With flu season typically starting in October and peaking between December and February, the Centers for Disease Control and Prevention (CDC) have developed two tests that identify the COVID-19 virus (SARS-CoV-2). The latest of these two tests, called the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, tests for influenza A and B viruses as well as SARS-CoV-2.
Along with the new test, the AMA has published new CPT additions and editorial revisions regarding response to the COVID-19 pandemic. The codes are approved for immediate use and can be found, along with long descriptions, in a recently published AMA press release. Short and medium descriptors for the new and revised codes can be found on the AMA website. Information about distinguishing the two seasonal infections from the infections caused by SARS-CoV-2 is the cpt Assistant Special Edition October update.
“Two of the newly approved codes report nucleic acid assays that allow a single test to simultaneously detect the novel coronavirus and a combination of common viral infectious agents, including influenza A/B and respiratory syncytial virus,” said AMA President Susan R. Bailey, M.D. “Concurrent detection promises to conserve important testing resources, allowing for ongoing surveillance of influenza while testing for the novel coronavirus.”
About the Multiplex Assay
While the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is critical because of its ability to assess three viruses in a single test and that more testing will help in the fight against these viruses, other benefits include:
Ordering the Assay
According to the CDC, the International Reagent Resource distributes the assay and supplies to registered state and local public health laboratories.
“During the COVID-19 pandemic, state public health laboratories can authorize county or city laboratories in their state to perform testing,” wrote the CDC. “These laboratories must be certified under the Clinical Laboratory Improvement Amendment (CLIA) to perform high-complexity tests, have appropriate laboratory equipment and training, and demonstrate testing proficiency under their state laboratory’s stewardship to maintain their status as an IRR-registered laboratory. The IRR does not supply clinicians, hospitals, or healthcare professionals with testing kits directly. A list of commercially available primers and probes for use with this test is not available at this time. However, the CDC has shared the primers and probes sequences, so other laboratories and companies may manufacture their own reagents.”
According to the CDC, the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which is a quadruplex assay, includes:
1. One primer mix and one probe mix. Primers and probes target:
2. A positive control FluSC2PC that confirms all four targets in the assay are working correctly
Read the article, “CDC’s Diagnostic Multiplex Assay for Flu and COVID-19 at Public Health Laboratories and Supplies,” for more information. You’ll also find resources and fact sheets regarding the assay and testing for COVID-19 and flu, including: