TALIS ONE Covid-19 Test System User Guide

TEST PATIENT SAMPLES
TALIS ONE COVID-19 test system
QUICK REFERENCE INSTRUCTIONS

For Use Under an Emergency Use Authorization (EUA) Only.
Read instructions carefully before performing the test.
Store COVID-19 Cartridges at 15­30°C.

****This document does not provide the full instructions for use (IFU). For the complete IFU, please visit:https://talisbio.com/ifu/talis-one- covid-19-test Please email care@talisbio.com if you require a printed copy free of charge. Refer to the Talis One COVID-19 Control Run Instructions for QC testing procedures.
Caution: Cartridges must be kept in their sealed foil pouches until opened for immediate testing, and maybe open for a maximum of 30 minutes prior to initiating testing on the Talis One instrument.
Caution: Use Standard Precautions and treat all patient samples and use test materials as potentially infectious. · Personal protective equipment (PPE), including lab coats, masks, eye protection, and new gloves should be worn at all times when performing patient tests. · Disinfect work surfaces and change gloves before each new sample run. · Handle and dispose of all used test materials and unused reagents according to your institution’s safety guidelines for hazardous materials, in compliance with applicable government regulations.

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1. Gather materials, confirm they are not expired, and log into the instrument.
2. Write in patient information (print clearly), or apply the label.
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3. Get sample tube, bring to room temperature (if needed), and swirl 6 times.
4. Remove the pipette from the pouch and squeeze firmly to fully compress.
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5. Insert pipette into tube and completely release bulb; allow to fill.
6. Ensure liquid is at or above the FILL LINE, or repeat steps 4-5.
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7. Open sample port and insert pipette tip. Squeeze firmly ONCE; while holding, remove from Cartridge.
8. Dispose of pipette and close lid until it clicks, then cap sample tube.
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9. Insert Cartridge until it clicks, with the label facing right. The instrument begins readings the Cartridge.
10. Wait while “Reading Cartridge” is displayed; then verify the information.

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

Interpretation of Results

The table below provides examples and descriptions of the three results possible for a completed run in the Talis One COVID-19 Test System: Detected, Not Detected, and Invalid.
For complete information on results interpretation and in-process errors, refer to the Talis One COVID-19 Test System Instructions For Use. For Troubleshooting, refer to the Talis One Instrument User Guide.

Results

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Interpretation

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| Targets detected with Talis One COVID-19 Test System.
SARS-CoV-2 target nucleic acids are detected.
| Targets not detected with Talis One COVID-19 Test System.
SARS-CoV-2 target nucleic acids are NOT detected.
| Test result invalid. Invalid results for Talis One COVID-19 Test System. Re- run the sample with a new Cartridge. If the repeat test is Invalid, a new specimen must be collected and run using a new collection kit and Cartridge.
Note: For specific error code details and resolution steps, see the Troubleshooting section of the Talis One Instrument User Guide.

This One COVID-19 Test System Quick Reference Instructions
152-0028857 REV. 02

Documents / Resources

| TALIS ONE Covid-19 Test System [pdf] User Guide
Covid-19 Test System, Covid-19, Test System
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