CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Nov. 24, 2021—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 existing SARS-CoV-2 S gene variants controls, alpha, beta, epsilon, and gamma, released in August.
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.