NKGen Biotech now offers an alternative to nasopharyngeal swab testing
The SalivaDirect™ test is an FDA authorized (EUA) test developed by Yale University to allow for a safer and less invasive way to collect specimens for COVID-19 testing. Yale’s researchers were able to remove the cumbersome RNA extraction step in the testing process that is typically used to obtain RNA from nasopharyngeal swabs. With saliva, this step is not necessary.
SalivaDirect™ is a new method for testing people suspected of SARS-CoV-2 infection. The test is performed using a dualplex RT-qPCR method using validated primer and probe sets developed by the US Centers for Disease Control and Prevention (CDC).
A simple, non-invasive saliva sample collection
Since the RNA extraction step is not needed, the time to process the test is shorter
SalivaDirect™ results have a clinical specificity of 100% and sensitivity of 94%
SalivaDirect™ is authorized by the FDA for the detection of nucleic acid from SARS-CoV-2 under an Emergency Use Authorization (EUA)
Elimination of the costly extraction procedure not only saves time but also reduces costs
What is the SalivaDirect™ Test?
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.
What does the test measure?
The test detects the presence of SARS-CoV-2 RNA indicating that a person is infected and has COVID-19. A positive result indicates SARS-CoV-2 RNA has been detected in the saliva sample submitted for testing. A negative result indicates that SARS-CoV-2 RNA was not detected in the saliva sample.
What specimen is required?
This test requires a simple non-invasive saliva sample, self-collected from individuals suspected of having COVID-19 infection, under supervision of a healthcare professional. No food or drink can be consumed 30 minutes prior to collection appointment.
Following Specimen Collection Guidelines, the saliva sample can be self-collected at the doctor’s office, at the NKGen Biotech facility (appointment required) or remotely via a Zoom appointment (call 949-396-6830 for more details on virtual collection appointments).
Saliva specimens are stable at room temperature for 5-7 days when collected in a sterile container as per instructions.
What do the test results mean?
A positive result indicates that SARS-CoV-2 RNA was detected and therefore the patient is infected and presumed to be contagious.
A negative result indicates that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. A negative result does not rule out COVID-19 and should not be used as the only basis for excluding the possibility of COVID-19.
How accurate is the test?
The test has a clinical specificity of 100% and clinical sensitivity of 94%
Specificity = ability of the test to detect and measure SARS-CoV-2 in a sample;
Sensitivity = ability of test to specifically measure only SARS-CoV-2 and not other viral nucleic acids in the sample
What is the test methodology?
SalivaDirect™ is an RNA-extraction free dualplex real-time reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container.
How is this different than the standard nasopharygeal swab PCR test?
The standard COVID-19 PCR test requires a long swab inserted into the nose which is uncomfortable and requires a healthcare professional to collect the specimen. SalivaDirect™ requires a self-collected saliva sample which is easy to obtain by just spitting into a sterile container and does not require close interaction with healthcare professionals. Both sample types utilize the same RT-PCR technology to identify SARS-CoV-2 in the sample.
Is the test for active or past infections?
The test is for active infections since it is designed to detect SARS-CoV-2 in the saliva samples of patient suspected of COVID-19 infection by healthcare providers.
Is the test authorized by the FDA?
Yes, under an Emergency Use Authorization (EUA).
The 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.
How do I order?
Physicians: If the physician is collecting the specimen, send specimen (collected as per Specimen Collection Guidelines) along with the completed COVID-19 SalivaDirect™ Test Order Form to NKGen Biotech for processing.
If the patient will be sent to the NKGen Biotech facility for specimen collection, the doctor must fax completed order form to 949-861-9565(FAX) prior to the patient calling for an appointment. After the test order has been faxed, patients should call NKGen Biotech at 949-396-6830 to set up an on-site collection appointment. Payment will be collected over the phone at the time of scheduling.
Patients: If the patient does not have a doctor’s order, they can call NKGen Biotech at 949-396-6830 to schedule an appointment and request a test order from one of our partner physicians by filling out a screening questionnaire.
Business accounts: Order instructions will be provided during the account set-up process. Please call 949-396-6830 to set-up a COVID-19 employee testing account.
How long until results are ready?
In most cases, results will be available within 2 business days from time of specimen receipt. Results will be provided to the ordering physician. Patients can obtain test results by contacting their healthcare provider. A POSITIVE result will be called to the provider and the patient. A NEGATIVE result will be called only if specifically requested on the lab order. Otherwise it will be distributed through normal lab reporting channels. Results will be reported to Public Health by the testing laboratory.
Do you bill insurance?
We do not currently accept health insurance. All tests are payable by credit card at time of service. An itemized receipt can be requested at time of payment which can be submitted to the patient’s insurance company for possible reimbursement.
SalivaDirect™ is a trademark of Yale University.