Twist Bioscience Corp has announced that its synthetic SARS-CoV-2 RNA Controls, which provide quality control for the development, verification, and ongoing validation for diagnostic tests are now included on the U.S. Food and Drug Administration (FDA) website as reference materials for SARS-CoV-2.

Twist offers two fully-synthetic SARS-CoV-2 RNA distinct reference sequences as positive controls for the development of both next-generation sequencing (NGS) and reverse-transcription polymerase chain reaction (RT-PCR) assays. In addition, these controls can be used to determine the limit of detection and monitor of day-to-day test variations.

• Twist Synthetic SARS-CoV-2 RNA Control 1 (MT007544.1)
• Twist Synthetic SARS-CoV-2 RNA Control 2 (MN908947.3)

The Twist synthetic controls are designed based on two specific SARS-CoV-2 variants and cover the full viral genome and are sequence-verified. For customers interested in alternative variants of SARS-CoV-2, Twist can create synthetic RNA controls within two weeks.

Customers purchasing synthetic controls are subject to Twist’s leading biosecurity screening protocols and applicable laws and regulations.

The FDA advised the following on the use of synthetic controls: "Please be aware of potential differences between the sequences these synthetic genomic materials are based on and the current circulating SARS-CoV-2 in the US. These differences could impact the performance of an assay and users should take this into consideration when selecting this material as a positive control. To promote RNA stability, steps should be taken to minimize exposure to degrading conditions for instance by spiking test material into a lysis buffer prior to adding negative clinical matrix."

In addition to working with customers to provide synthetic controls, Twist offers Research-Use Only (RUO) target enrichment next-generation sequencing (NGS) panels for viral detection and characterization of samples from patients testing positive for SARS-CoV-2, which can be used for environmental monitoring and surveillance testing, while also providing insight into full sequence information to track viral evolution and strain origin.

Twist is also synthesizing Clonal Genes and Gene Fragments that enable quick development of subunit vaccines from one or more antigen-presenting viral gene or peptide sequence, bypassing the need for scientists to handle live and potentially dangerous pathogens and eliminating the time needed to clone DNA fragments. And, Twist offers Research-Use Only (RUO) target enrichment NGS Panels for viral detection and characterization of samples. The company remains committed to continued innovation and delivery of products to meet the evolving needs of the research community.

For more information on the Twist Synthetic SARS-CoV-2 RNA controls, please click here