Sofia 2 Training
Please refer to Sofia 2 User Manual and assay Package Inserts for specific information
Allison Leone, Director New Market DevelopmentCheryl Miller, Vice President New Market Development
Quidel’s commitment to this program represents our latest efforts in fulfilling an unwavering commitment to the community Working harmoniously with government agencies,
nursing homes and BD Prioritizing systems and kits to this effort Developed the website quideltogetheragain.com Comprehensive training program Development of guides to simplify the testing
process Proactive concierge service to confirm training was
successful
Quidel Proprietary Confidential2
Quidel’s CommitmentHHS Nursing Home Initiative
“Alone we can do so little; together we can do so much.” Helen Keller
Government Agencies
Nursing Homes Diagnostics
Quidel Together AgainHHS Nursing Home Program Training
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Challenges
Learning what are good laboratory practices
How to set up equipment How to take a patient sample How to run quality controls When to run quality controls How to run a patient sample How to run multiple patient
samples (batch testing)
Limited CMS/HHS communications with facilities
Identify the key individual responsible at each location
Success is dependent upon each facility taking action and completing the entire training program
Apprehension/possible fear about being asked to test for COVID-19
Primary Challenge:Minimal experience in patient testing
Secondary Challenge:Communication/Perceptions
Training Overview
Comprehensive training program Online: self-paced learning modules Virtual: remote live demonstrations with Field
Application Specialist Live: on-site, scheduled as needed Print: all materials are available for printing
and on the focused initiative website Measure: Which facilities received training
certification with personal follow-up
Training
Online
Virtual
LivePrint
Measure
The Plan to Address the ChallengesTraining Overview
Customer Journey
Receives Notice from HHS Unit and
kits are shipping
Nursing Home
Staff logs onto quideltogetheragain.com
for Online and Virtual training signup
Training Instructions
E-mail Confirmation
Nursing Home receives shipment with Quidel
Instruction Card
Run Calibration, QC and Begin Testing Patients and Staff
Watch Online modules and sign up for Virtual Training
Begin TestingStaff Trains
Quidel sends e-mail and confirmation of
shipment
Shipment Received
quideltogetheragain.com
Training Process
Certified
Take Quiz and complete
documentation
Training Overview
Step One: Online Training Step Two: Virtual Training
Online training video modules accessible through
quideltogetheragain.com
Sign up for Virtual live training via webinar provided by a Field
Application Specialist
Step Three: Certification
Complete training quiz and receive your required Training
Certification
quideltogetheragain.com
Training Process
Journey Begins: Website
Log onto Quidel Together Again to begin the training
process
Training Overview
Quidel Together AgainIntroduction to Sofia and Testing
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SARS-CoV-2 is the virus that causes COVID-19 or Coronavirus 2019, which was labeled as a pandemic by WHO
SARS-CoV-2 is part of the coronavirus family Coronaviruses are common in humans and in a variety of animals SARS-CoV-2 is a beta coronavirus along with MERS-CoV and SARS-
CoV, which all have their origin in bats
SARS-CoV-2 likely emerged from an animal reservoir and begun in Wuhan, China
ANTIGEN TEST
Identification of current infections Looks for nucleocapsid proteins Detected in nasal passages Tested on symptomatic patients
COVID-19 Background
Quidel Together AgainHow to Use Sofia 2
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The Sofia SARS Antigen FIA kit contains everything you need to run the test from swabs, to reagents to cassettes. Kits are stored at room temperature,
15°C to 30°C Kit contents are stable until the expiration date
printed on the outside of the box Do not freeze Sofia 2 operates between 15°C to 30°C/59°F to 86°F. The proper operating humidity is
20% to 85% RH non-condensing. 12-month expiration from date of manufacture
Your installation pack will have a foil pouch containing a Calibration Cassette - Keep the Calibration Cassette in a safe place.
In a few weeks, the nursing homes will receive a package with plastic tubes (batch testing support) and directions on how to batch (run multiple patient samples at a time)
REUSABLE Calibration Cassette Keep the Calibration Cassette in a safe place.
Training ProcessHow to use Sofia 2
Sofia2 as easy as 1-2-3
Step 1 Set up and
Calibrate
Step 2 Run Controls
Step 3 Run Patient
Training ProcessHow to use Sofia 2
Front Back
Sofia 2 Set UpHow to use Sofia 2
When turning on Sofia 2 for the first time, Sofia 2 will prompt to enter the ZIP Code where it is located.
After you enter the zip code hit the Home button
Sofia 2 Set Up – Enter Zip CodeHow to use Sofia 2
Step 1
Step 2
Enter Supervisor code 1234Then select “Run”
Follow Prompts, Insert Calibration Cassette into drawer
In 10 seconds the calibration is complete
Run CalibrationHow to use Sofia 2
Quidel Technical Support 1.800.874.1517Home Button
If calibration fails, make sure the Calibration Cassette was not in the light, place back in the foil pouch for 15 minutes
and then try again.
