COVID-19 CE-IVD MARKED SCREENING & POOLING SOLUTIONS

How Your Lab Can Play a Role

HOW CAN YOUR LAB PLAY A ROLE?

Using the appropriate SARS-CoV-2 CE-IVD marked test, your lab can easily pivot from diagnostics, to screening asymptomatic individuals. PerkinElmer can help you get there by immediate deployment of solutions you need. According to the FDA companion resource, a highly sensitive RT-PCR test should be used for screening asymptomatic individuals without known exposure to SARS-CoV-21.

A highly sensitive RT-PCR test for screening asymptomatic individuals

The PerkinElmer SARS-CoV-2 Real-time RT-PCR CE-IVD marked assay has the same formulation as the PerkinElmer New Coronavirus Nucleic Acid Detection Kit which is the most sensitive, commercially available COVID-19 molecular diagnostic test authorized for emergency use, as reported by FDA’s reference panel study2. A 10-fold increase in LOD above PerkinElmer’s test can increase false negative rate by 13%3.

Saliva is a desirable as a specimen type for SARS-CoV-2 testing because collecting saliva is much easier and less invasive than collecting other sample types. Not only is saliva collection easier, it is also faster, more scalable than swab collection, and also reduces health care workers’ exposure to sick patients. Note that saliva samples need to be collected under observation or by a healthcare provider. A complete automated workflow is also available for testing of saliva samples.

PerkinElmer, Inc. is one of the few entities that manufactures a molecular diagnostic test kit to screen pooled asymptomatic individuals – this capability is at the very heart of a successful COVID-19 testing program1.

Pooling reduces costs for COVID-19 screening

PerkinElmer’s OneSource® Laboratory Services organization and field application specialist teams have been instrumental in enabling labs to significantly scale up daily testing capacity in a matter of days to screen school children and other communities. PerkinElmer has a strong, vertically integrated supply chain that encompasses the development and manufacture of critical components such as viral nucleic acid extraction, RT-PCR, automation equipment, plastics and consumables enabling cost-effective, reliable, and single-source solutions for SARS-CoV-2 screening, surveillance, and diagnosis.

References:

  1. FDA. A Closer Look at Coronavirus Disease 2019 (COVID-19) Diagnostic Testing
  2. Lowest limit of detection and most sensitive reflect a comparison of analytical sensitivity between Emergency Use Authorized COVID test kits as reported in FDA SARS-CoV-2 Reference Panel on October 7, 2021.
  3. Arnaout R. et al. SARS-CoV2 testing: the limit of detection matters.
Contact your PerkinElmer representative today to ensure that your lab is ready for screening & pooling!

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