Product Manual

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Sofia SARS Antigen FIA Page 3 of 22
◼ Sofia or Sofia 2 Calibration Cassette (for use with either Sofia or Sofia 2)
◼ Sofia SARS Antigen Control Swab Set for additional QC (20384)
WARNINGS AND PRECAUTIONS
◼ For in vitro diagnostic use.
◼ For prescription use only
◼ This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency
Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to
perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care
(POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance,
or Certificate of Accreditation.
◼ This test has been 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 only authorized 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 the authorization is revoked sooner.
◼ Do not use the kit contents beyond the expiration date printed on the outside of the box.
◼ Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used
kit contents.
◼ Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.
◼ Do not reuse the used Test Cassette, Fixed Volume Pipettes, Reagent Tubes, solutions, or Control Swabs.
◼ The user should never open the foil pouch of the Test Cassette exposing it to the ambient environment
until the Test Cassette is ready for immediate use.
◼ Discard and do not use any damaged or dropped Test Cassette or material.
◼ The Reagent Solution contains a salt solution (saline). If the solution contacts the skin or eye, flush with
copious amounts of water.
◼ To obtain accurate results, the Package Insert instructions must be followed.
◼ The Calibration Cassette must be kept in the provided storage pouch between uses.
◼ Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
◼ Sample collection and handling procedures require specific training and guidance.
◼ The test is intended to be used with direct anterior nasal swabs and is not validated for use with swabs in
viral transport media.
◼ When collecting an anterior nares swab sample, use the Nasal Swab supplied in the kit.
◼ Use the appropriate Fixed Volume Pipette in accordance with test procedures.
◼ Do not pour sample from the Reagent Tube into the Test Cassette sample well. Use the provided Small,
Clear 120 µL Fixed Volume Pipette when adding the sample to the Test Cassette.
◼ To obtain accurate results, do not use visually bloody or overly viscous samples.
◼ Do not write on the barcode of the Test Cassette. This is used by Sofia and Sofia 2 to identify the type of
test being run and to identify the individual Test Cassette so as to prevent a second read of the Test
Cassette by the same Sofia or Sofia 2.
◼ As the detection reagent is a fluorescent compound, no visible results will form on the test strip. Sofia or
Sofia 2 must be used for result interpretation.
◼ To obtain accurate results, an opened and exposed Test Cassette should not be used inside a laminar flow
hood or in a heavily ventilated area.
◼ Testing should be performed in an area with adequate ventilation.
◼ Dispose of containers and unused contents in accordance with Federal, State, and Local regulatory
requirements.
◼ Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
◼ Wash hands thoroughly after handling.
◼ For additional information on hazard symbols, safety, handling and disposal of the components within this
kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.