Cue IN9100208-1 COVID-19 Test Instruction Manual

Cue IN9100208-1 COVID-19 Test

Summary and Explanation

An outbreak of respiratory illness of unknown etiology in Wuhan City, Hubei Province, China was initially reported to the World Health Organization (WHO) on December 31, 2019.1 Chinese authorities identified a novel coronavirus (2019-nCoV) which has resulted in thousands of confirmed human infections in multiple provinces throughout China and exported cases in several Southeast Asian countries and more recently the United States. Cases of severe illness and some deaths have been reported. The International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2. The Cue COVID-19 Test is a molecular in vitro diagnostic test that aids in the detection and diagnosis of SARS-CoV-2 and is based on widely used nucleic acid isothermal amplification technology. The Cue COVID-19 Test contains primers and probes and internal controls used in molecular tests for the in vitro qualitative detection of SARS-CoV-2 RNA. The Cue COVID-19 Test detects SARS-CoV-2 nucleic acid in nasal specimens.

Intended Use

The Cue COVID-19 Test is a molecular diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens collected with the Cue Sample Wand. The Cue COVID-19 Test is intended for use in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19. This test is intended for professional use or for consumer self-testing. The sample types for professional use include healthcare professionals or self- collected direct nasal swabs and previously collected individual nasal specimens in viral transport media (VTM). The sample types for consumer self- testing include adult self-collected direct nasal swabs or adult collected direct nasal swabs from children 2 years of age or older. The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand, and the Cue Health App on compatible mobile smart devices named on the Cue Health website at www.cuehealth.com. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with a medical history and other diagnostic information is necessary to determine the infection status. Positive results do not rule out bacterial infection or co- infection with other viruses. Consumers who test positive with the Cue COVID-19 Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for medical management decisions. Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for medical management, should be tested with different authorized molecular tests. Consumers who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their physician or healthcare provider. The Cue COVID-19 Test is intended for use by healthcare providers and operators working in a point of care professional environment and for self-use in a non-laboratory setting.

Principles of the Procedure

The Cue COVID-19 Test utilizes isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 nucleic acids. This test is a molecular nucleic acid amplification test (NAAT) that detects the genetic material of SARS-CoV-2 using a molecular amplification reaction that is an equivalent alternative amplification method to polymerase chain reaction (PCR). The Cue COVID-19 Test primers amplify the nucleocapsid (N) region of the gene enabling detection. The Cue COVID-19 Test forward primers are conjugated to biotin. Cue COVID-19 Test reverse primers are conjugated to Horseradish Peroxidase (HRP). RNase P serves as the internal control. The RNase P forward primer is conjugated to a small hapten, Digoxigenin (Dig). The RNase P reverse primer is conjugated to HRP. The RNAse P internal control has been designed to control for presence of human cellular material in the sample and proper assay execution including sample inhibition, amplification, and assay reagent function. If RNase P is not detected, the Cue COVID-19 Test will return an “Invalid” result. In positive samples where target amplification is strong, the internal control is ignored and the target amplification serves as the control to confirm that the clinical sample was not inhibitory and that assay reagent performance was robust. When the user inserts the Cue Sample Wand with nasal sample into the cartridge, the test automatically begins. Heating, mixing, amplification, and detection take place within the cartridge. The current flow from the electrodes provides a semi-quantitative nanoampere measurement that is converted to a positive or negative result (based on a pre-determined cutoff). The Cue COVID-19 Test takes about 20 minutes from Sample Wand insertion to results.

Materials Provided

• Cue COVID-19 Test Cartridge Pack REF C1021
  Contains a foil pouch with a plastic tray. The plastic tray contains one (1) single-use Cue COVID-19 Test Cartridge and one (1) single-use wrapped sterile Cue Sample Wand.

A small pouch called a desiccant is under the cartridge. This pouch has material inside to protect the Cue COVID-19 Test Cartridge from damage due to humidity. Throw away the desiccant after the cartridge is used. Contact Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378) if any component is missing or damaged or if a cartridge foil pouch is not sealed.

Materials Required But Not Provided

• Cue Health Monitoring System
  Purchase the Cue Health Monitoring System (REF C0201) from Cue Health Inc., by contacting Cue Health Customer Support at support@cuehealth.com or call 833. CUE.TEST (833.283.8378).

• Mobile Smart Device
  Go to www.cuehealth.com for the list of compatible mobile smart devices. BLUETOOTH® wireless technology and Wi-Fi® or cellular capability are required to download the Cue Health App.

• Cue Health Mobile Application installed on the mobile smart device
  Download the Cue Health App from the Apple® App Store® or Google Play™ Store.

• Control Swabs
  As applicable to professional use environments, purchase the Cue COVID-19 External Control Swabs Pack (REF C2113) that contains three Cue COVID-19 Test Positive Control Swabs (REF C2111) and three Cue Test Negative Control Swabs (REF C2112) from Cue Health Inc., by contacting Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378).

Precautions – General

• For in vitro diagnostic use.
• This test has been authorized only for the detection of nucleic acid from SARS CoV-2, not for any other viruses or pathogens.
• Performance of the Cue COVID-19 Test has only been established with Cue Sample Wand direct nasal swab samples and, as applicable to professional use environments, by dipping the Cue Sample Wand into a tube containing an individual nasal specimen in viral transport media (VTM).
• Positive results are indicative of the presence of SARS-CoV-2-RNA.
• Synthetic nucleic acid is used to make the Positive Control Swabs. However, control swabs, nasal samples and test cartridges should be handled as though they could transmit disease. Observe established precautions against microbial hazards during use and disposal.
• To be used in conjunction with the Cue Cartridge Reader and Cue Health App.
• The Cue Cartridge Reader needs to be on a level surface when the Cue COVID-19 Test Cartridge is inserted and while the test is running. Do not move the Cue Cartridge Reader while the test is running.
• While the test is running, avoid exposure of the Cue Cartridge Reader to vibrations.
• Do not use the Cue COVID-19 Test Cartridge past the Use By date on the cartridge foil pouch label.
• Do not use the Cue Sample Wand past the Use By date on the Wand label.
• The Cue Health Monitoring System must be cleaned and disinfected after each use. See the Cue Health Monitoring System User Manual for instructions.

