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Customer Training Presentation
Presenter
Title
Date
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GNMK-IMC-2033-E
ePlex® Training Presentation
• ePlex Technology
• Cartridge Design
• Respiratory Pathogen (RP) Panel
• Kit Storage and Handling
• Sample Preparation and Running a Test
• Resulting and Reports
• ePlex Graphical User Interface and Software
• ePlex Instrument Maintenance and Troubleshooting
• Customer Resources and Technical Support
2 For In Vitro Diagnostic Use GNMK-IMC-2033-E
EPLEX TECHNOLOGY
Electrowetting TechnologyProgrammable manipulation of fluid by voltage
For In Vitro Diagnostic Use GNMK-IMC-2033-E4
Capacitive Current
Signal
ProbeCa
ptu
re P
rob
e
Target DNA
-0.2 0.0 0.2 0.4 0.6
100
110
120
130
140
150
160
170
180
nA
/mm
2
POTENTIAL (V)
GOLD ELECTRODE
Redox-dependent
Faradaic Signal
Ferrocene
e-
eSensor® Detection TechnologyElectrochemical detection enabling high degree multiplexing
For In Vitro Diagnostic Use GNMK-IMC-2033-E5
EPLEX CARTRIDGE DESIGN
Integrated Cartridge DesignSingle-use, self-contained cartridge
Electrically Erasable
Programmable Read-Only
Memory (EEPROM)
Accession/Sample Barcode
Label
Sample Port
Liquid Reagent
Module (LRM)
Printed Circuit Board
(PCB)
Cartridge IDBlisters
For In Vitro Diagnostic Use GNMK-IMC-2033-E7
Lysis and ExtractionFully integrated onboard reagents with on board lysis and magnetic bead extraction
Bottom view of ePlex cartridge LRM
For In Vitro Diagnostic Use GNMK-IMC-2033-E8
Liquid Reagent Module (LRM) – Storage Blisters
Printed Circuit Board (PCB) + Top Plate – Dry Reagent Storage
ThermocyclingFully automated PCR and exonuclease digestion
Bottom view of ePlex cartridge (PCB)
For In Vitro Diagnostic Use GNMK-IMC-2033-E9
Precise digital fluidic control from extraction to rapid RT-PCR to eSensor detection technology
Innovative Electrowetting and eSensor Detection Technology
For In Vitro Diagnostic Use GNMK-IMC-2033-E10
KIT STORAGE AND HANDLING
Kit Storage and Handling
• Kit Details
– Each kit contains: 12 cartridges and 12 Sample Delivery Devices (SDDs)
– Kit should be stored between 2−8◦C
• Cartridges and SDDs:
– Should not be used past expiration date
– Cannot be reused
– Should be disposed of in biohazard container immediately after use
• Cartridge Details
– Must be run on instrument within 2 hours of opening foil pouch
• Sample can be loaded at any point during this timeframe
For In Vitro Diagnostic Use GNMK-IMC-2033-E12
Sample Delivery Device (SDD) Details
• Visually confirm the presence of liquid in vial
– Tap on benchtop to collect liquid on bottom of vial before use
• Do not use if the vial contains no liquid (see below)
• If you receive a vial without liquid, contact Customer Service for a replacement
A B C
Visible liquid in bottom
of tube
Visible liquid on side
walls of tube
No visible liquid in
bottom or side walls of
tube
Ok to Use Ok to Use Do NOT Use
For In Vitro Diagnostic Use GNMK-IMC-2033-E13
Sample Storage and Stability
• Sample type is a nasopharyngeal swab in
commercially available liquid transport media
– Includes Copan, eSwab/Amies, BD, Remel M4,
M4-RT, M5, M6
• Room temperature (15-30°C):
– up to 12 hours
• Refrigerated (2-8°C):
– up to 10 days
• Frozen (-20 to -80°C):
– Up to 12 months
– No more than 2 freeze/thaw cycles
– Thaw completely before testing
For In Vitro Diagnostic Use GNMK-IMC-2033-E14
EPLEX RESPIRATORY PATHOGEN (RP) PANEL
ePlex Respiratory Pathogen (RP) Panel
• Comprehensive coverage of 21 pathogens:
– 19 viruses and 2 bacteria
• Internal controls monitor performance
– DNA control monitors extraction and amplification of DNA targets
• Intended Use:
– The GenMark ePlex® Respiratory Pathogen (RP) Panel is a qualitative
nucleic acid multiplex in vitro diagnostic test intended for use on the
ePlex System for simultaneous detection and identification of multiple
respiratory viral and bacterial nucleic acids in nasopharyngeal swabs
(NPS) obtained from individuals exhibiting signs and symptoms of
respiratory tract infection.
