PerkinElmer’s Covid-19 assay granted FDA EUA for asymptomatic testing

15 January 2021 (Last Updated January 15th, 2021 12:36)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to PerkinElmer’s Covid-19 RT-PCR assay to test individuals without symptoms.

PerkinElmer’s Covid-19 assay granted FDA EUA for asymptomatic testing
Approximately 60% of total Covid-19 transmissions come from asymptomatic carriers. Credit: Testalize.me / Unsplash.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to PerkinElmer’s Covid-19 RT-PCR assay to test individuals without symptoms.

The test can be used for the qualitative detection of SARS-CoV-2 nucleic acid in human oropharyngeal, nasopharyngeal, and anterior nasal swab specimens.

According to the Centers for Disease Control and Prevention, approximately 60% of total Covid-19 transmissions come from asymptomatic carriers.

Furthermore, according to FDA’s reference panel comparative data, the PerkinElmer test kit has the lowest limit of detection (LoD) compared with other authorised Covid-19 molecular diagnostic tests.

PerkinElmer Diagnostics vice-president and general manager Masoud Toloue said: “The data is clear – it’s imperative we have reliable and accurate testing for asymptomatic individuals, especially as we’re seeing new strains of the virus appear that are even more contagious.

“PerkinElmer is in a unique position to help this cause, as we’re one of the few suppliers to have a EUA for asymptomatic testing, maintain the most sensitive test on the market, along with a strong supply chain, and have the capability to do sample pooling to save time and resources for diagnostic laboratories.”

In March, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit had received FDA EUA for sample pooling to test more people without needing to expand resources.

Meanwhile, PerkinElmer announced that its EUROIMMUN business has launched a SARS-CoV-2 Interferon Gamma Release Assay (IGRA) for Research Use Only (RUO) to analyse the T-cell activity reactive to SARS-CoV-2.

The assay uses whole blood samples for determination of T-cell activity against SARS-CoV-2 by identifying interferon-gamma, a molecule, which is released by the T-cells after coming in contact with the virus.

Based on the ELISA technology, the assay can be handled manually or automatically in laboratory settings.