Coronavirus disease, commonly called COVID-19, is an infectious disease caused by a newly discovered coronavirus. 

Most people infected with COVID-19 will experience mild to moderate respiratory illness and recover without requiring special treatment. Populations that are vulnerable to more severe illness from COVID-19 include those with underlying medical problems such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer, are more likely to develop serious illness.

Young adults infected with COVID-19 may not report typical symptoms, such as fever or respiratory symptoms, and some may not report any symptoms at all. 

People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness, including hospitalization and death. Symptoms may appear 2-14 days after exposure to the virus.

Signs and symptoms of COVID-19 include, but are not limited to:

• New loss of taste or smell
• Flu-like symptoms
• Cough
• Shortness of breath or difficulty breathing
• Fever
• Chills
• Body or muscle aches
• Nausea
• Vomiting
• Diarrhea
• Sore throat
• New loss of taste or smell

When an individual is infected and does not have symptoms or has not yet developed symptoms, they can still be infectious and contribute to the spread of COVID-19. This makes the testing for COVID-19 of utmost importance for the health and well-being of all in our community.

What are the saliva screening and nasal swab test?

The saliva screening uses individual saliva samples from each person to see if the virus that causes COVID-19 is present. The individual saliva samples will be grouped and analyzed with saliva samples from others. This practice is called “pooling.”  FDA describes pooling as mixing samples in a ‘batch’ and testing the pooled sample. By doing this, samples from a large number of people can be analyzed with a smaller number of tests. Each batch of 8-16 samples will be analyzed for COVID-19. While samples are screened in a group, if there is a positive sample within the pool, the saliva samples in that pool are tested again to separately identify the individual or individuals who may be infected with the virus that causes COVID-19. Only those individuals whose saliva indicated the presence of the virus are asked to submit a nasal sample. Those whose saliva was screened in the pool but who do not have indications of the virus are not asked to quarantine and are not asked to submit a follow up sample.  

What will I be asked to do and what are the risks?

You will be asked to provide a saliva sample for screening. There are no known discomforts or risks associated with providing a saliva specimen. The only risk of this effort is the potential loss of privacy, but we will use measures to limit who has access to your information. Participation in CSU’s public health effort is mandatory. You can choose to provide a saliva sample or, if you choose not to provide saliva or a required follow up nasal swab sample, you may be required to go into quarantine.

Why is this screening and testing necessary?

Colorado State University is monitoring for the prevalence of COVID-19 infection among students, faculty and staff for the health of the university community. Saliva screening may be followed up by an FDA-certified COVID-19 nasal swab test, which, in combination with quarantine and contact tracing, will assist CSU to mitigate the spread of COVID-19.

How much will this cost me?

The saliva screening and, if needed, the follow up nasal swab tests, are free to students, faculty and staff. The cost of these tests is 100% covered by CSU. If you choose to get tested through a testing site that is not associated with this effort, including the CSU Health Network, the costs of those tests are your responsibility.

Will I be told if I am positive or negative for the virus after taking the saliva screening?

You will receive results from your saliva screening that will indicate if you need a follow up FDA-approved nasal swab test, or if no further action is required. Only those members of our university community whose saliva screening indicates that the coronavirus that causes COVID-19 may be present will be required to get a nasal swab test. The nasal swab test will confirm whether or not you have COVID-19.

What if I am notified that my saliva sample indicates the presence of COVID-19, but I do not want to get confirmatory nasal swab test?

In the event you choose to not get the confirmatory nasal swab test, then it will be presumed that you are positive for COVID-19. You will be required to quarantine for at least 14 days.

Why is the use of my data important?

We will use the data generated from saliva screening and nasal swab tests to analyze the potential spread of COVID-19 among students, faculty and staff. and to proactively put in place control measures to mitigate further spread.

Will my saliva sample (biospecimen) be banked/saved? 

CSU will retain your saliva for public health evaluations as part of measures to understand COVID-19 spread, among other public health efforts. This is not considered research but rather part of the public health effort to minimize the spread of COVID-19. The participation for use of your samples will not be retained for non-public health efforts unless you provide your consent in a separate document.

Is this test authorized by the U.S. Food and Drug Administration (FDA)?

The saliva screening used by CSU does not require authorization by the FDA since it is being administered as a public health activity under emergency conditions. The university is analyzing saliva samples to monitor for infection among large groups of individuals, which does not require FDA oversight. While this screening has not been cleared by the FDA, it can provide meaningful results which may lead to further tests and interventions that can assist in controlling this pandemic on campus. The benefits of its use outweigh the risks of not being tested for COVID-19. If your saliva screening indicates that an FDA-authorized nasal swab test is needed, you will be directed to take that test.

