Enabling science is vital in the fight against COVID-19. PerkinElmer is actively working with global customers – which include specialty and reference diagnostic labs, clinics, hospitals, pharmaceutical and biopharmaceutical labs, academia and governmental and research institutes – to combat the pandemic. Their innovative detection, workflow and research solutions are being used to drive better outcomes as the world responds to COVID-19.
PerkinElmer is providing both serological and RT-PCR testing solutions for laboratories across the globe:
- Antibody tests, the Anti-SARS-CoV-2 ELISAs for immunoglobulin classes A and G from EUROIMMUN (a PerkinElmer company), have received CE mark and can now be applied to COVID-19 diagnostics. Immunoglobulin class G received FDA Emergency Use Authorization (EUA) and is the first time the FDA has taken an active role in validating an assay.
- These tests may determine how quickly antibodies to the virus are made, which could help identify individuals who have developed immunity.
- Laboratories across the world have validated these assays (see examples from our press room), and now with EUA in hand, will have the seal of approval to continue to promote the assays to their patients and clients.
- Beaumont Health Research Institute is launching America’s largest serological testing study using two PerkinElmer, Inc. EUROLabWorkstations and EUROIMMUN Anti-SARS-CoV-2 ELISA testing kits.
RT-PCR Test and Extraction
- New Coronavirus RT-PCR test which received U.S. FDA Emergency Use Authorization (EUA):
- Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) are using this kit to detect SARS-CoV-2, the virus that causes COVID-19.
- This test is also marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.
- EURORealTime SARS-COV-2 received CE mark and has been submitted to the FDA for EUA. (*with the two RT-PCR tests, PerkinElmer’s approach is to initiate parallel efforts and leverage supply chain and capacity at its global factories)
- Conforming to EU regulations, European clinical laboratories are using this kit to detect COVID-19.
- Received FDA EUA amendment to add PerkinElmer’s chemagic Viral DNA/ RNA 300 Kit H96 and chemagic 360 instrument to New Coronavirus RT-PCR test.
- This solution helps address the serious bottleneck laboratories have been experiencing, as it provides RNA extraction from the viral particle prior to RT-PCR.
The breadth of PerkinElmer’s total workflow solutions enables clinical diagnostics customers to rapidly process samples at high volumes:
- The automated SARS-CoV-2 PCR detection workflow solutions can be used with the PerkinElmer New Coronavirus RT-PCR test (RUO) or any other 2019-nCoV PCR assay (RUO).
- To alleviate high throughput demands while reducing manual tasks, PerkinElmer can standardize nucleic acid isolation and PCR assay set-up with the JANUS G3 workstation in delivering plug-and-play automation (RUO).
- To produce accurate, reproducible sequencing results, PerkinElmer’s NGS offerings include nucleic acid extraction solutions, instrumentation, and assays to simplify nucleic acid and library analysis, workstations to automate library preparation, library preparation kits, and software for the analysis of complex sequencing data (RUO).
- LabChip GX Touch Nucleic Acid Analyzer– provides DNA and RNA quantitation and sizing using automated capillary electrophoresis separation.
Critical Solutions for Research and Analysis
For pharmaceutical laboratories studying new drugs and vaccines or potentially repurposing existing drugs for COVID-19, PerkinElmer provides a variety of instruments, reagents, software and services — from molecular, immune and pathogen research to sample automation and pharma manufacturing, and QA/QC. These include:
- Signals Medical Review and TIBCO Spotfire – informatics solutions that help obtain, visualize, analyze and gain better insights faster from vast amounts of new drug and vaccine data or existing clinical trial data.
- Opera Phenix and Operetta CLS – high content cellular imaging platforms to enable understanding of the pathogenesis of viral infections and immune host responses, as well as support compound screens for drug repurposing, discovery and development.
- EnVision and VICTOR Nivo with Alpha, DELFIA, and HTRF biomarker reagent kits – provide detection and characterization of viral proteins and host immune markers.
- QSight, LAMBDA, and Spectrum series instruments- can be used in the preclinical development stage to analyze drug metabolism and protein characterization, as well as during material characterization in manufacturing and QA/QC workflows.
- OneSource service teams – continue to help pharmaceutical companies keep critical lab instruments and software assets up and running, especially during these challenging times.
- Spectrum Two+ spectrometer – an FT-IR spectrometer that provides a fast and reliable method for production labs to determine the ethanol and isopropanol content of hand sanitizers according to the World Health Organization and FDA-approved formulations.
Solutions in action
PerkinElmer’s COVID-19 solutions have been implemented by research institutions across the world, including laboratories affiliated with Baylor University, Medical College of Georgia, Rutgers, University of Buffalo, and one of the largest research laboratories in Brazil.
Helping their communities
PerkinElmer remains steadfast in helping to fight COVID-19, organizing donations of instruments and critical reagent kits to help screen and diagnose the disease in critical locations around the world. We have so far co-donated instrumentation and kits worth more than $1 million
For more information, visit perkinelmer.com.