Twist's SARS-CoV-2 quality controls added to FDA materials

By The Science Advisory Board staff writers

March 26, 2020 -- Twist Bioscience's synthetic SARS-CoV-2 RNA quality controls for the development, verification, and validation of diagnostic tests for SARS-CoV-2 are now included in the U.S. Food and Drug Administration's (FDA) reference materials.

Twist offers two fully synthetic SARS-CoV-2 RNA distinct reference sequences as positive controls for the development of both next-generation sequencing and reverse transcription polymerase chain reaction assays. The following controls also 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.


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