Research & Development
PerkinElmer wins CE Mark for SARS-CoV-2 RT-PCR Assay for saliva and sample pooling
20 November 2020 -

Healthcare company PerkinElmer Inc reported on Thursday the receipt of the CE-IVD mark for its PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay to pool up to five specimens of saliva collected from individuals suspected of COVID-19 or asymptomatic individuals.

The company added that the 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. The assay obtained its CE mark in 2020 spring.

In conjunction, the CE mark provides labs with the option to accept saliva specimens and implement sample pooling using the PerkinElmer SARS-CoV-2 Real-time RT-PCR Assay. 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 based on the US FDA's reference panel comparative data.

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