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:
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.
Surveillance test results, including from pooled surveillance testing, are not submitted to the local, state, tribal, or territory health department.
The school is responsible for collecting consent forms and following up with parents after it obtains the results from Ginkgo.
Please coordinate with the Test Champion on next steps.
Please coordinate with your Test Supervisor on how staff testing will be conducted at your school. Teachers can be part of the classroom pool or part of a pool with other staff members. Alternatively, teachers and staff may be tested individually on a routine basis.
The whole process is designed to have minimal impact on in-class learning. Typically, it takes about 10-15 minutes depending on how comfortable the class is with the procedure. We’ve noticed in our pilots that the process speeds up after the first testing day.
Though we designed the protocol to be safely carried out by teachers, we understand that not all teachers have the same comfort level with handling biohazard material. Please coordinate with your Test Supervisor to arrange for a school nurse or healthcare professional to help with this process.
Please coordinate with your Test Supervisor on how testing will be run at your school. Typically, teachers safely open empty collection tubes at the start of sample collection and close and sanitize the tube at the end of sample collection. Because we designed the protocol to not require a school nurse or healthcare professional, the samples are safe to handle with the necessary PPE as outlined by your State and Public Health Officials. The minimal PPE to handle these samples is a face mask and gloves.
Teachers do not administer the tests. The testing protocol for pooled classroom testing is a self-collected anterior nasal swab. Students will collect their own swabs. In case students cannot collect their own swabs, a school nurse or outside healthcare professional can administer the test.
Teachers oversee the classrooms on test days. Teachers will observe students while they self-collect samples from a safe distance and will ensure a smooth collection process either inside the classroom or at a central collection spot.
If you have a positive PCR test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this PCR test can give a positive result that is wrong (a false-positive result).
Positive results from a rapid antigen test indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses.
In the case of a positive result, a licensed physician from PWN Health’s Team will contact you to provide clinical guidance on the meaning of those results. Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
A negative PCR test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative PCR test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness.
However, it is possible for this PCR test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the PCR test is negative. If this is the case, your healthcare provider will consider the PCR test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.
Negative rapid antigen test results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative rapid antigen test results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative rapid antigen test results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
It is important that you work with your healthcare provider to help you understand the next steps you should take.
There is a very small chance that this rapid antigen test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. Your healthcare provider will work with you to determine how best to care for you based on the rapid antigen test results along with medical history, and your symptoms. Please see the FDA Patient Fact Sheet for more information.
It is possible for this rapid antigen test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID- 19 even though the rapid antigen test is negative. If your rapid antigen test result is negative, your healthcare provider will consider the rapid antigen test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay. Please see the FDA Patient Fact Sheet for more information.
We recommend that you consult the Coronavirus (COVID-19) Isolation/ Quarantine information PDF provided by PWNHealth.
For specific information about the limitations of the IBX Test, please refer to the patient fact sheet. You may also refer to the questions above, “What does it mean if I have a positive test result?” and “What does it mean if I have a negative test result?” questions above.
A PCR test may not detect the virus in early stages of infection. In addition, a PCR test may not detect the virus if there was a problem with your sample, such as when the sample is not collected as directed. There is also the possibility of a false negative (a negative result that is incorrect) even if you’ve had recent exposure to the virus along with symptoms consistent with COVID-19.
A rapid antigen test may not detect the virus if there was a problem with your sample, such as when the sample is not collected as directed. There is also the possibility of a false negative (a negative result that is incorrect) if you’ve had recent exposure to the virus and/or symptoms consistent with COVID-19.
There has been very positive feedback and support from school staff, students and parents during our initial pilots. “The Ginkgo student-administered COVID testing is an easy process for my scholars,” said Matt Condon, principal of Collins Middle School in Salem, MA. “Our scholars learn and can be an active participant in the community fight of the spread of COVID-19.”
Ginkgo does not require any sort of commitment to continue with our services after the pilot. It is entirely left to the discretion of the school to continue or to stop the service.
