COVID-19 Diagnostics Research

COVID-19 Diagnostics Research

COVID-19 Diagnostics Research is a fast track technology development program that leverages the NIH National Institute for Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technologies Research Network (POCTRN), and will support novel solutions that build US capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches today.

The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern (C-THAN) is a member of POCTRN. At the direction of the NIH leadership, C-THAN’s research focus has pivoted from HIV/AIDS to Covid-19. The C-THAN network, including several African partner institutions, has embraced this challenge and is now focusing exclusively on the Test Us program.

• We want to learn the best ways to test for COVID-19 in people who may or may not have symptoms such as: cough, fever, fatigue, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, shortness of breath, and muscle or body  aches.
• We are studying new types of tests that are being developed to find out which ones work best.

• Evaluating new COVID-19 tests helps us learn which tests are accurate, quick and easy to use.

COVID-19 Diagnostics Research exists to help find scalable, inexpensive, accurate, and usable point of care technologies (POCT) that enable detection of SARS-CoV-2 (Coronavirus). It is critical that we evaluate the performance and usability of these technologies in a variety of populations and settings.

It is also important that each POCT be evaluated with samples that represent those collected from the general public as opposed to a limited set of samples in a laboratory setting.

Any device must be evaluated for its usability as well.

We will conduct at least one clinical study for each POCT identified by COVID-19 Test Us and deemed appropriate for testing by NIH and COVID-19 Diagnostics Research leadership. Based on sample size calculations and guidance from the FDA, we recommend each clinical study arm involve at least 193 asymptomatic participants (minimum 20 true positives and 170 asymptomatic). Participants will be identified and enrolled using an NIBIB-supported digital platform (Eureka). Participants will also be enrolled and tested at NIBIB-supported research centers (POCTRN – Emory, Johns Hopkins, Northwestern, UMass Medical, UCSF) as well as at research centers identified through the Trial Innovation Network/Centers for Clinical and Translational Science and Practice Based Research Network. Studies will focus on enrollment of diverse populations, including those particularly hard-hit by the COVID-19 pandemic.

We are testing new ways to detect COVID-19 in people who may or may not feel sick. To do this we are studying new types of tests to find out which are best.

Individuals can have the COVID-19 illness with a wide variety of symptoms or without obvious symptoms. Improving upon the medical devices used to detect the virus will help slow the spread of the virus.

In this study:

• You will provide samples for two tests: a standard test and a research test.
• You will be asked about your experience with the research test.

We expect that you will be in this research study for about one hour for the consent process, testing, and surveys.

If we ask you to travel to a testing location, we will tell you days and times when the testing site will be open. We will tell you if you will be able to set up an appointment ahead of time or if you can drop by during those times. You may have to wait when you arrive.

You will be asked to take two tests for COVID-19: one experimental test and one standard test. You may need to travel to a local testing center. You will answer some questions about yourself and to tell us what you think of the new test. You will be asked to share the information you provide and your test results with many researchers.

You will be given the results of the standard test. If you test positive for COVID-19 infection, you will need to self-isolate. The local health department will be notified of positive test results and they may contact you. The experimental COVID-19 test will be chosen at random from a number of different tests being developed.

• Samples usually come from different parts of the nose or mouth.
• Tests will be conducted by, or under the supervision of a healthcare professional.

If you test positive for COVID-19, there may be negative effects. For example, you may need to miss work or stay away from others for 10-14 days even if you do not feel sick.

The tests can be uncomfortable, and they might make you gag. You might also feel anxious or nervous about being tested for COVID-19. You might feel embarrassed or uncomfortable answering questions about your health or background or having research staff watch you collect samples for the COVID-19 tests.

It is possible that being tested for COVID-19 could lead to a delay in diagnosing or lead to a failure to diagnose other infectious or non-infectious conditions as a cause of symptoms.

Your personal information could be lost or stolen. We will take reasonable steps to help prevent this, like keeping information in restricted areas and on secure computer networks.

Even though we will not share your name or other identifying information in reports and analyses, there is a risk that someone could identify you if they try very hard. There is also a risk that others could use your information including test results to support harmful ideas about groups and communities who participate in this research.

