What do my results mean?

Your results are reported as either positive/detected, negative/not detected or indeterminate.

• A positive result means that the SARS-2 COVID-19 viral RNA particles were detected in your sample.
• A negative result means that the RNA particles were NOT detected in your sample.
• An indeterminate result can be reported for a few reasons; if your sample was received by the laboratory without a cap, without the cap being attached properly or if your saliva sample is inadequate or was collected after eating, drinking, smoking or chewing gum, then the lab will not be able to process your specimen and you will receive an indeterminate result. To prevent an inadequate saliva sample, be sure to follow ALL directions in your test kit and tightly attach the cap to your saliva collection tube once you have provided your saliva sample. DO NOT eat, drink, smoke or chew gum for at least 30 minutes prior to providing your sample.

What if I get a positive test result?

If you receive a positive test result, you should isolate yourself according to the CDC guidelines:
https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html

How do I get my results?

When your results are ready, you will automatically receive an SMS and an email with a link to log into AZOVA to view and download a PDF copy of your lab results. You will also receive your own COVID Credentials. Your COVID Credentials are a shareable lab result tool that allows you to track diagnostic test and antibody test results from any lab and to share them with anyone you need to.

How quickly will I receive my COVID-19 test results?

Once you send your kit to the lab (next day shipping is included where available), you can expect your results within 12 to 48 hours from the time the lab receives your kit.

What is the difference between quarantine and isolation?

Quarantine is the process of keeping someone who might have been exposed to COVID-19 away from others. If you have been exposed to someone who tested positive to COVID-19, please refer to the CDC guidelines for quarantine here. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html
Isolation is the process for isolating someone who is sick or who tested positive for COVID-19 away from others. You can read more about CDC isolation guidelines here. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html

What if I test positive and I am not sick?

A COVID-19 infection can be completely asymptomatic or can cause mild to severe illness. If you test positive and you are not sick, that DOES NOT mean that this test caused a false positive result. Though a false positive result is possible, it is very rare and unlikely with a RT-PCR test. If you tested positive and you have no symptoms, the CDC recommends that you should isolate and can be with others after 10 days have passed since the date you had your positive test. You can also test positive BEFORE you develop symptoms. This is another scenario in which you can get a positive test without symptoms. It is not recommended to follow up with an antigen test as the antigen tests are currently less sensitive than a PCR test. Please refer to the CDC guidelines here: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html

What if I test negative and I have symptoms that may be consistent with COVID-19?

There are many viruses or bacterial infections that can cause the same or many of the same symptoms as COVID-19. It is possible to also be infected with more than one virus or bacterial infection at the same time. PCR testing can be negative at the very beginning of COVID-19 infection, but will become positive later in the infection as the viral counts rise. It does not mean this test is incorrect, but means that you may not have yet been shedding enough viral particles for the infection to be detected or you may have a different viral or bacterial infection. It is recommended that you seek medical attention in this case. Regardless, you should isolate yourself if you are sick.

What is a COVID-19 PCR Saliva Collection Test Kit?

This is the most convenient way to get a COVID-19 test from the comfort of home. Purchase as many kits as you need. Use the kits within 60 days of purchase. While supplies last.

Who can use this collection kit?

This COVID saliva PCR test can be used by any person who can provide a saliva sample. No painful nasal swabs! Receive your kit and get tested when you need it. Get your results right on your phone! PCR testing is the gold standard and most accurate form of COVID testing available today. This test has a 98% sensitivity (correctly identifies someone who is infected) and 99% specificity (correctly identifies someone who is not infected).

What is a PCR test and why is it preferred? Is this the same as an RT-PCR test?

A PCR test is a type of "molecular diagnostic test". It is performed in a high complexity laboratory on special machines that are designed to detect the presence of viral RNA particles. If the particles are detected, the test is considered positive. PCR testing is the gold standard and is the most accurate and is more likely to detect the SARS-CoV-2 virus that causes COVID-19 than other tests on the market. A PCR test is most likely to tell you that you have the virus when you do and to tell you that you do not have the virus when you don't. Please note, this test is a real time PCR test, also called RT-PCR.

How accurate is this test? Why should I consider PCR testing over antigen testing?

PCR testing is much more sensitive than most antigen tests. Antigen tests usually have a sensitivity of approximately 80% whereas our PCR test is 98% sensitive. This means that an antigen test will not detect that you have the virus up to 20% of the time even though you do, whereas a PCR test will not detect it only 2% of the time on average. The PCR test is the most sensitive testing option available today.

How does the test work? What does it measure?

The test determines whether you are currently infected by testing for the presence of the SARS-CoV-2 virus in your saliva. It does this by detecting unique genetic RNA markers that are specific to the virus. This is not an antibody test.

Is this the same type of test they use in hospitals and doctor’s offices?

