Concentric's COVID-19 Testing Service

Have an access code? Click here to create your account.

Sign In

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 c​ontact 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.

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

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.

Is this PCR test FDA-approved or cleared?

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.

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

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.

Is this rapid antigen test FDA-approved or cleared?

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.

Are these viral tests (i.e. nucleic acid or antigen test) or antibody tests?

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

Who should get tested?

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).

How does the PCR test work?

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

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

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

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

For more information on positive and negative results associated with the 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.

How does the rapid antigen test work?

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

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

What will my COVID-19 rapid antigen test results tell me?

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.

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

Potential risks include:

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

Potential benefits include:

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

How do I prepare for the COVID-19 PCR test?

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

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

How do I prepare for the COVID-19 rapid antigen test?

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.

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.

Can my child get tested?

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.

Should my child get a COVID-19 PCR test? Should my child get a COVID-19 rapid antigen 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.

What will my child’s COVID-19 rapid antigen test results tell me?

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.

How do I prepare my child for testing?

  • 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.

Please note:

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.

About the Tests
  • What is COVID-19?

    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.).

  • What tests am I being offered by Concentric by Ginkgo?

    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.

  • What is the IBX Test offered by Concentric by Ginkgo?

    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:

  • What is a COVID-19 PCR test?

    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.

  • What is the Access Bio test offered by Concentric by Ginkgo?

    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

  • What is a COVID-19 rapid antigen test?

    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.

  • How is a COVID-19 PCR test performed?

    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.

  • How is a COVID-19 rapid antigen test performed?

    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.

Consent
For Teachers
  • How will I access the results for the classroom?

    Please coordinate with the Test Champion on next steps.

  • Do I need to provide a sample for the classroom pool?

    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.

  • How much time will I need to allocate for testing?

    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.

  • What if I am not comfortable opening and closing the collection tubes?

    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. 

  • Will I need to touch the samples?

    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.

  • Do teachers have to administer tests for students?

    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.

  • What is my role in pooled classroom testing?

    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.

How to Interpret the Results
  • What does it mean if I have a positive test result?

    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.

  • What does it mean if I have a negative test result?

    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.

  • What is the risk of a false positive or false negative result?

    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.

  • Where can I find any additional information on quarantine and isolation?

    We recommend that you consult the Coronavirus (COVID-19) Isolation/ Quarantine information PDF provided by PWNHealth.

  • Are there any limitations to COVID-19 PCR tests?

    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.

  • Are there any limitations to COVID-19 rapid antigen tests?

    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.

Pilot Program
Pooled Testing Overview
  • Will classroom testing stop when teachers and students receive vaccines?

    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.

  • Is each classroom one pool or will the pool be larger than one classroom?

    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.

  • Are the samples from the pool automatically tested individually in the case of a positive result or are students individually responsible for seeking follow-up testing?

    The decision to do follow-up testing is up to the discretion of the school. 

  • If a pooled sample comes back positive, does the entire class go remote until individual tests are run?

    The decision to quarantine a classroom is up to the discretion of the school based on its established policies.

  • Are there different protocols for pooled testing vs. individual testing?

    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.

  • Are there any controls to avoid false negatives?

    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.

  • If a student who has recovered from COVID-19 is in a pool, is there a possibility of that pool coming up as a false positive?

    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.

  • Many schools work with local labs for PCR testing. Are you willing to partner with these labs?

    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.

  • Is this test FDA-approved, cleared or authorized?

    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.

  • What type of swab is used for this test?

    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.

  • Is this a molecular test or an antigen test?

    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.

  • What is the accuracy of this test?

    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.

  • What is pooled classroom testing?

    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.

Pooling
Results
Testing Procedure
What to Know about Children and COVID-19
  • What is the risk of my child getting sick from COVID-19?

    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).

  • How do I protect my child from COVID-19?
    You can protect your child from COVID-19 by encouraging them to take the same safety precautions as everyone else:
    • Avoid close contact with people who are sick.
    • Stay home when you are sick, unless you are seeking medical care.
    • Clean and disinfect frequently touched objects and surfaces (including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks).
    • Launder items, including washable plush toys, using the warmest water setting allowed for the items. Dry them completely. Dirty laundry from an ill person can be washed with other people’s items.
    • Wash your hands often with soap and water for at least 20 seconds.
    • Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and water aren’t available. Always wash hands with soap and water if your hands are visibly dirty.
    • Avoid touching your eyes, nose, and mouth with unwashed hands.
    Be sure to also track and follow community safety measures, such as school closures. Discourage children and teens from gathering in other public places while school is closed to help slow the spread of COVID-19 in the community. Please refer to the CDC’s website for the most up-to-date information about precautions concerning children.
  • Should children wear face masks?

    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.

  • Should my child be around other children?

    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.

  • Should my child be around other people?

    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.

  • How do I talk to my child about COVID-19?

    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.

  • Are COVID-19 symptoms different for children?

    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:

    • Fever
    • Cough
    • Nasal congestion or runny nose
    • Sore throat
    • Shortness of breath
    • Nausea or vomiting
    • Diarrhea
    • Tiredness
    • Headache and muscle aches
    • Refusing to eat or drink

    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.

  • What should I do if my child has symptoms of COVID-19?

    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.

  • What is multisystem inflammatory syndrome in children (MIS-C), and how is it related to COVID-19?

    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.

  • Should my child get tested if they have symptoms of multisystem inflammatory syndrome in children (MIS-C)?

    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.

When to Use the Test