Product Manual

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Sofia SARS Antigen FIA Page 7 of 22
If both the Positive and Negative Controls fail, repeat testing with new Positive and Negative Controls a second
time. If only a single Control fails, the user has the option of repeating both the Positive and Negative Controls
OR to repeat only the Control that failed. The user may select “Skip” on the Sofia display or on the Sofia 2
display to skip the Control test that previously passed. The QC Results will show a skipped Control test as
“unknown” or on Sofia 2.
Additional External Control swabs may be obtained separately by contacting Quidel Customer Support Services
at 800.874.1517 (in the U.S.) or 858.552.1100.
SAMPLE COLLECTION AND HANDLING
SAMPLE COLLECTION
Direct Anterior Nares Swab Sample
Use the nasal swab supplied in the kit.
Prior to collecting the nasal swab, the patient should be instructed to blow their nose. To collect a direct
anterior nasal swab sample, carefully insert the swab (provided in the kit) into the nostril that presents the
most secretion under visual inspection. Using gentle rotation, push the swab until resistance is met at the level
of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then
remove it from the nostril. Specimens collected from asymptomatic individuals cannot be synchronized to
onset of symptoms and should be evaluated as part of a serial testing program.
SAMPLE TRANSPORT AND STORAGE
Samples should be tested as soon as possible after collection. Based on data generated with the SARS-CoV-2
Antigen FIA, direct anterior nasal swabs are stable for up to 48-hours at room temperature or 2° to 8°C.
TEST PROCEDURE
All clinical samples must be at room temperature before beginning the assay.
Specimens processed in Reagent Tubes (rehydrated) have an in-use stability of up to 1 hour at room
temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight.
Expiration date: Check expiration date on each individual test package or outer box before using. Do not use
any test past the expiration date on the label.
Swab Test Procedure
1. Verify that is set to the desired mode: WALK AWAY or READ NOW.
See the “Using Sofia and Sofia 2” section for more information.
2. Dispense all of the Reagent Solution into the Reagent Tube. Swirl
the Reagent Tube to dissolve its contents.
3. Place the patient swab sample into the Reagent Tube. Roll the swab at least 3
times while pressing the head against the bottom and side of the Reagent Tube.
Leave the swab in the Reagent Tube for 1 minute.