Precautions – Cue COVID-19 Test Cartridge and Cue Sample Wand Handling

• Open the Cue COVID-19 Test Cartridge foil pouch when you are ready to test. Do not open the foil pouch more than 30 minutes before you begin a test.
• Do not use scissors or sharp objects to open the foil pouch as damage to the contents can occur.
• The Cue Sample Wand is sterile. Do not use if the packaging is damaged or accidentally opened before use. Open another cartridge foil pouch for a sterile Cue Sample Wand.
• If the Cue COVID-19 Test Cartridge or Sample Wand is dropped, cracked, found to be damaged when opened, do not use and discard.
• Store and use the Cue COVID-19 Test Cartridge at the temperatures provided in the storage and testing conditions sections below.
• The Cue COVID-19 Test Cartridge will heat up inside the Cartridge Reader for one minute. Insert the Cue Sample Wand with the nasal sample when the Cue Health App screen shows that the cartridge heat cycle is complete. Do not wait longer than 10 minutes after the heat cycle is complete to insert the Cue Sample Wand.
• After the test is complete, remove the Cue COVID-19 Test Cartridge with the Cue Sample Wand still inside and dispose of according to the appropriate local waste guidance and regulations.

Precautions – Used Test Cartridge Disposal

• Used cartridges are sealed with very low risk of transmitting infectious agents requiring standard precautions. Follow your local environmental waste guidance and regulations for proper disposal of used cartridges.

Precautions – Nasal Sample Collection

• Treat all biological specimens as if capable of transmitting infectious agents. Wear protective equipment as appropriate.
• Follow standard safety precautions for handling biological specimens.
• Nasal sprays, gels, or cream may not be used before collecting a nasal sample.
• When collecting a direct nasal sample, both nostrils must be swabbed with the Cue Sample Wand prior to running the test.
• You must insert the Sample Wand with nasal sample into the Cue COVID-19 Test Cartridge within 5 minutes of collecting the nasal sample.
• The risks of collecting a nasal swab sample include irritation, bleeding, and infection inside the nose where the nasal sample was collected.

Limitations

• Performance of the Cue COVID-19 Test has only been established with Cue Sample Wand direct nasal swab samples and, in applicable professional use environments, by dipping the Cue Sample Wand into a tube containing an individual nasal specimen in viral transport media (VTM).
• Detection of SARS-CoV-2 RNA may be affected by sample collection methods, presence or absence of symptoms, and/or stage of infection.
• A false negative result may occur if a sample is improperly collected or handled. False negative results may also occur if inadequate numbers of organisms are present in the sample.
• As with any molecular test, mutations within the target regions of SARS-CoV-2 could affect primer and/or probe binding resulting in failure to detect the presence of virus.
• The performance of the Cue COVID-19 Test has not been assessed in a population vaccinated against COVID-19.
• This test cannot rule out diseases caused by other bacterial or viral pathogens.
• Analyte targets (viral nucleic acid) may persist in vivo, independent of virus viability. Detection of analyte targets does not imply that the corresponding viruses are infectious or are the causative agents for clinical symptoms.
• This assay should not be used within 30 minutes of administering nasal or throat sprays.

Cue COVID-19 Test Cartridge Storage Conditions
Store the unopened Cue COVID-19 Test Cartridge Pack and the foil pouches inside the pack in the temperature range shown in the table below. Do not use a cartridge that has been stored outside of this temperature condition.

Do not use a cartridge beyond the Use By date on the cartridge foil pouch label.
Cue COVID-19 Testing Conditions
Run a Cue COVID-19 Test in the temperature range shown in the table below. Do not run the Cue COVID-19 Test if you are outside of this temperature condition.

Quality Control (QC) for Professional Use Environments

Positive and Negative Controls
Controls may be used to show that the Cue COVID-19 Test is working properly. The Cue COVID-19 Test Positive Control Swab (REF C2111) and Cue Test Negative Control Swab (REF C2112) are available separately.
The Cue Positive and Negative Control Swabs may be stored at room temperature (15-30 ºC / 59-86°F). Controls are tested using the same procedure as for a nasal sample. Cue Health recommends that a Cue Test Negative Control Swab and a Cue COVID-19 Test Positive Control Swab be run:

• Once for each new lot of cartridge packs received
• When problems with testing are suspected or identified
• Alternatively, as deemed necessary in order to conform with your internal quality control procedures, with local, state and/or federal regulations, or accrediting groups

If correct control results are not obtained, repeat the test using a new Control Swab, and a new test cartridge. If the control testing continues to fail, do not perform additional clinical specimen tests or report results. Contact Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378) before testing additional clinical specimens. Purchase Cue COVID-19 Test Positive Control Swabs and Cue Test Negative Control Swabs from Cue Health Inc., by contacting Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378).
Specimen Collection and Handling
The Cue Sample Wand must be used with the Cue Health Monitoring System and the Cue COVID-19 Test Cartridge. To collect a direct nasal swab sample, both nostrils are swabbed with the same Cue Sample Wand. While swabbing in both nostrils do not attempt to scrape or remove excess mucus.

• Insert the tip of the Cue Sample Wand into one nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.
• Then, insert the same Cue Sample Wand into the other nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.

Self-collection of nasal swab samples was validated only in the adult (18 years of age and older) population. Adults should collect the nasal swab sample from individuals less than In applicable professional environments, the Cue Sample Wand may also be dipped into a VTM tube containing an individual nasal specimen. Instructions for sample dipping are provided in Step 5-7a. The Cue Sample Wand containing the nasal sample must be inserted into the cartridge within 5 minutes of sample collection.

Directions for Running the Cue COVID-19 Test
Follow the step-by-step instructions provided below.

Step 1: Obtain Items Required but Not Provided in the Cartridge Pack
You will need the items below to run the Cue COVID-19 Test. These items are not included in the Cue COVID-19 Test Cartridge Pack.

• Cue Health Monitoring System. You can purchase the system from Cue Health Inc., by contacting Cue Health Customer Support at support@cuehealth.com or by call
  833. CUE.TEST (833.283.8378).

• Go to www.cuehealth.com for the list of compatible mobile smart devices. BLUETOOTH wireless technology and Wi-Fi or cellular capability are required to download the Cue Health App.

• The Cue Health App installed on your mobile smart device. Download the Cue Health App from Apple App Store or Google Play Store.