We have designed our testing procedure to be as straightforward as possible, but we understand that these are difficult times. Our tests can be self-administered by children and require minimum supervision by staff. From what we have seen so far, a classroom is able to collect samples within 15 minutes (outside of registration, onboarding, etc., which can take up to an hour or two). Ginkgo does not provide onsite support, but other vendors are available to support swabbing and other logistics if required.
The school will decide how often a classroom participates in testing.Many schools have chosen to conduct weekly testing.
Our pilot program runs from Jan 4th to Feb 4th. Schools can begin testing at any point during this period. All sample collection during this pilot phase will end on Feb 4th.
The pilots will take place throughout the month of January. The school will decide on a testing schedule and communicate about testing dates.
There are no financial arrangements between Ginkgo/Concentric and the school for participation in this pilot program.
The protocols we have developed have already been tested at our pilot schools in December and have proven to be successful. Our goal for expanding our pilot program in January is to further optimize and scale the process for sample collection and processing, to ensure that on-site protocols work for schools of all sizes and for all age groups and abilities. Schools will receive test results and have an opportunity to develop communication strategies for their teachers, families, and students, as well as determine what logistics, training, and infrastructure works for them to provide this kind of testing for their community.
According to the latest information, about $42.5 billion in federal funding is available for K-12 public schools for testing. Additionally, CARES Act funds no longer expire on December 31st and can be used for testing. We’ve also seen local education foundations and nonprofit organizations support K-12 testing efforts.
We do not charge different prices for different districts.
When we launch, we estimate the cost to be about $150 USD per pool of 25+ people (~$5-7 per student).
There is no cost associated for the school or the participants during the pilot phase. Schools however will incur costs in terms of staff time for coordination and communication associated with the implementation of the pilot.
A school district can enroll all of their schools in this pilot program.
We have started piloting this program at both private and public schools in Massachusetts, Rhode Island and Louisiana. Five schools were part of the December pilot program. We aim to add 200+ schools across the nation into our program in January.
According to a recent white paper by The Rockefeller Foundation, “there is a challenge in setting vaccination priorities — supporting those most at risk of illness and death like health care workers and nursing home residents — and the need to reopen schools, manufacturing facilities, businesses and other public venues. We read that teachers may not receive vaccines until at least the second wave of vaccinations, which is unlikely to occur until spring or later. Students will likely have to wait until the third or fourth waves, which may not arrive until fall.” Given this information, we do believe that testing at the classroom is important and will not only benefit schools, but also the community at large.
In most cases, one classroom is considered one pool. If the classroom size is too small, multiple classrooms can be pooled together. Currently, the minimum number for a pool is 5 while the maximum for a pool is 25 individual swabs.
The decision to do follow-up testing is up to the discretion of the school.
The decision to quarantine a classroom is up to the discretion of the school based on its established policies.
Yes, the protocols for pooled testing and individual testing are different. For classroom pooling, individual swabs are collected by each student in a class and combined into one collection tube, which is then run as a single test.
We have multiple controls in the test process: RNA extraction controls, high and low positive controls using spiked in virus, negative controls, and rt-PCR controls.
Yes. We recommend that individuals who have recently tested positive for COVID-19 not be included in pooled testing for at least 3 months post recovery as they may still produce a positive test result.
During the early pilot phase we are processing samples in the Ginkgo lab facility. We are in the process of building a network of lab partners across the nation to increase testing capacity. Local partner labs can also support follow up testing in necessary after a positive pool result.
Our test is not FDA-approved, cleared or authorized. Our test was developed following the FDA’s guidelines for molecular diagnostic tests. The test has been validated and is conducted in our CLIA-certified lab located in Boston, Massachusetts. A copy of the test validation report is available upon request.
This is a self-collected anterior nasal (AN) swab. Unlike a nasopharyngeal swab, which reaches deep into the nose to take a sample from the back of the throat, an AN sample is taken from the lower part of the front of the nose , at least half an inch inside the nostril. This method both increases comfort and requires less PPE than nasopharyngeal swabs. Instead of a healthcare provider performing the test, students can easily collect their own samples under teacher supervision.
