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BD, the BD Logo, the BD Veritor and BD Synapsys are trademarks of Becton, Dickinson and Company. © 2020 BD and its subsidiaries. All rights reserved.

Prepared for HHS

September 3, 2020

Harness the power of simplicityBD Veritor™ System for Rapid Detection of SARS-CoV-2

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• BD Veritor™ for Rapid Detection of SARS-COV-2

• Support Enablement

• Q & A

Agenda

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The BD Veritor™ Plus System for rapid COVID-19 (SARS-CoV-2) testingThe portable, easy-to-use BD Veritor™ Plus System provides reliable COVID-19 (SARS-CoV-2) results in 15 minutes

Simplify SARS-CoV-2 Testing

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Easy to UseReliable and fast results

Automated Reporting BD Capabilities

• One platform for Flu A+B, RSV,

Group A Strep assays & SARS-

CoV-2

• Similar workflow to the BD

Veritor™ System Flu A+B Assay

• Portable instrument

• Ease of implementation &

training

• EUA authorized

• Objective read (Digital Immunoassay)

• Delivers results within same patient visit -15 min

• May improve patient experience

• Manufacturing capabilities ( up to 2.8M SARS-CoV-2 tests per week by the end of September)

• 10,000 new instruments end of September

• Global supply chain

• Broad portfolio

• Technical Service & support

• Training (eLearning capabilities)

The BD Veritor™ System for Rapid Detection of SARS-CoV-2 provides a solution that is easily scalable

• Bi-directional LIS connectivity

• Anytime Anywhere Access Real-time

• Robust Cybersecurity

• Reports and analytics

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When to test for SARS-CoV-2Different tests are appropriateat different times and fordifferent objectives. Which testis appropriate depends ona variety of criteria, including:

What’s the testing objective(e.g. inform diagnosis, confirm diagnosis,guide quarantine, clear for returnto work)?

What’s the patient’s conditionand potential exposure(e.g. highly symptomatic, mildly symptomatic, asymptomatic)?

What’s the patient care settingand access to a lab?

How quickly do you needan answer?

Progression of infection1,2

References:1. Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020;323(22):2249–2251 2. Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 26, 845–848 (2020)

Detection unlikely PCR - likely positive PCR - likely negative

Ag test - likely negative

Antibody detection

Ag test - likely positive

Progression of infection

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Product specifications

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BD Veritor™ System for the Rapid Detection SARS-CoV-2

Detection of SARS-CoV-2 antigen (nucleocapsid protein)in nasal swabs

Symptomatic patients only (Under EUA, Use is at the discretion of the treating HCP)

Direct nasal swabs (only authorized sample type)

Assay incubation time of 15 min, with approximate 1 minute sample preparation time*

Can be used in High to Moderately Complex and CLIA-waived environments

* Package insert 500048916

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BD Veritor™ System For Rapid Detection of SARS-CoV-2 (SKU #256082)

Kit contents

30 individual wrapped test cassettes

30 pre-filled reagent tubes

30 nasal swabs

Positive and negative controls

Package insert ONLYAVAILABLE ELECTRONICALLY (paper copy expected in kits in Sept)

Quick reference instructions

Nasal Sampling process instructions

What is not included in the kit, but needed to perform the test:

BD Veritor™ Plus System Analyzer (Cat. No. 256066)

Gloves

Appropriate PPE

8BD, the BD Logo, the BD Veritor and BD Synapsys are trademarks of Becton, Dickinson and Company. © 2020 BD and its subsidiaries. All rights reserved.

External controls

Swab controls (one positive and one negative) are provided with each BD Veritor™ System for Rapid Detection of SARS-CoV-2

These controls provide quality control material to assess reagents performance and to evaluate if the operator can properly perform the test and get valid results

Each new kit lot

Each untrained operator

Each new shipment of test kits

As required by internal quality control procedures and in accordance with local, state and federal regulations or accreditation requirement

Positive and negative controls should be run once for:

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Workflow similar to CLIA-waived BD Veritor™ System Flu A+B

BD Veritor™ System for Rapid detection of SARS-CoV-2

Detection of SARS-CoV-2 antigen in samples processed from nasal swab

Assay time of 15 min, with 1 min of hands on-time*

* Taken from online resource: bd.com/bd-Veritor-plus-system-for-rapid-covid-19-sars-cov-2-testing Simple Use Section. 20/08/2020

Collect patient sample Remove cap & insert swab into tube

STEP 1 STEP 2Mix sample with reagent, then remove swab

STEP 3Close dispensing cap, then dispense sample into test device

STEP 4Insert test device into the

analyzerFor Walk Away mode, insert

immediately

For Analyze Now mode, insert after

processing sample

STEP 5


Insert and walk-away

Easy Sample Processing

BD Veritor™ Plus Analyzer workflow allows batching using Analyze Now mode of the instrument

*5 minute incubation for Group A Strep*10 minute incubation for Flu A+B or RSV*15 minute incubation for SARS-CoV-21

1See slide 27 for special information about this product

3,500 test reads, printing and expandable capabilities

Results reported in minutes

Read test-results in <10 seconds

Analyze Now Mode Walk Away Mode

5-15 min*

5-15 min*

Incubate on bench top


Leveraging the study done by Medical College of Wisconsin (2019, ASM), BD Veritor Flu A+B data suggests that ~10 tests can be processed in

20 min by one operator and one BD Veritor Analyzer (i.e. ~30 tests/one hour)

