FDA Grants Emergency Use Authorization for Single Test to Differentiate Between COVID-19, Flu, RSV

Samples for the test are isolated from nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs.

Officials with the FDA have issued an emergency use authorization for PerkinElmer’s PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay, a single test that can detect and differentiate between SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). Samples for the test are isolated from nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs.1

“As we enter the flu season, this timely emergency use authorization will be welcome by laboratories that are looking to test for common respiratory illnesses alongside COVID-19,” said Arvind Kothandaraman, managing director of specialty diagnostics at PerkinElmer, in a press release. “The new test will help to alleviate confusion arising from similar symptoms caused by these infections and reduce further strain on the health care system during a pandemic.”1

COVID-19, flu, and RSV infections are often difficult to differentiate between based on symptoms alone and each of the viruses are highly contagious. CDC guidelines encourage laboratories performing COVID-19 testing to adopt a multiplex method to detect and differentiate between SARS-CoV-2 and influenza viruses. The PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay, a multi-analyte test, allows for the conservation of resources by avoiding multiple tests on samples collected from individuals with a respiratory infection consistent with COVID-19.1

According to PerkinElmer, the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay targets 2 specific genomic regions of SARS-CoV-2: the nucleocapsid gene and ORF1ab. Mutations in spike proteins, seen in a number of variants of concern, do not have a significant impact on the safety or efficacy of the test. The company also reports that the assay uses a dUTP/UNG carryover prevention system to avoid false positives created by contamination of PCR products.2

REFERENCES

PerkinElmer receives FDA Emergency Use Authorization for respiratory SARS-CoV-2 panel [news release]. BusinessWire; October 7, 2021. Accessed October 8, 2021. https://www.businesswire.com/news/home/20211007005608/en

PerkinElmer; PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel 1. Accessed October 8, 2021. https://perkinelmer-appliedgenomics.com/home/sars-cov-2-testing-solutions/pkamp-respiratory-sars-cov-2-rt-pcr-panel-1-eua/