January 2022—Bio-Rad Laboratories launched its Exact Diagnostics SARS-CoV-2 S Gene Delta-Kappa Variants Control for research testing. The control includes lineages B.1.617.1, B.1.617.2 (AY sublineages), and B.1.617.3.
The product is an addition to the company’s SARS-CoV-2 S gene variants controls alpha, beta, epsilon, and gamma, which were released in August. All are intended to be validated as independent external run controls and used for research testing with molecular assays targeting mutations in the S gene.
The controls consist of synthetic RNA transcript of the variants of the SARS-CoV-2 S gene in a matrix simulating transport media. The product also contains human genomic DNA, 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 SARS-CoV-2 delta-kappa variant S genes and human gDNA are internally targeted to 200,000 copies/mL and 75,000 copies/mL, respectively, using Bio-Rad Droplet Digital PCR to ensure lot-to-lot consistency. Open-vial stability is seven days at 2° to 8°C and shelf life is 18 months at −20°C or 12 months at 2° to 8°C.
Bio-Rad Laboratories, 510-724-7000