PRE-TEST INFORMATION

Concentric's COVID-19 Test

What is Concentric by Ginkgo’s COVID-19 PCR test?

Ginkgo Bioworks, Inc. (“Ginkgo”) has engaged Rutgers, The State University of New Jersey, acting through RUCDR Infinite Biologics (“Rutgers”) to allow us to provide access to The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay performed in the Rutgers Clinical Genomics Laboratory, a CLIA-certified high complexity laboratory (the “Rutgers Test”).

The version of the Rutgers Test offered by Concentric by Ginkgo is a saliva-based test.

The Rutgers Test being offered by Concentric by Ginkgo is a PCR (polymerase chain reaction)-based test that is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal, oral swabs, or saliva.

A PCR (polymerase chain reaction) test checks for genetic material (viral RNA) produced by the virus. This is used to detect the presence of the virus that causes COVID-19.

Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.

This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration that circumstances exist justifying emergency use of In Vitro Diagnostics (IVDs) for the detection and/or diagnosis of COVID-19, unless it is sooner terminated or revoked (after which the test may no longer be used).

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 nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

Who should get tested?

The Center for Disease Control (CDC) indicates (as of July 2, 2020 update) that there are five populations for which SARS-CoV-2 testing with viral tests (i.e., nucleic acid or antigen tests) is appropriate:

  • Individuals with signs or symptoms consistent with COVID-19
  • Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
  • Asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings
  • Individuals being tested to determine resolution of infection (i.e., test-based strategy for Discontinuation of Transmission-based Precautions, HCP Return to Work, and Discontinuation of Home Isolation)
  • Individuals being tested for purposes of public health surveillance for SARS-CoV-2

Generally, viral testing for SARS-CoV-2 is considered to be diagnostic when conducted among individuals with symptoms consistent with COVID-19 or among asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2 to control transmission, or to determine resolution of infection. Viral testing is screening when conducted among asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification, and surveillance when conducted among asymptomatic individuals to detect transmission hot spots or characterize disease trends. To learn more, visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

How does the test work?

Prior to testing, authorization from a physician is required. This process is enabled by our platform.

After an organization enrolls, its members are invited to sign in to our portal and fill out a health questionnaire. Healthcare providers are provided by PWNHealth, who will evaluate your questionnaire responses and determine who is eligible for testing. PWNHealth is an independent healthcare provider network that provides oversight services and has partnered with Concentric's platform provider, ixLayer.

Eligible individuals can then proceed to the designated Test Center at a specified time in order to collect their sample.

Samples are shipped to our partner laboratory at Rutgers Clinical Genomics Laboratory, and results are communicated back to the individuals and organizations through our portal powered by ixLayer (who provides this portal in compliance with all applicable privacy laws and individual authorization).




What will my COVID-19 PCR test results tell me?

A PCR test can be used to detect the virus that causes COVID-19 on the day of sample collection. If your results are positive, it is important to limit your exposure to other people and continue to monitor your symptoms. If your results are negative, the test did not detect the presence of the virus that causes COVID-19 in the sample you provided.

For more information on positive and negative results associated with the Rutgers Test, please see the patient fact sheet.

After receiving your results, you will have an opportunity to speak with a licensed physician from our healthcare provider network partner, PWNHealth, who can answer any questions you may have about your test results and help determine next steps in care.

Depending on your test results, PWNHealth’s Care Coordination Team may attempt to contact you to notify you of your results and schedule a telehealth consult with a physician or other healthcare provider.

What are the known and potential risks and benefits of the test?

 

Potential risks include:

  • Possible incorrect test results. For more information, please see the below FAQ section “How to interpret the results.”

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and others in your community.

How do I prepare for the test?

You should NOT eat, drink, smoke, or chew gum for 30 minutes before giving your saliva sample.

You do not need to do anything to prepare for the test. You do not need to fast or stop taking any medications before testing. Further instructions will be provided to you at the lab or in your test kit.

Where can I get more information?

We encourage you to consult our FAQ or contact us at support@concentricbyginkgo.com.

 
If you feel like you are having a medical emergency, please call 9-1-1​. You should contact your healthcare provider​ if your symptoms get worse or you experience any new symptoms. ​​If you are experiencing trouble breathing, persistent pain or pressure in your chest, new confusion, inability to wake or stay awake, bluish lips or face, or any other symptoms that are severe or concerning to you, please seek immediate medical care.
 

Frequently Asked Questions

About the test

When to use the test

How to interpret the results

for businesses & organizations

Contact us if you are an organization seeking to understand how testing can help you and your community.

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POWERED BY GINKGO BIOWORKS

Concentric is powered by Ginkgo Bioworks, a synthetic biology company in Boston. Biology is the most advanced manufacturing technology on the planet. We're inspired by the power of biology and driven to build tools that make it possible to access that power in new ways. For press inquiries, please email us at press@ginkgobioworks.com.