• This includes approximately one min specimen prep, then staggering cartridge inoculation and read

The BD Veritor System for Rapid Detection of SARS-CoV-21 has a similar workflow to BD Veritor Flu A+B, with the exception of a 15 min

incubation period

• Calculations show an operator could potentially process ~10 tests/25 min for SARS-CoV-2 (~24 tests/one hour)

• Calculations for two operators using one BD Veritor Analyzer show potentially doubling the capacity (~60 tests/hour for Flu A/B) and (~48 tests/hour for

SARS-CoV-2)

• Calculations for an 8 hr shift (one operator and instrument)= Flu A+B of ~240 tests/8 hours; SARS-CoV-2 of ~192 tests/8 hours

Parameters to consider: Freshly collected specimens should be processed within 1 hour. After processing the swab in the extraction reagent, the sample

should be analyzed within 30 minutes

BD Veritor™ System has batching capability in Analyze Now workflow

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Add 3 drops of sample, incubate 15 minfor SARS-CoV-2

Reads in less than 10 seconds~1 min prep time per sample, prepared sample in reagent vial must be used

within 30 min

Collect nasal swab (15-20 sec per sample), Swab samples must be processed

within an hour

~10 tests per 25 min for SARS-CoV-2

1See slide 20 for special information about this product

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Clinical Performance

BD Veritor™ System for the Rapid Detection SARS-CoV-2

226 direct nasal swabs prospectively collected and enrolled from individual symptomatic patients (within 5 days of symptom onset) who were suspected of COVID-19

21 geographically diverse sites across the United States

Performance of the BD Veritor System Assay was compared to results of a nasopharyngeal or oropharyngeal swab stored in 3 mL viral transport media tested with an Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2

PPA* NPA*

BD Veritor™ System for Rapid Detection of

SARS‐CoV‐2 kit

84% (95% C.I. 67-93%)

100%(95% C.I. 98-100%)

No cross-reactivity with other human coronavirus 229E, OC43, NL63 was observed

No cross-reactivity with Influenza A, Influenza B, SARS, MERS, among others. For full list please refer to package insert

* Package insert 500048916

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† The intended use of the BD Veritor System for Rapid Detection of SARS-CoV-2 assay only includes those who are suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms.

• • This test has not been FDA cleared or approved;• This test has been authorized by FDA under an EUA for use by authorized laboratories;• This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

References: 1. BD Veritor System for Rapid Detection of SARS-CoV-2 package insert. Franklin Lakes, NJ: Becton, Dickinson and Company. *CDC, accessed July 21, 2020 @https://www.cdc.gov/ coronavirus/2019-ncov/covid-data/covidview/index.html. **At a prevalence of 10%; the negative predictive value is the probability that persons with a negative test result truly do not have the disease. ***At a prevalence of 10%; the positive predictive value is the probability that persons with a positive test result truly have the disease.

Simplify COVID-19 Testing

BD, the BD Logo, the BD Veritor are trademarks of Becton, Dickinson and Company. © 2020 BD and its subsidiaries. All rights reserved.

Scanning capabilities facilitate traceability and may reduce manual transcriptions errors. Information that can be scanned in includes:

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BD Veritor™ InfoScan module

Features and benefits

• Data access options for traceability

• The BD Veritor InfoScan module is necessary to scan the USB unlock barcode sticker provided with the BD Veritor Plus Analyzer, to unlock the USB port on the instrument. If the USB unlock barcode sticker is lost, please contact BD technical services

• Once the USB port is unlocked, data is downloadable using the data download USB cable (provided with the BD Veritor InfoScan) to connect the BD Veritor Plus Analyzer to a local computer. The data file will be downloaded as a .CSV file

• Print enabled – printer purchased separately

• Operator ID

• Specimen ID

• Kit Lot information

Barcode scanner can read the full 128 ASCII character set which includes all U.S.

keyboard characters.

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BD Veritor™ Plus System connectivity with BD Synapsys™ informatics

BD Veritor™ reader sends results via USB

BD Veritor™ Plus System

Connect Intel NUC

BD Synapsys™ web and DB server

BD Synapsys™ informatics sends results to LIS/EMR via ASTM/HL7

Anytime Anywhere Access Robust CybersecurityBi-directional

LIS ConnectivityReports & analytics

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E-Learning Platform

Maximizing the capabilities of the BD Veritor™ Plus System BD offers two supporting resources to help users get started with their online training

BD’s eLearning platform enables users to quickly train staff and implement point-of-care testing

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Continued Support

bdveritor.com/bd.com/COVID-19

https://www.bdveritor.com/

https://www.bd.com/en-us/offerings/capabilities/microbiology-solutions/point-of-care-testing/bd-veritor-plus-system-for-rapid-covid-19-sars-cov-2-testing

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Our approach to implementation

Step 01 Step 02

Step 04Step 03

Develop customized plan

Customizing our services and tools

to best fit your implementation needs

Your needs

Understanding your specific

implementation challenges and

needs

Dedicated customer service, BD

technical support, and eLearning platform

- just a few tools we use to make sure

you continue to be successful

Deployment

Deployment which includes in-

person “train the trainer” programs

as well as virtual training and online

tools

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2

4Ongoing support


Thank you!

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Special information applicable to the BD VeritorTM System for Rapid Detection of SARS-CoV-2

For use under Emergency use Authorization only

This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or

revoked sooner

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