Yes. This is the same testing technology that is used in the hospital setting. Most of the tests currently available use a nasopharyngeal swab. This test uses a simple saliva sample to test for COVID-19.

How do I collect my saliva sample?

Follow the instructions provided with the kit to collect a saliva sample.

Are there any states that don't allow me to take this test?

You can take this test in all 50 states.

How many test kits can I purchase?

You can purchase as many test kits as you need.

Can I return this test kit for a refund?

This product is non returnable and is not eligible for a refund.

Why do I need to complete a health assessment and get a lab order before I can take this test?

The Emergency Use Authorization (EUA) for this test requires a health assessment and a lab order before you can take this test. To get a lab order you must also answer specific health-related questions that are required for COVID testing. This information will be shared with appropriate state reporting agencies required by law.

Are my COVID test results shared with my state?

COVID test results reporting is required in every state. The required information will be shared on your behalf to your state as required by law.

Is my health information safe and protected?

YES! Protecting your personal health information is the NUMBER ONE priority of AZOVA. AZOVA maintains HIPPA, SOC2, and HITRUST data security certifications. These certifications require an ongoing security audit process on all AZOVA systems.

Can I take the test whenever I want?

You can take this test when you need it. Before you take the test, you must complete the health assessment and get a lab order. When you are ready to take the test, activate your kit ID barcode at register.azova.com and follow the instructions to take your test.

Is there an expiration date on the test kit?

Yes. Check the “collect saliva by” date listed on the sticker on the saliva collection device to see the expiration date of your device. Typically the test kit has a shelf life of 24 months.

I received my test kit, now what do I do?

Follow the instructions inside your test kit to activate your kit ID barcode and take your test. This will link your sample to your lab order so you can get your results.

When should I activate my test kit?

Activate your unique test kit ID AFTER you have requested a lab order and when you are actually taking your test. The date and time that you activate your kit will be listed as the collection date on your lab result. This may be important when you are traveling and need a specific testing time to be documented. The collection date and time on your report cannot be changed once your kit is registered.

How do I collect my saliva sample?

Follow the instructions provided with the kit to collect a saliva sample.

How long is my sample stable for?

Your sample is stable for 72 hours from the time you take it and should be processed within 72 hours from the time you activated your kit. Activate your kit at the SAME time you take the sample.

Is it required to take my test with video observation?

Observation during testing is required for travel to certain locations and for participation on some athletic teams. The video observation service enables verification that the person who is taking the test is actually the person whose sample is sent to the lab. If you are traveling please check the state or country that you are going to and determine what the requirements are for that location. This test IS approved as part of the Hawaii Trusted Testing Partner program and is approved for travel to Bermuda. You will receive a compliant form to upload to the Hawaii travel site once you get your results. You must complete the video observation in order to get the form for travel to Hawaii and Bermuda.

What if I submit my sample without video observation?

Your test will still be processed by the lab, however, you will not receive a video observation certificate and you will not receive a certificate for travel to Hawaii or Bermuda if you do not complete your test under video observation.

Is this test approved for travel to Hawaii?

Yes. This test is approved for travel to Hawaii through the Hawaii trusted testing partner program.

Is this test approved for travel to Bermuda?

Yes. This test is approved for travel to Bermuda. Please check for testing requirements and timelines before you book your flights.

We use the P23 TaqPath Sars-cov-2 Assay and the Infinity Biologix TaqPath SARS-CoV-2 Assay. Your home collection instructions card includes the name of the assay that will be run for your test.

If you received the P23 COVID-19 Test Collection Kit from AZOVA, your test is the P23 TaqPathSARS-CoV-2 Assay.

Fact sheet for healthcare providers | Fact sheet for patients | Home Collection instructions for patient

If you received the AZOVA COVID-19 Test Collection Kit, your test is the Infinity Biologix TaqPath SARS-CoV-2 Assay.

Fact sheet for healthcare providers | Fact sheet for patients | Home Collection instructions for patient

This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

This test 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 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Can you ship to a PO Box?

No. The test kit cannot be shipped to a PO Box. Please provide a physical address for us to ship your kit to.

What is the fastest way to get my test kit to the lab?

Your test kit(s) will be delivered the next day when you drop off your kit box at the nearest UPS store before the cutoff time for overnight shipping for next day service. DO NOT drop your kit off at a drop box as it may not be picked up in time. Please call your local UPS store to ask for the cutoff time AND to find out if next day air service is available. Certain remote locations DO NOT have next day air service. If your location does not offer next day air service, it will get to the lab via second day service. UPS DOES NOT DELIVER ON SUNDAYS. UPS does deliver on Saturdays and the lab will receive specimens on Saturdays. Do not physically take your test kit to the laboratory. Your kit will be rejected.

Do I need to take my sample to the UPS store on the same day that I provide my saliva sample?

Yes. Be sure to take your test early enough to get it to the UPS store before the cutoff time for UPS next day air.