Bio-Rad, COVDK, SARS-CoV-2 S Gene Delta-Kappa Variants Control

INTENDED USE:
The Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control is intended to be validated as an independent external run control and used for research testing with molecular assays targeting mutations in the Spike (S) gene of the SARS-CoV-2 Delta and/or Kappa variants to monitor assay performance. This product is to be used with assays detecting SARS-CoV-2 Delta and/or Kappa variant RNA, and to be processed in the same manner as patient specimens to monitor all steps of molecular assays.

PRODUCT DESCRIPTION:
The Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control consists of a synthetic RNA transcript of the Delta variant SARS-CoV2 S gene (Lineage B.1.617.2 and AY sublineages), Kappa variant SARS-CoV-2 S gene (Lineage B.1.617.1) and Lineage B.1.617.3 in a matrix simulating transport media. This product also contains human genomic DNA (human gDNA; which includes the human RNase P) for internal control needs, allowing laboratories to monitor the entire process of a molecular assay including extraction, amplification, and detection. The extraction of this product is optional.

The Delta-Kappa variant S gene RNA transcript and human genomic DNA are internally targeted to 200,000 copies/mL and 75,000 copies/mL, respectively, using Bio-Rad Droplet Digital PCR (ddPCR) to ensure lot-to-lot consistency

LIMITATIONS:
For research use only. Not for use in diagnostic procedures.