Research & Development
PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals
20 November 2020 - - US-based diagnostics, life science company PerkinElmer, Inc's SARS-CoV-2 Real-time RT-PCR Assay received CE-IVD marking for the use of saliva as specimen type and the option to pool up to five specimens collected from individuals suspected of COVID-19 or asymptomatic individuals, the company said.

SARS-CoV-2 testing using saliva is less invasive, reduces the risk of exposure to healthcare workers involved in sample collection and need for frequent replacement of personal protective equipment.

Labs in countries accepting CE mark now have the option to accept saliva specimens and implement sample pooling using the PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay.

Sample pooling using saliva specimens is a critical advancement made possible by PerkinElmer's chemistry and stringent manufacturing systems.

The PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay is built on the most sensitive SARS-CoV-2 test with the lowest limitation of detection in the market, according to the FDA's reference panel comparative data.

The assay originally obtained its CE mark in the spring of 2020.

PerkinElmer continues to work on the frontlines of improving COVID-19 testing.

The company's comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
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