Biomeme recommends two different SARS-CoV-2 Positive Controls:
BEI NR-52285: Viral Genomic RNA (from SARS-Related Coronavirus 2, Isolate USA-WSA1/2020 or Exact Diagnostics COV019: SARS-CoV-2 Standard (http://www.exactdiagnostics.com/sars-cov-2-standard.html) See Page 9: Biomeme SARS-CoV-2 IFU v2.1
Below, greater detail is provided on the recommended preparation of Exact Stock SARS-CoV-2 Positive Control in order to utilize it based on your specific needs. This can also be located on Page 17 of the IFU.
Preparation and Storage of Exact Stock:
- Exact SARS-CoV-2 Standard is shipped in 300µL aliquots.
- It is recommended that the user aliquots out further into 12µL aliquots.
- This will provide approximately 25 aliquots. Each aliquot of Exact Diagnostics Stock should be frozen in a lab grade freezer, at –80 or –20 degrees Celsius.
Creating and Using Positive Control:
- First, take one 12µL aliquot of Exact Diagnostics Stock out of the freezer and let thaw.
- Take 10µL of the stock and put into the first well of the M1 sample cartridge along with 20µL of RPC using desired micropipette (See Step 3 in the QuickStart Guide-Substitute patient sample, or Page 14 of the IFU).
- Perform M1 sample prep as you would with a patient sample (See Step 5 in the QuickStart Guide or Pages 15-16 of the IFU).
- Using a micropipette, create approximately 34 aliquots consisting of 22 µL of your elution from the last chamber of the M1 Prep (this will be your positive control (PC)).
- Store aliquots in a lab grade freezer, at –80 or –20 degrees Celsius.
- When ready to use your Positive Control, take out one 22µL aliquot out from the freezer and let thaw
- Add 20µL of the prepared PC into desired SARS-CoV-2 Go-strip wells.
If prepared efficiently, each 300µL aliquot of Exact Diagnostic Stock should create enough Positive Control to run approximately 800-reactions.
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