Behind the Science
The SynergyDX COVID-19 testing for domestic and international travelers is developed on the PerkinElmer Completely Automated Liquid Handling Workflow.
The PerkinElmer New Coronavirus Nucleic Acid Detection Test Kit was authorized by the FDA under the Emergency Use Authorization (EUA) on the March 24, 2020. The detection kit is a real-time RT-PCR test intended for the qualitative detection of COVID-19 in human oropharyngeal, nasopharyngeal, and anterior nasal swab samples. The kit identifies the SARS-CoV-2 virus that causes COVID-19 by isolating and amplifying the nucleic acid targets N and the ORF1ab genes. This kit has been validated by Synergy Diagnostic Laboratory for the detection of the SARS-CoV-2 virus in human saliva.
The SynergyDX gentle, anterior nasal swab for international travelers attributes include:
- Specific: Detection of SARS-CoV-2 ORF1ab and N genes
- Sensitive: Limit of detection of 7.14 to 27.24 copies/mL
- Reliable: Performance verified with case studies from outbreak’s point of origin
Recently, the FDA posted “FDA’s Performance Comparison of Nucleic Acid-based SARS-CoV-2 Assays” on the FDA website. In summary the FDA found that the PerkinElmer New Coronavirus Nucleic Acid Detection Kit had the lowest Level Of Detection of the assays tested. the lower the Level Of Detection the greater sensitivity. Synergy has validated a highly sensitive test at only 15 copies/mL.
The FDA developed an experiment to precisely compare the performance of the nucleic acid-based SARS-CoV-2 assays which have received EUA authorization and published a comparative performance analysis. This assessment used the FDA SARS-CoV-2 Reference Panel which allowed a consistent determination of the relative sensitivity of these tests and their cross-reactivity with the MERS-CoV virus. As can be seen in Table 2 on the FDA website, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit had the lowest LOD of the assays tested.
Sensitive & Specific Nucleic Acid-based Detection of COVID-19 ORF1ab and N Genes
Our SynergyDX, COVID-19 test runs on a High Through-put platform allowing for the ability to test thousands of samples per work shift under the supervision of our CLIA certified and licensed clinical laboratory. Samples are tested individually at scale using automated instruments in a state-of-the-art CLIA laboratory.
We are on a mission to help solve the coronavirus spread. Our R&D continues with wastewater surveillance and epidemiology. To learn more please contact us at firstname.lastname@example.org