be well COVID-19 Test User Guide

be well COVID-19 Test

Product Information

Specifications

• Storage Specifications: Fresh mid-turbinate Nasal Swab samples should be inserted directly into be.wellTM Assay Buffer and tested as soon as possible after collection. The be.wellTM Analyzer and be.wellTM Test Kit can operate at room temperature and in uncontrolled relative humidity, non-condensing.
• Operating Conditions: The test should be run at room temperature in a cool, dry environment.
• Temperature Definitions: The be.wellTM Analyzer should be kept flat on a level surface while inserting the be.wellTM COVID-19 Cartridge and until the test is complete.
• Materials Required and Provided:
  • A. be.wellTM COVID-19 Cartridge
  • B. Nasal Swab
  • C. be.wellTM Assay Buffer
  • D. Transfer Pipette
• Materials Required but not Provided: be.wellTM Analyzer (to be purchased separately from Alveo Technologies)

FAQ

• Q: What should I do if any parts of the be.wellTM COVID-19 Test Kit are missing or damaged?
  • A: Do not use the kit and contact Alveo Support at support@alveotechnologies.com or call +1-833-BE-WELL-0 (+1-833-239-3550).
• Q: How should I dispose of used Nasal Swabs, be.wellTM Assay Buffer, Transfer Pipettes, and be.wellTM COVID-19 Cartridges?
  • A: Follow all local, state, and federal guidelines for disposal of these materials.
• Q: Can I use the be.wellTM COVID-19 Test Kit past its expiration date?
  • A: No, it is recommended not to use the kit past the expiration date.

Information

• For use with the be.wellTM Analyzer and be.wellTM Mobile App.
• For the qualitative detection of SARS-CoV-2 nucleic acid.
• For mid-turbinate Nasal Swab specimens only.
• For professional use only.

Scan to View Training Video

IMPORTANT: Read the be.wellTM COVID-19 Test Instructions For Use (IFU) for complete information.

MATERIALS REQUIRED

MATERIALS REQUIRED AND PROVIDED

• A. be.wellTM COVID-19 Cartridge
• B. Nasal Swab
• C. be.wellTM Assay Buffer
• D. Transfer Pipette

Note

• If any parts are missing or damaged, do not use and contact Alveo Support at support@alveotechnologies.com, or call us at +1-833-BE-WELL-0 (+1-833-239-3550)

MATERIALS REQUIRED BUT NOT PROVIDED

• Purchase the be.wellTM Analyzer from Alveo Technologies by contacting Alveo Customer Support: support@alveotechnologies.com, or call us at +1-833-BE-WELL-0 (+1-833-239-3550).
• The be.wellTM Analyzer comes with one charging cable and one power adapter.

CAUTION

• Keep the work area clean to prevent contamination. Wear disposable gloves and appropriate PPE while handling samples and change gloves between testing each specimen.
• Follow all local, state, and federal guidelines for disposal of used Nasal Swabs, be.wellTM Assay Buffer, Transfer Pipettes, and be.wellTM COVID-19 Cartridges.

SET UP WORKSPACE

IMPORTANT: Ensure all be.wellTM COVID-19 Test Kit components are at room temperature before use.

On a clean, flat surface, place be.wellTM Analyzer, mobile device with be.wellTM Mobile App installed on it, and unopened be.wellTM COVID-19 Test Kit materials: be.wellTM COVID-19 Cartridge, Nasal Swab, be.wellTM Assay Buffer, and Transfer Pipette.

Conditions: Ensure the test is run at room temperature in a cool, dry environment. Set up a new workspace for each be.wellTM COVID-19 Test. Change gloves between handling samples and setting up a new test.

SET UP SYSTEM

• Charge be.wellTM Analyzer with power source. The be.wellTM Analyzer is ready for use when LED Indicator Lights are flashing blue.
  • Note: Keep the be.wellTM Analyzer plugged in if running multiple tests.
• First time use only: Download the be.wellTM Mobile App from the Apple® App Store.
• First time use only: Follow the on-screen instructions to register an account and agree to the Terms of Use.
• Log in to the be.wellTM Mobile App. Ensure be.wellTM Analyzer is flashing blue lights and “Set up Workspace” was completed.

START NEW TEST

• Add Patient I D on the home screen.
  • Note: Add a new patient ID for each person being tested.
• Manually enter the Patient ID or scan the patient’s barcode using the mobile device’s camera.
  • Note: If using the be.wellTM System with Health Passport Worldwide (HPW), manually enter or scan the patient’s HPW barcode as described above.
• Select Yes if the Patient ID is correct, then tap the same Patient ID displayed on the home screen.
• Tap Start New Test.

PAIR be.wellTM ANALYZER

• Follow on-screen instructions in the be.wellTM Mobile App to pair be.wellTM Analyzer with mobile device.
• be.wellTM Analyzer lights will be solid blue once paired. Tap Connect a Different be.wellTM Analyzer if the mobile device paired with an incorrect be.wellTM Analyzer; otherwise, tap Next Step.
• When prompted, remove be.wellTM COVID-19 Cartridge from pouch and scan QR code found on be.wellTM COVID-19 Cartridge. Confirm the Patient ID and be.wellTM COVID-19 Cartridge UDI.