• Additional information can be found in the Package Insert, which
is available on the GenMark Customer Resource CenterGNMK-IMC-2035-D
For In Vitro Diagnostic Use GNMK-IMC-2033-E16
Viral Targets
Adenovirus
Coronavirus (229E, HKU1, NL63, OC43)
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A
Influenza A H1
Influenza A H1-2009
Influenza A H3
Influenza B
Parainfluenza 1
Parainfluenza 2
Parainfluenza 3
Parainfluenza 4
Respiratory Syncytial Virus A
Respiratory Syncytial Virus B
Bacterial Targets
Chlamydia pneumoniae
Mycoplasma pneumoniae
Quality Control
• Internal Controls– DNA control: Schizosaccharomyces pombe
• Extraction
• Bead delivery and movement within the cartridge
• Amplification of DNA targets
– RNA control: In vitro transcripts (IVTs)
• Amplification of RNA targets and movement within the cartridge
• External Controls– Positive and negative controls should be tested with each new lot of reagents or monthly, whichever
occurs first.
• Controls should be run in accordance with laboratory protocols and accrediting organizations
– Previously characterized positive samples or commercially available material can be used as positive controls
– Blank media or commercially available negative material can be used as negative control
• If negative control result is positive for any target, please contact Technical Support
Internal and External Controls
For In Vitro Diagnostic Use GNMK-IMC-2033-E17
External Controls
– Synthetic DNA and RNA in a non-infectious stabilizing matrix
– Store at -20°C or colder
– Bring controls to room temperature before use
– This takes about 15 minutes after removing from freezer
– Flick the tube several times, then vortex for 10-15 seconds immediately before use
– Tap tube on benchtop to gather material to the bottom of the tube
– Do not pool or dilute controls!
– Designed for use with the ePlex RP panel and may not be compatible with other
respiratory panels
Maine Molecular Quality Controls (MMQCI)
GNMK-IMC-2035-D
Product RP Controls
Part # M306
Contents 2 sets of 5 single-use vials:
4 positive vials, 1 negative vial per set
For In Vitro Diagnostic Use GNMK-IMC-2033-E18
External Controls
• Purified, intact virus particles and bacterial cells that have been chemically modified to render
them non-infectious and refrigerator stable
– Note: Coronavirus HKU1 is a synthetic target
• Store at 2- 8°C
• Do not pool or dilute controls!
• See website for package insert and complete details on panels
• Designed for use with the ePlex RP panel and may not be compatible with other respiratory
panels
ZeptoMetrix NATrol™ Respiratory Verification Panel
Product RP Panel
ZeptoMetrix Part # NATRVP-GMK
Contents 4 sets of 5 single-use vials
5 positive vials, no negative per set
For In Vitro Diagnostic Use GNMK-IMC-2033-E19
External Control Set-up
•Configure QC based on detected vs. not detected targets for each assay
– Complete set of QC, or
– Rotation of each – only 1 control per set amount of time
•Set parameters to alert that QC is due
– New lot
– Amount of time
•Generate barcodes to be used with external QC pools
– Instrument will recognize as control and generate External Control report type
Customizable QC software
For In Vitro Diagnostic Use GNMK-IMC-2033-E20
Recommended Proficiency Testing Options For Use with Multiplex Respiratory Panels
Panel
Item #
Panel Name Procedure Program Information
CAP*
(College of
American
Pathologists)
Preferred:
IDR
Infectious
Disease,
Respiratory Panel
Identification of bacteria and viruses including
Adenovirus, C. pneumoniae, Coronavirus, Human
metapneumovirus, Influenza A/B, M.
