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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.
The best way families can support school testing is to provide their consent to allow their student to participate. Working together, schools and families can be advocates for community wellbeing; participating in pooled testing empowers you with data that can help safeguard the health and wellbeing of teachers, students, and your community.
Only students with completed consent forms are able to participate in testing. Schools manage gathering consent forms from families either using processes that already exist at their school or using our online platform. Once consents are collected, the testing team at a school will receive a roster of students whose legal guardians have given consent. This team may be composed of principals, health services staff, and teachers.
Our pooled test provides a result for an entire classroom, not for individuals. So, in the case of a positive pool, the school would know that at least one person in the class is likely positive but would not know the specific student.
We provide test results directly to schools, so the school will communicate with you about results. We take privacy concerns very seriously and will never use test results for any reason other than to provide your school with knowledge to help make decisions about safeguarding your community and continuing in-person learning. Click here to learn more about how we protect the privacy of students and others who use our pooled test.
Schools often follow up positive pools by providing resources for individual testing. For instance, the state of Massachusetts recommends that schools follow up positive pools with rapid tests that they provide. Please check with your school about its specific guidelines and available resources.
If a student has tested positive for COVID-19 within the last three months, they should not be included in pooled testing because they may still produce a positive test result. This is due to the fact that our test may detect leftover viral particles in a student’s nose.
Students swab their own noses with a short swab that goes only half an inch into the nostril. A support staff or school administrator like a nurse observes the students perform their swabs from a safe distance, but there is no physical contact.
If students have trouble performing the swabbing, a nurse or other trained staff member Concentric or the school provides can help. However, the test is so easy that kindergarteners typically can do it with no issues.
We designed the test to take as little class time as possible. It usually takes 10-15 minutes to test an entire class for the first time and speeds up after the first day.
No, teachers do not touch the swabs used by students. Students self swab. Our service also offers support staff to help run school testing programs. If a school doesn’t use our support staff, the school’s testing team (which can be school administrators, nurses, teachers, or support staff) only need to open the clean, empty collection tubes and then later close and wipe them with an alcohol wipe we provide after the students drop their swabs into the tube.
Some schools conduct testing outdoors or at a central location, like a gym. Others conduct testing in classrooms. In that case, teachers observe from a safe distance while students self-swab.
Some schools include teachers in their classroom pools. Others test teachers and staff separately, especially if they move around to different classrooms. Check with your school about their specific testing strategy.
Testing an entire classroom usually takes about 10-15 minutes and speeds up after the first day. The students become pros at swabbing their nose.
In our experience, not only can kindergarteners perform their own swabs, they often do the best of all the grades. Our test can be used by any grade, K through 12.
Click here to get started! You can schedule time with our team to discuss your school’s options.
We’re here for you! The first thing we do with new customers is provide them with comprehensive instructions explaining how to set up and run a testing program. We provide you with all the information you need to make sure everything runs smoothly. As of August 2021, we’ve provided our pooled testing service to over 1,000 schools; we’ve learned a lot about what schools need and are constantly improving our service to better serve you.
Pooling covers many people with just one test; this dramatically reduces the cost of testing without sacrificing accuracy, saving your school’s resources. Pooling can also take less coordination, effort, and time from schools, and we’d rather schools use their time with students to educate and enrich them.
If the pooled test result is negative, it’s unlikely anyone is infected and students continue learning uninterrupted. If the pool result is positive, someone in the classroom is most likely sick; you can then follow up to stop an outbreak—for just the cost, time, and effort of one test.
When a positive pooled test result occurs, a pod can use diagnostic tests to help confirm who is sick. The decision to do this follow-up testing is up to each school. A common next step is to provide individual testing for students in the positive pool.
All students in a class, pod, or cohort swab their own noses and place their samples in a single tube (that’s the pooling step). The samples in that tube are then run as a single sample, using one test. See it in action here.
If students have trouble performing the swabbing, schools can provide a nurse or other trained staff member to help. However, the test is so easy that kindergarteners typically can do it with no issues.
The CDC recommends that schools use layered prevention strategies—including testing—to support full-time in-person learning. The CDC also recommends testing at least once per week when using testing programs like our pooled service. However, they suggest considering testing more than once per week in areas with higher rates of community spread. School communities should develop a testing strategy—including the frequency of testing—to meet their community’s needs. (CDC guidance as of August 2021)
You know the old saying: “knowledge is power.” Tools like pooled testing empower you to make great decisions. Without knowing the specific prevalence of COVID-19 in your classrooms, it’s tough to make informed decisions about safeguarding your community, returning to school, or continuing in-person learning.
No. Since pooled tests do not provide results for individuals, the results are not reported to public health authorities. We only share the results of pooled tests with the individuals that you tell us to.
One of our pooled tests combines swabs from 5 to 25 people. There are different regulations for tests that provide individual results and tests that provide “population-level” results—that is, results for groups of people. Tests that do not give individual results, like our pooled test, do not require FDA authorization. For more information on how different types of tests are regulated, visit this CDC webpage to learn more.
Each pool consists of samples from 5 to 25 people.
Molecular tests, which detect the genetic code of the virus, are typically highly accurate at detecting the virus that causes COVID-19. Click here to read our validation reports for our lab at Ginkgo and our partner labs across the country. Fair warning: the information is a bit dense!
Our pooled test uses short nasal swabs that go just a half inch into the nostril; think: cotton swabs. We do not use the long “brain tickler” swabs for our pooled test. We like to say, “if you can pick your nose, you can take this test!”
We offer a pooled test that can test 25 people using one test. Our pooled test works by detecting the genetic code of the virus that causes COVID-19. These tests are sometimes known as “molecular tests” or “PCR tests.”
For individual diagnostic testing, we offer rapid antigen and PCR tests. Both of these types of tests can be used as a follow up to pooled testing, to help pinpoint infections.
Our pooled test was developed specifically for K-12 schools. We also provide testing for colleges, corporations, senior living facilities, and more. If you have questions about whether Concentric is a good fit for your school or organization, contact us.
Ginkgo Bioworks is a company that uses the most advanced technology on the planet — biology — to solve problems. Understanding how biology works allows us to do all kinds of things: provide COVID-19 tests for millions of people; clean polluted wastewater; improve vaccine manufacturing; and so much more! Concentric is our way of using what we know about biology to help communities during the pandemic.
Concentric by Ginkgo is a COVID-19 testing service that aims to make testing accessible for every school in America. We use a method called pooling to dramatically lower costs without sacrificing accuracy. Pooling makes it possible to test every student in America every week.