Step 2: Set Up Your System
Read the Cue Health Monitoring System Quick Start Guide and the User Manual before you run a Cue COVID-19 Test. The Quick Start Guide will help you quickly set up your Cue Health Monitoring System and get ready to run a test. The User Manual gives you all the information you need to use your Cue Health Monitoring System correctly and safely. The Quick Start Guide or the User Manual will show you step-by-step how to do the following:

1. Unpack and set up the Cue Cartridge Reader.
2. Download the Cue Health App by going to the Apple App Store or Google Play Store and searching for the Cue Health App.
3. Set up your Cue Account in the Cue Health App. Once you have set up a Cue Account, you may create and edit account profiles for persons being tested. All your test data will be saved under your Cue Account in the Cue Health App and on the Cue Health secure cloud server.
4. Pair Cue Cartridge Reader(s) to your mobile smart device.
5. Connect the Cue Health App to a paired Cue Cartridge Reader to run a Cue COVID-19 Test.
6. Learn more about your Cue Health Monitoring System and all the above system set-up steps in the Cue Health Monitoring System User Manual.

Step 3: Review All Information
Review the information provided in this Cue COVID-19 Test Instructions for Use before running a test. If you do not understand the instructions, do not run a test. Contact Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378) for help. The Cue Health App uses pictures and videos to walk you through, step-by­ step, how to collect a nasal sample and run a Cue COVID-19 Test. If you do not follow the instructions, the test may not run as it should, and you may not receive a test result or the test result may not be correct.
Step 4: Open the Cue Health App on Your Mobile Smart Device and Follow the On-Screen Instructions

1. The first time you use the Cue Health App you must accept the “Terms of Use and End User License Agreement” and the “Privacy Policy”.
2. A Cue Health App update may be required before you run a test. Follow any on-screen instructions for updating the Cue Health App.
3. The first time you use the Cue Health App you will need to tap Create Account. After Creating an Account you may Login.
4. Make sure that the Cue Cartridge Reader you will be using is paired to your mobile smart device. Follow the Cue Health Monitoring System’s Quick Start Guide or User Manual and the on-screen instructions to pair the Cue Cartridge Reader to the mobile smart device.
5. Make sure that the Cue Health App is connected to the Cartridge Reader that you will be using for the Cue COVID-19 Test. Follow the Cue Health Monitoring System User Manual and the on-screen instructions to connect to the Cartridge Reader.
6. Follow the on-screen instructions to run a test. Step 5 below also tells you how to run a test using the Cue Health App.

Step 5: Run a Cue COVID-19 Test
Log into your Cue Account. After logging into your account, tap on Manage Profiles. Choose the person’s name or barcode ID for the person being tested or add a new profile. To add a new profile, tap the + sign to type in a person’s identification information and SAVE; or tap the barcode icon to scan a barcode ID. Tap on the name or barcode ID, then tap on +BEGIN NEW TEST. If prompted, select your organization or select “NOT TESTING FOR AN ORGANIZATION”. The instructions below are the same step-by-step instructions as shown in the Cue Health App videos and screens.
REMINDER: If your mobile smart device loses battery charge while performing the test, the test on the Cartridge Reader will still run to completion. The test result will be saved. The mobile smart device must be charged to see the test result. Make sure your mobile smart device is close to the Cartridge Reader after a test completes so you can view the result on the screen in the Cue Health App.

Step 5-1: View Intended Use
Read the Intended Use presented to you in the Cue Health App and then you may continue.
Step 5-2: View Precautions
Precautions are important to follow to ensure that the test runs correctly.
Read the Precautions presented to you in the Cue Health App and then you may continue.
Step 5-3: Pair the Cue Health App to the Cue Cartridge Reader(s)
Connect the Cartridge Reader to power. Follow the Cue Health App videos and screen instructions to pair the Cue Cartridge Reader(s) that will be used for the test(s) to your mobile smart device. When a paired Cartridge Reader is within range of the BLUETOOTH wireless technology of the mobile smart device, the Reader is “connected” to the Cue Health App. The same instructions are in the Quick Start Guide and the Cue Health Monitoring System User Manual.
Step 5-4: Gather the Materials to Run the Test
Place the Cue Cartridge Reader and a Cue COVID-19 Test Cartridge foil pouch in front of you. See the Cue Health App video showing these materials that you need to run a test as shown in Figures 5-4.

REMINDER: Open the Cue COVID-19 Test Cartridge foil pouch when you are ready to test. Do not open the foil pouch more than 30 minutes before you begin a test.

Step 5-5: Prepare the Cue COVID-19 Test Cartridge and Cue Sample Wand for a Test
Tear open the top of the cartridge foil pouch and remove the plastic tray with the Cue COVID-19 Test Cartridge and sterile Sample Wand. Remove the Cue COVID-19 Test Cartridge and the wrapped Sample Wand from the tray.
See the Cue Health App video showing how to prepare the Cue COVID-19 Test Cartridge and Cue Sample Wand for a test as shown in Figures 5-5.

Step 5-6: Insert the Cue COVID-19 Test Cartridge into the Cue Cartridge Reader
See the Cue Health App video showing how to insert the cartridge into the Cue Cartridge Reader as shown in Figure 5-6-1.

REMINDER: The cartridge must be inserted first before the Sample Wand. The cartridge must be inserted logo side up. The Cue Cartridge Reader needs to be on a level surface when the Cue COVID-19 Test Cartridge is inserted and while the test is running. Do not move the Cue Cartridge Reader while the test is running. Support the back of the Cue Cartridge Reader with one hand and hold the Cue COVID-19 Test Cartridge in the other hand. Insert the cartridge (logo side up) into the Cartridge Port of the Reader. When you have fully inserted the cartridge, all five lights on top of the Cue Cartridge Reader will flash. When you have inserted the cartridge all the way in, the cartridge will start to heat up to prepare for a test and you will see the Cue Health App video as shown in Figure 5-6-2. When the cartridge has finished heating up, the progress circle will show 100%.

Step 5-7: Collect a Nasal Specimen with the Cue Sample Wand and Insert into the Cartridge
When the cartridge heating cycle is completed, the Cue Health App will advance to the Collect Sample screen. You may collect a direct nasal sample or, in applicable professional environments, you may dip the Cue Sample Wand into a VTM tube containing an individual nasal specimen. Proceed to Step 5-7a for instructions on sample dipping into an individual nasal specimen in VTM. Continue below for collecting a direct nasal sample. Open the wrapped Cue Sample Wand on the side labeled “Open Here”. Grasp the handle of the Cue Sample Wand and remove it from the wrapping. The Wand is sterile. Make sure the Wand tip does not touch anything. You will see a video on how to collect a direct nasal sample and insert the Cue Sample Wand into the cartridge as shown in Figures 5-7-1 and 5-7-2.

