09:00 uur 20-11-2020

PerkinElmer SARS-CoV-2 RT-PCR-assay ontvangt CE-markering voor speeksel- en monsterpooling om symptomatische en asymptomatische personen te testen

Niet-invasieve monsterverzameling en batchverwerking om symptomatische en asymptomatische personen te testen – een doorbraak in COVID-19-testen

WALTHAM, Massachusetts – (BUSINESS WIRE) – PerkinElmer, Inc. kondigde vandaag aan dat zijn PerkinElmer® SARS-CoV-2 Real-time RT-PCR-test CE-IVD-markering heeft ontvangen voor het gebruik van speeksel als monstertype en de mogelijkheid om te poolen maximaal vijf monsters verzameld van personen die worden verdacht van COVID-19 of asymptomatische personen.

SARS-CoV-2-testen met speeksel zijn minder invasief, verminderen het risico van blootstelling van gezondheidswerkers die betrokken zijn bij het nemen van monsters en de noodzaak van frequente vervanging van persoonlijke beschermingsmiddelen.

Labs in landen die de CE-markering accepteren, hebben nu de mogelijkheid om speekselmonsters te accepteren en monsterpooling te implementeren met behulp van de PerkinElmer SARS-CoV-2 Real-time RT-PCR-test. Het samenvoegen van monsters met behulp van speekselmonsters is een cruciale vooruitgang die mogelijk wordt gemaakt door de chemie van PerkinElmer en de strenge productiesystemen. De PerkinElmer SARS-CoV-2 real-time RT-PCR-test is gebaseerd op de meest gevoelige SARS-CoV-2-test met de laagste detectielimiet op de markt, volgens de vergelijkende gegevens van het FDA-referentiepanel.

PerkinElmer SARS-CoV-2 RT-PCR Assay Receives CE Mark for Saliva and Sample Pooling to Test Symptomatic and Asymptomatic Individuals

Non-invasive sample collection and batch processing to test symptomatic and asymptomatic individuals – a breakthrough in COVID-19 testing

WALTHAM, Mass.–(BUSINESS WIRE)– 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.

About PerkinElmer

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


Chet Murray

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