For your time, we will provide a $20 gift card after we receive your samples and survey responses.

There are no benefits to your health from your taking part in this research. Also, we cannot promise any benefits to others from your taking part in this research. However, possible benefits to others include being tested for COVID-19. Our main goal is to learn about whether new COVID-19 tests work and what it’s like to use them.

If we ask you to travel to a testing location, we will tell you days and times when the testing site will be open. We will tell you if you will be able to set up an appointment ahead of time or if you can drop by during those times. You may have to wait when you arrive.

You can also consult this calendar.

We test samples as soon as we can. Once we test the samples, we are required by the FDA to keep the results and any information that is already entered into the database.  Some samples will be used up in testing. If there are leftover samples, we will keep them in case we need to recheck the test. There is no genetic testing and we will not use your samples for any other purpose without your permission.

• You will receive results of a standard test usually in about one week.

No. The standard COVID-19 test is not perfect, but it is an accepted test. There is a chance that the test will say you do not have COVID-19 when in fact you do (a false negative). There is a small chance that the test will say you have COVID-19 when in fact you do not (a false positive). Because COVID-19 is so new, we do not know exactly how often the test is wrong. We can only tell you that the Food and Drug Administration (FDA) allows its use in qualified labs right now, and we are using qualified labs.

In some cases, we may recommend that you repeat the standard test. This is not expected to happen frequently. It may happen if the novel test has been authorized for emergency use by the FDA and is being tested using the procedures that the FDA has authorized. In this case, if the standard test is negative and the novel test is positive, we will offer to repeat the standard test at no cost to you and to give you those results.

• Contact your local healthcare provider.
• If you do not have a healthcare provider and have serious symptoms, contact your local emergency department.
• Isolate yourself from others for 10-14 days from the test date, if possible.
• We are required to share your test results and how to contact you with the local Department of Public Health.

If you test positive for COVID-19 using the standard test, your local health department will be notified. The laboratory conducting the test is required to do this. The health department may then contact you and the people that have been in close contact with you so they can also be tested, such as your family, friends, neighbors, and coworkers. Some of these contacts may need to be tested, but this will not be done as part of this study.

If you are an employee participating in the study at your worksite and you test positive for COVID-19 using the standard test, it is possible that the research personnel may be required to notify your employer of the positive test results. If this is the case, the research personnel will tell you about this before you agree to participate in this study.

• Data helps researchers evaluate new COVID-19 tests.
• Only researchers will see your data.

All potentially eligible and consenting clinical study participants will undergo a brief self-administered survey that includes information required for randomization, including age/sex/race and ethnicity, and to establish eligibility (e.g., COVID-19 symptoms). Eligible and consenting participants will be asked to present for POCT device and gold-standard testing as part of a brief study examination. Brief usability and acceptability questionnaires will be completed after conducting POCT SARS-CoV-2 testing. Participants will undergo a telephone follow-up 3-5 days after testing to deliver gold-standard SARS-CoV-2 test results.

• How COVID-19 Spreads
• How to Protect Yourself and Others

• What to do if you are sick
• Isolate if you are sick
• Quarantine if you might be sick
• Managing Covid-19 symptoms at home (CDC handout)
• Caring for someone sick at home

• What Older Adults Need to Know (CDC Video)
• Nursing Homes and Long-term care facilities
• People with underlying medical conditions
• Preparing for COVID-19 in Nursing Homes
• People Who Need Extra Precautions

• COVID-19 and Women’s Healthcare
• Taking Care of Yourself During Covid-19
• Mental Health for Pregnant and Postpartum Women

• Talking with children about Coronavirus Disease 2019
• Keeping Children Healthy
• What steps can my family take to reduce the risk of getting COVID-19?
• Parent/Caregiver Guide to Helping Families Cope with the Coronavirus Disease 2019 (COVID-19)
• Helping Children Cope
• Cloth Face Coverings for Children
• Caring for Children and Youth with Special Health are Needs
• Signs Your Teen Needs More Support

• Coping with Stress
• Grief and Loss
• Coronavirus and Mental Health: Taking Care of Ourselves During Infectious Disease Outbreaks
• Taking Care of Your Emotional Health