Frequently asked questions
- What is SalivaDirect?
- SalivaDirect is a new method developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. It is ideal for large-scale testing and offers a number of advantages over traditional testing methods. SalivaDirect received emergency use authorization (EUA) from the U.S. Food and Drug Administration on Aug. 15, 2020.
- Can I buy a SalivaDirect kit through your website or the Yale School of Public Health to test myself or my family?
- No. We are the developers of the test but we do not offer any direct testing. Additionally, SalivaDirect is a complex protocol, or process, that requires a certified laboratory and trained technicians to conduct the testing. This means that you have to contact labs offering SalivaDirect, directly. Some may have at-home kits available for you to order where you can provide your saliva sample and mail this back to the lab that you ordered from.
- Where can I get tested?
- A list of the SalivaDirect designated labs who have granted us to share their details, is provided on our website. These laboratories may not be able to test individuals directly but can point you to facilities that are providing the test. We are continuing to work to develop testing partnerships that may be of use to you or your organization. We will make updates on this website as they become available.
- Can schools get their students tested with SalivaDirect? How about other organizations?
- See the list of labs who have received designation under our EUA to run SalivaDirect. While we are working to develop testing partnerships that may be of use to you or your organization, we also suggest reaching out to local CLIA certified laboratories to encourage them to work with you to implement SalivaDirect testing to help provide you with testing options. High-complexity CLIA labs can apply for designation.
- How much does a SalivaDirect test cost?
- While Yale University is not charging laboratories who have been designated under the EUA, these laboratories do need to charge for the tests to cover their costs. The exact price a lab may charge for a single SalivaDirect depends on a number of factors including costs for their facilities, their staff, their instrumentation and logistics required for test collection and result delivery. Our mission with SalivaDirect however, was to drive down testing costs and help make testing more accessible around the country. For this, the method we developed greatly reduces the cost of reagents (the substances used in chemical analysis) required to test your sample. With this method, we have reduced testing costs to $1.29-$4.30 for the reagents per test (however the cost of the test is higher due to the other expenses a laboratory may have as indicated above). This cost is expected to further drop with large-volume purchases and the use of robotics for high-volume automated testing. SalivaDirect also does not require expensive tubes containing special preservatives to collect your saliva sample, which further reduces costs.
- How else is SalivaDirect different from other testing methods?
In addition to being less expensive, SalivaDirect offers a number of other advantages. They include:
- It is non-invasive. SalivaDirect requires only a small sample of saliva as opposed to the standard nasopharyngeal (NP) swab. The NP method requires what is essentially a long Q-tip that is inserted deep into the nostril and then rotated.
- It is quick and safe. Because SalivaDirect only requires a small saliva sample, the time requirement for an individual is minimal, even less than a minute. People basically have to spit into a small container. The procedure is safer in that there is less risk of exposure to health care workers collecting the samples.
- It is accurate. Results show that SalivaDirect is highly sensitive and is accurate 94% of the time, comparable to results for NP-based tests.
The limit of detection as determined by blinded standards sent out by the FDA to all labs with an EUA shows that the sensitivity of SalivaDirect is comparable to many other great PCR tests out there - including those with RNA extraction.
- My lab is also working on COVID-19 testing. Can we use the SalivaDirect test?
- Potentially yes. If your lab is a high-complexity CLIA certified laboratory and located within the United States it can request designation to implement SalivaDirect under our EUA by filling out application form.
- Will SalivaDirect be further improved in the coming weeks and months?
- Definitely. Everything can be improved, including SalivaDirect. We are looking at ways to scale up automation and to make the test results even faster. A simplified and rapid test has the ability to be used by individuals in a point-of-care setting.
- Is an at-home saliva collection kit available?
- We are currently working to develop a kit to bridge onto our EUA.
- I am an employer and wish to test my employees, how can I use SalivaDirect?
- Contact your local labs and work with them to become authorized to use SalivaDirect.
- How can we become a distributor of SalivaDirect?
- A SalivaDirect is not a point-of-care, or at-home rapid test, nor is it a test kit one can buy. So there is no product to distribute from SalivaDirect™. Only high complexity CLIA-certified labs can become authorized to run SalivaDirect™. If you are interested in contacting these labs for business opportunities, their contact information can be found on our webpage under the designated labs.
Protocols & methods
- Where can I find the SalivaDirect protocol?