REMINDER: It is important to collect the nasal sample at the time of the Collect Nasal Sample screen and insert the Cue Sample Wand with the nasal sample into the Cue COVID-19 Test Cartridge shortly after collecting the nasal sample. The Cue COVID-19 Test Cartridge should not be in the Cartridge Reader without the inserted Sample Wand for more than 10 minutes. To collect a direct nasal swab sample, both nostrils are swabbed with the same Cue Sample Wand. While swabbing in both nostrils do not attempt to scrape or remove excess mucus.

• Insert the tip of the Cue Sample Wand into one nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.
• Then, insert the same Cue Sample Wand into the other nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of the nostril and rotate the Wand against the wall 5 times.

Support the back of the Cue Cartridge Reader and insert the Cue Sample Wand with nasal sample into the port of the Cue COVID-19 Test Cartridge. Make sure the wand is inserted all the way in until Test in Progress is shown on the Cue Health App screen.
Step 5-7a: Sample Dipping in Applicable Professional Environments
Skip this step if you have already collected a direct nasal sample with the Cue Sample Wand. Open the wrapped Cue Sample Wand on the side labeled “Open Here”. Grasp the handle of the Cue Sample Wand and remove it from the wrapping. The wand is sterile. Make sure the wand tip does not touch anything Follow these instructions for dipping the Cue Sample Wand into a tube containing an individual nasal specimen in VTM.

• Use the appropriate PPE.
• With the cap on, agitate the VTM specimen tube to ensure proper mixing.
• Uncap the VTM specimen tube and insert the Sample Wand tip into the tube tilting the VTM tube, if necessary, until the Sample Wand tip comes in contact with liquid. The Sample Wand flocked tip will absorb the sample.
• Carefully remove the Cue Sample Wand from the VTM specimen tube.
• Support the back of the Cue Cartridge Reader and insert the Cue Sample Wand with the nasal specimen into the port of the Cue COVID-19 Test Cartridge. Make sure the Wand is inserted all the way in until Test in Progress is shown on the Cue Health App screen.

REMINDER: It is important to collect the Cue Sample Wand nasal specimen by dipping into the individual sample tube at the time of the Collect VTM Sample screen in the Cue Health App and insert the Sample Wand with the nasal specimen into the Cue COVID-19 Test Cartridge promptly. The Cue COVID-19 Test Cartridge should not be in the Cartridge Reader without the inserted Sample Wand for more than 10 minutes.

Step 5-8: Test Progress
The test will start as soon as the Cue Sample Wand is inserted into the Cue COVID-19 Test Cartridge. It takes about 20 minutes for the Cue COVID-19 Test to run. Once the test starts, the Cue Health App will show the test progress as percent completed as shown in Figure 5-8.

Step 5-9: View the Result
The Cue Health App will show the Cue COVID-19 Test result when the test is complete. The result is saved in the Cue Account profile that was selected before the test started. See Step 6 below for understanding the test results and what each result means.
Step 5-10: Remove the Cue COVID-19 Test Cartridge with Sample Wand After Testing
Remove the cartridge from the Cue Cartridge Reader by holding the Cartridge Reader with one hand and carefully pulling the cartridge out of the Reader with the other hand. The Sample Wand should still be inside the cartridge. Used cartridges should be considered capable of transmitting infectious agents requiring standard precautions. Used cartridges are sealed with very low risk of transmitting infectious agents. Follow your local environmental waste guidance and regulations for proper disposal of used cartridges.

Step 6: Understand The Test Results
The Cue Health App shows the result as Negative, Positive, Invalid, or Canceled.

Step 6-1: Understanding a Negative Result
A Negative result (See Figure 6-1) means that Cue COVID-19 Test did not detect the SARS-CoV-2 virus in the sample.

• For consumers self-testing: A negative result means the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result with all other aspects of your history such as symptoms and possible exposures to decide how to care for you. It is important you work with your healthcare provider to help you understand the next steps you should take.

• More information about a Negative result:

  • A negative test result for this test means that SARS-CoV-2 RNA was not present in the sample above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or health management decisions. A negative result does not exclude the possibility of COVID-19. Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for health management, should be tested with different authorized molecular tests.

  • When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of recent exposures and the presence of clinical signs and symptoms consistent with COVID-
    19. The possibility of a false negative result should especially be considered if recent exposures or clinical presentations indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illnesses) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities.

  • Risks of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in an increased risk of spread of COVID-19 within the community, or other unintended adverse events.

  • For the most up to date information on COVID-19, please visit: www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection.html

Click on back < at the top left of the Cue Health App Screen to return to a screen where you can run a new test.
Step 6-2: Understanding a Positive Result
A Positive result (See Figure 6-2) means that the Cue COVID-19 Test detected the SARS-CoV-2 virus in the sample.

• For consumers self-testing: It is very likely you have COVID-19 and it is important to be under the care of a healthcare provider. It is likely you will be asked to isolate yourself at home to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive). Your healthcare provider will work with you to determine how best to care for you based on your test results along with your medical history and your symptoms.
• More information about a Positive result:
  • When diagnostic testing is positive, the possibility of a false positive result should be considered in the context of recent exposures and the presence of clinical signs and symptoms consistent with COVID-19.
  • Risks of false positives include: unnecessary monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends, limitations in the ability to work; delayed diagnosis and treatment for the true infection causing the symptoms; unnecessary treatment or therapy, or other unintended adverse effects.
  • For the most up to date information on COVID-19, please visit: www.canada.ca/en/public-health/services/diseases/2019-novelcoronavirusinfection.html

Click on back < at the top left of the Cue Health App Screen to return to a screen where you can run a new test.

Step 6-3: Understanding an Invalid Result
An Invalid result means that a system error occurred and the Cue Health Monitoring System is unable to provide the SARS-CoV-2 result. Retesting is required. Common causes of invalid results are:

• You did not collect enough sample
• A processing error occurred inside the cartridge

If the result is invalid, retest. Click on START RETEST NOW. You must use a new Cue COVID-19 Test Cartridge and a new Cue Sample Wand.

Step 6-4: Understanding Test Result Canceled
You will see a test result of Canceled if you purposely cancel the test by tapping “Cancel” in the top right corner of the Cue Health App screen or if the system cancels the test due to a mechanical error or because you did not follow the test instructions correctly. Examples of when the system will cancel a test include: the Cartridge Reader is moved or tilted while the test is running, the test cartridge is removed before the test is completed, the Sample Wand is inserted into the cartridge too soon or too late. If the result is canceled, retest. Click on START RETEST NOW. You must use a new Cue COVID-19 Test Cartridge and a new Sample Wand.

