Glenbard District 87 has entered into a contract with SafeGuard Surveillance, LLC. SafeGuard Surveillance will perform an RT-LAMP surveillance analysis for COVID-19 on saliva samples provided by students and staff. These samples are collected at home and returned to the school each week for analysis. If a sample indicates a potential presence of COVID-19, the individual will be referred to a CLIA-certified lab for a diagnostic test. CLIA is the Clinical Laboratory Improvement Amendments to the Public Health Services Act. Parents/guardians will not be contacted if their student receives a negative result.
The primary goal of the program is to allow for more consistent in-person instruction for students by serving as a more accurate way to assess the risks of returning to our hybrid model and lessening community spread. To achieve this goal, the program must have participation from all students and staff.
Note: In response to a March 30 New York Times article about SafeGuard Surveillance that had inaccuracies, SafeGuard Surveillance provided the following FAQ:
Is Safeguard Surveillance violating any federal regulations on testing?
No federal regulations have been violated. Per CMS: “Generally, SARS-CoV-2 surveillance testing can be performed in a facility that is not CLIA certified, and may use a test or technique NOT authorized by the FDA, provided that patient-specific results are not reported. If at any time a patient-specific result is reported, the facility is subject to CLIA and required to obtain an appropriate CLIA certificate in accordance with 42 CFR part 493.” https://www.cms.gov/files/document/clia-university-lab-testing.pdf
Does Safeguard provide patient-specific results, deliver a diagnosis, or provide results?
No, Safeguard Surveillance does not provide patient specific results, provide a diagnosis, or provide results and none of the following terms are utilized by Safeguard Surveillance based on direct guidance from CMS: “negative, positive, inconclusive, presumptive positive, a result of clinical significance, or a result of potential clinical significance”.
Is Safeguard Surveillance Lab authorized to run a diagnostic test and a diagnostic lab?
Per CMS guidelines, SafeGuard has been running a non-diagnostic surveillance test and referring participants to diagnostic tests in CLIA certified laboratories, as indicated by those guidelines. However, SafeGuard recently submitted a CLIA application and received a CLIA number, which allows them to perform diagnostic tests. At this time, SafeGuard prefers to continue to run its lab-developed-non-diagnostic test, as this will not disrupt the workflow established with clients and participants.
Is Safeguard preparing to file for an EUA or FDA approval?
It is a common misconception that CLIA labs need to use FDA approved tests. This is not true. CLIA labs can perform internally validated, Lab Developed Tests (LDTs). SafeGuard plans to submit an EUA application for its test, and they are aware of other submitted EUAs by academic colleagues using the same test that would likely cover SafeGuard’s test. However, while submitting an EUA application is technically “free”, it requires a tremendous investment of time and resources, and they feel that the article misrepresented this fact in a disappointing way.
Does Safeguard Surveillance provide surveillance or screening?
The issue associated with these terms is that surveillance testing does not normally allow for the reporting of individual results to participants. However, the guidance clearly demonstrates that there is a mechanism to refer individuals to diagnostic tests in the context of surveillance, and SafeGuard has been extremely careful to adhere to this guidance. This clear CMS guidance was issued in the context of the COVID-19 pandemic, and absent this guidance, the service SafeGuard provides to clients could be construed as screening. However, given the very clear CMS guidance, which states that surveillance testing can be used to refer individuals to diagnostic tests, SafeGuard is confused as to why the NYT article did not include this information in the story. The author of the story was provided with this information. SafeGuard remains firm in its good-faith commitment to this guidance, but should situations develop that force them to leverage their CLIA certification, they are prepared to do this to minimize any interruption of service to clients to ensure the ability to provide safe in-person learning environments for students. Doing so would disrupt the workflow SafeGuard established with clients, which is why they have not chosen to do this at this time.
