LumiraDx SARS-CoV-2 Ag Test

Intended Use

This test is for HEALTHCARE PROFESSIONAL USE ONLY. It allows for rapid results on the LumiraDx Instrument touchscreen. Testing is limited to laboratories certified under CLIA and authorized for use at the Point of Care (POC) settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The test does not differentiate between SARS-CoV and SARS-CoV-2. Positive results indicate the presence of viral antigens, but clinical correlation is necessary. Negative results are presumptive and may require confirmation with a molecular assay, especially in cases of high likelihood of infection.

Assay Principle

The LumiraDx SARS-CoV-2 Ag Test is a single-use fluorescence immunoassay. The test procedure involves collecting a swab sample, eluting it into Extraction Buffer, and adding a drop of the sample to the Test Strip. The LumiraDx Instrument measures fluorescence to determine the result within 12 minutes.

Materials Provided

• LumiraDx Test Strips
• LumiraDx Test Product Insert
• RFID Tag
• Extraction Buffer Vials
• Dropper Lids
• LumiraDx SARS-CoV-2 Ag Test Quick Reference Instructions
• Sterile Nasal Collection Swabs (included with specific product codes)

Materials Required but Not Provided

• LumiraDx Instrument
• LumiraDx SARS-CoV-2 Ag Quality Controls
• LumiraDx Connect (if connectivity required)
• Standard nasal or nasopharyngeal collection equipment (if swabs not included in kit)

Warnings and Precautions

• Read all instructions carefully before performing the test.
• For in vitro diagnostic use and prescription use only.
• Authorized for the detection of proteins from SARS-CoV-2 only.
• Serial testing is recommended for individuals with negative results.
• Do not use damaged or expired test components.
• Ensure proper sample collection, storage, and transport.
• The test cannot be visually interpreted; the LumiraDx Instrument must be used.
• Dispose of all kit components as Biohazard waste.
• Exercise normal laboratory safety precautions, including wearing protective clothing.
• Minimize the risks of cross-contamination.
• Avoid contact with skin, eyes, and mouth.

Sample Collection

Follow universal collection precautions. For nasal swabs and nasopharyngeal swabs, adhere to CDC Swab Collection Guidelines and manufacturer recommendations. Users should be trained in appropriate sample collection and handling.

Anterior Nasal Swab Sampling:

1. Tilt patient’s head back 70°.
2. Collect sample from both nostrils using the same swab, inserting less than one inch into the first nostril until resistance is met.
3. Rotate the swab against the nasal wall for 10-15 seconds. Repeat in the second nostril with the same swab.
4. Place the swab into the Extraction Vial.

Nasopharyngeal Swab Sampling:

1. Tilt patient’s head back 70°.
2. Gently insert swab through the nostril parallel to the palate until resistance is encountered (depth equal to distance from nostrils to outer ear opening).
3. Gently rub and roll the swab for several seconds to absorb secretions. If necessary, collect from the other nostril with the same swab.
4. Slowly remove the swab while rotating it.
5. Place the swab in the extraction vial.

Sample Extraction

1. Remove the seal from the Extraction Vial.
2. Place and soak the Patient Swab in the Extraction Buffer for 10 seconds, stirring well.
3. Squeeze the swab against the side of the vial to remove excess liquid. Discard the swab in biohazard waste.
4. Attach the Dropper Lid to the Extraction Vial. The extracted sample is stable for 5 hours at room temperature or can be frozen at -80°C for up to 5 days.
5. Gently invert the Extraction Vial five times just before applying the sample.

Performing a Test

1. Ensure the LumiraDx Instrument is prepared.
2. Gently invert the Extraction Vial five times.
3. Apply one drop of the extracted sample to the Sample Application Area of the inserted Test Strip.
4. Close the Instrument door within 10 seconds.
5. The result will appear on the Instrument touchscreen within 12 minutes.
6. Dispose of used materials in appropriate biohazard waste.
7. If retesting is needed, use a new Test Strip with the same extraction vial.

Interpretation of Results

Positive Result: Indicates the presence of SARS-CoV-2. The individual likely has COVID-19 and is contagious. Follow local guidelines for isolation and seek follow-up care.

Negative Result: Indicates that SARS-CoV-2 was not detected. Results are presumptive and may require confirmation with a molecular assay, especially if symptoms persist or there is a high likelihood of infection.

Repeat Testing: For individuals with symptoms, test again in 48 hours if the first test is negative. For asymptomatic individuals, test two more times at least 48 hours apart if the first test is negative.

Invalid Test Results

If an issue occurs, an error message will be displayed on the Instrument touchscreen with instructions. Contact LumiraDx Customer Services if problems persist.

Quality Control

The LumiraDx Instrument and Test Strips have integrated quality control functions. Quality Control Tests using LumiraDx Quality Control solutions can be performed to meet regulatory compliance requirements.

Clinical Performance

The document includes detailed tables and analysis of the LumiraDx SARS-CoV-2 Ag Test's clinical performance, including Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for both anterior nasal swabs and nasopharyngeal swabs. It also details Limit of Detection (LoD) studies, cross-reactivity, and interference studies.

Storage and Handling

Store Test Strips between 2°C and 30°C (36°F and 86°F). Do not freeze or store above 30°C. Use by the expiration date. Handle Test Strips carefully, avoiding contact with the sample application area and contacts.

Manufacturer Information

LumiraDx UK Ltd, Dumyat Business Park, Alloa, FK10 2PB, UK. LumiraDx US Office: 221 Crescent St, Suite 502, Waltham, MA 02453. Telephone: 1-888-586-4721.

References

• World Health Organisation www.who.int
• Centers for Disease Control and Prevention www.cdc.gov