Disposal of the Used Cue COVID-19 Test Cartridge
After each test, the Cue COVID-19 Test Cartridge with the Sample Wand still inside must be removed from the Cue Cartridge Reader. Used cartridges are sealed with very low risk of transmitting infectious agents. Follow your local environmental waste guidance and regulations for proper disposal of used cartridges.

Cue COVID-19 Test Performance

Limit of Detection – Viral Genomic RNA
Limit of Detection (LoD) testing was performed with genomic RNA from SARS- Related Coronavirus 2, Isolate USA-WA1/2020. The RNA was diluted in clinical nasal matrix to obtain 4 low level concentrations. The dilutions were tested in triplicate in 2 Cue COVID-19 Test cartridge lots by 2 operators on each of 3 days for a total of 36 replicates per dilution. 15 µL of the RNA dilution was applied to a Cue Sample Wand before testing. The LoD was determined as the lowest concentration with ≥ 95% detection. The LoD was confirmed with 20/20 replicates testing positive.

Cue COVID-19 Test Limit of Detection Confirmation

Material

| Claimed LoD Genome Copies/Sample

Wand

| Claimed LoD Genome

Copies/µL of Sample

| Confirmation Positives/Replicates
---|---|---|---
SARS-CoV-2 viral

genomic RNA

| 20| 1.3| 20/20

The claimed Limit of Detection is 20 genome copies/Sample Wand
Limit of Detection – Natural Clinical Samples
Cue confirmed the LoD of 20 Genome Copies/Sample Wand with 20 replicates of a natural clinical patient sample in VTM determined by ddPCR (absolute quantitative droplet digital PCR) to be at the 20 Genome Copies/Sample Wand concentration. The Cue COVID-19 Test demonstrated 100% detection of 20 replicates of this clinical sample.
Limit of Detection – Live SARS-CoV-2 Virus
Samples containing live SARS-CoV-2 virus were tested at 20 virions, 40 virions, 60 virions, 100 virions and 1000 virions, which is 1x, 2x, 3x, 5x, and 50x LoD relative to the Cue COVID-19 LoD of 20 copies of SARS-CoV-2 genomic RNA per wand. 15µL of live virus diluted in clinical nasal matrix was applied to a Cue Sample Wand before testing in the Cue COVID-19 Test. Samples at 20 virions (20 replicates) and 1000 virions (5 replicates) were also tested in the EUA CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR Diagnostic Test. Live virus diluted in clinical nasal matrix was added to 1 mL of VTM and tested in the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic test.

Virions/ Sample

Wand

| Virions/

µL of Sample

| Cue COVID-19

Detected/Tested

| Cue COVID- 19

% Detected

| CDC RT-PCR

Detected/Tested

| CDC RT- PCR

% Detected

---|---|---|---|---|---
20| 1.3| 15/20| 75%| 7/20| 35%
40| 2.7| 18/20| 90%| Not tested| N/A
60| 4.0| 5/5| 100%| Not tested| N/A
100| 6.7| 9/9| 100%| Not tested| N/A
1000| 66.7| 5/5| 100%| 5/5| 100%

During the study, any samples with invalid results, canceled tests, or suspected sample addition errors were replaced.

Analytical Reactivity/Inclusivity
The Cue COVID-19 Test utilizes a forward and reverse primer and a probe targeting the N (nucleocapsid protein) gene of the SARS-CoV-2 virus. The probe imparts greater specificity to the amplification reaction. Due to the limited availability of SARS-CoV-2 isolates for inclusivity testing, in silico analysis was used to evaluate the extent of homology between each of the Cue COVID-19

Test primers/probe and sequenced SARS-CoV-2 isolates available in public databases. The original in silico analysis utilized sequences available early in the pandemic from the NCBI public database (https://www.ncbi.nlm.nih.gov/labs/virus/vssi/#/, data downloaded March 2020) and the GISAID public database (https://www.gisaid.org/, data downloaded April 2020). The results from this analysis are summarized in the table below. The forward primer matched 100% to all sequences. The reverse primer matched all but one sequence in the NCBI database and one sequence in the GISAID database. A few sequences from the GISAID database showed mismatches to the probe, but these strains were all collected pre-pandemic from non-human hosts.
Cue COVID-19 Test Reactivity/Inclusivity Evaluation (March/April 2020)

Primer

| % of 1551

GISAID strains with perfect match

| ****

% of 313 NCBI

strains with perfect match

| % of all analyzed genomes with perfect match
---|---|---|---
Forward| 100.00| 100.00| 100.00
Reverse| 99.94| 99.68| 99.89
Probe| 99.61| 100.00| 99.68

An updated analysis was performed in December 2020. Sequence data was obtained from the GISAID database, where the sample collection was specified as occurring between November 5 and December 14, 2020. Sequences were filtered to select for completeness and high coverage. Because of the high number of resulting sequences (19319) obtained with these query parameters, a random subset of 2000 sequences was chosen for the downstream analysis.
After performing alignment via Clustal Omega (https://www.ebi.ac.uk/Tools/msa/clustalo/), sequences were visualized in Geneious (v. 9.0.5) and mismatch occurrences were analyzed. In all cases, mismatch occurrence reflected a single base mismatch. There are no sequences that exhibited a mismatch to more than one primer/probe. The results are summarized below.

Cue COVID-19 Test Reactivity/Inclusivity Evaluation (Worldwide, November 5 – December 14, 2020)

Primer

| # of GISAID

strains with perfect match

| # of GSAID strains containing mismatch| % of GISAID

strains with perfect match

---|---|---|---
Forward| 1998| 2| 99.90 %
Reverse| 1988| 12| 99.40 %
Probe| 1971| 28*| 98.60 %

A similar analysis was performed, but with the sample location restricted to North America, and with samples collected between October 15 and December 1, 2020. The resulting sequences were aligned and then analyzed within Geneious software (v. 9.0.5) to determine the number of sequences that contained mismatches to each of the primers/probe. Results are summarized in the table below. In all cases, mismatch occurrence reflected a single base mismatch. Only 3/2087 samples (0.14%) showed a mismatch in sequence to more than one primer/probe. Overall, the analysis indicates a very high level of conservation of the targeted genomic locus within the North American population.

