Exact Diagnostics SARS-CoV-2 S Gene Alpha, Beta, Delta-Kappa, Gamma and Epsilon Variant Controls

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The Exact Diagnostics SARS-CoV-2 S Gene Variant Controls consists of synthetic RNA transcript of the variants of the SARS-CoV-2 S gene in a matrix simulating transport media. These products also contain 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 S gene variant and human gDNA are internally quantitated at 200,000 copies/mL and 75,000 copies/mL, respectively, using Bio-Rad Droplet Digital PCR (ddPCR) to ensure lot-to-lot consistency.

• Quantitation with digital droplet PCR
• Human genomic DNA (gDNA) background
• High quality matrix to ensure lot-to-lot reproducibility
• 18 month shelf life from date of manufacture when stored at -20°C
• 12-month shelf life when stored at 2-8°C

Targets

Synthetic RNA Transcripts:

• Alpha Variant (B.1.1.7)
• Beta Variant (B.1.351)
• Delta-Kappa Variants (B.1.617.1, B.1.617.2, AY sublineages, B.1.617.3)
• Epsilon Variant (B.1.427, B.1.429)
• Gamma Variant (P.1)

Refer to My eInserts or the package insert (IFU) of currently available lots for specific analyte and stability claims.