This article is intended to provide recommendations for using rapid antigen tests as a follow-up for pooled testing (specifically BinaxNOW™ and Access Bio CareStart™). This article (and other supporting articles on follow-up testing) is not intended to replace FDA guidance. Test Supervisors should perform all testing according to the FDA-authorized Instructions for Use and any other authorized labeling provided with the test kits.
The recommendations found in these articles are based on the direction provided by states currently conducting follow-up testing in schools.
We rely on four key sources:
- CDC guidelines for COVID-19 testing
- Best clinical practices defined by our clinical partners
- State recommendations from states participating in pooled and follow-up testing
First, a positive pool is identified.
- Positive results are communicated to the Test Champion.
- The Test Champion isolates the positive pool.
- The Test Champion organizes follow-up testing at school that same day. This can occur in the classroom of the positive pool or in a designated room to isolate students.
- The Test Taker checks in.
- A test kit is registered and assigned to the Test Taker.
2. Sample Collection
- A sample is collected from the Test Taker, applied to the cassette, and the timer is started.
3. Result Readout + Interpretation
- The result is read and interpreted. The result is then recorded in the portal.
4. Positive Individuals are Identified
- The Test Champion communicates the result to parents.
- The Test Champion isolates any positive students and sends them home.
Returning to Class
Students who test negative may be allowed to return to class, depending on if they have been in close contact with the positive student or if they have any symptoms.
A "close contact" is defined by the CDC as someone who was within 6 feet of an infected person for a cumulative total of at least 15 minutes over a 24-hour period starting from 2 days before the onset of illness.
Decisions regarding when to return students who test negative to the classroom will be determined by the school’s Test Champion.
A note on follow up testing
Our Standard Operating Procedures designed in accordance with the manufacturer’s guidelines. We encourage you to follow these guidelines. Please consult your organization's health and safety professionals before customizing your testing solution.
- Access Bio CareStart™ and BinaxNOW™ rapid antigen tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA (Emergency Use Authorization).
- When using this product, be sure to follow the Instructions for Use (IFU) [and any other FDA-authorized labeling] provided with the test kits. IFUs can be accessed here: BinaxNOW™ and Access Bio CareStart™.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- This product is only authorized as long as the circumstances exist that justify authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner