Article

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/

Newsletter

Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.

Related Videos
Tired scared retiree man holding chest with anginal symptoms, pallor and diaphoresis at home. Suffering male with cardiac origin pain, prexcordial pressure, arrhythmia risk, urgent medical attention - Image credit: DimaBerlin | stock.adobe.com
Image credit: Sebastian Kaulitzki | stock.adobe.com
Health and nutrition: the role of glp-1 in diabetes management with apple and syringe - Image credit: Thanayut | stock.adobe.com