Abstract
Diagnosing UK COVID-19 Variant VUI 202012/01
On December 20, 2020, the European Center for Disease Prevention and Control published a threat assessment brief on rapid increase of a SARS-CoV-2 variant in the United Kingdom. This SARS-CoV-2 variant is called VUI 202012/01 (linage B.1.1.7). It is primarily characterized by multiple mutations in the spike protein of the SARS-CoV-2 virus. Preliminary analysis suggests a strong correlation between the new variant and increasing incidence of COVID-19 in the affected geographical area.
The SARS-CoV-2 RNA transcript encodes the replicase complex ORF1ab, the spike protein (S), viral envelope (E), membrane (M), and the nucleocapsid proteins (N). The deletion 69-70 in the spike protein of the variant described above has been reported to cause a negative result using RT-PCR assays that target the S-gene. To ensure your assay can detect the new UK variant, use an RT-PCR test that does not rely on the S-gene for accurate detection. The VUI 202012/01 variant does not affect PerkinElmer RT-PCR assay's ability to accurately detect SARS-CoV-2. All of PerkinElmer's SARS-CoV-2 RT-PCR assays were designed to identify SARS-CoV-2 ORF1ab and N genes.
Avoiding False Negatives
Limit of detection (LoD) is of critical importance because every 10-fold increase in the LoD of a COVID-19 viral diagnostic test is expected to increase the false negative rate by 13%. The FDA published a comparative performance analysis of the FDA EUA nucleic acid-based SARS-CoV-2 assays. As can be seen in Table 2 on the FDA website, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit had the lowest LOD of more than 100 commercially available kits compared in the reference panel study*.
Importance of Assay Sensitivity for Pooling
The ability to pool samples prior to nucleic acid extraction from multiple individuals is critical to allow for cost-effective testing. For accurate detection in pooled samples, a very sensitive RT-PCR assay is needed as the samples are diluted by each other in the pool prior to testing.
Protect Your Lab from SARS-CoV-2 Testing Supply Chain Interruptions
Supply chain interruptions can have a significant impact on a lab's SARS-CoV-2 testing capacity, delaying, decreasing, or even preventing a lab's ability to perform testing. If your testing has been disrupted due to your inability to obtain needed resources, a shift in testing methodology can give you the flexibility you need to better react to the world's rapidly changing needs.
To address growing supply constraints worldwide, PerkinElmer has expanded the production capacity of our coronavirus workflow components including reagents, instruments, and consumables. We have the capability to ship millions of our extraction and RTPCR tests to our customers. In addition, PerkinElmer is one of the few companies with single-source SARS-CoV-2 workflows giving customers the ability to order all components from one source.
For emergency use authorization only. Products may not be licensed in accordance with the laws in all countries. Please check with your local representative for availability.
