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Cue COVI D-19 Test for Home and Over The Counter (OTC) Use 

No Prescription Required 

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular 

diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2 in 

anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. It is 

intended for use in adults (self-swabbing) or children ;,2 years of age (swabbed by 

an adult). 

The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the 

Cue COVID-19 Test Cartridge, the Cue Sample Wand nasal swab, and the Cue 

Health Mobile Application. 

Requirements 

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before purchase and download the Cue Health Mobile Application. ___. · 

Questions? 

Contact Cue Customer Support at support@cuehealth.com or caJI toll-free at (833) 

CUE-TEST - (833) 283-8378 to request a physical copy of the Instructions for Use and 

Fact Sheets, free of charge. 

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Cue COVID-19 Test for Home and Over The Counter (OTC) Use

1 | Page *Images are not to scale. 
1 IN9100005_2.0 2021-10 

 

 

 

 

 

 

 

 

 

COVID-19 

 

 

The CueTM COVID-19 Test for Home and Over The Counter (OTC) Use

Instructions For Use

 

No Prescription Required 

For Use Under an Emergency Use Authorization (EUA) Only 

 

Use with the Emergency Use Authorization Only Cue Health Monitoring System and Cue Health 

Mobile Application 

 

 

For In Vitro Diagnostic Use 

 

 
2 IN9100005_2.0 2021-10

Cue COVID-19 Test for Home and Over The Counter (OTC) Use 

Instructions for Use 

Introduction 

COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory 

illness, was first identified in Wuhan, China, and has now spread globally, including the United States. 

COVID-19 can present with a mild to severe illness although some people infected with COVID-19 may 

have no symptoms at all. COVID-19 is contagious and can be spread even before a person shows 

symptoms of being sick (e.g., fever, coughing, difficulty breathing). Some people may test positive for 

COVID-19, but not have any symptoms of infection. These people are considered asymptomatic but may 

still be able to transmit infection to others.

Intended Use 

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular diagnostic test 

for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab 

specimens collected with the Cue Sample Wand.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use 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. It is authorized for nonprescription home use.

This test will give a positive or negative result for COVID-19. The test does not differentiate between 

SARS-CoV and SARS-CoV-2. Results are for the identification of the SARS-CoV-2 viral RNA. Viral 

RNA is generally detectable in anterior nasal swab specimens during the acute phase of infection. 

Positive results indicate the presence of viral RNA, but clinical correlation with past medical history 

and other diagnostic information is necessary to determine infection status.

Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent 

detected may not be the definite cause of disease.

Negative results in an asymptomatic individual are presumptive and confirmation with a molecular 

assay performed in a laboratory, if necessary, for patient management may be performed. Negative 

results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or 

management decisions for the individual, including infection control decisions. Negative results 

should be considered in the context of an individual’s recent exposures, history and the presence of 

clinical signs and symptoms consistent with COVID-19. It is important to consult your healthcare 

provider to discuss your results and if additional testing is necessary.

The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 

Test Cartridge, the Cue Sample Wand nasal swab, and the Cue Health Mobile Application (Cue 
3 IN9100005_2.0 2021-10

Health App) on the compatible mobile smart devices named on the Cue Health website 

at www.cuehealth.com.

Test results will be reported to relevant public health authorities in accordance with local, state, and 

federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In 

Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC. Automatic 

test result reporting will be performed by Cue Health using the Cue Health App and the Cue Health 

secure cloud server.

When Should the Cue COVID-19 Test for Home and Over The Counter (OTC) Use Be Used? 

You should use the test if you believe you have symptoms (e.g., fever, cough, difficulty breathing) of 

COVID-19. If you do not have symptoms, you should use the test if you have been in close contact 

with someone who has COVID-19. Another reason to test when you do not have symptoms is if you 

live in an area or have been to a place where there are many cases of COVID-19.

Adults should test children ≥2 years of age. 

 

Precautions 

General 

• This product is an in vitro diagnostic meaning this test is performed outside the body.

• This product has not been FDA cleared or approved, but has been authorized by FDA under an 

Emergency Use Authorization.