This method of testing uses a molecular test that detects the presence of the viral RNA. In Ginkgo’s lab, we use a molecular test similar to qPCR based on a technology known as next-generation sequencing (NGS), in which a small part of the coronavirus genome is sequenced or “read” to determine whether or not that virus is present in a sample. We are also partnering with and validating PCR labs to run pooled molecular tests.
We have validated our Concentric by Ginkgo next-generation sequencing (NGS) assay both for individual and pooled samples. When analyzing individual samples (which is not the planned use of the assay for pooled testing pilots), we found a 96% percent positive agreement and 100% percent negative agreement with both nasopharyngeal and anterior nasal swab clinical samples run with a high sensitivity RT-qPCR assay. When testing contrived 35-dry swab pooled samples at no virus (0 copies/mL), low viral concentrations (1500 copies/mL) and high viral concentrations (75,000 copies/mL), we found 100% concordance with the expected result.
Classroom pooling is a method of surveillance testing where lower nasal swabs from everyone in a class are mixed together and tested with a single molecular test. This gives schools and districts population-level data to make informed public health decisions at a fraction of the cost of individual testing plans.
No, the results are sent to the school. Please contact your school administration for more information.
As this is a pilot, turnaround time is not guaranteed. However, we have been returning results to our pilot customers within 36-72 hrs after the Ginkgo lab receives the sample.
We will be communicating results on an online website and will communicate results using this website when it is ready.
One of our pilot schools has demonstrated that 1st graders can safely and effectively collect their own samples. However, the decision to allow 1st graders to collect their own samples is made by the school.
School staff and teachers will communicate with students prior to testing day. During sample collection, teachers will observe and provide instructions.
The minimum number of students needed for a pool to be effective is 5. It is up to the school to decide if smaller classrooms can be combined with other classrooms to meet the minimum number of samples required.
Even with a completed consent, students can still opt out of testing.
Teacher samples can be added to the classroom pool. However, we have observed schools choose individual diagnostic testing periodically for teachers and staff, as teachers may move around to different classrooms.
All students who have returned a completed consent form and who have not tested positive for COVID-19 in the last 3 months can participate in testing.
For self-collected nasal swabs, teachers in the classroom will observe students from a safe distance to ensure they are correctly executing the AN swab. For assisted collection, a school nurse or outside healthcare practitioner can collect the samples.
For students who cannot self-collect, the school nurse or an outside healthcare practitioner can collect the samples.
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.
Surveillance test results, including from pooled surveillance testing, are not submitted to the local, state, tribal, or territory health department.
The school is responsible for collecting consent forms and following up with parents after it obtains the results from Ginkgo.
There has been very positive feedback and support from school staff, students and parents during our initial pilots. “The Ginkgo student-administered COVID testing is an easy process for my scholars,” said Matt Condon, principal of Collins Middle School in Salem, MA. “Our scholars learn and can be an active participant in the community fight of the spread of COVID-19.”
Ginkgo does not require any sort of commitment to continue with our services after the pilot. It is entirely left to the discretion of the school to continue or to stop the service.
We have designed our testing procedure to be as straightforward as possible, but we understand that these are difficult times. Our tests can be self-administered by children and require minimum supervision by staff. From what we have seen so far, a classroom is able to collect samples within 15 minutes (outside of registration, onboarding, etc., which can take up to an hour or two). Ginkgo does not provide onsite support, but other vendors are available to support swabbing and other logistics if required.
The school will decide how often a classroom participates in testing.Many schools have chosen to conduct weekly testing.
Our pilot program runs from Jan 4th to Feb 4th. Schools can begin testing at any point during this period. All sample collection during this pilot phase will end on Feb 4th.
The pilots will take place throughout the month of January. The school will decide on a testing schedule and communicate about testing dates.
There are no financial arrangements between Ginkgo/Concentric and the school for participation in this pilot program.
The protocols we have developed have already been tested at our pilot schools in December and have proven to be successful. Our goal for expanding our pilot program in January is to further optimize and scale the process for sample collection and processing, to ensure that on-site protocols work for schools of all sizes and for all age groups and abilities. Schools will receive test results and have an opportunity to develop communication strategies for their teachers, families, and students, as well as determine what logistics, training, and infrastructure works for them to provide this kind of testing for their community.
