About SHIELD Illinois
SHIELD Illinois is a COVID-19 screening testing program and infrastructure designed to help safely open schools, protect workplaces, and save lives. This specific test was designed by University of Illinois Urbana-Champaign researchers and was supported by the university’s leadership team. The testing and strategy created by these individuals was named SHIELD. Our mission as a land-grant institution is to use our capabilities and resources for the public good by deploying this method of targeting, testing, and informing beyond the U of I System to the entire state of Illinois.
The test developers came up with this name to evoke the concept of putting a protective shield around the University of Illinois campus.
The test has gone through the rigorous review process of the United States Food and Drug Administration (FDA) against an extensive set of well-established requirements/parameters; authorization means the covidSHIELD saliva test fulfilled all the requirements of the FDA before being authorized for use in CLIA-certified laboratories for COVID testing, specifically during public health emergencies such as the current COVID-19 pandemic.
Testing Practices
SHIELD collection sites follow a strict set of hygienic and sanitary practices to ensure the testing facilities remain safe for both staff and test-takers.
Anyone can test through their SHIELD Illinois sponsor organization (employer, school, university, governmental agency or other organization) or at any one of our free SHIELD community testing sites.
This question comes up a lot, but no, the covidSHIELD test only targets specific COVID-19 markers and is not able to test for other communicable disease, substances, or DNA.
The test is self-administered and non-invasive. After checking in with a collection site staff member, you will receive a vial to deposit a small amount of saliva into. Then, you place the vial in a collection rack and leave the collection site.
You will need to provide around 2mL of saliva (not bubbles) for the sample to be processed correctly (the vials used will often have a marking noting how much saliva is needed).
You should not eat, drink or put anything in your mouth one hour before taking the salvia-based test. This includes smoking, drinking, chewing gum, using mouth wash, etc.
Drink lots of water and if you can, brush your teeth one hour before the test.
The substances put in your mouth may interfere with the test and cause the sample to be invalid or rejected.
People utilizing a SHIELD community testing site must provide an email address or phone number as identification to be tested and receive results.
The laboratory that processes the tests needs to identify the sample to the person who provides the sample, requiring a date of birth. Also, all positive test results must be reported to the Illinois Department of Public Health in accordance with the Illinois Control of Communicable Diseases Code (77 Ill. Adm. Code 690.200(a)(5)); demographic information is required for this reporting process.
Results are known within 24 hours from the time a sample is received in one of our labs.
SHIELD Illinois supports a secure information management system for tracking and reporting results.
The notifications are as follows:
Negative – The COVID-19 virus was not detected.
Positive – The virus was detected.
Invalid – The sample provided was non-optimal and could not produce the appropriate data during processing at the lab (This is likely due to a poor-quality sample, not following the fasting requirements, or interfering material found in the sample. It’s recommended you take another test, following the 1- hour fasting requirement, and focusing on producing the specimen from saliva, not sputum).
Inconclusive – The sample was able to be processed in the lab, but it was not able to definitively provide a detected/not detected result (It is recommended the person retest).
Rejected – The sample was not able to be processed at the lab (This is likely due to low sample volume, the cap coming off the tube in transport or other damage to the tube, and/or extremely poor sample quality. It is recommended the person retest and follow the 1-hour fasting requirements, focusing on producing the specimen from saliva, not sputum).
This is an important question. Only you or your parent/guardian, the lab and the ordering physician have access to an individual’s test results. By law, positive test records are also reported to the relevant public health department(s) for contact tracing. If an organization is set up to receive results for their constituents (e.g., a school or an employer), then their assigned administrator will have access to those patients’ results. This is only done with patient consent.
Our supportive collection site staff members can help you produce a sufficient saliva sample. However, in order to complete the test, an acceptable saliva specimen is required (i.e., no food, liquids, or other substances in the mouth for one hour prior). For younger children, we can provide a curriculum designed to guide them through the steps and the reasons for the test.
Drooling does not generate an appreciable amount of aerosols, so there is nothing to worry about with airborne particles.
Drooling does not generate an appreciable amount of aerosols, so there is nothing to worry about with airborne particles.
If the ventilation of the testing site is good, minimal time is needed.
At the present time, the SHIELD Illinois test must be completed in the testing room under observation of the collection staff. SHIELD must maintain chain of custody due to FDA, EUA and CLIA lab regulations.
At the present time, the SHIELD Illinois test must be completed in the testing room under observation of the collection staff. SHIELD must maintain chain of custody due to FDA, EUA and CLIA lab regulations.
Test specimens are safely and permanently destroyed once testing is completed by being placed in biohazard containers, securely stored, and incinerated by hazardous materials personnel.
SHIELD Illinois has seven CLIA-certified laboratories throughout the state, including in Decatur, Itasca, Maywood, Normal, North Chicago, Rockford, and Springfield.
SHIELD Illinois reports positive results to the Illinois Department of Public Health, which reports those results to the corresponding local health department for contract tracing purposes.
Masks are required for all staff and testers to minimize exposure pursuant to CDC guidelines.