• This product has been authorized only for the detection of nucleic acid from SARS CoV-2, not 

for any other viruses or pathogens.

• The emergency use of this product 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 Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the 

authorization is revoked sooner.

• All test results must be reported to the appropriate public health authorities. Automatic test 

result reporting must be performed by Cue Health using the Cue Health App and the Cue 

Health secure cloud server.

• The Cue COVID-19 Test Cartridge is used 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.

• Only anterior nasal samples collected with the Cue Sample Wand can be used for the Cue 

COVID-19 Test for Home and OTC Use.

• 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.
4 IN9100005_2.0 2021-10

• Wash your hands with soap and water for at least 20 seconds, rinse, and dry before collecting a 

nasal sample and after testing. 

• The Cue Health Monitoring System must be cleaned and disinfected after each use. See the Cue 

Health Monitoring System User Manual for instructions.

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, or 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 in general waste.

• Do not open the Cue COVID-19 Test Cartridge.

• Do not remove the Wand from the Cue COVID-19 Test Cartridge.

Nasal Sample Collection 

• Do not use any nasal sprays, gels, or creams before you collect a nasal sample. 

• Both nostrils must be swabbed prior to running the test with the Cue Sample Wand nasal swab.

• You must insert the Sample Wand with nasal sample into the Cue COVID-19 Test Cartridge 

within 5 minutes of collecting the nasal sample.

• You may feel sore or you may bleed a little inside of your nose after collecting your nasal 

sample. There is a chance that you could develop an infection inside your nose where the nasal 

sample was collected. Contact your healthcare provider if you think an infection has developed. 

Limitations 

• It is difficult to determine if persons with no symptoms have COVID-19. Persons who test 

negative may become positive later. Persons who test too late may have had COVID-19 and are 

no longer infected on the day of testing.

• There is a chance that the test may give a negative result even if COVID-19 infection is present

(false negative). A false negative can occur when the sample was not collected or handled 

properly, or not enough sample was collected.

• A false negative can also occur if the virus genetic material changes such that the test cannot 

detect the presence of the virus.
5 IN9100005_2.0 2021-10

• There is also a chance that the test can give a positive result even if COVID-19 infection is not 

present (false positive).

• You should always discuss your test results with your healthcare provider. Do not use this test as 

the only guide to manage your illness.

• The performance of this test was established based on the evaluation of a limited number of clinical 

specimens. The clinical performance has not been established in all circulating variants, but is 

anticipated to be reflective of the prevalent variants in circulation at the time and location of the 

clinical evaluation. Performance at the time of testing may vary depending on the variants 

circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change 

over time.

Cue COVID-19 Test Cartridge Pack (REF C1018) 

Each Cue COVID-19 Test Cartridge Pack contains one or more foil pouches. 

Each foil pouch contains a plastic tray with:

• One (1) single-use Cue COVID-19 Test Cartridge

• 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

theCueCOVID-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 toll-free at 

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 toll-free at 833.CUE.TEST 

(833.283.8378).
6 IN9100005_2.0 2021-10

• Mobile Smart Device with Bluetooth® and Wi-Fi or cellular capability 

Go to www.cuehealth.com for the list of compatible mobile smart devices.

• Cue Health Mobile Application installed on the mobile smart device 

Download the Cue Health App from the Apple App Store or Google Play.

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.

Storage Temperature 59°F (15°C) to 86°F (30°C)

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 for Home and OTC Use in the temperature range shown in the table

below. Do not run the test if you are outside of this temperature condition. Use caution if using 

this device outdoors as it has not been tested at extreme high or low temperatures or high 

humidity.

Operational Temperature 59°F (15°C) to 86°F (30°C)

Directions for Running the Cue COVID-19 Test for Home and OTC Use 

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 for Home and OTC Use. 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 call toll-free at 

833.CUE.TEST (833.283.8378).

• Mobile smart device with Bluetooth® and Wi-Fi or cellular capability. Go to 

www.cuehealth.com for the list of compatible mobile smart devices.