Cue COVID-19 Test Reactivity/Inclusivity Evaluation (North America, October 15 – December 1, 2020)

Primer

| # of GISAID

strains with perfect match

| # of GSAID strains containing mismatch| % of GISAID

strains with perfect match

---|---|---|---
Forward| 2079| 8| 99.62 %
Reverse| 2081| 6| 99.71 %
Probe| 2074| 12*| 99.42 %

An analysis was also performed to examine several emergent viral variants of special interest: the UK variant B.1.1.7, the South African variant B.1.351, and the Brazilian variant P.1. The GISAID query for the B.1.1.7 variant resulted in a set of 721 strain sequences. Those sequences were downloaded and examined within Geneious Prime software (v. 2021.0.1). The results are summarized below. For each primer/probe, greater than 99.0% of the sequences are a perfect match.

Cue COVID-19 Test Reactivity/Inclusivity Analysis of B.1.1.7 Variant Strains (Worldwide, February 5 – February 15, 2021)

Primer

| # of GISAID strains with perfect match| # of GSAID strains containing mismatch| % of GISAID strains with perfect match
---|---|---|---
Forward| 717| 4| 99.44%
Reverse| 714| 7| 99.03%
Probe| 719| 1*| 99.86%

The GISAID query for the B.1.351 variant resulted in a set of 676 strain sequences. Those sequences were downloaded and examined within Geneious Prime software (v. 2021.0.1). The results are summarized below. For each primer/probe, at least 99.7% of the sequences are a perfect match.

Cue COVID-19 Test Reactivity/Inclusivity Analysis of B.1.351 Variant Strains (Worldwide – all available sequences as of February 15, 2021)

Primer

| # of GISAID

strains with perfect match

| # of GSAID strains containing mismatch| % of GISAID strains with perfect match
---|---|---|---
Forward| 676| 0| 100.00%
Reverse| 676| 0| 100.00%
Probe| 674| 2| 99.70%

The GISAID query for the P.1 variant resulted in a set of 358 strain sequences. Those sequences were downloaded and examined within Geneious Prime software (v. 2021.0.1). The results are summarized below. For each
primer/probe, at least 98.5% of the sequences are a perfect match.

Cue COVID-19 Test Reactivity/Inclusivity Analysis of P.1 Variant Strains (Worldwide – all available sequences as of February 23, 2021)

Primer

| # of GISAID

strains with perfect match

| # of GSAID strains containing mismatch| % of GISAID strains with perfect match
---|---|---|---
Forward| 357| 1| 99.72%
Reverse| 351| 5*| 98.60%
Probe| 348| 5**| 98.58%

Two strains had an ambiguous result due to “N” base calls, and were thus not included in the analysis for this primer. Five strains had an ambiguous result due to “N” base calls, and were thus not included in the analysis for this primer.

Analytical Specificity – Cross-Reactivity
A study was performed testing 31 potentially cross-reacting organisms with the Cue COVID-19 Test. Each organism was diluted in clinical nasal matrix and tested in triplicate. The organisms, concentrations, and test results are shown in the table below. None of the 31 organisms cross-reacted in the Cue COVID-19 Test at the concentrations tested.

Cue COVID-19 Test Cross-Reactivity Evaluation

6.90E+04

| genome copies / µl| ****

0/3

Streptococcus pneumonia| 4.73E+07| CFU/mL| 0/3
Streptococcus pyogenes| 4.30E+08| CFU/mL| 0/3
Bordetella pertussis| 1.17E+09| CFU/mL| 0/3
Mycoplasma pneumoniae| 2.47E+06| CFU/mL| 0/3
P.jiroveci-S.cerevisiae Recombinant| 1.56E+07| CFU/mL| 0/3
Pseudomonas aeruginosa| 6.14E+07| CFU/mL| 0/3
Staphylococcus epidermidis| 1.17E+09| CFU/mL| 1/9*
Streptococcus salivarius| 1.79E+08| CFU/mL| 0/3
Human Coronavirus 229E| 1.26E+05| TCID50/mL| 0/3
Human Coronavirus 0C43| 1.26E+05| TCID50/mL| 0/3
Human Coronavirus HKU1 RNA| 7.50E+04| genome copies / µl| 0/3
Human Coronavirus NL63| 1.10E+04| TCID50/mL| 0/3

SARS Coronavirus (Inactivated)

| 10 fold dilution of stock with Ct values from 25-

28

| ****

Ct value

| ****

1/3

MERS-Coronavirus (Inactivated)| 4.17E+04| TCID50/mL| 0/3
Adenovirus Type 1| 3.39E+06| TCID50/mL| 2/9
Human Metapneumovirus| 1.70E+04| TCID50/mL| 0/3
Parainfluenza 1| 4.17E+04| TCID50/mL| 0/3
Organism| Titer| Units of Measurement| Detected/Tested
---|---|---|---
Parainfluenza 2| 4.17E+04| TCID50/mL| 0/3
Parainfluenza 3| 8.51E+06| TCID50/mL| 0/3
Parainfluenza 4| 1.60E+03| TCID50/mL| 0/3
Influenza A/New York/18/09 (Inactivated)| 1.15E+06| TCID50/mL| 0/3
Influenza B/Indiana/17/2017| 1.00E+07| TCID50/mL| 0/3
Enterovirus Type 70| 5.00E+05| TCID50/mL| 0/3
Respiratory Syncytial Virus B| 9.55E+05| TCID50/mL| 0/3
Rhinovirus type 1A| 1.51E+05| TCID50/mL| 1/10
Pooled human nasal wash| 10%| percent of total volume| 0/3
Candida albicans| 5.02E+07| CFU/mL| 0/3

Analytical Specificity – Cross-Reactivity In Silico Analysis
An in silico analysis for possible cross-reactions with all of the 31 organisms in the table above was also conducted by mapping the Cue COVID-19 Test primer/probe sequences to the organism’s genome sequences. For each viral organism, an alignment of strains was generated to serve as the basis for the analysis. Adenovirus was an exception, as only a single reference sequence was used. Twelve viruses contained strains exhibiting ≥80% sequence homology with the forward primer; three viruses contained strains exhibiting ≥80% sequence homology with the reverse primer; and one virus (SARS-CoV-1) contained strains with ³80% sequence homology with the probe. Of all the viruses analyzed, only SARS-CoV-1 showed sequence homology to more than one Cue COVID-19 Test primer/probe at the ≥ 80% sequence homology level. For the in silico analysis of the microbial organisms, NCBI’s blastn tool was used to search for primer sequence homology among the listed microbes. Only Streptococcus salivarus showed ³80% sequence homology to the forward and reverse primers, but low homology to the probe. Furthermore, Streptococcus salivarus did not exhibit any cross-reactivity in wet testing. With the exception of SARS-CoV-1, the Cue COVID-19 Test, designed for the specific detection of SARS-CoV-2 virus, showed no significant combined homologies with the potential cross-reactants analyzed in silico that would predict potential Cue COVID-19 Test false results.