According to the latest information, about $42.5 billion in federal funding is available for K-12 public schools for testing. Additionally, CARES Act funds no longer expire on December 31st and can be used for testing. We’ve also seen local education foundations and nonprofit organizations support K-12 testing efforts.
We do not charge different prices for different districts.
When we launch, we estimate the cost to be about $150 USD per pool of 25+ people (~$5-7 per student).
There is no cost associated for the school or the participants during the pilot phase. Schools however will incur costs in terms of staff time for coordination and communication associated with the implementation of the pilot.
A school district can enroll all of their schools in this pilot program.
We have started piloting this program at both private and public schools in Massachusetts, Rhode Island and Louisiana. Five schools were part of the December pilot program. We aim to add 200+ schools across the nation into our program in January.
Please coordinate with the Test Champion on next steps.
Please coordinate with your Test Supervisor on how staff testing will be conducted at your school. Teachers can be part of the classroom pool or part of a pool with other staff members. Alternatively, teachers and staff may be tested individually on a routine basis.
The whole process is designed to have minimal impact on in-class learning. Typically, it takes about 10-15 minutes depending on how comfortable the class is with the procedure. We’ve noticed in our pilots that the process speeds up after the first testing day.
Though we designed the protocol to be safely carried out by teachers, we understand that not all teachers have the same comfort level with handling biohazard material. Please coordinate with your Test Supervisor to arrange for a school nurse or healthcare professional to help with this process.
Please coordinate with your Test Supervisor on how testing will be run at your school. Typically, teachers safely open empty collection tubes at the start of sample collection and close and sanitize the tube at the end of sample collection. Because we designed the protocol to not require a school nurse or healthcare professional, the samples are safe to handle with the necessary PPE as outlined by your State and Public Health Officials. The minimal PPE to handle these samples is a face mask and gloves.
According to a recent white paper by The Rockefeller Foundation, “there is a challenge in setting vaccination priorities — supporting those most at risk of illness and death like health care workers and nursing home residents — and the need to reopen schools, manufacturing facilities, businesses and other public venues. We read that teachers may not receive vaccines until at least the second wave of vaccinations, which is unlikely to occur until spring or later. Students will likely have to wait until the third or fourth waves, which may not arrive until fall.” Given this information, we do believe that testing at the classroom is important and will not only benefit schools, but also the community at large.
In most cases, one classroom is considered one pool. If the classroom size is too small, multiple classrooms can be pooled together. Currently, the minimum number for a pool is 5 while the maximum for a pool is 25 individual swabs.
The decision to do follow-up testing is up to the discretion of the school.
The decision to quarantine a classroom is up to the discretion of the school based on its established policies.
Yes, the protocols for pooled testing and individual testing are different. For classroom pooling, individual swabs are collected by each student in a class and combined into one collection tube, which is then run as a single test.
We have multiple controls in the test process: RNA extraction controls, high and low positive controls using spiked in virus, negative controls, and rt-PCR controls.
Yes. We recommend that individuals who have recently tested positive for COVID-19 not be included in pooled testing for at least 3 months post recovery as they may still produce a positive test result.
During the early pilot phase we are processing samples in the Ginkgo lab facility. We are in the process of building a network of lab partners across the nation to increase testing capacity. Local partner labs can also support follow up testing in necessary after a positive pool result.
Our test is not FDA-approved, cleared or authorized. Our test was developed following the FDA’s guidelines for molecular diagnostic tests. The test has been validated and is conducted in our CLIA-certified lab located in Boston, Massachusetts. A copy of the test validation report is available upon request.
This is a self-collected anterior nasal (AN) swab. Unlike a nasopharyngeal swab, which reaches deep into the nose to take a sample from the back of the throat, an AN sample is taken from the lower part of the front of the nose , at least half an inch inside the nostril. This method both increases comfort and requires less PPE than nasopharyngeal swabs. Instead of a healthcare provider performing the test, students can easily collect their own samples under teacher supervision.
