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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:
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:
Potential benefits include:
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.
IBX PCR Test:
Access Bio Antigen Test:
We encourage you to consult the resources listed above, the rest of our FAQ, or our Support Center.
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:
This test may also be helpful if:
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.
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.
COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally, including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.).
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 Clinical Genomics Laboratory, a CLIA-certified high complexity laboratory.
Ginkgo has also 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 IBX Test 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.
The version of the IBX Test offered by Concentric by Ginkgo is a saliva-based test.
Important information about the IBX PCR test can be found here:
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.
The Access Bio test is a rapid antigen test. The test is authorized for use as a visually read lateral flow immunochromatographic assay for the detection of SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. The SARS-CoV-2 viral antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection.
Important information about the Access Bio rapid antigen test can be found here:
FDA EUA Letter
Access Bio IFU
FDA HCP Fact Sheet
FDA Patient Fact Sheet
Antigen tests detect the presence of a specific viral antigen, which implies current viral infection. This determines if an individual is actively infected with COVID-19 and can spread it to others. Antigen tests are relatively inexpensive and can be used at the point-of-care, showing results in about 15 minutes.
A PCR test is typically conducted either by a nasal swab, throat swab, or saliva collection. A nasal swab or throat swab test requires the insertion of a swab into your nose and/or the back of your throat. A saliva test requires providing a sample of your spit into a collection tube.
The version of the IBX Test offered by Concentric by Ginkgo is a saliva-based test.
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.
Prior to testing, authorization from a physician is required.
Test results for the Access Bio rapid antigen test are interpreted at 10 minutes.
The school will retain all of the consent forms for the students. At the beginning of each testing day, teachers will be given a roster of students whose legal guardians have given consent. Only students with completed consent forms will be able to contribute to the pooled test.