• The Cue Health App installed on your mobile smart device. Download the Cue Health App 

from the Apple App Store or Google Play.

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 for Home and OTC Use. 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:
7 IN9100005_2.0 2021-10

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 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 for Home and OTC Use.

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 for Home and OTC Use

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 toll-free at 

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 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 for Home and OTC Use. Follow the Cue Health 

Monitoring System User Manual and the on-screen instructions to connect to that

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.
8 IN9100005_2.0 2021-10

Step 5: Run a Cue COVID-19 Test for Home and OTC Use 

Log into your Cue Account. After logging into your account, tap on Manage Profiles. Choose the 

person’s name or you may add a new profile. To add a new profile, tap the + sign to type in a 

person’s identification information and SAVE. Tap on the name, then tap on BEGIN TEST.

REMINDER: Wash your hands with soap and water for at least 20 seconds, rinse, and dry before 

collecting your or another person’s nasal sample and after testing.

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. Limitations are 

important to understand before you run the test. See the Precautions and Limitations 

sections in this document.

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 onscreen instructions to pair the Cue Cartridge Reader that will be used for the test to your 

mobile smart device. When a paired Cartridge Reader is within Bluetooth range 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 Figure 5-4.
9 IN9100005_2.0 2021-10 

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.

Figure 5-4 

Step 5-5: Prepare the Cue COVID-19 Test Cartridge 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 Figure 5-5. 

Figure 5-5 
10 IN9100005_2.0 2021-10 

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. 

 Figure 5-6-1 

 

REMINDER: The cartridge must be inserted first before the Sample Wand. The 

cartridge must be inserted logo side up.

 

REMINDER: 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 COVID19 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%.

REMINDER: The cartridge must heat up for the full 100% heat cycle before the Sample 

Wand is inserted into the cartridge. All of the LED lights on the Reader will flash 5 times 

when the cartridge is ready for the Sample Wand.
11 IN9100005_2.0 2021-10 

Figure 5-6-2 

Step 5-7: Collect a Nasal Sample 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. 

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 nasal sample and insert the Cue Sample Wand 

into the cartridge as shown in Figures 5-7-1 and 5-7-2. 

 

 Figure 5-7-1 Figure 5-7-2 
12 IN9100005_2.0 2021-10 

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 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, donot insert any further. Keep gentle pressure

on the outer wall of the nostril and rotate the Wand against the wall 5 times. 

 

REMINDER: You must insert the Sample Wand with nasal sample into the Cue 

COVID-19 Test Cartridge within 5 minutes of collecting the nasal sample.

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 5-8: 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 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. 

Figure 5-8 
13 IN9100005_2.0 2021-10 

Step 5-9: View the Result 

The Cue Health App will show the Cue COVID-19 Test for Home and OTC Use 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 must not be removed and should still be inside the cartridge. Used 

cartridges should be considered capable of transmitting infection and require standard 

precautions. Dispose of the used Cue COVID-19 Test Cartridge with Sample Wand in 

general waste. 

Step 5-11: What to do After Receiving the Cue COVID-19 Test for Home and OTC Use 

Result 

If you have concerns, contact your healthcare provider to discuss your Cue COVID-19 

Test for Home and OTC Use results. 

If your result is negative, meaning the test did not detect the SARS-CoV-2 virus that 

causes COVID-19, there is still a chance that you may have COVID-19 or another illness. 

Your healthcare provider may ask you to take additional medical tests to make a 

diagnosis.

If your result is positive, meaning the test did detect the SARS-CoV-2 virus that causes 

COVID-19, there is still a chance that you may not have COVID-19. Your healthcare 

provider may ask you to take additional medical tests to make a diagnosis.

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 the Cue COVID-19 Test for Home and OTC Use

did not detect the SARS-CoV-2 virus that causes COVID-19 and it is unlikely that you 

currently have COVID-19 infection. 

• Contact a healthcare provider to discuss your results. Your healthcare provider may 

ask you to take additional medical tests to make a diagnosis.

