FDA grants EUA to PerkinElmer SARS-CoV-2 RT-PCR assay
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FDA grants EUA to PerkinElmer SARS-CoV-2 RT-PCR assay

08 Oct 2021 (Last Updated October 8th, 2021 09:58)

With the help of samples obtained from nasopharyngeal swabs, the test can detect Covid-19 and other infections.

FDA grants EUA to PerkinElmer SARS-CoV-2 RT-PCR assay
PerkinElmer’s new test can identify and distinguish between SARS-CoV-2, influenza A, influenza B and RSV simultaneously. Credit: Belova59 / Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the PerkinElmer PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.

The single test can be used in eligible labs on an immediate basis to qualitatively identify and distinguish between SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) simultaneously.

It can detect Covid-19, flu and RSV infections using samples obtained from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.

A multi-analyte reverse transcription-polymerase chain reaction (RT-PCR) test such as PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 permits labs to preserve valuable resources.

Such assays can alleviate several tests on samples obtained from people who are suspected of having respiratory viral infection, which is similar to Covid-19 infection.

PerkinElmer speciality diagnostics managing director Arvind Kothandaraman said: “As we enter the flu season, this timely EUA will be welcome by laboratories that are looking to test for common respiratory illnesses alongside Covid-19.

“The new test will help to alleviate confusion arising from similar symptoms caused by these infections and reduce further strain on the healthcare system during a pandemic.”

The company noted that testing using PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 is permitted for Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified labs that meet the needs to conduct high complexity tests.

Furthermore, another assay of PerkinElmer, PKamp Respiratory SARS-CoV-2 RT-PCR Panel, obtained CE mark for marketing as an in vitro diagnostic (IVD) device in more than 30 nations.

It is a multi-analyte respiratory panel that can detect Covid-19.

Covid-19, flu and RSV infections cannot be easily distinguished based only on symptoms and are extremely contagious.

The US Centers for Disease Control and Prevention recommends the usage of the multiplex method in Covid-19 testing labs, which would aid in identifying SARS-CoV-2 from influenza viruses.

In March, PerkinElmer introduced two research-use-only assays for the detection of genomic mutations linked to SARS-CoV-2 variants.

The PKamp VariantDetect SARS-CoV-2 RT-PCR Assay and next-generation sequencing-based NEXTFLEX Variant-Seq SARS-CoV-2 Kit both use nucleic acid extracted from specimens that previously tested positive.