SalivaDirect: Lab authorization request form
SalivaDirect received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) on August 15th, 2020.

The SalivaDirect FDA EUA is for a Laboratory Developed Test, but we have the right to designate other labs its use.

Only high complexity CLIA-certified labs in the United States can become authorized to run SalivaDirect. Please fill out this form if you would like to receive more information on how to become a designated lab.
Email address *
Contact name *
Contact phone number *
Is your laboratory based in the United States? *
At present, SalivaDirect is only emergency use authorized (EUA) within the United States. As our SalivaDirect EUA is for a protocol, not a manufactured kit, we do not have any tests to distribute. However, since SalivaDirect is based on an open-source protocol (available at https://dx.doi.org/10.17504/protocols.io.bjswknfe), you are welcome to use it.
City, State *
Zip code *
Website for lab or institution *
Is your laboratory CLIA-certified for High Complexity testing? *
CLIA laboratory name *
CLIA/CAP license number *
Are you a for-profit lab? *
Please describe your reasons for wanting to implement SalivaDirect: *
What are your target testing populations? *
Required
How many tests do you anticipate processing per day? *
What is your current turnaround time for test results? *
How are test orders currently submitted and results returned? *
Does your lab have experience working with human saliva as a clinical sample type? *
Do you have access to at least 5x SARS-CoV-2 positive and 5x negative saliva samples for CLIA verification? *
If you answered "yes" to the above question, please detail how many of each sample type you have. If you answered "no", please detail how you will gain access to these samples for CLIA verification. *
What qPCR instrument do you anticipate using for SalivaDirect? *
Listed below are the instruments that have so far been validated for SalivaDirect. We are planning on validating more platforms. If your instrument is not listed, please list all platforms you hope to use to test in 'Other.' Note: at this time, we do not anticipate SD being validated for the Abbott IDnow platform.
Required
If you selected "Other", would you be open to collaboration on bridging studies with your qPCR cyclers?
Clear selection
If your lab has automation systems which you wish to use for SalivaDirect, which systems do you use?
Would you be open to collaboration on bridging studies for your automation systems?
Clear selection
Any additional questions or comments?
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