LumiraDx™ SARS-CoV-2 Ag Test

LumiraDx SARS-CoV-2 Ag Test Kit Components

Test Strip: Contains components for antigen detection.

Extraction Vial and Dropper Lids: Used for sample preparation and application.

Nasal Collection Swabs: Available with product codes L016000609024, L016000609048.

Warning and Precautions

Read all instructions carefully before performing the test. Failure to follow instructions may result in inaccurate test results.

All kit components can be discarded as biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information, available at https://lumiradx.com/us-en/what-we-do/diagnostics/test-technology/antigen-test.

Exercise normal precautions for handling laboratory reagents. Proper laboratory safety techniques should be followed at all times when working with SARS-CoV-2 patient samples. Patient swabs, used Test Strips, and used extraction buffer vials may be potentially infectious.

Serial testing is recommended for individuals with negative results: at least twice over three days (with 48 hours between tests) for symptomatic individuals, and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. For patients with symptoms longer than 12 days, consider testing at least three times over five days with at least 48 hours between tests.

In the USA, this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories certified under CLIA for moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

This product is authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform. It is intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in direct anterior nasal swab and nasopharyngeal swab specimens. It is intended for individuals suspected of COVID-19 within the first twelve (12) days of symptom onset, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19.

Study the LumiraDx Platform User Manual and LumiraDx SARS-CoV-2 Ag Test Strip Product Insert thoroughly before using these Quick Reference Instructions. This is not a complete product insert.

Operate the LumiraDx Platform at room temperature between 15°C and 30°C (59°F and 86°F) and 10% - 75% relative humidity. The extracted sample must be used within 5 hours of preparation when stored at room temperature. Extracted samples may be frozen at -80°C and used up to 5 days after freezing. Samples and extraction buffer must be at room temperature before testing.

Check expiration dates on the kit components before use. Do not use any test components beyond their expiration date.

Preparing the sample

Collect a patient swab sample before following steps 1-4 of Running the Test. Proper sample collection and handling are required for accurate results.

Storage and Stability: Store Test Strips at room temperature (2°C to 30°C / 36°F to 86°F). Test Strips are usable until the expiration date printed on the foil pouch and carton.

1. Remove seal: Remove the seal or blue screw cap from the top of the Extraction Vial containing the Extraction Buffer.
2. Soak Swab: Place and soak the Patient Swab in the Extraction Buffer for 10 seconds. Stir the swab against the side of the vial 5 times.
3. Squeeze Swab: Remove the Patient Swab while squeezing the Extraction Vial to remove liquid from the swab. Discard the swab in biohazard waste.
4. Attach Dropper Lid: Firmly attach the clear or purple Dropper Lid to the top of the Extraction Vial. The extracted sample must be used within 5 hours of preparation when stored at room temperature.

Cleaning and Disinfecting

Wipe the external surfaces of the LumiraDx Instrument with a soft, slightly damp cloth when visibly dirty. Disinfect the Instrument after each patient test or if contamination is suspected, and at least once per day when in use, using LumiraDx approved materials. Allow the surface to remain wet for 1 minute and let air dry. Avoid USB ports and power inlet. Do not spray or pour solution directly onto the Instrument. Do not put any objects or cleaning materials into the Test Strip slot.

Running the Test

1. Select 'Patient Test' from the Instrument Home Screen. Enter patient details using the Keyboard or Barcode Scanner. Refer to the Platform User Manual for barcode scanner instructions.
2. Remove the Test Strip from its pouch, gripping only the blue portion. Do not bend the Test Strip or touch any part other than the blue portion.
3. When prompted, open the Instrument door and gently insert the Test Strip. The thick black alignment rib on the Test Strip should be on the left and align with the black line on the Instrument. Do not apply the sample until prompted. Install the Lot Calibration file if using a new Test Strip Lot for the first time. Refer to the Platform User Manual.
4. Select the appropriate sample type and confirm the test type.
5. Gently invert the Extraction Vial five times just before applying the sample to the Test Strip.
6. Apply one whole drop of the sample onto the Test Strip Sample Application Area when prompted by the Instrument.
7. Close the door when prompted to continue the test.
8. Results are displayed within 12 minutes. Tap 'Finish' to complete testing or tap 'Comment' to leave a comment or reject the Test. All test results must be read using the LumiraDx Instrument.

INTERPRETATION OF RESULTS

COVID-19 Positive (+)

A positive test result indicates that the virus causing COVID-19 was detected. The individual is very likely to have COVID-19 and is contagious. Contact the patient's doctor/primary care physician and the local health authority immediately. Instruct the patient to adhere to local guidelines regarding self-isolation.

There is a very small chance of an incorrect positive result (false positive). Positive results do not rule out bacterial infection or co-infection with other viruses. The detected agent may not be the definite cause of disease.

Individuals testing positive should self-isolate and seek follow-up care. Additional confirmatory testing with a molecular test may be necessary if there is a low likelihood of COVID-19 (e.g., individuals without known exposures or in low-prevalence communities).

COVID-19 Negative (-)

To increase the chance of an accurate negative result:

• Test again in 48 hours if the individual has symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.

A negative test result indicates that the virus causing COVID-19 was not detected. A negative result does not rule out COVID-19. There is a higher chance of false negative results with antigen tests compared to molecular tests like PCR.

If the test is negative but COVID-19-like symptoms (fever, cough, shortness of breath) continue, consider follow-up testing for SARS-CoV-2 with a molecular test or testing for other respiratory diseases. Seek follow-up care with a healthcare provider if applicable.

All negative results should be treated as presumptive. Confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection (e.g., close contact, suspected exposure, or in high-prevalence communities).

Negative results do not rule out SARS-CoV-2 infection and should not be the sole basis for treatment or patient management decisions, including infection control.

Invalid Results:

If an issue occurs, a message will be displayed on the Instrument touch-screen. Alert messages are highlighted by an orange banner, and error messages include a symbol. Messages contain descriptions and instructions. Error messages include an identifying code for troubleshooting.

Example of an error screen: If the On Board Control (OBC) fails, an error message will be shown, and no test result will be returned. Follow on-screen instructions to dispose of the Test Strip and start a new test. If the problem persists, contact Customer Services.

Quality Controls

To complete Quality Control assessment, use the LumiraDx SARS-CoV-2 Ag Quality Control Pack (available separately). If controls do not perform as expected, do not report patient results. Retest using a new Test Strip. If problems persist, contact LumiraDx Customer Services.

Customer Service

If the LumiraDx SARS-CoV-2 Ag Test or the LumiraDx Instrument does not perform as expected, contact LumiraDx Customer Services at 1-888-586-4721 or customerservices.us@lumiradx.com.

Manufacturer Information

LumiraDx UK Ltd, Dumyat Business Park, Alloa, FK10 2PB, UK.

Company Number: 09206123

Copyright © 2023 LumiraDx UK and affiliates. All rights reserved. LumiraDx and Flame logo are protected trademarks of LumiraDx International LTD. Full details of these and other registrations of LumiraDx can be found at lumiradx.com/IP. All other trademarks are the property of their respective owners.

OS-04276-01 APPROVED FOR USE IN THE US, EMERGENCY USE AUTHORIZED ONLY.