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

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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 Again

HHS Nursing Home Program Training

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 Again

Introduction to Sofia and Testing

Quidel Proprietary Confidential

◼ 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

◼ Clinical study using 209 direct nasal swabs, patients 5 days or less from onset of symptoms

99.5% Overall Agreement*96.7% PPA (sensitivity)100% NPA (specificity)

We have met the sensitivity hurdle required by the FDA for Emergency Use Authorization, and currently have 30 positive clinical samples within an n=209 study using direct nasal swabs of patients at 5 days or less from onset of symptoms. We recommend running direct swabs for the best performance.

*Please refer to Sofia SARS Antigen FIA Package Insert.

Reference Extracted RT-PCR

assay 95% CI

POS NEG Total PPA 96.7% 83.3% 99.4%

Sofia SARS Antigen FIA Assay

POS 29 0 29 NPA 100.0% 97.9% 100.0%

NEG 1 179 180 PPV 100.0% 88.3% 100.0%

Total 30 179 209 NPV 99.4% 96.9% 99.9%

Prevalence 14.4% 10.2% 19.8%

% agreement 99.5%

Quidel Together Again

How to Use Sofia 2

Cat. #20374 – 25 Tests per kit – nasal swabCat. #20383 – 25 Tests per kit – nasopharyngeal swab (not used in nursing homes)

▪ 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.

Kit Facts

▪ The Sofia SARS Antigen FIA kit contains:▪ Individually Packaged Test Cassettes (25)

▪ Reagent Tubes (25) (glass tubes)

▪ Reagent Solution (25): (looks like eyedrops)

▪ Sterile Nasal Swabs (Kit #20374)

▪ Small, Clear 120 µL Fixed Volume Pipettes (25)

▪ SARS Positive and negative Control Swabs (1)

▪ Package Insert (1)

▪ Quick Reference Instructions (1)

▪ Kit Addendum (1)

▪ QC Card (located on kit box)

▪ 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

Step 1

Enter Patient ID or Order number if required. Otherwise skip.

Make sure you are in WALK AWAY Mode (analyzer times for you).

Select “Run Test” (arrow button). Insert the Test Cassette into the drawer and close

Prepare Your Sample

Step 2

Run a Patient SampleHow to use Sofia 2

Step 4

Step 3

Touch the arrow (bottom corner), insert Test Cassette. In 15 minutes or less you will have a result.

The system will prompt you for status, toggle to “Out Patient” then enter the patient’s age.

Run A Patient SampleHow to use Sofia 2

Quidel Together Again

How Run Batch Mode(Multiple Patients at a Time)

Batch Processing – Draft Not Approved How to use Sofia 2

Batch Processing – Draft Not Approved How to use Sofia 2

Quidel Proprietary Confidential

Batch Processing – Draft Not Approved How to use Sofia 2

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 Together Again

Connectivity and Reporting

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

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

Training Portal Enhancements – New

Training Portal Enhancements – New

Training Portal Enhancements – New

Quidel Together Again

Reordering

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 at allison.leone@Quidel.com

Cheryl Miller at cmiller@Quidel.com

Thank You

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