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In a clinical trial, the Scout COVID-19 Test had an overall accuracy of 96.1%. The PPA/sensitivity was 87.7% and the NPA/specificity was 100%. However, excluding samples with very low levels of virus, the PPA was 97.9%. The Scout COVID-19 Test can also detect all Variants of Concern, including Delta, BA.1, BA.2, BA.4, and BA.5.

Users must connect to a network using their mobile device to download the Scout Connect mobileapplication, to log in to their account or to recover login credentials. Once logged in, no IT network connection is required to run a test. An IT network connection will be required to access software updates and back up test data associated with the account to Scout’s secure and HIPAA compliant cloud database. The IT Network must enable connection to the internet. For example, Wi-Fi or cellular data connectivitywill satisfy the required characteristics. Scout recommends use only on secure networks (e.g., WPA3/WPA2 Wi-Fi or LTE cellular), although this is not a requirement for use. Communications from Scout Connect to the IT Network are encrypted prior to transmission using HTTPS protocol; only a public key and encrypted messages are sent.Personal health information does not flow between the Scout Hub and Scout Connect. Only raw dataoutputs are sent via Bluetooth from the Hub to the mobile device. Scout Connect sends encrypted testinformation to a secure cloud storage database via the IT Network. There is no intended information flowbetween Scout Connect or the Scout Hub and other devices on the IT Network.

Solid Green: Hub is ready for use.Flashing Green: Hub is running a test.Flashing Yellow: The Hub lid is open. Close the lid. If discovered early, it is likely that closing the lid will solve the problem, but there is a possibility that if discovered later, the Test Results in the Scout Connect, the Scout mobile app, will indicate "Cancelled" or "Invalid Results" and the test will have to be redone. Flashing Red: The Hub is receiving an error condition. Troubleshoot the condition. If troubleshooting fails to correct the issue, contact Scout Customer Support.Flashing Blue: The Hub is cooling down. Wait until the LED light is solid green before starting a new test.

The test requires the Hub, a single-use test kit, and a mobile iOS device running the Scout mobile app, Scout Connect. The test kit contains the nasal swab, the assay tube (inserted into the top of the Hub), and the squeeze vial.

Gently insert swab tip just inside the nostril, about 1/4 of an inch. DO NOT go past the soft rim of the nostril. Gently and swiftly make 5 BIG CIRCLES against the inside walls of each nostril (Left and Right), about 2 seconds total per side. Do not spin the swab. Do not attempt to scrape or remove excess mucus. Ensure no visible blood or mucus is present on swab before proceeding. The swab should look like it does not have anything on it. If mucus or blood is present, discard swab and restart with a new swab. Too much mucus may cause invalid results. Mucus could be runny or dry and crusty. If your test result is INVALID, clean nostrils well with a tissue or saline wipe prior to retesting with a new nasal swab. NOTE: For small children, use just the very tip of the swab. You may need a second person to hold the child’s head while swabbing.

The minimum age to take the Scout COVID test is age 2. Adults should closely supervise and administer the test for children between the ages of 2 to 13 years old.

The Scout Hub and power adapter are reusable. Do not throw the Scout Hub away as it can be used many times. Consult local guidelines and requirements for proper disposal of the Scout Hub and power adapter at the end of its expected service life.

An Invalid result means the test was completed, as indicated by the Hub light either flashing Blue or is a Solid Green. However, under "Test Results" in the Scout Mobile App, it says "Invalid". This indicates that the test was not able to tell if you have COVID-19 or not. This can happen if the test did not run properly. Causes of an invalid result are: 1) excess mucus collected on the nasal swab, 2) blood collected on the nasal swab, 3) touching the tip of the nasal swab with your hands or other objects, resulting in contamination of the nasal swab, 4) opening the Hub lid during the test, 5) unplugging the Hub during the test. If the test is invalid, clean nostrils well with a tissue or saline wipe prior to retesting. Then use a new Test Kit to collect a new nasal specimen and re-run the test. If the test is still invalid after testing again, please call Technical Support for further guidance. Until you retest, continue to be vigilant about social distancing, wear a mask when in the vicinity of others, and wash your hands on a regular basis throughout the day.