USING INSTRUCTIONS

STEP 1:  COLLECT NASAL SAMPLE

For best performance, Nasal Swab sample should be tested as soon as possible after collection.

• Open Nasal Swab packet. Grasp Nasal Swab handle and remove it from the packaging.
  • Note: The Nasal Swab is sterile. Open just before use.
• Insert Nasal Swab tip into one nostril (approx. 2-3 cm, or up to the stopper on Nasal Swab). If resistance is felt, do not insert any further.
• Keep Nasal Swab in contact with the inside wall of the nostril and make 5 large circles.
• With the same Nasal Swab, repeat steps B and C in the other nostril.

Note: Do not scrape the inside of the nose or try to remove excess mucus.
Failure to swab both nostrils properly may result in invalid test results.

STEP 2:  MIX SAMPLE WITH be.wellTM ASSAY BUFFER

• Open be.wellTM Assay Buffer and insert Nasal Swab.
• Stir Nasal Swab against be.wellTM Assay Buffer vial wall 10 times.
• Remove Nasal Swab and recap be.wellTM Assay Buffer.
• Invert sealed be.wellTM Assay Buffer vial and flick 3-10 times to mix further.
• Dispose of Nasal Swab in an appropriate waste container.

STEP 3:  COLLECT SAMPLE FROM be.wellTM ASSAY BUFFER

• Uncap be.wellTM Assay Buffer. Pick up Transfer Pipette.
• Firmly squeeze the TOP bulb of Transfer Pipette and lower the stem into be.wellTM Assay Buffer until it touches the bottom of the vial.
• Slowly release the TOP bulb while tip is still in the fluid to fill Transfer Pipette stem. Remove Transfer Pipette from be.wellTM Assay Buffer once the stem is fully filled.
• If Transfer Pipette stem has air bubbles or gaps, dispense fluid back into be.wellTM Assay Buffer vial by squeezing the TOP bulb and repeat from step 3B.

STEP 4:  FILL be.wellTM COVID-19 CARTRIDGE WITH SAMPLE

• Hold be.wellTM COVID-19 Cartridge upright and firmly insert Transfer Pipette into sample port.
• Slowly squeeze the TOP bulb to dispense all the fluid into the be.wellTM COVID-19 Cartridge and, without letting go of the squeeze, remove the Transfer Pipette.

STEP 5: INSPECT TRANSFER PIPETTE STEM

• Inspect Transfer Pipette stem to ensure no fluid remains. If fluid remains, repeat from Step 1 with fresh Nasal Swab and new materials.
  • Note: If sample was sucked back into the Transfer Pipette stem after filling the be.wellTM COVID-19 Cartridge, dispose of the be.wellTM COVID-19 Cartridge, collect a new sample, and start test again.
• Securely close the cap on be.wellTM COVID-19 Cartridge.
• Dispose of Transfer Pipette and be.wellTM Assay Buffer.

STEP 6: TEST SAMPLE

• When directed by the be.wellTM Mobile App, insert be.wellTM COVID-19 Cartridge fully into be.wellTM Analyzer port.
• Blue lights will circle when test begins.
  • Note: Once the be.wellTM COVID-19 Cartridge has been inserted into the be.wellTM Analyzer, the test starts immediately and the be.wellTM COVID-19 Cartridge should not be removed or inserted into another be.wellTM Analyzer.
• Press Got it on the be.wellTM Mobile App. Enter symptoms.
  • WAIT! DO NOT touch or move be.wellTM Analyzer while testing is in process.
• When Test Complete appears in the be.wellTM Mobile App, remove and discard be.wellTM COVID-19 Cartridge.

STEP 7: INTERPRET be.wellTM COVID-19 TEST RESULT

Read and record the results. Refer to Instructions For Use (IFU) for more guidance on reading the results.

• Negative: No SARS-CoV-2 virus was detected in sample. If inconsistent with symptoms or exposure history, test again with a different authorized test.
• Positive: SARS-CoV-2 virus was detected in sample.
• Invalid: The presence of SARS-CoV-2 virus could not be determined in sample. Repeat testing using new test components and new nasal sample. If results are again invalid, test with a different commercial test.

Note: Results do not rule out other viral or bacterial infections.

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Contact

• Email Us: support@alveotechnologies.com
• Call Us: +1-833-BE-WELL-0 (+1-833-239-3550)
• Website: www.alveotechnologies.com

IMPORTANT: These are not the complete Instructions For Use (IFU). Read the be.wellTM COVID-19 Test Instructions For Use (IFU) for complete information.

Alveo, the Alveo logo, and be.well are registered trademarks of Alveo Technologies, Inc.
Apple® and App Store are trademarks of Apple Inc., registered in the U.S. and other countries and regions.

Alveo Technologies, Inc.

1000 Atlantic Ave., Suite 114, Alameda, CA 94501 USA
Qarad EC-REP BV, Pas 257, 2440 Geel, Belgium

References

• Advancing Molecular Testing and Diagnostics | Alveo Technologies

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