Rapid Molecular COVID-19 Test Is Focus of New DOH Guidance

The Department of Health (DOH) issued new guidance on Oct. 22, 2020 regarding the uses of rapid molecular tests for COVID-19, such as the Abbott ID NOW. The guidance provides that rapid molecular tests, like rapid antigen tests, may be used to test individuals associated with nursing homes, assisted living facilities, and other congregate settings. However, like the rapid antigen tests, the molecular tests require proper interpretation, and confirmatory testing is required under certain circumstances. To date, we are unaware of any distribution of rapid molecular tests to long term care providers; only rapid antigen tests have been provided by the federal government to long term care providers. The antigen tests are the subject of earlier DOH guidance described here.

The molecular testing guidance notes that rapid molecular tests are generally less sensitive than lab-based molecular tests, resulting in a higher percentage of false negatives. In May 2020, the U.S. Food and Drug Administration (FDA) issued an alert notifying the public of studies showing that the Abbott ID NOW had produced suspected false negative results. In October, Abbott released interim results of post-authorization studies showing stronger performance. The specificity of the Abbott ID NOW tests is reported to be nearly as high as standard molecular tests and is expected to produce roughly an equivalent rate of false positives. However, the predictive value of any test varies based on pre-test probability (i.e., prevalence in the community and presence of symptoms). When community prevalence is low, false positives are more likely. When community prevalence is high, false negatives are more likely.

As a result, the reliability of rapid molecular test results depends on the clinical context and the level of community transmission. DOH has published a graphic algorithm to instruct providers when to seek confirmatory, lab-based molecular testing. The algorithm is similar to, but distinct from, the algorithm published for rapid antigen tests. It contains separate paths for testing in an "Outbreak/High Prevalence Area" and in a "Non-Outbreak/Low Prevalence Area." Generally, positive results do not trigger a confirmatory test, except when the individual is asymptomatic and in a Non-Outbreak/Low Prevalence area. Negative results trigger a confirmatory test if the individual is symptomatic, regardless of community prevalence. In addition, under the molecular testing algorithm, confirmatory testing should be considered if the negative result is received in an Outbreak/High Prevalence Area, even if the individual is asymptomatic.

The DOH guidance is accompanied by a Frequently Asked Questions (FAQ) document. LeadingAge NY members with limited service lab (LSL) registrations and multiple care sites may be interested in Question 12, which presumably applies to any testing conducted under the registration. In response to the question "Can a facility with an LSL perform testing off site?", the document states that this is permitted if the LSL receives approval to perform Community Screening by completing the "Add and/or Delete Test Procedures" form and inserting next to "Test Procedure Name," "Request Off-Site Community Screening Approval."

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838