• There is a chance that the test may give a negative result even if you have COVID-19

(false negative). A reason for a false negative is that the sample was not collected or 

handled properly, or not enough sample was collected.
14 IN9100005_2.0 2021-10 

• A false negative can also occur if the virus genetic material changes such that the test 

cannot detect the presence of the virus. 

• Even though you do not have COVID-19, you may still have another type of illness. 

There are many other viruses that cause similar symptoms to COVID-19 and these 

may be the cause of your symptoms. 

• Tell your healthcare provider if you have symptoms or no symptoms. 

• Tell your healthcare provider to view the Cue COVID-19 Test Fact Sheet for Healthcare 

Professionals at www.cuehealth.com. 

• Regardless of the test result, it is important that while you are sick you should 

practice social distancing and good hygiene. 

• If you develop symptoms or your symptoms persist or become more severe, if you are 

concerned about your health, or if you develop one of the emergency warning signs 

(www.cdc.gov/coronavirus), then you should seek medical attention immediately. 

 

 

A Negative test result means that the Cue 

COVID-19 Test for Home and Over The 

Counter (OTC) Use did not detect the SARSCoV-2 virus in your sample. 

It is unlikely that you currently have 

COVID-19. If you took this test while you 

have symptoms, a negative test result usually 

means that your current illness was not 

caused by the SARS-CoV-2 virus. There are 

many other viruses that cause similar 

symptoms to COVID-19. Regardless of the 

test result, while you are sick, practice social 

distancing and good hygiene 

Patient Fact Sheet and COVID-19 Info

 Figure 6-1 

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 the Cue COVID-19 Test for Home and OTC Use

detected the SARS-CoV-2 virus that causes COVID-19 and it is very likely that you 

currently have COVID-19 infection. 
15 IN9100005_2.0 2021-10 

• You should self-isolate at home per CDC recommendations to stop spreading the 

virus to others. Consult the CDC recommendations regarding self-isolation at 

www.cdc.gov/coronavirus. 

• Consult your healthcare provider as soon as possible and tell him or her that you 

tested positive for COVID-19 using the Cue COVID-19 Test for Home and OTC Use. 

• Tell your healthcare provider if you have symptoms or no symptoms. 

• Tell your healthcare provider to view the Cue COVID-19 Test Fact Sheet for 

Healthcare Professionals at www.cuehealth.com. 

• There is a chance that the test may give a positive result that is wrong (a false positive 

result). 

• There is still a chance of co-infection with another type of illness.

• If you do not have any symptoms, particularly if you live in an area with low 

numbers of COVID-19 infections and have had no exposure to anyone diagnosed 

with COVID-19, additional testing to confirm your result may be required.

A Positive test result means that the Cue 

COVID-19 Test for Home and Over The 

Counter (OTC) Use detected the SARS-CoV-2 

virus in your sample.

It is very likely you have COVID-19 and it is 

important to be under the care of a healthcare 

provider. You should self-isolate at home, as per 

CDC recommendations, to stop spreading the 

virus to others (www.cdc.gov/coronavirus). 

There is a very small chance that this test can 

give a positive result that is wrong (a false 

positive). 

What you need to do: 

You should contact your healthcare provider for 

 Figure 6-2 

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. 

Patient Fact Sheet and COVID-19 Info
16 IN9100005_2.0 2021-10 

Step 6-3: Understanding an Invalid Result 

An Invalid result (see Figure 6-3) means that a system error occurred, and the Cue Health 

Monitoring System is unable to provide a result. Retesting is required. Common causes of 

invalid results are:

• You did not collect enough sample

• A processing error occurred inside the cartridge

Figure 6-3 

If the result is invalid, retest. Click on START RETEST NOW. You must use a new Cue 

COVID-19 Test Cartridge and a new 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. 

An Invalid result means that a system error occurred 

and the Cue Health Monitoring System is not able to 

provide your COVID-19 result.

 

What you need to do: 

If you have another Cue COVID-19 Test Cartridge 

remaining in your kit, tap on START RETEST NOW. 