Who will see the analysis of my saliva screening sample?

You will not see your screening data, but you will be told whether you need a COVID-19 diagnostic test, which is a nasal swab test. We may need to disclose your information to others involved in CSU’s COVID-19 monitoring efforts, including but not limited to, whether you will need an additional COVID-19 nasal swab test. If you are a student: Once you receive the results from an additional COVID-19 nasal swab test, these results will be included in your education records for your future reference.

The groups of individuals who may see all or part of your screening and testing information include, but are not limited to:

• The laboratories providing the screening and testing;
• Those authorized to have access at Colorado State University, including but not limited to, those who facilitate participant registration, laboratory testing, test analysis, public health COVID monitoring and contact tracing activities;
• Local, county, state and federal agencies that are monitoring the spread and infection of COVID-19.

Why am I being asked to participate in any of this?

Participation in this public health effort is mandatory. You can choose to provide a saliva sample, or if you refuse to do so, you may be asked to quarantine for at least 14 days. The benefits of participating in this screening by providing a saliva sample are that you are contributing to monitoring for SARS-CoV-2 infection within the CSU community, and if the FDA-authorized tests identify individuals with COVID-19, this could lead to early identification and quarantine of people with the infection. If confirmed by FDA-authorized tests, and followed up by quarantine and contact tracing, this could benefit the health and well-being of yourself, your friends, your family and the members of CSU’s university community.

Who do I contact if I have questions?

Additional information is available online at https://covid.colostate.edu 

For questions about the public health testing efforts at Colorado State University, please contact: pandemic_preparedness_team@Mail.colostate.edu

For questions about the use of your data please contact: csu_covid_test@Mail.colostate.edu

For questions about the retention of your saliva sample for future public health effort uses please contact: pandemic_preparedness_team@Mail.colostate.edu.

Please carefully read the following informed consent:

1. I, or my parent or legal guardian if I am under the age of 18 years, have read the information provided in this Informed Consent Form.
2. I authorize screening through the collection of a saliva specimen to be obtained in accordance with the screening laboratory’s instruction and guidance.
3. I authorize CSU and/or an independent laboratory acting on CSU’s behalf to conduct screening and testing for COVID-19 through the collection of a saliva sample or other sample type as ordered by a public health official.  I understand that if I refuse this testing, I may be required to quarantine for at least 14 days.
4. I authorize that the need for me to follow-up with an additional COVID-19 diagnostic test can be disclosed to the CSU Public Health Administrator, the laboratory conducting the testing, and to any applicable county, state, or other governmental entity as may be required by applicable law. If I am a student: To the extent there is a need for me to follow-up with an additional COVID-19 diagnostic test , any follow-up test results or any information collected from or about me as part of my participation in the tests are “Education Records” under the Family Educational Rights and Privacy Act (FERPA), I specifically consent to this information being disclosed to the CSU Public Health Administrator, the laboratory conducting the testing, and to any applicable county, state, or other governmental entity as may be required by applicable law.
5. I acknowledge that a positive screening result for my saliva sample is an indication that I need a follow-up COVID-19 diagnostic test to determine whether I am infected with the virus that causes COVID-19 and that I must follow-up and get a confirmatory nasal swab test with an FDA-authorized test.
6. I acknowledge that if my confirmatory nasal swab test is positive, or if I choose to not proceed with confirmatory nasal swab testing, I must isolate or quarantine myself consistent with CSU’s COVID-19 Health and Safety Policy and all applicable federal, state and/or local guidance or orders on isolation and quarantine in an effort to avoid infecting others.
7. I understand that by signing this document and agreeing to undergo COVID-19 screening and testing that I am not creating a doctor-patient relationship with CSU.  I understand that CSU is not acting as my medical provider.  Screening does not replace confirmatory testing or treatment by my medical provider.  I assume complete and full responsibility to take appropriate action with regards to my test results.  I agree I will seek medical advice, care, and treatment from my medical provider if I have questions or concerns, or if my symptoms or condition worsens.
8. I understand that, as with any biological test, there is the potential for false positive or false negative test results to occur.

By signing this form, I acknowledge that I have access to a copy of CSU’s Notice of Privacy Practices.  You will be given a copy of this form to keep.

Please do not proceed with acceptance unless you fully understand this information.