The Exact Diagnostics SARS-CoV-2 S Gene Gamma Variant 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 Gamma variant to monitor assay performance. This product is to be used with assays detecting SARS-CoV-2 Gamma variant RNA, and to be processed in the same manner as patient specimens to monitor all steps of molecular assays.
The Exact Diagnostics SARS-CoV-2 S Gene Gamma Variant Control consists of a synthetic RNA transcript of the Gamma variant SARS-CoV-2 S gene (Lineage P.1) 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 Gamma variant S gene 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.
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