pneumoniae, Parainfluenza 1 – 4, RSV, and
Rhinovirus/Enterovirus
• 5 x 1.0-ml liquid simulated respiratory specimens
• For lab using molecular multiplex panels
• Three shipments/yr
Alternate:
ID2
Nucleic Acid
Amplification,
Respiratory
Identification of bacteria and viruses including
Adenovirus, Coronavirus/Rhinovirus, Human
metapneumovirus, Influenza, parainfluenza, and
RSV
• 6 x 1.0-ml liquid simulated respiratory specimens
• For labs using Nucleic Acid Amplification testing
(NAAT)
• Two shipments/yr
API
(American
Proficiency Institute)
370 Respiratory
Pathogen Panel
Identification of bacteria and viruses • 5 x 1.0-ml liquid specimens
• For labs using molecular multiplex panels
• Three shipments/yr
For more information please refer to the manufacturer’s website:
• Link to CAP: https://www.cap.org/laboratory-improvement/proficiency-testing
– *Pretreatment with 20 µL of Proteinase K is required when testing CAP respiratory proficiency samples. Please contact Customer Support to receive
a free of charge kit of single use aliquots of Proteinase K from GenMark upon receipt of CAP samples.
– Instructions for pretreatment are available on the Customer Resource Center
• Link to API: https://www.api-pt.com/
For In Vitro Diagnostic Use GNMK-IMC-2033-E21
EPLEX SAMPLE PREP AND RUNNING A TEST
Materials Required
1. Pipette capable of dispensing 200 µL
2. Pipette tips, aerosol resistant, RNase/DNase-
free (if available)
• Extended length tips preferred
3. Vortex for controls and samples
4. Standard Personal Protective Equipment
5. BSL-2 hood
23
1
2
3
4
5
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Laboratory Setup
• Bring frozen samples and controls to room
temperature
• Decontaminate laboratory areas and
affected equipment with 10% bleach
followed by 70% ethanol or isopropyl
alcohol
• Ensure surfaces are dry before continuing
with sample setup
24 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Sample Preparation / Cartridge Setup
1. Open pouch, label cartridge and SDD with sample ID
2. Vortex sample for 3-5 seconds
3. Tap SDD on benchtop to collect liquid in bottom of vial
in order to visualize presence of liquid
– Do not centrifuge SDD
4. Remove purple top and pipette 200 µL of sample into
vial
5. Replace purple top and vortex SDD for 10 seconds
– This should be done immediately before loading
sample into cartridge
6. Remove white top from tip of SDD and dispense entire
volume of liquid into cartridge
– Minimize bubbles when dispensing liquid
7. Firmly snap cap into place to seal cartridge
– Bubbles can be present when closing the cap
8. Load onto ePlex instrument
Refer to Package Insert for detailed procedure
For In Vitro Diagnostic Use GNMK-IMC-2033-E25
Instrument Login
• Manual– Choose from multiple usernames
using dropdown menu
– Type in password
• Barcode– 2D barcodes printable for users
– Barcode contains both username and password
• Active Directory Integration– Log into ePlex instrument using Windows credentials
• Managed from the central directory service and must adhere to the organization-wide authentication and authorization policy
• Users can log in and out without disrupting samples
• Auto Logout– Can be set in software from 0-120 minutes
26 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Security and Access Control
•Supports customer defined strong password complexity policies
– Alpha, numeric, case, and special characters
• Minimum 8 characters
• At least one uppercase character (A-Z)
• At least one Lowercase character (a-z)
• At least one number (0-9)
• At least one special character (`~!@#$%^&*()_-+={[}]:;”<,’>.?/)
•Supports automated account lockout policy after a pre-defined number of
consecutive unsuccessful login attempts
– Configurable control to allow 1 – 10 login attempts
•Supports controls to prevent use of previous passwords
– Configurable control to prevent 1 – 24 password reuse
27
Password Requirements for Improved Security
