcode scanner compatible with one of the following formats:
GS1-128, Industrial 2 of 5, Interleaved 2 of 5, Code 128, Code 39
Note: The instrument must be configured by a service representative to enable
barcode scanning. If you want to add a barcode scanner to the instrument after
initial installation, contact Thermo Fisher Scientific to request an update to your
configuration.
MLS
Whatman™OmniSwab 09-923-376 (WB100035)
Puritan 3" Sterile Standard Cotton Swab w/Semi-Flexible Polystyrene Handle 25-8032 PC
Network and password security requirements
Network configuration and security
The network configuration and security settings of your laboratory or facility (such as firewalls, anti-
virus software, network passwords) are the sole responsibility of your facility administrator, IT, and
security personnel. This product does not provide any network or security configuration files, utilities, or
instructions.
If external or network drives are connected to the software, it is the responsibility of your IT personnel
to ensure that such drives are configured and secured correctly to prevent data corruption or loss. It
is the responsibility of your facility administrator, IT, and security personnel to prevent the use of any
unsecured ports (such as USB, Ethernet) and ensure that the system security is maintained.
Password security
Thermo Fisher Scientific strongly recommends that you maintain unique passwords for all accounts in
use on this product. All passwords should be reset upon first sign in to the product. Change passwords
according to your organization's password policy.
It is the sole responsibility of your IT personnel to develop and enforce secure use of passwords.
Chapter 1 Product information
Network and password security requirements 1
RapidHIT™ID System v1.3.1 User Guide 11

Workflow
Obtain swab or substrate samples according
to your standard operating procedure.
▼
Sign in.
▼
Scan the sample cartridge barcode or enter
the sample identification number.
IMPORTANT! Do not include the following in
sample IDs: "ladder", "posctrl", or "negctrl"
(case does not matter). The software
processes any sample IDs that contain these
names as allelic ladders or controls.
▼
Insert the swab or substrate sample into a
sample cartridge.
▼
Insert the sample cartridge into the instrument.
The run starts automatically.
▼
Chapter 1 Product information
Workflow
1
12 RapidHIT™ID System v1.3.1 User Guide

The countdown timer starts at 110 minutes.
The typical run time is ~90 minutes.
Note: The timer stops when the run is
complete. The timer does not decrease to 0
minutes. For more information, see “Run times
for dierent sample cartridges” on page 22.
▼
Remove the sample cartridge from the
instrument, then view the result.
▼
Review results and run applications in the
RapidLINK™Software.
Chapter 1 Product information
Workflow 1
RapidHIT™ID System v1.3.1 User Guide 13

Collect and prepare the sample
■Sample collection: GlobalFiler™Express and NGM SElect™Express sample cartridges ....... 14
■Sample collection: RapidINTEL™sample cartridges ...................................... 14
Sample collection: GlobalFiler™Express and NGM SElect™
Express sample cartridges
Sample cartridges were validated using the following swab types, but other swab types have been used
successfully with both cartridges.
•GlobalFiler™Express—Puritan 3" Sterile Standard Cotton Swab w/Semi-Flexible Polystyrene
Handle (Puritan Cat. No. 25-8032 PC)
•NGM SElect™Express—Whatman™OmniSwab, (Fisher Scientific™Cat. No. 09-923-376
[WB100035])
IMPORTANT! When you handle buccal swabs, follow your standard operating protocol for the use of
safety glasses, lab coats, and chemical-resistant, disposable gloves (powder-free).
Sample collection: RapidINTEL™sample cartridges
Blood and saliva samples have been validated for use with RapidINTEL™sample cartridges. Samples
were processed for validation as described in RapidINTEL™Sample Cartridge for Blood and Saliva
Samples Validation User Bulletin (Pub. No. MAN0018979).
IMPORTANT! When you handle samples, follow your standard operating protocol for the use of safety
glasses, lab coats, and chemical-resistant, disposable gloves (powder-free).
2
14 RapidHIT™ID System v1.3.1 User Guide