You must use a new Cue COVID-19 Test Cartridge 

and a new Sample Wand from an unopened foil 

pouch in the Cue COVID-19 Test Cartridge Pack. 
17 IN9100005_2.0 2021-10 

Figure 6-4 

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 and disposed of in general waste.

Cue COVID-19 Test for Home and OTC Use 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. 

Limit of Detection Confirmation 

No test result available. The Reader was tilted 

while the test was running. The test was 

canceled.

What you need to do: 

If you have another Cue COVID-19 Test 

Cartridge remaining in your kit, tap on 

START RETEST NOW. You must use a new 

Cue COVID-19 Test Cartridge and a new 

Sample Wand from an unopened foil pouch 

in the Cue COVID-19 Test Cartridge Pack
18 IN9100005_2.0 2021-10

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 – 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 Test for Home and OTC Use 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 for Home and OTC Use. 

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, cancelled tests, or suspected sample addition errors were replaced.

Analytical Reactivity/Inclusivity 

The Cue COVID-19 Test for Home and OTC Use 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 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 
19 IN9100005_2.0 2021-10

were all collected pre-pandemic from non-human hosts.

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 100.0 100.0 100.0

Reverse 99.9 99.7 99.9

Probe 99.6 100.0 99.7

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. 

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 99.9 %

Reverse 1988 12 99.4 %

Probe 1971 28* 98.6 %

*One strain had an ambiguous result due to a degenerate base call, thus it was not included in the analysis for the 

probe. 

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 
20 IN9100005_2.0 2021-10

very high level of conservation of the targeted genomic locus within the North American 

population.

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 99.6 %

Reverse 2081 6 99.7 %

Probe 2074 12* 99.4 %

*One strain had an ambiguous result due to a degenerate base call, thus it was not 

included in the analysis for the probe.

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.

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 99.4%

Reverse 714 7 99.0%

Probe 719 1* 99.9%

*One strain had an ambiguous result due to a degenerate base call, thus it was not 

included in the analysis for this probe.

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). 
21 IN9100005_2.0 2021-10

The results are summarized below. For each primer/probe, at least 99.7% of the 

sequences are a perfect match.

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 0 100.0%

Reverse 676 0 100.0%

Probe 674 2 99.7%

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.

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 99.7%

Reverse 351 5* 98.6%

Probe 348 5** 98.9%

*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 for Home and OTC Use. 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 test at the 

concentrations tested.

 

 

Cross-Reactivity Evaluation 
22 IN9100005_2.0 2021-10

Organism Titer Units of 

Measurement Detected/Tested

Chlamydia pneumoniae 1.47E+07 CFU/mL 0/3

Haemophilus influenzae 7.87E+07 CFU/mL 0/3

Legionella pneumophila 6.82E+08 CFU/mL 0/3

Mycobacterium tuberculosis 

(genomic DNA) 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

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*
23 IN9100005_2.0 2021-10

Organism Titer Units of 

Measurement Detected/Tested

Pooled human nasal wash 10% percent of total 

volume 0/3

Candida albicans 5.02E+07 CFU/mL 0/3

*A fresh dilution was prepared and the potential cross-reactant was retested.

 

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 for Home and OTC Use

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 ≥80% sequence 

homology with the probe. Of all the viruses analyzed, only SARS-CoV-1 showed 

sequence homology to more than one 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 one microbial 

organism showed ≥80% sequence homology to more than one of the three test

primers/probe.

With the exception of SARS-CoV-1, the Cue COVID-19 Test for Home and OTC Use, 

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 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 for Home and OTC Use. 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 
24 IN9100005_2.0 2021-10

the substances interfered in the Cue COVID-19 Test for Home and OTC Use at the 

concentrations tested.

 

Interfering Substances Evaluation 

Substance Concentration

Detected / 

Tested 

Negative Nasal 

Matrix

Detected / Tested 

Positive Nasal 

Matrix (SARS-CoV2 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

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
25 IN9100005_2.0 2021-10

Substance Concentration

Detected / 

Tested 

Negative Nasal 

Matrix

Detected / Tested 

Positive Nasal 

Matrix (SARS-CoV2 RNA present at 

3X LoD)

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

*A fresh dilution was prepared and the potential interferent was retested.