The Cue COVID-19 Test, designed for the specific detection of SARS-CoV-2 virus, showed no significant combined homologies with the potential cross- reactants analyzed in silico that would predict potential Cue COVID-19 Test false results.
Analytical Specificity – Interfering Substances
A study was performed to assess substances with the potential to interfere with the performance of the Cue COVID-19 Test. Potential interferents were tested at the highest concentration likely to be found in a nasal sample. Each interfering substance in negative clinical nasal matrix was tested in triplicate. Each interfering substance was also tested in triplicate in the presence of genomic RNA from SARS-Related Coronavirus 2, Isolate USA-WA1/2020, at 3X LoD. The substances, concentrations, and test results are shown in the table below. None of the substances interfered in the Cue COVID-19 Test at the concentrations tested.
Cue COVID-19 Test Interfering Substances Evaluation

Substance

| ****

Concentration

| Detected/Tested
---|---|---

Negative Nasal Matrix

| Positive Nasal

Matrix (SARS-CoV- 2 RNA present at 3X LoD)

Afrin| 20% (v/v)| 0/3| 3/3
Saline Nasal Spray| 20% (v/v)| 1/9*| 3/3
Zicam Allergy Relief| 15% (v/v)| 0/3| 3/3
Chloroseptic Max| 20% (v/v)| 0/3| 3/3
Neo-Synephrine| 20% (v/v)| 0/3| 3/3
Mucin| 0.5% (w/v)| 0/3| 3/3
Zanamivir (Relenza)| 0.3 mg/ml| 0/3| 3/3
Mupirocin| 10 mg/ml| 0/3| 3/3
Tamiflu (Oseltamivir phosphate)| ****

0.01mg/ml

| ****

0/3

| ****

3/3

Budesonide| 0.05 mg/ml| 0/3| 3/3
Flunisolide| 0.04 mg/ml| 0/3| 3/3
Dexamethasone| 0.5 mg/ml| 0/3| 3/3
Beclomethasone| 0.068 mg/mL| 0/3| 3/3

Substance

| ****

Concentration

| Detected/Tested
---|---|---

Negative Nasal Matrix

| Positive Nasal

Matrix (SARS-CoV- 2 RNA present at 3X LoD)

Biotin| 3.5 ug/mL| 0/3| 3/3
Xofluza (baloxavir marboixil)| ****

0.01mg/ml

| ****

0/3

| ****

3/3

Nasacort/Triamcinolone| 0.04 mg/ml| 0/3| 3/3
Flonase/Fluticasone| 0.04 mg/ml| 0/3| 3/3
Mometasone| 0.04 mg/ml| 0/3| 3/3
Tobramycin| 2.5mg/ml| 0/3| 3/3
Whole Blood| 1% (v/v)| 0/3| 3/3
Chloroseptic (solid)| 20% w/v| 1/9| 3/3
Galphimia Glauca| 20% w/v| 0/3| 3/3
Rhinallergy| 20% w/v| 1/9| 3/3

Clinical Evaluation – Prospective Clinical Study in Emergency Departments
A prospective clinical study was conducted in 2 emergency departments (ED) located in an epicenter for the COVID-19 outbreak in the US. The study was IRB approved. Patients presenting at either of two EDs with signs and/or symptoms of COVID-19 as determined by the healthcare provider were tested using the Cue COVID-19 Test at point of care. Testing was performed by untrained operators with no prior laboratory training or experience. The Cue COVID-19 Test results were compared to the results from the healthcare institution’s standard of care EUA test for SARS-CoV-2. There was 100% agreement for positive cases and 92% agreement for negative cases.

| Institutional Standard of Care EUA SARS-CoV-2 Test
---|---
Positive| Negative
Cue COVID-19

Test

| Positive| 6| 3
Negative| 0| 35

Clinical Evaluation – Prospective Clinical Study in a Drive-Thru Testing Center4
A prospective clinical study was conducted at a mid-western community drive- thru specimen collection and testing center. The study was IRB approved. Adult outpatients were referred for testing after nurse triage based upon symptoms, exposures, or other criteria for COVID-19 testing. Patients with positive results for SARS-CoV-2 were both symptomatic and asymptomatic. Patients were tested using the Cue COVID-19 Test at the point of care, drive-thru setting. Testing was performed by untrained operators with no prior laboratory training or experience. The Cue COVID-19 Test results were compared to the results from the healthcare institution’s standard of care EUA PCR test for SARS-CoV-2. There was 92% agreement for positive cases and 98% agreement for negative cases.

| Institutional Standard of Care EUA SARS-CoV-2 PCR Test
---|---
Positive| Negative

Cue COVID-19 Test

| Positive| 22| 4
Negative| 2*| 239

Clinical Evaluation – Prospective Clinical Studies with Symptomatic and Asymptomatic Lay Users
Prospective Lay User Study #1: Cue Health conducted prospective studies at 4 urgent care locations in the Seattle, Washington area and at 2 Cue Health locations to evaluate use of the Cue COVID-19 Test by lay users in a simulated home use environment. All subjects successfully followed the instructions in the Cue Health App to run the Cue COVID-19 Test, start to finish without any assistance. Adult lay users (≥18 years of age) self-collected or collected from their child (<18 years of age) a Cue Sample Wand nasal swab and ran the Cue COVID-19 Test. Adult and child subjects were enrolled in an “all comers” style at the urgent care sites. Adult subjects at the Cue Health locations were enrolled to enrich inclusion of asymptomatic positive subjects by including subjects who were known positive for COVID-19. Among the total 286 subjects, 276 were adult ≥18 years of age self-swabbing and self-testing in the Cue COVID-19 Test and 10 were children <18 years of age where their parent collected the nasal sample and ran the Cue test. Thirteen samples could not be included as there was no comparator assay (3/13) result or Cue result (10/13) available. Among the 10 unavailable Cue test results, 7 tests were canceled, and 3 tests had invalid results. The 7 canceled tests were 5 cartridge flow errors, 1 tilt threshold exceeded, and 1 user accidentally canceled the test while in progress. Demographics for the 273 subjects included in the analysis are presented below.

