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Request Designation

SalivaDirect is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.

SalivaDirect has received an Emergency Use Authorization from the United States Food and Drug Administration (FDA) that limits the emergency use of SalivaDirect testing only to laboratories formally designated as authorized laboratories by Yale School of Public Health under the EUA 202097.

Laboratory Eligibility Requirements

SalivaDirect logo

A clinical laboratory interested in receiving SalivaDirect designation as an authorized laboratory under the EUA 202097 must meet the following criteria:

  1. Located in the United States
  2. Certified to perform high complexity tests as specified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a
  3. Have access to the validated equipment, materials and reagents as described in the Authorized Labeling under the EUA 202097
  4. Have laboratory personnel appropriately trained in RT-PCR techniques and using personal protective equipment to perform SalivaDirect test
  5. Generate CLIA verification data using SalivaDirect protocol with at least 5 negative and 5 positive SARS-CoV-2 saliva samples (the exact number is to be decided by the CLIA laboratory director) and submit the data in a specified template for review by the SalivaDirect team.
    The laboratory networks with more than 5 laboratory sites are exempt from this CLIA verification requirement and will be responsible for verification of CLIA status of their individual laboratory sites and must certify in writing that the sites meet all requirements within the EUA 202097 and Authorized Laboratory Network Agreement.

Laboratory Designation Process

Clinical laboratories that meet the criteria above and are interested in being designated as authorized laboratories to offer SalivaDirect to their consumers as part of their laboratory services under the EUA 202097 must follow these steps:

  1. Initial Request for Designation: All laboratories must fill out the online Request Form to register and start the review process. Laboratories are encouraged to review the Designation Package which contains the SalivaDirect Protocol, a Template for CLIA verification data, and the Authorized Laboratory Agreement (or Authorized Laboratory Network Agreement, as applicable). Please read all information in its entirety and follow the steps below.
  2. Review and Designation Process: In addition to meeting the eligibility criteria listed above, all laboratories must complete the following steps to receive designation:
    1. Generate and submit CLIA verification data obtained by running SalivaDirect protocol with at least 5 negative and 5 positive SARS-CoV2 saliva samples; the exact number of samples is to be decided by the CLIA laboratory director.
      Laboratories must adhere to the exact SalivaDirect protocol and use exact reagents, primers/probes, PCR kits and PCR instrumentation currently authorized by the FDA and outlined in the Protocol. If a laboratory does not have access to saliva samples or uses instrumentation that has not been validated yet, see “A NOTE TO CURRENTLY INELIGIBLE LABORATORIES” below.
      The CLIA verification data must be formatted as specified in the data Template and titled “{Lab Name} - Verification Data” and submitted for technical review to salivadirect@gmail.com with the subject “{Lab Name} - Verification Data”
      Laboratory networks with five (5) or more laboratory sites are exempt from the CLIA verification step and will be responsible for verification of CLIA status of their individual laboratory sites and must certify in writing that the sites meet all requirements contained within the EUA 202097 and Authorized Laboratory Network Agreement.
    2. Fill out and submit Authorized Laboratory Agreement (or Authorized Laboratory Network Agreement, as applicable).
      Yale University has created a standard Authorized Laboratory Agreement* that will be used to designate successfully vetted laboratories to offer the SalivaDirect test under the EUA 202097 and Yale-owned SalivaDirect marks (trademark and logo).
      Laboratory directors must fill out the Agreement and sign where indicated (including Exhibits), and send it (preferably, together with CLIA verification data file) to with the email subject “{Lab Name} - SalivaDirect Data and Agreement”
      Please note that we are unable to sign the Agreement until your CLIA verification data are reviewed and approved.
      *Laboratory networks with five (5) or more CLIA-certified laboratory sites should use Authorized Laboratory Network Agreement (will be sent upon request).
      The terms and conditions of the Authorized Laboratory Agreement and Authorized Laboratory Network Agreement are final.
    3. Agreement signatures Once all conditions outlined above are met, Yale University will sign the Authorized Laboratory Agreement (or Authorized Laboratory Network Agreement, as applicable) and email the fully executed copy of the Agreement to your laboratory director or other authorized signatory official (please provide the signatory’s name and email address, if different from the contact we have on file), together with complete Instructions For Use.

    As soon as (and not before) you receive the signed by Yale University Authorized Laboratory Agreement (or Authorized Laboratory Network Agreement, as applicable), your laboratory is officially designated as authorized laboratory to offer SalivaDirect testing to consumers under the EUA 202097 and the SalivaDirect trademark and logo. Your laboratory must continue to comply with the terms and conditions of the signed Agreement and the EUA 202097 to maintain its status (see OBLIGATIONS OF THE DESIGNATED LABORATORIES below).

  3. Training and Onboarding Process SalivaDirect technical team will hold weekly video calls on Wednesdays and Fridays at 10:30 AM ET (subject to the team’s availability) to answer technical questions, offer troubleshooting tips, and alert about updates to the protocol and EUA as they become available. All laboratories will be sent weekly call reminders with a request to submit their questions to salivadirect@gmail.com in advance of the call. The calls may be recorded for internal use and to compile the FAQs that will be posted on SalivaDirect website.

Obligations of the Designated Laboratories

  1. The designated laboratories must follow the Intended Use as described in the Instructions For Use, and only use the validated products and instruments for SalivaDirect testing. Complete Instructions For Use will be provided to the designated laboratories together with the fully executed Agreement.
  2. The designated laboratories will be required to report any false positive or false negative findings or significant deviations from the established performance characteristics to Yale University (salivadirect@yale.edu) and separately to the FDA (by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088). If significant problems arise, the SalivaDirect team will make the required protocol changes and amend the EUA as appropriate.
  3. SalivaDirect will notify designated laboratories of any protocol changes (such as newly validated reagents or instruments/platforms) and provide the updated Instructions For Use and/or Fact Sheets.

Our Mission in the development of SalivaDirect has been to make SARS-CoV2 testing widely accessible - and importantly, affordable, to everyone. In line with this mission, we are providing the rights to use the SalivaDirect protocol under the EUA and SalivaDirect trademark to all vetted laboratories free of charge. It is our hope that the laboratories will use SalivaDirect to pass on the cost-saving measures that we have identified to their consumers.

A Note to Currently Ineligible Laboratories

If your laboratory does not currently meet the eligibility requirements you will be notified of your status. You may still work with us towards the designation.

  1. If your laboratory does not have access to the validated instrumentation, you may:
    1. Wait until the SalivaDirect team conducts validation studies and the additional instrumentation is added to the EUA. Please check our website for updates.

      or

    2. Work together with SalivaDirect team to conduct bridging studies to validate your instrumentation and amend the current EUA, if warranted. Email us if you are interested in collaborating.

      The SalivaDirect team is currently validating or planning to validate the following PCR instrumentation: AriaMX, CFX384, QuantStudio 5 (96 and 384), QuantStudio 6 (96 and 384), QuantStudio 7 (96 and 384), QuantStudio 12k. The SalivaDirect team is NOT planning to validate otherwise fully automated RNA extraction and PCR platforms. We are prioritizing separate PCR instrumentation as they permit greater flexibility to laboratories including more cost-effective reagents.
  2. If your laboratory does not have access to at least 5-/5+ SARS-CoV2 saliva samples to generate the required CLIA verification data, you will have to work with your local hospitals or other partners to obtain saliva samples. Some of our designated laboratories may be willing to share saliva samples; we may be able to connect you to these labs, with their permission.

Important Information about SalivaDirect™

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.