Synthetic Viral Controls

Twist’s Synthetic human Mpox Virus (hMPXV) Controls are based on sequences from either the Congo Basin (CB) or West African (WA) clades of hMPXV, formerly known as Monkeypox, and provide coverage of ≥80% of the viral genome. As a result, these controls support the design of custom assays targeting regions of the genome relevant to orthopoxvirus research and can be used for both amplicon and capture-based detection methods. Twist’s hMPXV controls have been validated and are compatible with CDC recommended real-time PCR testing procedures for Mpox detection. Control 1 and Control 2 are composed of 154 and 151 overlapping 1.8kb fragments, respectively, which tile the genome at an interval of 900bp. Each control is present at  copies and provided at a concentration of approximately 100,000 copies/uL. The figure on the right shows a taxonomic relationship between the WA and CB clades of hMPXV as well as other orthopoxviruses. Please contact your local sales representative for more information.

Note: The Twist Synthetic human Mpox Virus
(hMPXV) Controls are not ISO-13485 certified

Virus name Genbank IDs, virus type, and length for each virus included in the Twist Respiratory Virus Controls

Twist has created synthetic RNA controls for several viral genomes. These variants were selected to cover a wide range of sequence diversity. Each control consists of six non-overlapping 5 kb fragments generated from Twist Gene Fragments then transcribed into ssRNA. These controls provide coverage of greater than 99.9% of the bases of the SARS-CoV-2 viral genome. The majority of the controls are provided in the standard format which consist of 100 μL at a concentration of approximately one million copies per microliter. Twist also offers certain controls in Assay Ready and Encapsulated Formats that are supplied as a desiccated pellet. The Assay Ready Controls are supplied at approximately two million copies per tube. The Encapsulated Controls are supplied at approximately 50,000 copies per tube. The Twist Assay Ready Synthetic SARS-CoV-2 RNA Control was developed in partnership with the US CDC and integrated into the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which tests for influenza A, B and SARS-CoV-2 simultaneously. The Twist Assay Ready Synthetic SARS-CoV-2 RNA Control is now available for customers outside the CDC. 

Twist Bioscience Encapsulated Control products offer a unique storage and delivery method for Twist’s established Synthetic SARS-CoV-2 RNA controls. Just as protein encapsulation of viruses offers more stable molecular storage, Twist’s Encapsulated Control products leverage a novel method to seal a metal capsule around a desiccated pellet to enhance stability of the RNA controls. Due to the enhanced stability, they can be shipped and stored at room temperature, reducing cost and improving accessibility globally. The Encapsulated Controls are sold in a rack of 16 or 96 tubes, are single use, and have a 5-year shelf life from the date of manufacture.

Available SARS-CoV-2 Controls

Best practices for using Assay Ready and Encapsulated Controls

For the Storage and use of Assay Ready or Encapsulated SARS-CoV-2 Controls please review the Following documents:

• Twist Assay Ready Synthetic Controls Storage and Use Document
• Twist Sars-CoV-2 Encapsulated RNA Control Storage and Handling Guide

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, along with the identification and differentiation of SARS-CoV-2 PANGO lineages and the identification of specific SARS-CoV-2 genomic mutations, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.