- The protocol is publicly available. Please note that in order to offer the SalivaDirect test to your consumers, your laboratory is required to be designated by the Yale School of Public Health (YSPH) and receive the complete Instructions For Use (IFU).
- How can my lab get designated to use SalivaDirect?
- The designation process is available here.
- How does saliva compare to other sample types (nasopharyngeal swab, nasal swab etc.) in terms of sensitivity and specificity for SARS-CoV2?
- Results from our validation work when developing SalivaDirect are available here. While data from our submission to the FDA is also available, we have a more extensive overview of how SalivaDirect performs as compared to other sample types in our SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity preprint. In addition, the limit of detection as determined by blinded standards sent out by the FDA to all labs with an EUA shows that the sensitivity of SalivaDirect is comparable to many other great PCR tests out there - including those with RNA extraction.
- Can you provide me with a list of equipment that we can perform SalivaDirect testing on?
- Here is the current list of validated equipment that can be used for SalivaDirect. Only validated equipment can be used. However, this list is updated as more equipment is bridged on to the EUA. If you don’t see your equipment listed and would like to get your equipment bridged, contact us to discuss this at email@example.com.
- Can other fluorophores/PCR kits/proteinase K be used instead of what is listed on the EUA?
- SalivaDirect can only be run with the validated reagents and equipment listed on our EUA. However, we validated multiple reagents and platforms in an effort to circumvent any supply chain issues, as well as to help keep prices for listed reagents down through competition between suppliers. If you have a preferred reagent or supplier that you would recommend for inclusion on our EUA, please contact us to discuss bridging this onto our EUA.
- What if we don’t have one of the PCR platforms listed on the EUA? Do we have to buy all new PCRs?
- Our mission with SalivaDirect was to help labs easily implement saliva testing. By including a variety of PCR instruments onto our EUA we hoped that most labs would be able to utilize existing platforms and help avoid the expense of purchasing additional equipment which could put pressure on the supply chain and mean an extra expense. If your PCR instrument is not currently listed, before purchasing additional equipment, please contact us to see if we can work together to bridge your existing platform onto our EUA.
- Do we need to submit CLIA verification data (such as 5 positive and 5 negative saliva samples) for each different kit manufacturer we intend to use?
- No, we have done all that validation for you. Your CLIA verification data is just to demonstrate that you have successfully implemented SalivaDirect in your lab and allows us to assist you with troubleshooting if we identify any issues with your data.
- Can frozen specimens that are thawed be used for validation?
- Does a second RT-qPCR (if needed) work from a frozen sample?
- Yes, we have had success with retesting either frozen saliva samples or the prepared lysate after a couple of freeze/thaw cycles.
- Can the PCR systems listed on the EUA also be used for the heat inactivation step?
- We currently have a class II type A2 biosafety cabinet; is this sufficient for processing samples for this protocol?
- Before implementing SalivaDirect, you should consult with your CLIA director, local EHS and/or local state health department to confirm the safest way to conduct SARS-CoV-2 testing and carry out the SalivaDirect protocol in your lab.
- How long does it take to test samples using SalivaDirect?
- This will vary between labs. While we have found that one technician can run 93 samples in around 3 hours, differences in workflow, sample volume, data reporting, and other factors, could affect how long it takes to complete this protocol in your lab.
- Do we have to use 8-strip tubes for sample processing? Can we use a 96-well deep plate instead?
- The use of 8-strip tubes helps to prevent cross contamination between samples which could occur if sealing and re-opening plates, or if plates are not adequately sealed when vigorously vortexing the sample. However, this doesn’t mean that you can only run 8 samples at a time. You can combine these strips and process a full PCR plate of samples at once.
- Are the protocols for the 96- and 384-well format PCRs different?
- While the cycling conditions are the same, the 384-well format requires a smaller reaction volume, so is indeed different to that detailed for the 96-well format.
- What data do we need to share with the SalivaDirect team as part of the designation process? Does it have to be exactly 5+ and 5- saliva samples?
- As part of the designation process we ask that you share your CLIA verification data with us. Your CLIA verification is to be conducted at the discretion of your CLIA laboratory director, which could be a certain number - decided by them - of positive and negative saliva samples. We ask to see your CLIA verification data as if we notice any potential issues we will be able to troubleshoot these with you.
- Can SalivaDirect be used with automation to help increase sample throughput?
