Concentric’s COVID-19 Testing Service

Information for Test Takers

There are many causes of fever, cough, and shortness of breath. COVID-19 is just one condition that may cause these symptoms. This test does not rule out the possibility of other illnesses and infections that may be present instead of or in addition to COVID-19.

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.

Ginkgo Bioworks, Inc. (“Ginkgo”) has engaged Infinity BiologiX LLC (“IBX”) to allow us to provide access to the Infinity BiologiX TaqPath SARS-CoV-2 Assay (the “IBX Test”) performed in the Infinity BiologiX Genomics Laboratory, a CLIA-certified high complexity laboratory.

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

The IBX 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 produced by the virus (i.e. the nucleic acids that compose the viral RNA). This is used to detect the presence of the virus that causes COVID-19.

No. This PCR 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.

Ginkgo has secured access to rapid antigen test kits from Access Bio, a global in vitro diagnostics company. This test is authorized for use at the point-of-care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The Access Bio test being offered by Concentric by Ginkgo is an antigen-based test that is designed to detect the virus that causes COVID-19 in respiratory specimens, specifically nasopharyngeal swab specimens.

An antigen test checks for protein material produced by the virus. This is used to detect the presence of the virus that causes COVID-19.

No. This rapid antigen 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 proteins from SARS-CoV-2, not for any other viruses or pathogens.

The IBX PCR test (which checks for the viral nucleic acids) and the Access Bio rapid antigen test are viral tests. The CDC recommends viral tests to diagnose infection with COVID-19. Unlike viral detection methods that can detect currently infected persons, antibody tests help determine whether the individual being tested was previously infected, even if that person never showed symptoms. Antibody tests for COVID-19 can play an important role in surveillance and epidemiologic studies, which can provide insights into the transmission dynamic of the virus among the general population. The CDC recommends getting viral tests in certain situations. To learn more, visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

The CDC indicates (as of September 18, 2020) that a healthcare provider may determine that you should get tested based on a number of considerations, including:

• If you have symptoms of COVID-19
• If you have been in close contact, such as within 6 feet of a person with documented SARS-CoV-2 infection for at least 15 minutes and do not have symptoms
• If you are in a high SARS-CoV-2 transmission zone and attended a public or private gathering of more than 10 people (without universal mask wearing and/or physical distancing)
• If you work in a nursing home
• If you live in or receive care in a nursing home
• If you are a critical infrastructure worker, healthcare worker, or first responder
• You are a member of a specific group of people that a healthcare provider or public health official recommends for testing (e.g., pregnant women admitted for labor and delivery, surgery).

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 providers, ixLayer and One Codex.

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 Infinity BiologiX Clinical Genomics Laboratory, and results are communicated back to the individuals and organizations through our portals powered by ixLayer and One Codex (who provides this portal in compliance with all applicable privacy laws and individual authorization).

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 IBX 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.

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 providers, ixLayer and One Codex.

Eligible individuals can then proceed to the designated Test Center at a specified time in order to collect their sample. This test is conducted by a nasal swab. The nasal swab test requires insertion of a swab into your nose. It is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings.

Test results for the Access Bio rapid antigen test are interpreted at 10 minutes; results are communicated back to the individuals and organizations through our portal powered by One Codex (who provides this portal in compliance with all applicable privacy laws and individual authorization).

Your test results may imply that you are currently infected with COVID-19, but your results will need to be confirmed by a COVID-19 PCR test. If your results are positive, it is important to isolate immediately and continue to monitor your symptoms. If your results are negative, this may suggest the virus was not present in the sample you provided. However, if you’re having symptoms of COVID-19, you may need to be tested with a COVID-19 PCR 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.

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.

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.

• Centers for Disease Control and Prevention: About Coronavirus Disease 2019
• World Health Organization: Coronavirus disease (COVID-19) outbreak
• PWNHealth: COVID-19 FAQs
• Centers for Disease Control and Prevention: Frequently Asked Questions
• Centers for Disease Control and Prevention: Overview of Testing for SARS-CoV-2
• Spectrum DNA Collection Device Instructions

Information for Test Takers Younger than 18 Years of Age

If your child’s condition changes before you are able to obtain the test or the test result, please contact your pediatrician or visit your local emergency room as soon as possible.

Testing is available for children 4 years of age and older. If your child has new or worsening emergency warning signs, such as 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, call 911 or seek emergency medical attention instead of ordering this test.

Your child should get tested if:

• They have symptoms of COVID-19.
• They live in or visit a place where people reside, meet, or gather in close proximity. This can include homeless shelters, group homes, detention centers, playgroups, schools, church, camp, daycare, etc.
• They have been in close contact with someone with confirmed COVID-19 within the past 14 days.

This test may also be helpful if:

• Your child may have been exposed and has an underlying condition that may increase the risk for severe disease.

If you have any other questions, we recommend that you speak with your child’s primary healthcare provider about testing recommendations to see if testing is right for your child at this time.

Your child’s rapid antigen test results may imply that they are currently infected with COVID-19, but the results may need to be confirmed by a COVID-19 PCR test. If your child’s results are positive, it is important to help them isolate immediately and continue to monitor their symptoms. If your child’s rapid antigen results are negative, this may suggest the virus was not present in the sample your child provided. However, if your child is having symptoms of COVID-19, they may need to be tested with a COVID-19 PCR test.

• It is important to set realistic expectations. While some children may enjoy the novelty of spitting into a tube, some children may find the testing experience to be stressful or worry generally about the need to take a test. Take time to reassure your child and after the test, praise and comfort your child as needed.
• Make sure your child is tested when they are less likely to be tired or hungry. The test requires that your child should not eat, drink, smoke, or chew gum for 30 minutes before giving their saliva sample; however, your child does not need to fast or stop taking any medications before testing for longer than the required 30 minutes. Eating and drinking plenty of water before the 30 minute refraining period will help lower the risk of lightheadedness and can help make the process smoother.
• For small children, it may be helpful to talk about feelings or practice calming techniques before the test. You can do this by making a game of staying still or practicing breathing exercises with your child. It may also be helpful to distract your child during the procedure.
• Before testing, discuss any concerns and questions with your child’s primary healthcare provider. Further instructions will be provided to you at the lab or in your test kit.

• Centers for Disease Control and Prevention: Caring for Children
• World Health Organization: COVID-19 Resources for Care for Young Children
• PWNHealth: COVID-19 FAQs

The PCR and antigen tests (together referred to as “tests”) have not been cleared or approved by the Food and Drug Administration (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 separate EUAs for these tests are 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. The EUAs will remain in effect (meaning these tests can be used) for the duration of the COVID-19 declaration justifying emergency of In Vitro Diagnostics (IVDs) for the detection and/or diagnosis of COVID-19, unless the EUAs are terminated or revoked by FDA (after which these tests may no longer be used).

The IBX PCR test has been authorized by the FDA under an EUA for use by authorized laboratories. The IBX PCR test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Access Bio rapid antigen test has been authorized by the FDA under an EUA for use at the point-of-care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The Access Bio rapid antigen test has been authorized only for the detection of protein from SARS-CoV-2, not any other viruses or pathogens.