Introduction to Testing
The FDA has identified two different intended uses of testing for COVID-19 infection, testing of “symptomatic” persons, those who believe they may have COVID-19 due to symptoms they are experiencing or who may have been exposed to infected persons, and testing of “asymptomatic” persons, those who are not experiencing any symptoms of COVID-19 nor have reason to suspect they have been infected.
Most of the diagnostic tests being performed today are under the intended use category of symptomatic testing. In contrast, the FDA does not regulate surveillance tests, such as that offered by TestTheTeam, which do not give individual results, but rather are used to survey “groups or teams” of asymptomatic persons. BioSpyder is an acceptable SARS-CoV-2 test to be used for surveillance testing on a school site, according to the CDPH and California COVID-19 Testing Task Force.
Organizations who perform COVID-19 testing use different testing technologies. Largely these tests are either Rapid Antigen Tests, which generally give a result within 30-minutes, and molecular testing which need to be run in a laboratory. RT-PCR, often referred to as the gold standard, is a molecular test and generally takes about 12-hours lab and prep-time to run. Molecular tests are generally significantly more specific and sensitive than Rapid Tests and most molecular tests have a sensitivity and specificity of ≥95%. TestTheTeam uses a molecular test developed by BioSpyder. Most molecular tests use nasal swabs for sampling whereas TestTheTeam uses saliva captured in mouthwash.
BioSpyder Testing at OLP
All community members will be asked to participate in the molecular based saliva test, which includes a 10 second gargle with a Listerine based mouthwash. They will do this during their Block A class every two weeks. Testing will be conducted in groups of 4, not individually. Pool Testing is a type of surveillance testing recommended by CDPH and the California COVID-19 Testing Task Force for school communities with a positivity rate below 5%. OLP is well below that threshold. No personal information will be shared with BioSpyder Technologies regarding individuals comprising the groups of 4. All of the student and employee information will remain confidential with the OLP Testing Team.
Results will come back for the entire group as either “detected” or “not detected.” If a group has a result of “detected” all members of the group will be offered a Nasal COVID-19 PCR test at OLP through our partnership with the UCSD Excite Lab. Results will be returned within 24 hours regarding a Positive/Negative COVID-19 PCR individual test. Students can also opt to be directly given a COVID-19 PCR test with their primary health-care provider.
Individuals who are even mildly symptomatic should not be on campus. Frequently, a common cold or runny nose is an early sign of COVID-19 and is misappropriated as allergies. This test is highly sensitive and will pick-up the COVID-19 virus at its earliest stages of infection.
Individuals should not eat or drink 30 minutes prior to testing. The test will not commence until 30 minutes after Block A has begun. Individuals should not have had a Positive COVID-19 test within 90 days of testing. If so, those individuals should opt-out of taking the test. Taking the saliva test will return a “Detected” result for the group, skewing the results.
A sensitive and specific molecular COVID-19 surveillance test. Tests for presence of the virus amongst groups of 4. Samples are taken from individuals by gargling with the provided mouthwash. Results are generated in 24 - 48 hours.
Surveillance testing (also known as screening) is used to evaluate the overall health of a school community, and if any members of a group are infected, even though they may not be exhibiting symptoms of infection. Surveillance testing of asymptomatic individuals is the next step in a multi-layered approach to overall school safety. It is used in conjunction with other mitigation strategies for successful K-12 in-person instruction. Testing can allow for early identification of cases and exclusion from school to prevent transmission.
The BioSpyder surveillance test uses an oral rinse, or mouthwash, to collect samples from the mouth and throat. This is a Listerine based oral rinse. The mouthwash is swished or gargled for 10 seconds and then spit back into the test vile. This is a self administered test.
Saliva is minimally invasive and painless and therefore more conducive for routine testing. Evaluations by TestTheTeam by BioSpyder and external parties have produced data that shows that our test is as sensitive and accurate as nasal swabs. Saliva is self-collected and eliminates the need to train specialized healthcare personnel on the collection process, making it easy to collect samples in the workplace or in the home.
TestTheTeam supplies regular mouthwash for the test. The manufacturer of this mouthwash advises that children under 12 not use it. The test kits and tubes should be kept out of reach of children and if accidentally swallowed, contact a Poison Control Center right away.
OLP will use surveillance testing of the entire community every two weeks. This testing is for non-symptomatic individuals, and for those who have not had a COVID-19 positive case in the last 90 days. Individuals who have had a COVID-19 positive case should not take another COVID-19 test for 90 days since infection. Symptomatic individuals should not be on campus, and should see their health care provider.
Those who have COVID-19 symptoms should not submit a sample and should contact their health provider. Those who have tested positive for COVID-19 in the last 90 days should not submit a sample. Those who have eaten or had something to drink within 30 minutes of testing should not submit a sample.
No. BioSpyder uses unique serial numbers to identify batches of tests. They do not collect any patient data. OLP will maintain confidential records of the serial number and student names. Those will not be shared at any point with BioSpyder.
If a batch returns a “Detected” result, the OLP COVID-19 Testing Team, led by Director of Facilities, Mrs. Toni Russo, will reach out to that group of 4 and immediately offer a COVID-19 PCR test, through the OLP partnership at the UCSD Excite Lab. The BioSpyder Oral Rinse Surveillance test could return a “detected” result due to many different scenarios. That group of 4 will be required to complete further evaluation through a COVID-19 PCR test with the OLP partnership at the UCSD Excite Lab (at no cost to the family), or a COVID-19 PCR test with your primary health care provider.
The TestTheTeam test has been shown to be as accurate and as sensitive as the RT-PCR – the gold standard in COVID-19 testing. Saliva molecular testing is more sensitive than the Rapid Antigen test currently being used by many schools for asymptomatic surveillance testing.
OLP is excited to be the first school to Pilot BioSpyder TestTheTeam in a k-12 school setting. It is currently being for Sports Teams, in Businesses, Corporations, Cities are using for large-scale asymptomatic surveillance testing, and for families in a residential setting. It is also available for purchase on their website.