Clinical Performance 

Prospective Clinical Study with Lay Users

Cue Health conducted prospective studies at 4 urgent care locations and at 2 Cue Health 

locations to evaluate use of the Cue COVID-19 Test for Home and OTC Use 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 for Home and OTC Use, 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 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 for Home and OTC Use and 10 were children <18 years of age where their parent collected 

the nasal sample and ran the Cue test. Thirteen (13) samples could not be included as there was 

no comparator assay result or Cue result available. Among the 10 unavailable Cue test results, 7 

tests were cancelled, and 3 tests had invalid results. The 7 cancelled tests were 5 cartridge flow 

errors, 1 tilt threshold exceeded, and 1 user accidentally cancelled the test while in progress. 

The rate of invalid or cancelled test results observed in this prospective clinical study was 3.7%

(10/273).

Demographics for the 273 subjects included in the performance analyses are presented below.

Age Range N %

<14 6 2.2%

14-23 66 24.2%

24-64 181 66.3%

>65 18 6.6%

N/A 2 0.7%
26 IN9100005_2.0 2021-10

Sex N %

Male 133 48.7%

Female 139 50.9%

Unknown 1 0.4%

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. 

All Data. Cue COVID-19 Test for Home and OTC Use vs FDA EUA Molecular 

Comparator (MC) 

MC 

Positive

MC 

Negative

MC 

Inconclusive

COVID-19 Positive 37 2 2*

COVID-19 Negative 1 231 0

*The 2 inconclusive samples by the comparator tested positive by the Cue COVID-19 

Test for Home and OTC Use.

Positive Percent Agreement (PPA): 97.4% (95% CI: 86.5% - 99.5%)

Negative Percent Agreement (NPA): 99.1% (95% CI: 96.9% - 99.8%)

Symptomatic Individuals. Cue COVID-19 Test for Home and OTC Use vs FDA EUA 

Molecular Comparator (MC) 

MC 

Positive

MC 

Negative

MC 

Inconclusive

COVID-19 Positive 27 2 1*

COVID-19 Negative 1 108 0

*The 1 inconclusive sample by the comparator tested positive by the Cue COVID-19 Test 

for Home and OTC Use.

PPA: 96.4% (95% CI: 82.3% - 99.4%)

NPA: 98.2% (95% CI: 93.6% - 99.5%)
27 IN9100005_2.0 2021-10

Asymptomatic Individuals. Cue COVID-19 Test for Home and OTC Use vs FDA EUA 

Molecular Comparator (MC) 

MC Positive MC Negative MC 

Inconclusive

COVID-19 Positive 10 0 1*

COVID-19 Negative 0 123 0

*The 1 inconclusive sample by the comparator tested positive by the Cue COVID-19 Test

for Home and OTC Use.

PPA: 100% (95% CI: 72.2% - 100%)

NPA: 100% (95% CI: 97.0% - 100%)

Customer Support 

If you have questions about this test, contact Cue Health Customer Support at 

support@cuehealth.com or call toll-free at 833.CUE.TEST (833.283.8378).

You can purchase the Cue Health Monitoring System and CueCOVID-19 Test Cartridge Packs by 

contacting Cue Health Customer Support at support@cuehealth.com or call toll-free at 

833.CUE.TEST (833.283.8378).

Symbols Used on the Product Labels 

The table below describes the symbols used on the CueCOVID-19 Test Cartridge Pack, the cartridge

foil pouch, and the Cue Sample Wand.

SYMBOL DESCRIPTION

In Vitro Diagnostic

Consult Instructions for Use

eIFU available on the Cue Health Mobile 

Application and at www.cuehealth.com

Serial Number

Do not use if seal or packaging is 

broken or damaged
28 IN9100005_2.0 2021-10

Storage temperature range

Catalog number

Manufacturer

Keep dry

Use By

Cue and the Cue logo are registered trademarks of Cue Health Inc.

Android and Google Play are trademarks of Google LLC.

Apple, App Store, iPhone, iPad and iPad Pro 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