Run CalibrationHow to use Sofia 2
Sofia2 as easy as 1-2-3
Step 1 Set up and
Calibrate
Step 2 Run Controls
Step 3 Run Patient
Training ProcessHow to use Sofia 2
Quality Control Summary A positive and negative control set is included
in every kit Run external controls
Once for every untrained operator For every new shipment of kits New lot numbers In accordance with your state and local laws
Log your controls (SD card, Virena, paper)
Always run the positive control first!
https://quickstart.quidel.com/docs/
Run ControlsHow to use Sofia 2
Sofia2 as easy as 1-2-3
Step 1 Set up and
Calibrate
Step 2 Run Controls
Step 3 Run Patient
Run ControlsHow to use Sofia 2
Sofia 2 as easy as 1-2-3
Training ProcessHow to use Sofia 2
Process a batch of samples rapidly:
Pipette sample onto Test Cassette Set timer and allow Test Cassette to incubate on bench
top for 15 minutes Insert Test Cassette into Sofia/Sofia 2 to get a test result
in about 11 seconds (1 minute for Sofia) Allows for multiple tests to be run with high throughput
(~40-50 tests per hour)
Process samples on demand:
Pipette sample onto Test Cassette and insert into Sofia/Sofia 2
Sofia/Sofia 2 will automatically time the test and report results in 15 minutes – no supervision required
WALK AWAY Mode READ NOW Mode
Flexible Workflow OptionsHow to use Sofia 2
Quidel Together Again
How Run Batch Mode(Multiple Patients at a Time)
Quidel Proprietary Confidential
Batch Processing – DRAFT Not APPROVED(Edited Version)
How to use Sofia 2
Quidel Proprietary Confidential
Batch Processing (Edited Version)
How to use Sofia 2
Quidel Proprietary Confidential
Batch Processing (Edited Version. More details will be sent)
Quidel Proprietary Confidential
How to use Sofia 2
You can document result then enter the next sample
Maintenance Use soft cloth with 70% Alcohol to clean the exterior of Sofia 2. Do not use
soap or other solutions. You may wipe the cassette drawer as well. No expiration date on the Sofia 2
Warranty Quidel warrants that the Equipment will be materially free from defects in materials and
workmanship for a period of twelve (12) months from the date of shipment.
Maintenance and WarrantyHow to use Sofia 2
Quidel Technical Support 1.800.874.1517
Quidel Together Again
Connectivity and Reporting
Quidel Proprietary Confidential
Public Health Health System
15,000 Connected Analyzers
Cloud-Based Data Management
Cloud 1
Cloud 2
Simple, secure and HIPAA compliant de-identified data is automatically transmitted via a secure, cellular network. Data securely stored and available
anytime, from anywhere, for authorized users. De-identified data may be shared with Federal, State and Local health organizations to support public and private
health partnerships. The
De-Identified Aggregation Value
Connection to LAN also allows for Identified data to automatically transmit to device connectivity software. As soon as a test is run, results appear immediately
in the patient’s EHR. There is no requirement for manual data entry, meaning labor can be reassigned to more value adding tasks
Identified Automated Patient Record Keeping
LAN-Based EHR Data Management
Connectivity Information Flow OptionsConnectivity
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1. Manual – Copy the screen to manually document on your log, the instrument will store up to 1000 results
2. USB – Configure Sofia 2 to automatically download all results to a USB stick (vs instrument). • You may purchase a configured Blank USB stick (1-32 GB required)• USB stick must be formatted as FAT or FAT32 (most new ones are already in this format)• If prompted to "scan and fix (recommended)" when USB is inserted into the PC, do not do this. This
will unformat the USB. • Example of USB
3. Purchase a Dymo Printer from Amazon or Quidel• https://quickstart.quidel.com/docs/printer/
4. Interface with your EMR or LIMS System. • https://connectme.quidel.com/docs/lis/sofia-2/
Reporting Options
Dependent upon State Requirements, the following are methods to capture results:
Training Overview
quideltogetheragain.com
Quidel Proprietary Confidential
Home PageWebsite Overview
Menu SelectionWebsite Overview
Online TrainingWebsite Overview
Virtual TrainingWebsite Overview
Menu SelectionWebsite Overview
CertificationWebsite Overview
Order More TestsWebsite Overview
SupportWebsite Overview
Home PageWebsite Overview
Quidel Together AgainReordering
Quidel Proprietary Confidential
Ordering More Tests Evaluate your testing run rate
If you process 75 tests per week plan on ordering at least three kits per week to meet your testing demand
Distribution partners Pricing is loaded with both McKesson and
Medline Contact your Prime Vendor by accessing
the contact information available on the quideltogetheragain.com website
Expand your testing menu by implementing Influenza A+B, RSV, Strep A+, & Lyme
Order More TestsHow to Order More Tests
Allison Leone – [email protected] Miller - [email protected]
Thank You
Quidel Proprietary Confidential 43
