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SalivaDirect - FAQ | Q&A


• What is a novel coronavirus (COVID-19)?

Coronavirus (also known as COVID-19) is a respiratory illness caused by SARS CoV-2. It was identified in Wuhan, China at the end of 2019 and has spread globally. There has been an increasing number of cases reported in the United States, and it has become a global Pandemic.

• What is the SalivaDirect Covid-19 Test?

This is a test that uses reagent developed by Yale University to help make COVID-19 PCR testing more accessible, comfortable and affordable.

• How accurate is the SalivaDirect Test?

100% Clinical Specificity and 94% Clinical Sensitivity

• What is the methodology for the SalivaDirect Test?

Real Time RT-PCR, DNA

• How long does it take to get the test results back?

Within 24hrs upon receiving

• Is this test authorized by the FDA?

Yes, under the Emergency Use Authorization (EUA).

• How long is my saliva sample stable for testing?

Room temperature for 30 days.

• How do I collect my sample?

Follow the instructions on our “instructions” page which shows how to secret saliva into the saliva tube provided to you.

• What is “observed collection”?

Saliva collection is self-collection, by definition. The quality and volume of sample are important, hence we require that the sample provider follow instructions and be observed by a healthcare professional. This healthcare professional will act as a specimen collector, and will ensure the collection materials are properly labelled with the identifying information of the sample provider. The specimen collector can be a school nurse, an athletic trainer, or any other category of healthcare professional.

• What happens if I don’t collect my sample correctly?

If you are not able to collect an adequate sample or you do not ship your sample within 24 hours of collection, our lab may not be able to perform your test. If this happens, we'll contact you to discuss next steps.

• Is it safe to send my sample by UPS?

Yes.

• What is the difference between the SalivaDirect Real Time RT-PCR test and the swab Real Time RT-PCR test?

Saliva enables non-invasive sampling, and observed self-collection, instead of nasal/ nasopharyngeal swab, which may be uncomfortable, may cause irritation, and requires a trained health professional for collection. Also, native saliva is submitted, which negates the use of transport preservatives (potentially interfering with PCR detection) between collection and testing time. Saliva is a more consistent biological sample, as opposed to swabs, which may not always be collected consistently.

• Which proteins are being identified using the SalivaDirect method?

The assay targets a specific region of the SARS-CoV-2 nucleocapsid (N1) and a human RNaseP (RP) control in every sample. It is important that we, as providers, verify the human origin of all samples received by the presence of human DNA in the collected fluid.

• Who is at high risk of getting very sick?

Severe cases are more likely to occur in older adults (above 65 years of age), as well as pregnant women, those with weakened immune systems, and those with underlying health issues (such as lung disease, diabetes, obesity, high blood pressure, heart conditions, stroke, kidney disease, liver disease, cancer, transplant, AIDS, lupus, and rheumatoid arthritis). However, serious disease can also occur in younger adults.

• Am I at risk of getting COVID-19?

The risk of getting COVID-19 depends on many factors, including where you live, recent travel history, and close contact with people who have symptoms.

• How can I protect myself from getting COVID-19?

Avoid close contact with people who are sick. Restrict any activities outside your home and maintain a safe distance (around 6 feet) between yourself and other people if COVID-19 is spreading in your community. This includes avoiding crowded areas, shopping malls, religious gatherings, public transportation, etc. Wear simple cloth face coverings in public settings (like grocery stores and pharmacies) where social distancing is difficult, especially in areas where COVID-19 is spreading. Stay home and quarantine when you are sick. Clean and disinfect frequently touched objects and surfaces (including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks). Wash your hands often with soap and water for at least 20 seconds. Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and water aren’t available. Always wash hands with soap and water if your hands are visibly dirty. Avoid touching your eyes, nose, and mouth with unwashed hands.

• What can I do to prevent spreading COVID-19?

Stay home. The less you travel, the less the Virus can travel. Cover your nose & mouth if travel is necessary and wash hands throughout the day.

• When should I seek medical care?

Seek medical attention immediately if you develop severe symptoms, especially if you experience any of the following:
Trouble breathing
Continuous pain or pressure in your chest
Feeling confused or difficulty waking up
Blue-colored lips or face

• Should I self-quarantine or self-isolate? How does it work?

If you have not been tested but may have been exposed to COVID-19, self-monitoring and self-quarantine is recommended to see if you get sick. If you have tested positive for COVID-19, self-isolation is recommended so that you do not pass the virus to others. What’s the difference between quarantine and isolation?
Isolation is separating individuals with COVID-19 from people who are not sick. Individuals are separated for a period of time until they are no longer infectious. Quarantine is separating individuals who may have been exposed to COVID-19 but haven’t been tested. They are separated for a brief period of time (14 days after possible exposure) to see if they develop symptoms.

• When can I stop in-home isolation?

The decision to discontinue in-home isolation for patients with COVID-19 should be made on a case-by-case basis in consultation with your healthcare provider. Follow-up with your healthcare provider to discuss discontinuation of in-home-isolation. See the CDC website for more information.

• What is a false negative result?

The test can sometimes show a negative result even if you are infected SARS-CoV-2, the virus that causes COVID-19. This can happen if: It is too early in infection for the test to detect the virus. There was a problem with your sample or the test itself. A false negative result on this test may be more likely to occur if your sample was not shipped back to our lab the same day it was collected. If your results are negative and you’re having symptoms, continue to follow isolation precautions and ask your healthcare provider if you need further testing. If your results are negative and you don’t have any symptoms, continue to monitor for any symptoms up to 14 days after your last possible exposure.

• What is a false positive result?

This test can sometimes show a positive result even if you are not infected with SARS-CoV-2, the virus that causes COVID-19. This test has been designed to minimize false positive results but they can still happen due to problems with the sample that can occur during collection, transport, and/or testing.

• Will someone contact me about my results?

Your physician will contact about your results. Access will report COVID-19 test results to your physician along with appropriate public health agencies in accordance with applicable requirements.

• Where can I learn more about COVID-19?

Centers for Disease Control and Prevention: About Coronavirus Disease 2019 (COVID-19) World Health Organization: Coronavirus disease (COVID-19) outbreak