
Description
Description
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
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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)
Spike Protein Mutations | Alpha Variant B.1.1.7 |
Beta Variant B.1.351 |
Epsilon Variant B.1.427/B.1.429 |
Gamma Variant P.1 |
Delta-Kappa Variants B.1.617.1 B.1.617.2 AY sublineages B.1.617.3 |
---|---|---|---|---|---|
COVA | COVB | COVE | COVG | COVDK | |
S13I | - | - | + | - | - |
T19R | - | - | - | - | + |
69-70del | + | - | - | - | - |
V70F | - | - | - | - | + |
K77T | - | - | - | - | + |
D80A | - | + | - | - | - |
T95I | - | - | - | - | + |
G142D | - | - | - | - | + |
144del | + | - | - | - | - |
W152C | - | - | + | - | - |
E154K | - | - | - | - | + |
E156G | - | - | - | - | + |
157-158del | - | - | - | - | + |
A222V | - | - | - | - | + |
W258L | - | - | - | - | + |
K417T | - | - | - | + | - |
K417N | - | + | - | - | + |
L452R | - | - | + | - | + |
T478K | - | - | - | - | + |
E484K | - | + | - | + | - |
E484Q | - | - | - | - | + |
N501Y | + | + | - | + | - |
A570D | + | - | - | - | - |
D614G | + | + | + | + | + |
H655Y | - | - | - | + | - |
P681H | + | - | - | - | - |
P681R | - | - | - | - | + |
A701V | - | + | - | - | - |
T716I | + | - | - | - | - |
D950N | - | - | - | - | + |
S982A | + | - | - | - | - |
Q1071H | - | - | - | - | + |
D1118H | + | - | - | - | - |
Refer to My eInserts or the package insert (IFU) of currently available lots for specific analyte and stability claims.
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The Exact Diagnostics SARS-CoV-2 S Gene Alpha 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 Alpha variant to monitor assay performance (1 x 0.25 mL)
For research use only. Not for use in diagnostic procedures.

The Exact Diagnostics SARS-CoV-2 S Gene Beta 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 Beta variant to monitor assay performance (1 x 0.25 mL)
For research use only. Not for use in diagnostic procedures.

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 Epsilon variant to monitor assay performance (1 x 0.25 mL)
For research use only. Not for use in diagnostic procedures.

The Exact Diagnostics SARS-CoV-2 S Gene Epsilon 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 Epsilon variant to monitor assay performance (1 x 0.25 mL)
For research use only. Not for use in diagnostic procedures.

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 (1 x 0.25 mL)
For research use only. Not for use in diagnostic procedures.

The product is negative for SARS-CoV-2. The product is formulated in a synthetic matrix and contains genomic DNA at 75,000 copies/mL (5 x 0.3 mL)
For research use only. Not for use in diagnostic procedures.