A Canceled result indicates that the test was not completed and needs to be repeated. The test will be canceled if the Hub is unplugged or loses power. Make sure the Scout Hub is on a stable surface and securely connected to power while running a test. The test will be canceled if the lid is open during the test. Make sure to close the lid securely before starting the test, and don’t open it until after the test is complete!

Typically it takes under 20 minutes to produce a positive test result and approximately 30 minutes for a negative test result. If the test goes beyond 40 minutes, there could be a loss of Bluetooth connectivity between the Scout Hub and the cell phone or tablet used to enter the User information and start the test. To re-establish Bluetooth connectivity, follow the instructions below: 1) If your iOS device has a home button, press that twice quickly to show all of the apps that are open. If your iOS device does not have a home button, place your finger at the base of the screen, hold, and swipe up. Either way, you should now see all the open apps, including the Scout Connect mobile app. 2) Swipe up on the Scout Connect app to close the application. 3) Reopen the Scout Connect app. 4) In the Scout Connect app, navigate to "Test Results" by clicking the second icon on the bottom. 5) Then, to re-establish Bluetooth connectivity, click on a few of the test results and then hit the back button. 6) The restart of the Scout Connect app and clicking on the test results should force the app to reestablish a connection to the Hub. It may then take a couple of minutes for the final result to be available. 7) You can do this any time that the test has taken longer than you should reasonably expect. This issue sometimes occurs when the iOS device loses a Bluetooth connection with the Hub. We are working to address this problem with future software updates.

If the Scout Hub LED light flashes red at any point, unplug the Scout Hub. Open the lid and check if the Scout Hub is empty. If a Snap Tube or debris is inside, remove it. Close the Scout Hub lid until it clicks. Reconnect the power cord to the Scout Hub again. If a test was already running, it will be canceled and the test will need to be rerun with a new Test Kit. If the Hub still flashes red, please contact Technical Support at help@scouthealth.com

When the lid to the Scout Hub is not fully closed, the Scout Hub LED will flash yellow. Fully close the lid to turn off the flashing yellow LED light.

When the Scout Hub LED is a solid green (not flashing), it means the Hub is ready for use.

When the Scout Hub LED light is flashing green, it means the Hub is running a test.

When the Scout Hub LED light is flashing blue, it means the test has been completed and the Hub is cooling down. A new test can not be run until the Scout Hub has cooled down, as indicated by the Scout Hub LED light returning to a solid green. If the room is warm, it will take longer for the Hub to cool down. Do not operate the Scout Hub in room temperatures above 86 degrees Fahrenheit.

A false negative occurs when a person does have COVID, but instead of returning a Positive COVID test result, the COVID test returns a Negative result. Hence the term, "False Negative". A false negative COVID test result may occur if: 1) The sample does not contain enough of the COVID virus needed for detection. 2) The virus mutates in the regions targeted by the test. 3) Inhibitors are present in the sample. 4) Users should wait at least 15 minutes after use of Afrin or glucocorticoid nasal spray before collecting a sample, as these substances can result in false negative results. 5) False negative and Invalid results may occur if there is blood on the swab. Do not use the swab if blood is visible on the tip.

Do not open the Scout Hub lid once the test has started. The Hub lid must stay closed while a test is running. A flashing yellow LED light on the Hub alerts the user that the lid is open during the test and the lid should immediately be closed. Leaving the lid open may result in a “Canceled” or “Invalid” test result.

Gently insert the Nasal Swab tip just inside the nostril, about 1/4 of an inch. DO NOT go past the soft rim of the nostril. For young children, use just the very tip of the swab. You may need a second person to hold the child still while swabbing. Children under the age of 13 should be supervised by an adult. The Scout COVID test is only to be used on children two years and older.

During account sign-up, on the Scout mobile app, Scout Connect, you have the option to check the box that allows your test results to be reported, along with your name, email and zip code. If you the box is left unchecked, nothing gets reported. The account name, email and zip code are stored on the Scout Server in order to allow account creation.

The test can detect COVID-19 positive samples in as few as 12 minutes, however for negative samples the test will run for 30 minutes.

Confirm the hub is plugged into an electrical socket. The USB connector is plugged into the back of the Hub. The USB connector is plugged into an electrical socket. After confirming the USB connector is plugged in to the hub and electrical socket, check for the green LED light on the front of the hub. If the LED light is still not on (lit green), call Scout Customer Support, 877-846-4522, for further assistance.