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Starting a Run
1. Scan the accession ID and cartridge barcode
2. Manual Entry
3. Select a Pending Test Order
3 ways to initiate a run
28 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Loading the Cartridge
• Carry the cartridge horizontally
– Do not load a wet cartridge into the ePlex instrument
• Scan cartridges one at a time
• Available bays will blink white when ready to load
– Insert cartridge into any available bay
– Wait for “Ready for next sample” to be visible before
scanning another cartridge (~10 seconds)
• User may cancel the run before inserting the cartridge
• PosID prevents entry of the wrong cartridge into the
instrument
• Processing icon will remain visible until pre-flight
checks have completed (~2min)
29 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Test Completion
• Upon run completion, bay LED will blink green
and cartridge will eject
– If cartridge does not automatically eject upon
completion of the run, contact Technical Support
• Remove cartridge and dispose of immediately
in Biohazard waste
30 For In Vitro Diagnostic Use GNMK-IMC-2033-E
EPLEX RESULTS AND REPORTS
ePlex Detection Report
• Lab information listed
• Patient and cartridge information
• Summary of detected targets
• “Detected” or “Not Detected” result for each
target
– Visual cues for “Detected” targets
• Areas for comments and flags
– Option to approve report and/or release to LIS or
auto-file results
– Optional electronic signatures
• Refer to Operator Manual for more
information
ePlex RP Panel shown
GNMK-IMC-2035-D
For In Vitro Diagnostic Use GNMK-IMC-2033-E32
ePlex Summary Report
• Create customized reports for surveillance
and monitoring
• Sort by date range, operator, or for particular
organisms
• For example:
– Monitor all influenza positives in the last month
– Summarize all tests run per week to review
positivity rates
– Review all tests run for a particular assay
ePlex RP Panel shown
GNMK-IMC-2035-D
For In Vitro Diagnostic Use GNMK-IMC-2033-E33
ePlex External Control Report
• Use ePlex software to define and track external
controls
– Allow easy tracking of external control testing
– Automated pass/fail analysis
– Optional alert for QC due
• Demonstrate QC of materials for lab accreditation
– Generate on-demand QC test reports for a given time
period,
control or by operator
– Eliminate need for manual/hard copy QC tracking and
reporting
ePlex RP Panel shown
GNMK-IMC-2035-D
For In Vitro Diagnostic Use GNMK-IMC-2033-E34
Reporting
• Signing a Report
– Can be done by an Operator or Supervisor-level user
– Manually enter user ID and password, OR
– Electronically sign with login 2D barcode
• Approving a Report
– Optional supervisor-level approval only
– Manually enter user ID and password, OR
– Electronically sign with login 2D barcode
• Send to LIS
– Customizable approval from supervisor to operator
– Can auto-send to LIS if configured
– Reports can be held from auto sending based on different
preferences in settings
Patient report search
For In Vitro Diagnostic Use GNMK-IMC-2033-E35
Exporting Results
–Reports Tab Options• View Report: On-screen view of report
• Send to LIS
• Export: Export data to location that is pre-defined in instrument settings
• Export As: Select file types (CSV, XML, PDF and TXT) and location
• Export Data: Full raw data export for selected samples if requested by Technical Support
36
Detection or QC Reports
A B C D E
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Report Scheduler
• Distribute epidemiology report data without
having to manually run the report
• Schedule a report to run automatically at
regular intervals
– Daily, weekly, monthly
• Reports can be:
– Emailed in csv format
– Printed
– Saved to a network folder
• Access Privileges
– Supervisor: View and Schedule reports
– Operator: View only
– Non-operators: can be added as recipients
• Infectious Disease, Pharmacy, Medical Director, etc.