1. What is the purpose of weekly COVID-19 surveillance?
The program goals include:
Studies have shown that weekly programs have reduced transmission rates in the areas they cover. Currently, the primary way Glenbard assesses the risk of COVID-19 coming into our buildings is by monitoring health department COVID-19 statistics, including positivity rate and cases per 100,000. With weekly analysis of saliva samples, Glenbard has a more accurate assessment of COVID-19 rates and risks on campus, providing an extra layer of reassurance for providing in-person instruction in addition to the many safety measures our buildings already have in place.
2. Who participates?
Students and staff participating in on-campus instruction and in-person extracurricular activities and athletics participate each week.
3. Does my student have to participate if they are in an on-campus athletic or extracurricular program?
Yes. Glenbard requires any student coming on campus for in-person extracurricular activities and athletics to be enrolled and participate in the weekly program.
4. Can my student participate if they are 100 percent remote?
We are offering this service to students and staff who are coming to school in person either for hybrid learning or for in-person extracurricular activities and athletics. If your student is currently 100 percent remote but you anticipate they may switch to hybrid learning or participate in an in-person sport or activity, you may sign the consent now, but surveillance will not be offered unless your student enrolls in an on-campus opportunity.
5. Can the rest of our family participate in this program?
Due to cost and lab processing constraints, only students and staff who will participate in on-campus learning or extracurricular programs may participate.
6. Do I need to pay for this program?
The saliva sample analysis will be provided free to students and staff. The District will cover the cost of the program, which is approximately $11 per sample.
7. How do I sign up?
To sign up, parents/guardians of students younger than 18 must login to PowerSchool and agree to the COVID-19 Student Consent and Waiver by Dec. 22.
8. I have multiple students attending Glenbard. Do I need to sign up separately for each one?
Yes, please agree to the COVID-19 Student Consent and Waiver in PowerSchool for each of your students in Glenbard by Dec. 22. We will assign a unique barcode to every participant, so we need to have information for each Glenbard student participating.
9. What does the program involve?
Students/staff will receive kits that include small vials with a unique barcode sticker affixed, plastic bags and instructions for collecting saliva samples at home. This is a quick process that involves depositing a saliva sample into the vial; putting the vial into a bag; and sanitizing the bag before returning it to a drop-off box at school. Names are not included with the samples.
10. How often are saliva samples be collected?
Samples are collected once a week. School administrators will provide a collection schedule.
11. When do I have to collect and drop off the saliva sample?
Samples should be collected as close as possible to the time they will be dropped off. We have collection boxes at each building. Students are assigned a drop-off deadline based on the days they are scheduled to attend school.
12. Who analyzes the samples?
Glenbard District 87 selected SafeGuard Surveillance, LLC to provide surveillance services. The company uses an RT-LAMP surveillance process. While the surveillance is non-diagnostic, it is highly reliable.
13. Is this surveillance like the rapid tests I have heard about?
SafeGuard Surveillance uses an RT-LAMP surveillance analysis, which is a molecular test. This surveillance is considered non-diagnostic because samples are collected at home and tested in a lab outside of a medical facility. This type of surveillance has been validated and used worldwide for its accuracy and sensitivity. The results of the surveillance should not be used as the sole basis, or any definitive basis, to diagnose or confirm COVID-19 or inform infection status. Further, a negative result of the surveillance does not rule out the possibility that any person for whom a surveillance is administered has COVID-19. If your student has symptoms or was recently exposed to a person with COVID-19 you should seek a diagnostic test from your healthcare provider.
14. Where can I find out more about RT-LAMP testing and its use in the detection of COVID-19?
These scientific research articles provide more information about LAMP testing:
Science Translational Medicine
Science Direct review
In addition, the U.S. Food and Drug Administration approved an at-home test on November 17, 2020, that also uses LAMP technology. It is not exactly the same as Glenbard’s program but does use the same RNA amplification process. Learn more here.
