PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals
PerkinElmer, Inc. announced today that its PerkinElmer® 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.
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.
“To strike the right balance between keeping the world economy moving while ensuring safe practices, governments and private organizations are working tirelessly to increase the number of times individuals are tested for COVID-19,” said Masoud Toloue, Ph.D., Vice President & General Manager, Diagnostics, PerkinElmer. “We expect our newly released saliva-based collection and asymptomatic test solution will play a large role in this effort.”
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 .
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com
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