37
Schedule automatic report distribution to recipients
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Report Scheduler
•Scheduler Main Interface
– Create new scheduled reports
– Manage existing schedules
38
User interfaceSelect to View
Report, Export,
Delete
Add new
ScheduleRun schedule
manually for a
given date
Manage
archived reports
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Templated Comments
• Allow users to define rules based on ePlex result data in
a logical IF, THEN structure
• ePlex software will process rules at the end of sample
runs and attach applicable Templated Comments to
Detection Report
• ePlex software will transmit Templated Comments to the
clinical staff via the LIS interface
– Guide the choice of appropriate antibiotic therapy
based on ePlex results
– Integrate rapid results with automated Templated
Comments to fast-track treatment intervention such
as antibiotic usage or patient isolation
39
Rules-based engine to improve antimicrobial stewardship
For In Vitro Diagnostic Use GNMK-IMC-2033-E
Templated Comments
• Tools > Templated Comments
– Select Assay
– Specify Rule ID
– Specify Description (optional)
– Define IF conditions
– Specify THEN comments
– Specify ELSE comments (optional)
• Access privileges
– Supervisor: View and define
– Operators: View only
40
User interface
Active
Assays list
User-defined
Rule ID
Select text area
to specify Logic,
Target and
Result conditions
to evaluate Add condition
Optional
description
User-defined
Comments to send to
LIS and/or print on
report
Add new rule
Select to Delete
User-defined
alternative
ELSE
Comments
For In Vitro Diagnostic Use GNMK-IMC-2033-E
EPLEX GRAPHICAL USER INTERFACE
Navigating the User Interface
Toolbar:
1. Navigation
2. Pending Test Orders
3. Manual Entry
4. Remote Access (Bomgar Button)
5. Help
6. Screen Capture
7. Current User
8. Logout/Shut Down Screen
9. Current Date and Time
10. Restart software
If there is an Alert or Error notification:
11. Bay Errors
12. Alerts
For In Vitro Diagnostic Use GNMK-IMC-2033-E42
Bay View Details
1. Bay Location
2. Assay Name
3. Accession ID
4. Patient ID
5. Run Operator
6. Bay Serial Number
7. Cartridge Serial Number/ID
8. Cartridge Lot Number
9. Cartridge Expiration Date
10. Sample Comments
11. Abort Cartridge Run
12. Close Bay View
13. Time Remaining/Progress Bar
For In Vitro Diagnostic Use GNMK-IMC-2033-E43
Restart, Logout and Shutdown
1. Restart the ePlex software
2. Switch users, shut down or change password
3. Logout or shut down software
4. To completely power off the ePlex instrument after the software has shut down, toggle to
the off “O” position on the power switch located in the back of the ePlex base on left side
(if facing instrument)
44 For In Vitro Diagnostic Use GNMK-IMC-2033-E
EPLEX INSTRUMENT MAINTENANCE AND TROUBLESHOOTING
Monthly Maintenance
1. Dampen a lint-free wipe with 10% sodium hypochlorite solution
– Do not attempt to clean or spray liquid inside of the ePlex bays
2. Wipe all exterior surfaces with the lint-free wipe
3. Wait at least 5 minutes
4. Dampen a lint-free wipe with ethanol or isopropanol
5. Wipe all exterior surfaces with the lint-free wipe
• Preventative Maintenance will be performed every 6 months by GenMark personnel.
Cleaning of the ePlex instrument
For In Vitro Diagnostic Use GNMK-IMC-2033-E46
Indicators and AlertsLEDs indicate Bay status
White Solid Ready
White Blinking Insert Cartridge
Blue Solid Running
Green Blinking Run Complete
Red Blinking Error
Off N/A Disabled
For In Vitro Diagnostic Use GNMK-IMC-2033-E47
Indicators and Alerts
Bay Error Notification
• Selecting this icon displays the Bay Error Summary view and includes bay location, date/time of the error and bay error message(s).
Alert Notification
• This icon is visible on the toolbar if there are any outstanding warning alerts that have not been viewed. A warning alert is used to notify a user of a system warning. The Alert icon will display the Tools > System Events screen displaying all alerts and will contain a numeric code and informational message.