There were 38 subjects with Positive results, 233 subjects with Negative results, and 2 subjects with Inconclusive results by the FDA Emergency Use Authorized (EUA) molecular comparator method. Among the subjects, 10 subjects were asymptomatic positive, 123 subjects were asymptomatic negative, and 1 subject was asymptomatic Inconclusive by the comparator.

Prospective Lay User Study #2: In association with a US and Canadian professional sports league, a study was conducted to evaluate the use of the Cue COVID-19 Test with lay users at home and assess the positivity rate among individuals asymptomatic for COVID-19. The study population included players, team staff, referees, gameday staff, vendors, and household members. From April 1, 2021 to July 22, 2021, a Cue Cartridge Reader and a supply of Cue COVID-19 Test Cartridge Packs were supplied to each participating household. Data for 5 participants with Cue COVID-19 Test positive results and reference RT-PCR positive results were reported to Cue Health. Among these 5 participants, 3 were asymptomatic and 2 were symptomatic for COVID-19.
Prospective Lay User Study #3: This study evaluated the ease of use of the Cue COVID-19 Test and comprehension of results. The study was designed as a Human Factors/Usability Study; however, a nasal swab was collected for reference SARS-CoV-2 RT-PCR testing in a central laboratory. The study was conducted at a medical research center in Redmond, Washington, USA. The study enrolled adults (≥18 years of age) self-testing and children (2-17 years of age) tested by their parent. Eligible subjects were lay persons presenting at the study enrollment site with or without symptoms or other epidemiological reasons to suspect COVID-19. After agreeing to the Informed Consent to participate in the study, adult subjects ≥ 18 years of age unboxed the Cue Cartridge Reader, paired the Reader to a mobile smart device, self-collected a Cue Sample Wand nasal sample or collected a nasal sample from their child (2-17 years of age), and tested that sample in the Cue COVID-19 Test. Parents self-tested as well as tested their child/children. After the subject self- tested using the Cue test, a healthcare provider collected a nasal sample using a commercial nasal swab for testing in a reference SARS-CoV-2 RT-PCR test. A total of 138 subjects were enrolled. The subject population included 95 adults self-testing and 43 children tested by their parents. The tables below describe the enrolled subject population and demographics.

User

|

N

---|---
Adult ≥18 self-testing| 95
Children 2-6 tested by parent| 8
Children 7-11 tested by parent| 16
Children 12-17 tested by parent| 19
Total| 138
| Male| Female
---|---|---
Adults| 37 (39%)| 58 (61%)
Children 2-17| 27 (63%| 16 (37%)
| N

18-25 years

| N

26-40 years

| N

41-55 years

| N

56-70 years

| N

70 years

---|---|---|---|---|---
Adults self- testing and/or testing a

child

|

31

|

23

|

15

|

11

|

15

| N

<High School

| N

High School

| N

Associate’s Degree

| N

Bachelor’s Degree

| N

Graduate degree

|

Declined

---|---|---|---|---|---|---
Adults self- testing or testing a

child

|

15

|

17

|

6

|

32

|

22

|

3

There were 138 total subjects in this study. Two subjects did not have a Cue test result; therefore 136 subjects were included the comparator analysis.

Clinical Evaluation – Retrospective Clinical Samples and Sample Dipping
The Cue COVID-19 Test was also evaluated with 76 frozen nasal specimens in viral transport media. The samples were de-identified and the study was IRB approved. The 76 samples were originally collected from patients suspected of SARS-CoV-2 infection by the healthcare provider. The samples were positive or negative by the healthcare institution’s standard of care EUA test for SARS- CoV-2.
The thawed sample was applied by dipping the Cue Sample Wand into the clinical sample VTM and immediately inserting into the Cue COVID-19 Test Cartridge. There was 100% positive (60/60) and negative (16/16) agreement of the Cue COVID-19 Test result with the institutional EUA.
Clinical Evaluation – Contrived Samples
Negative clinical samples and positive contrived clinical samples were prepared for this study. Sixty negative nasal samples were collected from consented healthy volunteers under IRB approval. Positive contrived samples were prepared from 30 of the negative samples by spiking with genomic RNA from SARS-Related Coronavirus 2, Isolate USA-WA1/2020, at the concentrations shown in the table below. Samples were randomized, de-identified, and blinded to the test operator. Sample concentration and test results are shown in the table below. Agreement with expected results was ≥ 95%.

Cue COVID-19 Test Clinical Evaluation – Contrived Samples

Sample Concentration| ****

Detected/Tested

| ****

% Agreement

---|---|---
Negative| 0/30| 100%
1-2X LoD| 19/20| 95%
5X LoD| 4/4| 100%
10X LoD| 4/4| 100%
50X LoD| 2/2| 100%

Customer Support

If you have questions about this test, contact Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378). You can purchase the Cue Health Monitoring System and Cue COVID-19 Test Cartridge Packs by contacting Cue Health Customer Support at support@cuehealth.com or call 833.CUE.TEST (833.283.8378).
References

1. Centers for Disease Control and Prevention.
   https://www.cdc.gov/coronavirus/2019-ncov/index.html (accessed July 12,

2. Donato LJ, Trivedi VA, Stransky AM, et. al. Evaluation of the Cue Health point-of-care COVID-19 (SARS CoV-2 nucleic acid amplification) test at a community drive-through collection center. Diagnostic Microbiology and Infectious Disease. 2021;100(1):115307. https://doi.org/10.1016/j.diagmicrobio.2020.115307

Symbols Used on the Product Labels
The table below describes the symbols used on the Cue COVID-19 Test Cartridge Pack, the cartridge foil pouch, the Cue Sample Wand, the Cue COVID-19 Test Positive Control Swab, and the Cue Test Negative Control Swab.

Cue and the Cue logo are registered trademarks of Cue Health Inc. Google Play is a trademark of Google LLC. Apple and App Store are trademarks of Apple Inc., registered in the U.S. and other countries and regions. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cue is under license. Other trademarks and trade names are those of their respective owners. Wi-Fi® is a registered trademark of Wi-Fi Alliance®.

Cue Health Inc.

San Diego, CA 92121 USA Email: support@cuehealth.com Phone: 833.CUE.TEST (833.283.8378) Website: www.cuehealth.com mdi Europa GmbH Langenhagener Str. 71, 30855 Langenhagen, Germany

References

• Diagnostic testing at the speed of life | Cue
• Redirecting
• Coronavirus Disease 2019 (COVID-19) | CDC
• ebi.ac.uk/Tools/msa/clustalo/
• GISAID - gisaid.org
• NCBI Virus

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