COVID-19 Testing Options from PerkinElmer Genomics

The scientific staff at PerkinElmer Genomics, led by our Chief Science Officer Dr. Madhuri Hegde, have been diligently working to support labs across the country in setting up their own COVID-19 testing assays utilizing both PerkinElmer (PerkinElmer® New Coronavirus Nucleic Acid Detection kit (EUA200055)) and EuroImmun (EUROREALTime SARS-CoV-2 (CE marked)) test kits. However, as we continue to hear about testing needs and shortages across the country, PerkinElmer Genomics has decided to take an even more active role in the fight against COVID-19 by launching our own testing assays in our high-throughput CLIA-certified testing laboratory in Pittsburgh, PA.

In order to support public health efforts, our laboratory will be launching both a molecular SARS-CoV-2 RT-PCR assay for the rapid detection of current COVID-19 infection as well as a serology assay that can detect IgA and IgG antibodies associated with a current or past COVID-19 infection. Please click here to read a recent letter from the FDA regarding the appropriate use of serological tests as it regards to COVID-19 screening and testing.

Currently, PerkinElmer Genomics is concentrating on providing testing for large medical institutions, local governments, and employers in an effort maximize our reach and testing capabilities. If you would like to learn more about our testing options, please fill out the form below and we will follow-up with you promptly. Please note that if you are a patient interested in pursuing testing, we would encourage you to contact your local and county hospitals and testing centers to inquire about available testing options in your area. Patients can also visit our friends at Everlywell and sign up to receive updates on when their COVID-19 test kits will be available for individual purchase.

The PerkinElmer® New Coronavirus Nucleic Acid Detection Kit assay received FDA EUA200055 authorization on 04/01/2020, and the EuroImmun EURORealTime SARS-CoV-2 RUO Kit is CE marked and currently seeking EUA approval. Both tests have been developed as Laboratory Developed Tests (LDT). RNA extraction is performed using the PerkinElmer Chemagic 360 instrument and chemistry.

  • Both of our SARS-CoV-2 RT PCR assays (PerkinElmer assay and EURO RealTime assay) include internal control (IC) that serve as both the extraction and amplification controls.
  • Current acceptable sample types for this assay include Nasopharyngeal or Oropharyngeal swabs.

Serological tests detect antibodies in the blood and are detected when an immune reaction to the pathogen has already taken place. These tests can determine who had previously been infected with COVID-19 (2-4 weeks or more prior to testing) and may have developed immunity. How long antibodies last and whether they are protective is being actively studied.

Our assay is run utilizing Enzyme Linked ImmunoSorbent Assay (ELISA) platform and provides in vitro determination of human antibodies of the immunoglobulin IgG against SARS-CoV-2.

  • The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The assay validation revealed that the positive percent agreement to PCR was 100% at and after 21 days following the onset of symptoms while the overall negative percent agreement to presumed negatives was 99%.
  • The antigen used in the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is the spike protein S1 domain, which is more likely to reflect virus neutralizing antibodies than antibodies to N capsid nucleoprotein.
  • Currently acceptable sample types for this assay are 0.25ML blood serum and Dried Blood Spots.

Click here for the FDA COVID-19 Fact Sheet