Product Manual

from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms. Clinical signs and
symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test 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.
The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does
not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens. Performance characteristics for influenza A and B were established
during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant
influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled “Update: Influenza Activity--United States, 2010-2011 Season, and
Composition of the 2011-2012 Influenza Vaccine.” Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected
based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for
novel virulent influenza viruses and sent to state or local health department for testing.
SARS-CoV-2, influenza A and influenza B viral antigens are generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence
of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States
and its territories are required to report all SARS-CoV-2results to the appropriate public health authorities.
Negative SARS-CoV-2 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient
management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection
control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
A negative test is presumptive for influenza A and B and it is recommended these results be confirmed by an FDA-cleared influenza A and B molecular assay. Negative results do not
preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions.
The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2
Instrument. The Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
EMERGENCY USE AUTHORIZATION – WARNING AND PRECAUTIONS
In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certified under the
CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This test 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 and influenza, not for any other viruses or pathogens.
In the USA, - this test is only authorized for the duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes 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 authorization is terminated or revoked sooner.
ASSISTANCE
If Sofia 2 or the assay does not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [e-mail], or your
local distributor.
Quidel Corporation
San Diego, CA 92121 USA
quidel.com
1449300EN00 (10/20)
Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
Study the Package Insert and User Manual thoroughly
before using Quick Reference Instructions. This is not a
complete Package Insert.