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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


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


Lysis and ExtractionFully integrated onboard reagents with on board lysis and magnetic bead extraction

Bottom view of ePlex cartridge LRM


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)


Precise digital fluidic control from extraction to rapid RT-PCR to eSensor detection technology

Innovative Electrowetting and eSensor Detection Technology


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


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


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


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


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


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


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


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


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/


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

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=wc03zA-nrCRUgM&tbnid=ATa0EQzuLcGVCM:&ved=0CAUQjRw&url=http://www.usascientific.com/vortex-genie-2.aspx&ei=PHXkUbiXBeqpiQLchoCgAg&bvm=bv.48705608,d.cGE&psig=AFQjCNEAdSRHeVQwmPKNAy2OGf9Q3Eg6zg&ust=1374013078798456

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


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


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


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


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


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)


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


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


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


GNMK-IMC-2035-D


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


GNMK-IMC-2035-D


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


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


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


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


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


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


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


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


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)


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


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


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.


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


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


ShareFile Upload Troubleshooting Package: https://genmarkdx.sharefile.com


https://genmarkdx.sharefile.com/

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


mailto:[email protected]

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


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


https://www.genmarkdx.com/account/create-account/

GenMark Customer Resource Center (CRC)User-friendly interface


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


QUESTIONS?

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