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Recommended Exact Stock SARS-CoV-2 Positive Control Preparation

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: 

  1. Exact SARS-CoV-2 Standard is shipped in 300µL aliquots.
  2. It is recommended that the user aliquots out further into 12µL aliquots.  
  3. 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: 

  1. First, take one 12µL aliquot of Exact Diagnostics Stock out of the freezer and let thaw.
  2. 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).  
  3. 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). 
  4. 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)). 
  5. Store aliquots in a lab grade freezer, at –80 or –20 degrees Celsius.  
  6. When ready to use your Positive Control, take out one 22µL aliquot out from the freezer and let thaw
  7. Add 20µL of the prepared PC into desired SARS-CoV-2 Go-strip wells.

Summary:  

If prepared efficiently, each 300µL aliquot of Exact Diagnostic Stock should create enough Positive Control to run approximately 800-reactions. 




Please write to support@biomeme.com if you have any further questions or concerns.

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