Currently samples have to be prepared manually, exactly as detailed in our protocol. However, if you have automation in place that you think will work for SalivaDirect, please contact us to discuss bridging experiments for the addition of your workflow to the EUA. We also recommend that you start by testing some saliva samples in an approach that is closely aligned to the steps in our protocol to test the potential for your system to handle and adequately process saliva samples. You may wish to compare some samples through both the manual SalivaDirect process and your proposed automated process to ensure concordant results. These results will also be helpful for us in assessing the potential for bridging your system onto our EUA.
- Will you be including any all-in-one extraction/RT-PCR machines?
- It is unlikely. Key to decreasing the cost of testing with SalivaDirect, while improving testing efficiency, was through removing RNA extraction. The all-in-one RNA extraction/PCR platforms would mean that a sample would be prepared as per the SalivaDirect protocol, then loaded onto these machines, taking additional time and cost through putting an RNA extraction step back into the method. By the time you’ve done the SalivaDirect work-up, it is at that stage ready to go straight onto PCR so using these machines will defeat the cost- and time-savings that SalivaDirect can offer.
- What is the SalivaDirect Authorized Laboratory Agreement?
Yale University has created a standard Authorized Laboratory Agreement as a fillable pdf form that will be used to designate qualified laboratories to offer the SalivaDirect test under the EUA 202097.
The Agreement must be filled out where indicated (including relevant Exhibits) and signed by an individual authorized to sign on behalf of the laboratory. Please rename your file, add your laboratory name to the subject line and email the agreement. Please note that Yale University will sign the Agreement only after your CLIA verification data are reviewed and approved by the SalivaDirect team. Laboratory networks with five (5) or more CLIA-certified laboratory sites should use the Authorized Laboratory Network Agreement that has been specifically designed for laboratory networks (please email us to request the multi-site Authorized Laboratory Network Agreement form).
Due to the high volume of agreements, Yale University cannot entertain requests to negotiate the terms and conditions of the Authorized Laboratory Agreement or the Authorized Laboratory Network Agreement. That being said, a federal or state entity that is forbidden under relevant law to execute the Agreement as is may contact us with required revisions.
- What are the SalivaDirect trademarks and who can use them?
- Yale University has filed trademark applications with the USPTO for the SalivaDirect™ trademark and corresponding logo displayed on our website. Only laboratories that have been officially designated as authorized laboratories by the Yale School of Public Health and have a fully-signed Authorized Laboratory Agreement or Authorized Laboratory Network Agreement can use the Yale-owned SalivaDirect marks in their print and other media in connection with the SalivaDirect test only.
- Why is there a confidentiality clause in the Authorized Laboratory Agreement?
- The SalivaDirect Instructions for Use (the “IFU”) document is the “product” authorized by the FDA for emergency use and can be shared only with laboratories designated as authorized laboratories by the Yale School of Public Health. Per terms of the EUA 202097 and the Authorized Laboratory Agreement, the designated laboratories must not share the IFU with anyone outside of their own laboratories or publicly post or display the IFU.
- Our laboratory has been designated by the YSPH to offer SalivaDirect tests. What are our responsibilities?
- Responsibilities of Authorized Laboratories, including reporting obligations and limitations of statements in print media, can be found in the EUA 202097 and Exhibit B of the Authorized Laboratory Agreement. Your laboratory must also continue maintaining the current CLIA status as a high-complexity laboratory and comply with all other applicable laws and regulations.
- Our laboratory has been designated by the YSPH to offer SalivaDirect tests. What statements about SalivaDirect testing can we post on our lab’s website?
- All your statements must comply with the terms of the EUA 202097 and the Authorized Laboratory Agreement. Please refer to Exhibit B of the Authorized Laboratory Agreement for a list of the EUA Requirements for Authorized Laboratories, including the Authorized Laboratories’ statements in print and other descriptive media. Below is the language about the SalivaDirect™ test that aligns with these requirements:
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™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.
SalivaDirect™ test has not been cleared or approved by the FDA; it has not been authorized to detect any other viruses or pathogens. SalivaDirect™ is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19.
- Our laboratory has multiple sites, does each site need to have a separate designation?
- Laboratory networks with five (5) or more CLIA-certified laboratory sites go through a slightly different process, under which we can designate multiple sites that are controlled by the same legal entity. Multi-site laboratory networks should contact us to request the Authorized Laboratory Network Agreement.
Important Regulatory 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.