15. How are results delivered?
Samples are dropped off at the lab each afternoon with results available within 24 hours. The lab informs school health personnel of any barcodes that produce a presumptive positive, and those health personnel then will look up the barcodes, inform those families/staff, and advise them to quarantine and seek a PCR diagnostic test from their doctor or a state testing center. Students and staff who receive a negative surveillance will not receive any notification.
16. Is there a risk of false negatives? How significant is that risk?
There is no test that has no risk of false negatives. This analysis method is extremely effective at identifying individuals with the high viral loads that are thought to drive the spread of COVID-19. The sensitivity limit of the surveillance does not pick up all cases from individuals with very low viral loads.
17. What happens if I receive a positive result?
Anyone with a positive result will be advised to quarantine and immediately contact their doctor or a state testing center to schedule a PCR test to confirm the results. Students and staff will be excluded from coming to our buildings during the quarantine period unless the PCR test provides a negative result, unless symptoms appear.
18. Does this change the advice that I should stay home if I am displaying one or more symptoms?
No. The Illinois Department of Public Health advice has not changed. You should stay home if one or more of the following symptoms appear: fever of 100.4 or more, new onset of moderate to severe headache, shortness of breath, new cough, sore throat, vomiting, diarrhea, abdominal pain from unknown cause, new congestion/runny nose, new loss of sense of taste or smell, nausea, fatigue from unknown cause and muscle or body aches. If this occurs, please contact your school’s health office to report the illness/symptoms.
19. How will Glenbard protect participants’ privacy?
Samples are provided with a barcode label that does not include a name. If there is a presumptive positive result, the lab will inform our school health personnel, who will look up the barcode and contact the family or staff member. The lab is not provided with any names of students or staff. The lab also will immediately destroy samples and will not keep any records related to students or staff. This is a non-invasive, private surveillance process. Glenbard is required to maintain confidentiality in compliance with the Family Education Rights Privacy Act (FERPA). Student identity data will never be shared with SafeGuard Surveillance.
20. Will any of the samples provided by Glenbard and the resulting analysis be used in any publications?
No. Samples are destroyed after surveillance, and SafeGuard Surveillance is not keeping any records related to our surveillance program. For information about disposal of saliva sample, click here.
21. Will this program replace other safety measures at Glenbard buildings?
This program does not take the place of our buildings’ health and safety measures, which include self-certification of temperature and COVID-19 symptoms, temperature surveillance, wearing masks, maintaining social distancing, cleaning protocols and regular washing of hands — all measures that already make the risk of in-school transmission low. The surveillance is an additional tool that can help ensure asymptomatic individuals do not come to our buildings and to mitigate the spread of COVID-19 in the community by identifying people who may have COVID-19 before they show symptoms and potentially transmit the virus to others.
22. How have the results of this surveillance been validated?
The results of this surveillance have been validated in studies published by the University of Wisconsin, University of Colorado and international institutions.
23. What return-to-school protocol will Glenbard use for an individual who gets a positive result?
Anyone with a positive result will be advised to quarantine and immediately contact their doctor or a state testing center to schedule a PCR test to confirm the results. Students and staff will quarantine unless the PCR test provides a negative result, unless symptoms appear.
24. Will Glenbard exempt individuals who have previously tested positive for COVID-19 from participating?
Our plan is for all students and staff to participate. If an individual tested as a presumptive positive, our health office would collaborate with DuPage County Health Department officials and then manage this issue with the parent/guardian or staff member.
25. The saliva sample has DNA, and I am concerned this is being sent to Glenbard and a lab. How is the sample being used?
The saliva sample is being used solely for RT-LAMP analysis to determine if there is a high probability of COVID-19 virus in the sample. It will not be used for any other purpose. The lab will destroy all samples following the analysis. Our contract with SafeGuard Surveillance, LLC contains this provision for handling samples. For information about disposal of saliva sample, click here.
26. Does the saliva sample analysis screen for the new COVID-19 variants?
Yes, SafeGuard Surveillance confirmed that their analysis will catch the new strains of COVID-19.
596 Crescent Blvd
Glen Ellyn, IL 60137