cue COVID-19 Test Instructions

cue COVID-19 Test

SET UP THE CUE HEAL TH MONITORING SYSTEM

1. Unpack the Cue Cartridge Reader.
   
   Download the Cue Health App to a compatible mobile smart device named on the Cue Health website at www.cuehealth.com.

The Cue Health App is available on the Apple® App Store® and Google™ Play Store.

OPEN THE CUE HEAL TH APP & FOLLOW THE ON-SCREEN INSTRUCTIONS

1. Set up your Cue Account. Follow the on-screen instructions for “Create Account.”
2. Follow the on-screen instructions to set up the Cartridge Reader. Connect the Cartridge Reader to power. Pair the Reader to your mobile smart device.

When prompted by the Cue Health App, adjustthe mobile smart device camera so the QR code is visible on-screen and inside of thecapture outline. When the QR code is recognized, the Cartridge Readeris securely paired. If the QR code does not scan quickly, make sure the Cartridge Reader is connected to power.

3. One or more Cartridge Readers may already be paired to your mobile smart device. Check that the Cartridge Reader you will use for the currenttest is connected to the Cue HealthApp.
   Go to the Dashboard screen by tapping on the home button at the bottom of the Cue Health App screen. Then tap on “ManageReaders.”
   Connect to the Cartridge Reader that you want to use for the current test by tapping on the name of the Cartridge Reader.
   

4. Tap on “Manage Profiles” on the Dashboard screen. Choose the profile for the patient 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 patient barcode ID. Tap on the name or patientbarcode ID, then tap on
   “+ BEGIN NEW TEST.

FOLLOW THE CUE HEALTH APP TO RUN A CUE COVID-19 TEST

1. Tap “+ BEGIN NEW TEST.” View the Cue COVID-19 TestIntended Use. If prompted, select your organization. Also view the Precautions of the test.

2. Place the Cue Cartridge Reader and a Cue COVID-19 Test Cartridge foil pouch in front of you. Make sure the Reader is charged or connected to power. The Reader needs to be on a level surface when the cartridge is inserted and while the test is running. Do not move the Reader while the test is running. Do not use a cartridge if the foil pouch is damaged.
   

3. Do not use a cartridge past the Use By date on the foil pouch label. Do not use a cartridge that has been stored below 59°F (15°C) or above 86°F (30°C).
   When you are ready to test, tear open the top of the cartridge foil pouch and remove the plastic tray with the Cue COVID-19 Test Cartridge and Cue Sample Wand. Remove the cartridge from thetray.

4. Insert the cartridge into the Cartridge Reader. Support the back of the Cartridge Reader withone hand and hold the cartridge in the other hand. Insert thecartridge into the port ofthe Cartridge Reader.
   When you have inserted the cartridge all the way in, all five lights on top of the Cartridge Reader will flash and the cartridge will pre-heat in preparation for testing. The cartridge must heat up for the full 100% heat cycle before the Sample Wand is inserted into the cartridge.

5. Remove the wrapped Wand from the tray. Open the Wand wrapper on the side labeled “Open Here.” Grasp the handle of the wand and remove it from the wrapping. Do not use a Sample Wand if the wrapper is damaged or opened or if the Wand tip touches anything before sample collection.

6. a. Cue Sample Wand Direct Nasal Swab: To collect a direct nasal swab sample, insert the tip of the 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 Sample Wand into the other nostril and follow the same collection instruction as for the first nostril. Do not try to remove excess mucus. Sample collection is demonstrated in a video in the Cue Health App.
   b. Alternate Sample Type Using a Previously Collected Traditional Nasal Specimen in VTM: To collect a VTM sample, gently invert the capped VTM tube to ensure mixing.
   Uncap the tube and insert the Cue Sample Wand tip into the tube, tilting the tube until the Wand tip comes in contact with liquid. The Sample Wand flocked tip will absorb the sample. Remove the Sample Wand from the VTM tube.

7. When the Cue Health App screen shows that the cartridge is “Ready”, insertthe Sample Wand into the cartridge. Insert the Sample Wand within 5 minutes after collecting the sample until Test in Progress is shown on the Cue Health App screen.

8. The Cue Health App will show the test progress. The Cue COVID-19 Testtakes about 20 minutes to run. Do not move the Cartridge Reader while the test is running.

9. When the testis complete, you will see the result on the Cue Health App screen.
   You will also see information to help you understand a Negative or Positive result. If the result is Invalid or Canceled you will see instructions for retesting. A Negative result means that the Cue COVID-19 Test did not detect SARS-CoV-2 virus in the sample.
   Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with different authorized or cleared molecular tests. A negative result does not rule out co-infections with other pathogens. A Positive result means that the Cue COVID-19 Test detected SARS-CoV-2 virus in the sample. Positive results do not rule out bacterial infection or co-infection with other viruses. An Invalid or Canceled result means that a system error occurred and there is no test result. Retest using a new Cue COVID-19 Test Cartridge and new Cue Sample Wand. Refer to the Cue COVID-19 Test Instructions for Use for more information on understanding test results.

10. Remove the Cue COVID-19 Test Cartridge from the Cartridge Reader after you see the result. Dispose of the used Cue COVID-19 TestCartridge with Sample Wand according to your institution’s environmental waste procedures for proper disposal of used cartridges. The Reader should be cleaned/disinfected after each use. Wipe with Clorox® Germicidal Wipes or equivalent (0.55% sodium hypochlorite).

Specimen Collection and Handling

Cue Sample Wand Direct Nasal Swab Sample
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.

Alternative Sample Type Using a Previously Collected Traditional Nasal

Specimen in Viral Transport Media (VTM)
Obtain a previously collected traditional nasal specimen in VTM collected in accordance with institutional or manufacturer’s instructions.

• Gently invert the capped 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.

Quality Control (QC)

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.
Control Swabs are stored at room temperature (15-30 ºC / 59-86 ºF). Control Swabs are tested using the same procedure as for a patient 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 toll-free at 833.CUE.TEST (833.283.8378) before testing additional clinical specimens.

Purchase the Cue COVID-19 External Control Swabs Pack (REF 2110) 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 toll-free at 833.CUE.TEST (833.283.8378).

Precautions

• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory
  Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• 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 authorization is revoked sooner.

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

C1018

eIFU available on the Cue Health Mobile Application

Rx Only

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.

cue
Cue Health Inc. San
Diego, CA 92121 USA
Cue Health Inc., Customer Support at support@cuehealth.com or call toll-free at 833.CUE.TEST (833.283.8378)
Contact Cue Health Customer Support to request a physical copy of the Instructions For Use and the Quick Reference Instructions, free of charge.

References

• Diagnostic testing at the speed of life | Cue

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