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Sofia SARS Antigen
Message*Must use Foam tipped swab for collection.*
Test Code
COVAG
Alias/See Also
COVID-19
SARS-CoV-2
SARS-CoV-2
CPT Codes
87426QW
Preferred Specimen
Foam tipped swab - Call Microbiology for swab (x3758, x3759)
Instructions
Nasal swab sample.
Transport Temperature
Room Temp
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Wrong swab collected for test.
Methodology
Sofia SARS Antigen FIA
FDA Status
Emergency Use Authorization
Limitations
This test has not been FDA cleared or approved; this test
has been authorized by FDA under an Emergency Use
Authorization (EUA). Authorization for use is approved until
the public health emergency is terminated or the EUA is
revoked by the FDA.
has been authorized by FDA under an Emergency Use
Authorization (EUA). Authorization for use is approved until
the public health emergency is terminated or the EUA is
revoked by the FDA.
Reference Range
Negative
Clinical Significance
The Sofia SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia and Sofia 2 to detect nucleocapsid protein from SARS-CoV and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2. The test detects, but does not differentiate, between the two viruses.
Negative 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, 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.
Performing Laboratory
LMH-Microbiology