Testing Guidance
Typically, people who are fully vaccinated do not need to be tested. However, the CDC recommends anyone with any signs of symptoms of COVID-19 get tested, regardless of vaccination status. Regular testing is also recommended for a vaccinated person working or living in high density/congregate settings (i.e., dormitory, jail, homeless shelter, or food production plant). Also, those working in health care settings should be tested, according to CDC’s guidance.
Yes, it is recommended that participants receive a negative COVID-19 test result as close to and no longer than 72 hours before competition. Individuals who are not fully vaccinated should continue with regular weekly testing per IDPH guidelines.
It is not recommended for people who have recovered and are within 90 days from symptom onset or a previous positive test, but testing should resume once the 90 days have passed.
Testing at least twice a week maximizes SHIELD’s ability to find infections early and break the transmission chain. However, if contact tracing is strong at your location, weekly testing can be effective.
Diagnostic tests identify current infections at the individual level and are performed when a person has signs of symptoms consistent with COVID-19, or when a person is asymptomatic but has a recent known/suspected exposure to SARS-CoV-2. Screening tests are intended to identify infected persons who are asymptomatic and without known or suspected exposure to SARS-CoV-2. The covidSHIELD test can be used for both diagnostic testing and screening.
Outbreak status is when five or more cases are linked epidemiologically that do not share the same household and are not listed as close contacts of each other outside the outbreak setting. Schools should conduct twice- weekly testing for unvaccinated staff and students until the school has gone two incubation periods (28 days) without identifying new cases.
The more frequently someone is tested, the less time they will be infectious and be able to spread the virus. When testing twice a week, an infection will be detected, on average, the day before peak infectiousness. With weekly testing, infections will be detected, on average, 1-2 days after peak infectiousness. Our research also shows that testing at least twice a week means that >95% of infections will be detected; weekly testing can miss 1 in 10 infections.
Frequent testing helps positivity rates remain low. SHIELD testing catches people who are positive (whether they show symptoms or not) and we are able to quarantine them in time to help reduce mass infection.
It varies from person to person, but typically within 3-5 days after exposure.
It varies from person to person, but typically within 4-7 days after exposure.
Test Effectiveness
In a recent study, the saliva test was shown to have a specificity of 98.9% and a sensitivity of 95.8%. The FDA-authorized covidSHIELD test targets three highly conserved regions of the viral genome for detection. High specificity offered by three-target detection, combined with frequent testing makes the SHIELD saliva-based test extremely accurate and one of the best tests available.
The official FDA emergency use authorization documents can be found here: https://www.fda.gov/media/146314/download
For a nasal swab, proper sample collection technique is needed to collect a small amount of mucosal material from a specific nasal region, making it error prone. In addition, the process is invasive, and many patients find the process either difficult or uncomfortable.
By comparison, no skill is needed for saliva collection. The patient simply drools saliva into a tube; the sample collection process is neither invasive nor uncomfortable. Because the sample collection is not from a specific region and the sample size is larger than collected by nasal swab chances of human error are minimal.
The FDA-authorized covidSHIELD saliva-based test has a very low limit of detection and sensitivity of 95.8%, which means it can detect infections in patient with low viral loads.
The test should be able to pick up the virus as early as 2-3 days after exposure.
No, the test is specifically designed to detect viral genomic material (i.e. RNA) present in viral particles or free form.
Our test looks for 3 different SARS-CoV-2 genes. That way, even if a mutation changes one gene, the test will still be able to detect the other two genes, making the covidSHIELD test particularly effective in identifying the virus regardless of variant.
Yes, the SHIELD test can detect all known variants. That ability is monitored rigorously by Thermo-Fischer, which produces the part of the test used to identify SARS-CoV-2.
The covidSHIELD test detects the presence of all COVID-19 strains regardless of variant. Only genetic sequencing can identify specific virus variants.
The covidSHIELD test detects the presence of all COVID-19 strains regardless of variant. Only genetic sequencing can identify specific virus variants.
If a Test is Positive
No. Follow-up testing is not needed. The covidSHIELD saliva-based test is a definitive rtPCR diagnostic test authorized by the FDA.
No, retesting is not required or recommended. The covidSHIELD saliva test has a specificity of 98.9% and sensitivity of 96.8%. The test targets three highly conserved regions of the viral genome for detection. High specificity offered by three-target detection, combined with frequent testing makes the SHIELD saliva-based test extremely accurate.
The covidSHIELD saliva test is more reliable overall compared to self-collected nasal specimens. In other words, self-collected nasal PCR has a higher false/negative rate and lower sensitivity in most studies.
Repeat testing after the initial positive test is neither required nor recommended. You should rely on your initial positive covidSHIELD test as definitive, take appropriate action to isolate and consult with your health care provider with any questions or concerns.
You should consult with your health care provider. It is not uncommon for tests to remain positive or be intermittently positive for several weeks following a COVID illness and these individuals are not infectious to others.
You should consult with your health care provider. SHIELD does not provide any other information except negative/positive results.
Address, phone number, and demographic information are also shared with IDPH. If a person does not have a phone or email, we share the sponsor organization’s information.
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