This method of testing uses a molecular test that detects the presence of the viral RNA. In Ginkgo’s lab, we use a molecular test similar to qPCR based on a technology known as next-generation sequencing (NGS), in which a small part of the coronavirus genome is sequenced or “read” to determine whether or not that virus is present in a sample. We are also partnering with and validating PCR labs to run pooled molecular tests.
We have validated our Concentric by Ginkgo next-generation sequencing (NGS) assay both for individual and pooled samples. When analyzing individual samples (which is not the planned use of the assay for pooled testing pilots), we found a 96% percent positive agreement and 100% percent negative agreement with both nasopharyngeal and anterior nasal swab clinical samples run with a high sensitivity RT-qPCR assay. When testing contrived 35-dry swab pooled samples at no virus (0 copies/mL), low viral concentrations (1500 copies/mL) and high viral concentrations (75,000 copies/mL), we found 100% concordance with the expected result.
Classroom pooling is a method of surveillance testing where lower nasal swabs from everyone in a class are mixed together and tested with a single molecular test. This gives schools and districts population-level data to make informed public health decisions at a fraction of the cost of individual testing plans.
Teachers do not administer the tests. The testing protocol for pooled classroom testing is a self-collected anterior nasal swab. Students will collect their own swabs. In case students cannot collect their own swabs, a school nurse or outside healthcare professional can administer the test.
Teachers oversee the classrooms on test days. Teachers will observe students while they self-collect samples from a safe distance and will ensure a smooth collection process either inside the classroom or at a central collection spot.
No, the results are sent to the school. Please contact your school administration for more information.
As this is a pilot, turnaround time is not guaranteed. However, we have been returning results to our pilot customers within 36-72 hrs after the Ginkgo lab receives the sample.
We will be communicating results on an online website and will communicate results using this website when it is ready.
One of our pilot schools has demonstrated that 1st graders can safely and effectively collect their own samples. However, the decision to allow 1st graders to collect their own samples is made by the school.
School staff and teachers will communicate with students prior to testing day. During sample collection, teachers will observe and provide instructions.
The minimum number of students needed for a pool to be effective is 5. It is up to the school to decide if smaller classrooms can be combined with other classrooms to meet the minimum number of samples required.
Even with a completed consent, students can still opt out of testing.
Teacher samples can be added to the classroom pool. However, we have observed schools choose individual diagnostic testing periodically for teachers and staff, as teachers may move around to different classrooms.
All students who have returned a completed consent form and who have not tested positive for COVID-19 in the last 3 months can participate in testing.
For self-collected nasal swabs, teachers in the classroom will observe students from a safe distance to ensure they are correctly executing the AN swab. For assisted collection, a school nurse or outside healthcare practitioner can collect the samples.
For students who cannot self-collect, the school nurse or an outside healthcare practitioner can collect the samples.
Based on all available evidence, children do not have a higher risk of getting COVID-19 than adults. While some children and infants get sick with the virus, adults make up most of the known cases. Most cases in children occur due to exposure from someone in their household. Hospitalization is most common in children less than 1 year old and those with underlying conditions (such as lung diseases or moderate to severe asthma, heart complications, or weakened immune systems from cancer, medications, or transplants).
The Centers for Disease Control and Prevention (CDC) recommends that every person aged 2 years and older wear a cloth covering or mask that covers their nose and mouth when they are out in public places. Cloth face coverings should NOT be put on babies or children younger than 2 because of the danger of suffocation. Wearing cloth face coverings is one safety measure that can help reduce the spread of COVID-19 when used in addition to other measures such as social distancing and frequent hand washing.
It is important that your child limits time with other children. If children meet in groups, it can put everyone at risk. Children can pass this virus to others who have an increased risk of severe illness from COVID-19. If children are playing outside their own homes, it is essential that they remain 6 feet from anyone who is not in their own household. For more information, visit the CDC website.
It is important that your child limits time with people who may be at high risk of severe illness from COVID-19. If others in your home have an increased risk, consider extra safety precautions to help separate your child from those people. Consider postponing visits or trips to see older family members and grandparents.