48 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Troubleshooting
• Test Did Not Start (DNS): Test stopped by instrument during pre-run checks (before countdown timer appears on screen)
– Remove the cartridge from the original bay
– Rescan or enter accession number and insert the cartridge in the same bay
– If the cartridge does not process successfully in the same bay, rescan or enter accession number and insert the cartridge into an alternate bay
– If the cartridge does not successfully process in an alternate bay, discard the original cartridge and retest the specimen using a new cartridge
– If the issue persists, send troubleshooting package to Technical Support to report the failure
• Test Did Not Finish (DNF): Test aborted by instrument or user during processing (after countdown timer appears on screen)
– Remove cartridge from the bay and discard
– Reset bay through the Bay Configuration software if it remains in the error state
– Retest the specimen using a new cartridge in an alternate bay
– Send troubleshooting package to Technical Support to report the failure
For In Vitro Diagnostic Use GNMK-IMC-2033-E49
Creating Troubleshooting Package
1. Navigate to the Troubleshooting tab
2. Select a date range when the issue occurred
3. Confirm “CTS Logs” is chosen from top
dropdown menu
– Or other, per Technical Support request
4. Press the “Export” button
– File will be saved in default location
– To change default location, navigate to General
tab under Settings
– “Export to Local” button used by GenMark
Service only
• Refer to the ePlex Customer Support Reference
in the Implementation Binder for more detail
• Call Technical Support or your local MAS for
assistance
50 For In Vitro Diagnostic Use GNMK-IMC-2033-E
ShareFile Upload Troubleshooting Package: https://genmarkdx.sharefile.com
For In Vitro Diagnostic Use GNMK-IMC-2033-E51
Help
• Operator Manual
– Accessed under the Help option
• Technical Support
– Telephone 1.800.eSensor (373.6767), Option 2
• Available for live support 24 hours a day, 7 days a week
– Email [email protected]
• Emails will be answered during business hours, 6:00 am – 5:00 pm PST
• When contacting GenMark Technical Support, please be ready to provide the following:
– Name/Institution
– E-mail Address
– Phone Number
– Panel/Test
– Troubleshooting Package
– Instrument Serial Number
52 For In Vitro Diagnostic Use GNMK-IMC-2033-E
Remote Access
• The Bomgar Remote Support Software enables remote access to the ePlex instrument through a
secure connection to diagnose, troubleshoot and resolve certain instrument software and connectivity
problems that may arise
• There are two ways to gain remote access:
– Bomgar Button - Remote access initiated by the end-user
– Jump Client - Remote access and support without end-user assistance
53 For In Vitro Diagnostic Use GNMK-IMC-2033-E
CUSTOMER RESOURCES
GenMark Customer Resource Center (CRC)
Enter account information and serial number for
instant access to:
• Package inserts
• Certificates of Compliance
• Safety Data Sheets
• Implementation Binder documents
• Technical Bulletins
Visit https://www.genmarkdx.com/account/create-
account/ to create an account
55
Your full service resource
For In Vitro Diagnostic Use GNMK-IMC-2033-E
GenMark Customer Resource Center (CRC)User-friendly interface
For In Vitro Diagnostic Use GNMK-IMC-2033-E56
Ordering Information
• Customer Service contact information
– T: 1-800-eSensor (373-6767), Option 1
– E: [email protected]
– F: 1-866-831-2001
– Available Monday-Friday 7:00 am – 5:00 pm PT
• Orders are processed the same day as they are received
– If received before 2 pm, orders will ship same day
– If received after 2 pm, orders will ship the following business day
– Orders are shipped for 2 day delivery
• Overnight delivery can be requested
• Refer to Implementation Binder for additional ordering information
ePlex Respiratory Pathogen Panel
Item # Kit Configuration Regulatory Status
EA001012 12 tests/kit IVD
For In Vitro Diagnostic Use GNMK-IMC-2033-E57
QUESTIONS?