Run the instrument to generate a
DNA profile
■Power on the internal computer ........................................................ 16
■Sign in to the instrument .............................................................. 17
■Parts of the sample identification screen ................................................ 19
■Enter the sample identification number ................................................. 19
■Insert the sample cartridge into the instrument (automatically starts the run) ................. 21
■Run times for dierent sample cartridges ............................................... 22
■Remove the sample cartridge from the instrument ........................................ 23
■Check the run result .................................................................. 24
■View and export the run results ......................................................... 25
■Sign out ............................................................................. 26
3
RapidHIT™ID System v1.3.1 User Guide 15

Power on the internal computer
IMPORTANT! Leave the main power switch (on the back panel) set to On at all times.
Power is necessary to maintain the gel temperature.
Press the power button on the front lower-right of the instrument.
The power button changes from green to blue .
The startup screen is displayed until the instrument finishes
the following operations.
• System check
• System prime, if needed (≤15 minutes)
The lock screen is displayed after system startup is complete.
12
Figure 1 Startup and lock screens
1Startup screen
2Lock screen
Chapter 3 Run the instrument to generate a DNA profile
Power on the internal computer
3
16 RapidHIT™ID System v1.3.1 User Guide

Sign in to the instrument
You can sign in using any of the authentication methods that are configured for your profile.
• To use facial recognition or fingerprint methods, position your face in front of the camera or touch
the fingerprint reader.
The sample identification screen is displayed.
Chapter 3 Run the instrument to generate a DNA profile
Sign in to the instrument 3
RapidHIT™ID System v1.3.1 User Guide 17

• To use a PIN, perform the following steps.
a. Touch the lock screen.
b. Touch .
c. Touch , then select your user name.
d. Enter your PIN with the keypad.
The sample identification screen is displayed.
If an error code is displayed when you sign in, see “An error code is displayed when you sign in” on
page 47.
Chapter 3 Run the instrument to generate a DNA profile
Sign in to the instrument
3
18 RapidHIT™ID System v1.3.1 User Guide

Parts of the sample identification screen
1
2
3 4 5
1No icon is displayed if the instrument is connected to the RapidLINK™Software.
Indicates that the instrument is not connected to the RapidLINK™Software
See “Check the RapidLINK™Software connection” on page 46.
2Touch to display the keyboard to enter a sample identification number.
3Touch to display the menu screen.
4Displays the run count for the primary (reagent) cartridge. The run count indicates the number of runs that have
been performed, not the number of runs that are remaining (for example, "65" indicates that 65 runs have been
performed). For more information, see “View primary cartridge information” on page 36.
5Touch to sign out and lock the touchscreen (displays the lock screen).
Enter the sample identification number
Scan a barcode with the camera
Note: You can also use a compatible handheld barcode scanner. For information on the compatible
scanner, see “Required materials not supplied” on page 10.
1. If the sample identification screen is not displayed, touch
until it is displayed.
2. Hold the barcode in front of the camera at the top left of the instrument.
When the camera reads the barcode, the sample identification number is displayed.
Chapter 3 Run the instrument to generate a DNA profile
Parts of the sample identification screen 3
RapidHIT™ID System v1.3.1 User Guide 19

Enter a sample ID or barcode
1. If the sample identification screen is not displayed, touch
until it is displayed.
2. Touch the sample identification screen.
3. Touch
to display the keypad.
1
1Keypad
Note: The software allows you to enter the following characters for sample ID: /\?%*:|'.<> space.
However, it changes these characters to underscore(_) when it creates the data file for the sample.
The sample ID with underscores is displayed in the RapidLINK™Software.
4. Enter the sample ID or barcode, then touch Enter.
IMPORTANT! Do not include the following in sample IDs: "ladder", "posctrl", or "negctrl" (case
does not matter). The software processes any sample IDs that contain these names as allelic
ladders or controls.
The sample identification number is displayed.
Chapter 3 Run the instrument to generate a DNA profile
Enter the sample identification number
3
20 RapidHIT™ID System v1.3.1 User Guide