DOH FAQs on COVID-19 Antigen Testing Require Serial Tests for Symptomatic Individuals

The Department of Health (DOH) issued Frequently Asked Questions (FAQs) last week regarding the use of point-of-care (POC) and at-home COVID-19 antigen tests. The FAQs were issued in response to changes in the tests' Food and Drug Administration (FDA) emergency use authorizations (EUAs) regarding serial testing of symptomatic individuals. Specifically, the FDA is requiring test manufacturers to instruct users to conduct serial testing of both symptomatic and asymptomatic individuals who test negative.

When using the POC and at-home tests, individuals with COVID-19 symptoms who test negative initially should receive a second test 48 hours later. Individuals who are asymptomatic and receive a negative result on the first test should receive a second test 48 hours later, and if negative again, a third test at least 48 hours from the second.

This is consistent with the Centers for Disease Control and Prevention (CDC) infection prevention guidance that has been in effect since September 2022 and should not require significant changes in facility procedures.

The DOH FAQs also affect limited service laboratories, including those operated by nursing homes and adult care facilities (ACFs). The FAQs state:

Q: If our facility is registered as a Limited Service Laboratory (LSL) and we are performing COVID-19 antigen testing, is our LSL required to perform serial testing as described in the instructions provided with a COVID-19 antigen test?

A: New York State Public Health Law requires an LSL to ensure that tests are performed in accordance with the manufacturers' instructions. If an LSL performs a COVID-19 antigen test on a symptomatic or asymptomatic patient and the result is negative, a follow-up test is required. The LSL should inform the patient that repeat testing is needed to determine if an individual is positive or negative for COVID-19 and that serial testing improves test accuracy.

Neither the revised FDA EUAs nor the FAQs apply to molecular or polymerase chain reaction (PCR) tests. 

Contact: Karen Lipson, klipson@leadingageny.org