Outbreaks can be stressful for adults and children. Talk with your child about the outbreak and reassure them that they are safe. When you speak, try to remain calm. Explain to your child that most illnesses from COVID-19 seem to be mild. Children respond differently to stressful situations than adults. If you need support, The Centers for Disease Control and Prevention (CDC) offers resources to help talk with children about COVID-19.
The symptoms of COVID-19 are similar in children and adults. However, children with the virus generally have mild symptoms and recover within one to two weeks. Symptoms in children include:
There is more to be learned about how the disease impacts children. For example, it’s not yet known whether some children may be at higher risk for severe illness, such as children with underlying medical conditions and special healthcare needs.
If your child develops symptoms of COVID-19, it is important to closely monitor them. Most people, including children, develop mild symptoms that resolve within two weeks. If your child develops symptoms of COVID-19, talk to your child’s healthcare provider about steps you should take to help your child recover at home. The Centers for Disease Control and Prevention (CDC) recommends both children and adults follow the same steps if they have the virus. See those steps here. Notify your child’s healthcare provider if someone else in your house becomes sick with COVID-19, so they can provide any advice specific for your child. 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. When you call, tell the operator you suspect your child has COVID-19 so that first responders can protect themselves and others.
New evidence suggests that children who have or have had COVID-19 may later develop an inflammatory condition similar to Kawasaki disease or toxic shock syndrome. This condition is called multisystem inflammatory syndrome in children (MIS-C). If you suspect that your child has symptoms of this inflammatory syndrome (fever, abdominal pain, vomiting, diarrhea, neck pain, rash, eye redness, or feeling overly tired), be sure to see your child’s healthcare provider right away. The good news is that this condition is treatable when caught early.
The Centers for Disease Control and Prevention (CDC) recommends that in individuals who have not been tested for COVID-19 and have symptoms of a condition that occurs after COVID-19 infection (like MIS-C), antibody testing may be used for further evaluation. Follow up with your child’s healthcare provider for further information about testing related to MIS-C.
An independent physician will determine whether to authorize your test request, if appropriate. This physician will be provided through PWNHealth. Before receiving a test, you will be asked to complete a short health questionnaire, which this physician will review.
Our healthcare provider network partner, PWNHealth, might deem certain individuals ineligible to take a test. In this case, PWNHealth will provide additional guidance, including what to do if the individual develops severe symptoms. Since advice given by PWNHealth is coming from an individual physician making medical recommendations, Concentric cannot vouch for advice given to you by a PWNHealth physician.
PWNHealth is an independent healthcare provider network that provides oversight services to you in connection with the laboratory testing that you have requested. PWNHealth and its services are independent from the laboratory and company from whom you requested and registered for a test and their services.
You should not get tested if you:
COVID-19 is a new disease and there is limited information regarding risk factors for severe disease. Based on currently available information and clinical expertise, older adults and people with underlying medical conditions are at higher risk for severe illness from COVID-19. Please note that the list of underlying conditions found below is meant to inform clinicians to help them provide the best care possible for patients, and to inform individuals as to what their level of risk may be so they can make individual decisions about illness prevention. We are learning more about COVID-19 every day. The information included here is potentially subject to rapid change as the science evolves. Please check the CDC’s website referenced at the bottom of this section to access CDC’s most up-to-date guidance.
As you get older, your risk for severe illness from COVID-19 increases. For example, people in their 50s are at higher risk for severe illness than people in their 40s. Similarly, people in their 60s or 70s are, in general, at higher risk for severe illness than people in their 50s. The greatest risk for severe illness from COVID-19 is among those aged 85 or older.
People of any age with the following conditions are at increased risk of severe illness from COVID-19:
COVID-19 is a new disease. Currently, there are limited data and information about the impact of underlying medical conditions and whether they increase the risk for severe illness from COVID-19. Based on what we know at this time, people with the following conditions might be at an increased risk for severe illness from COVID-19:
Children who have medical complexity, who have neurologic, genetic, metabolic conditions, or who have congenital heart disease might be at increased risk for severe illness from COVID-19 compared to other children.
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The IBX Test is authorized for use across 50 states in the United States.